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As of Amendment 6, however, because PFS","text_display":" for all patients every 4 weeks until disease progression. 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Patients will be contacted","text_display":"\n\nAll patients will continue to be followed for survival after progression. 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occur 30 days ( +1 week) after the last dose of study drug or prior to the initiation of subsequent","confidence":0.9980478286743164,"confidence_rate":0.999982235800552},{"cnt":[[361,1989],[1005,1989],[1005,2030],[361,2030]],"region":{"top_left_x":360,"top_left_y":1989,"width":646,"height":42},"line":93,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"619ed5d1589645a8a5e79c91456bf587","type":"text","conversion_output":true,"text":"antineoplastic therapy, whichever comes first.","text_display":" antineoplastic therapy, whichever comes first.","confidence":1,"confidence_rate":1},{"cnt":[[322,2037],[1809,2037],[1809,2078],[322,2078]],"region":{"top_left_x":322,"top_left_y":2036,"width":1487,"height":42},"line":94,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca81dc2b111241dab0f6120ec44c2dc1","type":"text","conversion_output":true,"text":"c Before dosing on Day 1 of the next full treatment cycle upon implementation of Amendment 8, patients","text_display":"\nc Before dosing on Day 1 of the next full treatment cycle upon implementation of Amendment 8, patients","confidence":0.98486328125,"confidence_rate":0.999861350992615},{"cnt":[[361,2080],[1852,2080],[1852,2116],[361,2116]],"region":{"top_left_x":360,"top_left_y":2079,"width":1492,"height":38},"line":95,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61e8f9543f9f4108bc8bae2534e2302b","type":"text","conversion_output":true,"text":"must be reconsented. Reconsenting should be done in person. Remote reconsenting is permitted as long as","text_display":" must be reconsented. Reconsenting should be done in person. Remote reconsenting is permitted as long as","confidence":1,"confidence_rate":1},{"cnt":[[361,2118],[1734,2118],[1734,2159],[361,2159]],"region":{"top_left_x":360,"top_left_y":2118,"width":1374,"height":42},"line":96,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8fff0c8aef447e9993816795254d285","type":"text","conversion_output":true,"text":"the process adheres to site, sponsor, IRB/EC, regulatory, and GCP standards and local regulations.","text_display":" the process adheres to site, sponsor, IRB/EC, regulatory, and GCP standards and local regulations.","confidence":1,"confidence_rate":1},{"cnt":[[322,2166],[1803,2166],[1803,2204],[322,2204]],"region":{"top_left_x":322,"top_left_y":2165,"width":1481,"height":40},"line":97,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c0008d7ef0641968da0d452340ba46c","type":"text","conversion_output":true,"text":"d Patients should be assessed and treated according to standard of care. Collect and record only clinically","text_display":"\nd Patients should be assessed and treated according to standard of care. Collect and record only clinically","confidence":1,"confidence_rate":1},{"cnt":[[361,2206],[926,2206],[926,2245],[361,2245]],"region":{"top_left_x":360,"top_left_y":2206,"width":566,"height":40},"line":98,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74c9b02d74e74d01b7bdd696967b1e3d","type":"text","conversion_output":true,"text":"significant findings as AEs in the eCRF.","text_display":" significant findings as AEs in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[322,2252],[1790,2252],[1790,2292],[322,2292]],"region":{"top_left_x":322,"top_left_y":2251,"width":1468,"height":42},"line":99,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68528ba73c2442e681585614cee153de","type":"text","conversion_output":true,"text":"e Alternative methods for administering study procedures/assessments may be considered when it is not","text_display":"\ne Alternative methods for administering study procedures/assessments may be considered when it is not","confidence":1,"confidence_rate":1},{"cnt":[[361,2290],[1876,2290],[1876,2331],[361,2331]],"region":{"top_left_x":360,"top_left_y":2290,"width":1516,"height":42},"line":100,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"620c93c51be44feebdba0ff809b5333b","type":"text","conversion_output":true,"text":"possible for the patient to come to the study site due to extenuating circumstances (eg, due to the COVID-19","text_display":" possible for the patient to come to the study site due to extenuating circumstances (eg, due to the COVID-19","confidence":0.9970715045928955,"confidence_rate":0.9999740464267123},{"cnt":[[361,2331],[1848,2331],[1848,2370],[361,2370]],"region":{"top_left_x":360,"top_left_y":2331,"width":1488,"height":39},"line":101,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0bacfa744451467791d265acfe217820","type":"text","conversion_output":true,"text":"pandemic). Alternative methods should be considered for performing the assessments by other means than","text_display":" pandemic). Alternative methods should be considered for performing the assessments by other means than","confidence":1,"confidence_rate":1},{"cnt":[[361,2372],[1813,2372],[1813,2411],[361,2411]],"region":{"top_left_x":360,"top_left_y":2371,"width":1454,"height":40},"line":102,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b26b13cc38447e0a161ff6978ecb78f","type":"text","conversion_output":true,"text":"the patient presenting to the clinic (eg, remote assessment, having lab assessment performed at a facility","text_display":" the patient presenting to the clinic (eg, remote assessment, having lab assessment performed at a facility","confidence":1,"confidence_rate":1},{"cnt":[[361,2411],[1858,2411],[1858,2451],[361,2451]],"region":{"top_left_x":360,"top_left_y":2410,"width":1499,"height":42},"line":103,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2fc12da16b1472a842a5af5f8af105f","type":"text","conversion_output":true,"text":"closer to the patient's home, etc.) If any of the following study procedures/assessments is missed because a","text_display":" closer to the patient's home, etc.) If any of the following study procedures/assessments is missed because a","confidence":1,"confidence_rate":1},{"cnt":[[361,2449],[1777,2449],[1777,2490],[361,2490]],"region":{"top_left_x":360,"top_left_y":2449,"width":1417,"height":42},"line":104,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2968b3b38c8947619ac16f8b010620e5","type":"text","conversion_output":true,"text":"site visit is done remotely, the study procedure/assessment is waived: complete physical examination,","text_display":" site visit is done remotely, the study procedure/assessment is waived: complete physical 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Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[361,249],[1566,249],[1566,294],[361,294]],"region":{"top_left_x":360,"top_left_y":249,"width":1207,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dcea39a3d0264ae494bf89e7f1d1bc90","type":"text","conversion_output":true,"text":"symptom-directed physical examination, hematology, clinical chemistry, concomitant","text_display":"\nsymptom-directed physical examination, hematology, clinical chemistry, concomitant","confidence":1,"confidence_rate":1},{"cnt":[[361,292],[707,292],[707,333],[361,333]],"region":{"top_left_x":360,"top_left_y":292,"width":347,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"63ea6657b890432abc33ffdf0dea484b","type":"text","conversion_output":true,"text":"medications/procedures.","text_display":" medications/procedures.","confidence":1,"confidence_rate":1},{"cnt":[[320,335],[1876,335],[1876,380],[320,380]],"region":{"top_left_x":320,"top_left_y":335,"width":1556,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53f91762f32044189a11a052a763aa2e","type":"text","conversion_output":true,"text":"f Treatment with IMiDs requires pregnancy testing in female patients of child-bearing age prior to each cycle.","text_display":"\nf Treatment with IMiDs requires pregnancy testing in female patients of child-bearing age prior to each cycle.","confidence":0.99853515625,"confidence_rate":0.9999872529709615},{"cnt":[[361,378],[1830,378],[1830,421],[361,421]],"region":{"top_left_x":360,"top_left_y":378,"width":1471,"height":44},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40480408462a4295b5fdb230d318e331","type":"text","conversion_output":true,"text":"A serum pregnancy test will be performed at the local laboratory for all women of childbearing potential.","text_display":" A serum pregnancy test will be performed at the local laboratory for all women of childbearing potential.","confidence":1,"confidence_rate":1},{"cnt":[[320,423],[1824,423],[1824,466],[320,466]],"region":{"top_left_x":320,"top_left_y":423,"width":1505,"height":44},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64a9550aafb64dddaff3d7ecf3a383d4","type":"text","conversion_output":true,"text":"g All central laboratory assessments are discontinued. Patients should be assessed and treated according to","text_display":"\ng All central laboratory assessments are discontinued. Patients should be assessed and treated according to","confidence":1,"confidence_rate":1},{"cnt":[[361,464],[1800,464],[1800,507],[361,507]],"region":{"top_left_x":360,"top_left_y":464,"width":1441,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1be4b834b5f2421bbc560974355de60f","type":"text","conversion_output":true,"text":"standard of care using local laboratory evaluations. Abnormal hematology and chemistry data are to be","text_display":" standard of care using local laboratory evaluations. Abnormal hematology and chemistry data are to be","confidence":1,"confidence_rate":1},{"cnt":[[361,503],[1835,501],[1835,546],[361,548]],"region":{"top_left_x":360,"top_left_y":500,"width":1475,"height":48},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0509160730074a3298596ed86baf1a32","type":"text","conversion_output":true,"text":"collected and recorded in the eCRF only to the extent that they are needed to document or support an AE.","text_display":" collected and recorded in the eCRF only to the extent that they are needed to document or support an AE.","confidence":1,"confidence_rate":1},{"cnt":[[361,544],[1755,544],[1755,587],[361,587]],"region":{"top_left_x":360,"top_left_y":543,"width":1396,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7dde6d619d0d40c1bbba51ca1eab382a","type":"text","conversion_output":true,"text":"Laboratory assessments to inform dosing decisions and routinely monitor patients do not need to be","text_display":" Laboratory assessments to inform dosing decisions and routinely monitor patients do not need to be","confidence":1,"confidence_rate":1},{"cnt":[[361,584],[677,584],[677,625],[361,625]],"region":{"top_left_x":360,"top_left_y":584,"width":317,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04f566fc646d41f1842818f826e1bce5","type":"text","conversion_output":true,"text":"recorded in the eCRF.","text_display":" recorded in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[318,627],[1824,627],[1824,677],[318,677]],"region":{"top_left_x":317,"top_left_y":627,"width":1508,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1731f4ea81714f0fbde1beae4e15c813","type":"text","conversion_output":true,"text":"h Patients should be assessed and treated per standard of care. All AEs/SAEs will be recorded in the eCRF","text_display":"\nh Patients should be assessed and treated per standard of care. All AEs/SAEs will be recorded in the eCRF","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[361,670],[1824,670],[1824,713],[361,713]],"region":{"top_left_x":360,"top_left_y":670,"width":1465,"height":44},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f2739d3405d4aff8368126801a49a67","type":"text","conversion_output":true,"text":"according to the criteria outlined in Section 10. Patient safety outside the protocol assessments should be","text_display":" according to the criteria outlined in Section 10. Patient safety outside the protocol assessments should be","confidence":1,"confidence_rate":1},{"cnt":[[361,709],[1813,709],[1813,754],[361,754]],"region":{"top_left_x":360,"top_left_y":708,"width":1454,"height":47},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8923c6de86644fab3d01d6f60cc9964","type":"text","conversion_output":true,"text":"monitored during the time between on-site visits at the investigator's discretion, per standard of care. At","text_display":" monitored during the time between on-site visits at the investigator's discretion, per standard of care. At","confidence":1,"confidence_rate":1},{"cnt":[[361,750],[1790,750],[1790,793],[361,793]],"region":{"top_left_x":360,"top_left_y":749,"width":1430,"height":44},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29f9aa1765664b01bb72835f2fcbae3f","type":"text","conversion_output":true,"text":"minimum, there will be a phone call with an investigator within the specified-visit window timeframe,","text_display":" minimum, there will be a phone call with an investigator within the specified-visit window timeframe,","confidence":1,"confidence_rate":1},{"cnt":[[361,791],[1033,791],[1033,831],[361,831]],"region":{"top_left_x":360,"top_left_y":790,"width":674,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56a240848d0949d0875da5cb4893ad5e","type":"text","conversion_output":true,"text":"which will include an assessment of AEs/SAEs.","text_display":" which will include an assessment of AEs/SAEs.","confidence":1,"confidence_rate":1},{"cnt":[[318,834],[1785,834],[1785,879],[318,879]],"region":{"top_left_x":317,"top_left_y":833,"width":1469,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26f80abbd7684c649d3c8fd1c4df9cce","type":"text","conversion_output":true,"text":"i Concomitant medications are to be collected and recorded in the eCRF only to the extent that they are","text_display":"\ni Concomitant medications are to be collected and recorded in the eCRF only to the extent that they are","confidence":1,"confidence_rate":1},{"cnt":[[361,877],[754,877],[754,917],[361,917]],"region":{"top_left_x":360,"top_left_y":876,"width":395,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"384f44f1348945d2a1460f3d44cc2757","type":"text","conversion_output":true,"text":"needed to document an AE.","text_display":" needed to document an AE.","confidence":1,"confidence_rate":1},{"cnt":[[316,922],[1777,922],[1777,969],[316,969]],"region":{"top_left_x":315,"top_left_y":921,"width":1462,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07a511093ccc4256abd80a90d14ee8fc","type":"text","conversion_output":true,"text":"j Only for patients who were receiving MLN9708 in combination with LenDex. 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Patients ultimately become refractory to approved therapies","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[1072,2585],[1126,2585],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2584,"width":54,"height":44},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"824bc050689d4c298cab36206b94bb2e","type":"page_info","conversion_output":false,"text":"20","text_display":"","confidence":0.9111328125,"confidence_rate":0.954532771831329}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-022","page":22,"lines":[{"cnt":[[322,129],[492,129],[492,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":170,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5702516703fe4eae95c1b375cf7631f5","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ea15286b85648d68abf2af6b7497d8d","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,251],[1846,251],[1846,303],[320,303]],"region":{"top_left_x":320,"top_left_y":251,"width":1526,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ead1e6ed78043378883315ff0e7e84e","type":"text","conversion_output":true,"text":"and have no alternative treatment options. In an effort to further target the proteasome with","text_display":"\nand have no alternative treatment options. In an effort to further target the proteasome with","confidence":1,"confidence_rate":1},{"cnt":[[322,314],[1843,314],[1843,363],[322,363]],"region":{"top_left_x":322,"top_left_y":313,"width":1522,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84015b12153749e3825e57205679706f","type":"text","conversion_output":true,"text":"improved activity in MM and other cancers, Millennium has developed MLN9708, a small","text_display":" improved activity in MM and other cancers, Millennium has developed MLN9708, a small","confidence":1,"confidence_rate":1},{"cnt":[[320,374],[922,374],[922,423],[320,423]],"region":{"top_left_x":320,"top_left_y":373,"width":602,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ad9bcfa099a45b9aaf69234e170c5a6","type":"text","conversion_output":true,"text":"molecule 20 S proteasome inhibitor.","text_display":" molecule 20 S proteasome inhibitor.","confidence":0.9970703125,"confidence_rate":0.9999348024046826},{"cnt":[[316,475],[1648,475],[1648,535],[316,535]],"region":{"top_left_x":315,"top_left_y":474,"width":1333,"height":61},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f261846e61cd4444bc12228726505d6d","type":"section_header","conversion_output":false,"children_ids":["66ae0c1b608d46d9892213e84d99144a"],"text":"","text_display":""},{"cnt":[[322,481],[1644,481],[1644,529],[322,529]],"region":{"top_left_x":322,"top_left_y":481,"width":1322,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66ae0c1b608d46d9892213e84d99144a","type":"text","conversion_output":true,"parent_id":"f261846e61cd4444bc12228726505d6d","text":"1.1.2 MLN9708, Millennium's Next-Generation Proteasome Inhibitor","text_display":"\n\n\\subsection*{1.1.2 MLN9708, Millennium's Next-Generation Proteasome Inhibitor}","confidence":1,"confidence_rate":1},{"cnt":[[322,569],[1867,569],[1867,621],[322,621]],"region":{"top_left_x":322,"top_left_y":569,"width":1545,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cec6c761464845b0a4974de70eeb3e03","type":"text","conversion_output":true,"text":"VELCADE (bortezomib), the first-in-class, small-molecule proteasome inhibitor developed","text_display":"\n\nVELCADE (bortezomib), the first-in-class, small-molecule proteasome inhibitor developed","confidence":0.94140625,"confidence_rate":0.9993439054221813},{"cnt":[[320,632],[1876,632],[1876,681],[320,681]],"region":{"top_left_x":320,"top_left_y":631,"width":1556,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a339e33badb41f8867474bcc1314fd3","type":"text","conversion_output":true,"text":"by Millennium Pharmaceuticals, Inc (Millennium), validated the proteasome as a therapeutic","text_display":" by Millennium Pharmaceuticals, Inc (Millennium), validated the proteasome as a therapeutic","confidence":1,"confidence_rate":1},{"cnt":[[320,694],[1727,694],[1727,746],[320,746]],"region":{"top_left_x":320,"top_left_y":693,"width":1408,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6343bcc22c324a4fac92307cfe1e2a8e","type":"text","conversion_output":true,"text":"target. Recognizing that proteasome inhibition is an effective anticancer therapeutic","text_display":" target. Recognizing that proteasome inhibition is an effective anticancer therapeutic","confidence":1,"confidence_rate":1},{"cnt":[[320,756],[1644,756],[1644,806],[320,806]],"region":{"top_left_x":320,"top_left_y":756,"width":1324,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6e806b6d39f4f0c837f5534672bbea7","type":"text","conversion_output":true,"text":"approach, Millennium has developed MLN9708 with the aim of improving the","text_display":" approach, Millennium has developed MLN9708 with the aim of improving the","confidence":1,"confidence_rate":1},{"cnt":[[318,816],[1863,816],[1863,870],[318,870]],"region":{"top_left_x":317,"top_left_y":816,"width":1546,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1dc8fc379de49c1bf4393fdc4872b17","type":"text","conversion_output":true,"text":"pharmacology of the agent, building on the efficacy seen with VELCADE in MM and other","text_display":" pharmacology of the agent, building on the efficacy seen with VELCADE in MM and other","confidence":0.97802734375,"confidence_rate":0.9997531676848477},{"cnt":[[318,881],[1820,881],[1820,932],[318,932]],"region":{"top_left_x":317,"top_left_y":880,"width":1503,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c9d05405de84ee094f91609e7aaf92b","type":"text","conversion_output":true,"text":"hematologic malignancies, and improving safety and convenience of drug administration.","text_display":" hematologic malignancies, and improving safety and convenience of drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[320,984],[1803,984],[1803,1033],[320,1033]],"region":{"top_left_x":320,"top_left_y":983,"width":1483,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed9884ec3e22438fb333facb40a7264b","type":"text","conversion_output":true,"text":"Like VELCADE, MLN9708 is a modified peptide boronic acid analog. MLN9708 is the","text_display":"\n\nLike VELCADE, MLN9708 is a modified peptide boronic acid analog. MLN9708 is the","confidence":1,"confidence_rate":1},{"cnt":[[320,1048],[1798,1048],[1798,1098],[320,1098]],"region":{"top_left_x":320,"top_left_y":1048,"width":1479,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9643070b15d4e8eb07442a208012565","type":"text","conversion_output":true,"text":"citrate ester of the biologically active dipeptide boronic acid, MLN2238. MLN9708 was","text_display":" citrate ester of the biologically active dipeptide boronic acid, MLN2238. MLN9708 was","confidence":1,"confidence_rate":1},{"cnt":[[320,1109],[1869,1109],[1869,1158],[320,1158]],"region":{"top_left_x":320,"top_left_y":1108,"width":1550,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b4ef697c24141f0a8de55736267b80f","type":"text","conversion_output":true,"text":"formulated to improve the chemical properties of MLN2238 for clinical delivery. MLN9708","text_display":" formulated to improve the chemical properties of MLN2238 for clinical delivery. MLN9708","confidence":0.7177734375,"confidence_rate":0.9964021258895926},{"cnt":[[320,1173],[1772,1173],[1772,1222],[320,1222]],"region":{"top_left_x":320,"top_left_y":1173,"width":1453,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afc218889dc74fb18f95f5d92be9ddbd","type":"text","conversion_output":true,"text":"rapidly hydrolyzes to MLN2238 upon contact with either plasma or aqueous solutions.","text_display":" rapidly hydrolyzes to MLN2238 upon contact with either plasma or aqueous solutions.","confidence":1,"confidence_rate":1},{"cnt":[[320,1233],[1680,1233],[1680,1283],[320,1283]],"region":{"top_left_x":320,"top_left_y":1233,"width":1361,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc2c8befb0f04d5994121b698c211d96","type":"text","conversion_output":true,"text":"MLN2238 is the active form that potently, reversibly, and selectively inhibits the","text_display":" MLN2238 is the active form that potently, reversibly, and selectively inhibits the","confidence":1,"confidence_rate":1},{"cnt":[[318,1298],[1807,1298],[1807,1347],[318,1347]],"region":{"top_left_x":317,"top_left_y":1297,"width":1490,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"533844f0f5184c49bd9d7e82c74306ff","type":"text","conversion_output":true,"text":"proteasome. 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MLN2238 was selective for the proteasome","text_display":" also inhibits the activity of the \\(\\beta 1\\) and \\(\\beta 2\\) sites. MLN2238 was selective for the proteasome","confidence":1,"confidence_rate":1},{"cnt":[[320,1661],[1721,1661],[1721,1712],[320,1712]],"region":{"top_left_x":320,"top_left_y":1660,"width":1401,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8f316ffd9ff469f9f07232f65098269","type":"text","conversion_output":true,"text":"over a panel of several proteases ( \\(IC _{50}\\) values between 20 and \\(100 \\mu M\\) ), 103 kinases","text_display":" over a panel of several proteases ( \\(IC _{50}\\) values between 20 and \\(100 \\mu M\\) ), 103 kinases","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[320,1727],[1794,1727],[1794,1777],[320,1777]],"region":{"top_left_x":320,"top_left_y":1727,"width":1474,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cce3ee8106f345fbbef9364c40409f42","type":"text","conversion_output":true,"text":"( \\(IC _{50}\\) values \\(>10 \\mu M\\) ), and receptors ( \\(IC _{50}\\) values \\(>10 \\mu M\\) ). MLN2238 and bortezomib","text_display":" ( \\(IC _{50}\\) values \\(>10 \\mu M\\) ), and receptors ( \\(IC _{50}\\) values \\(>10 \\mu M\\) ). 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Based on these favorable","text_display":" MLN2238 and bortezomib are 18 and 110 minutes, respectively). Based on these favorable","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[318,1985],[1465,1985],[1465,2035],[318,2035]],"region":{"top_left_x":317,"top_left_y":1985,"width":1149,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1143e3624d9a4026ba9baed01056b8ce","type":"text","conversion_output":true,"text":"characteristics, MLN2238 is anticipated to be effective against MM.","text_display":" characteristics, MLN2238 is anticipated to be effective against MM.","confidence":0.99462890625,"confidence_rate":0.9999252032150219},{"cnt":[[316,2084],[883,2084],[883,2144],[316,2144]],"region":{"top_left_x":315,"top_left_y":2083,"width":569,"height":62},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da9288abd08e4c98895f2dfda4afc0e1","type":"section_header","conversion_output":false,"children_ids":["6b4b6559a5b24fd1b7f08559b098ac03"],"text":"","text_display":""},{"cnt":[[322,2088],[879,2088],[879,2138],[322,2138]],"region":{"top_left_x":322,"top_left_y":2088,"width":557,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b4b6559a5b24fd1b7f08559b098ac03","type":"text","conversion_output":true,"parent_id":"da9288abd08e4c98895f2dfda4afc0e1","text":"1.2 Preclinical Experience","text_display":"\n\n\\subsection*{1.2 Preclinical Experience}","confidence":1,"confidence_rate":1},{"cnt":[[318,2174],[1274,2174],[1274,2237],[318,2237]],"region":{"top_left_x":317,"top_left_y":2174,"width":958,"height":63},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02e5c281830d49568af36d6b59da6449","type":"section_header","conversion_output":false,"children_ids":["c0b3383c4eca4b47b4a7b67892173afa"],"text":"","text_display":""},{"cnt":[[322,2179],[1270,2179],[1270,2230],[322,2230]],"region":{"top_left_x":322,"top_left_y":2178,"width":948,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0b3383c4eca4b47b4a7b67892173afa","type":"text","conversion_output":true,"parent_id":"02e5c281830d49568af36d6b59da6449","text":"1.2.1 Nonclinical Pharmacology: In Vivo Studies","text_display":"\n\n\\subsection*{1.2.1 Nonclinical Pharmacology: In Vivo Studies}","confidence":1,"confidence_rate":1},{"cnt":[[318,2269],[1846,2269],[1846,2318],[318,2318]],"region":{"top_left_x":317,"top_left_y":2268,"width":1529,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a79817faa91448cbe5450db6eb3cd11","type":"text","conversion_output":true,"text":"Antitumor activity was observed with MLN2238 in 4 xenograft models: CWR22 (a human","text_display":"\n\nAntitumor activity was observed with MLN2238 in 4 xenograft models: CWR22 (a human","confidence":1,"confidence_rate":1},{"cnt":[[318,2331],[1768,2331],[1768,2383],[318,2383]],"region":{"top_left_x":317,"top_left_y":2331,"width":1452,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63a33913e22b43f1aa953e647101c400","type":"text","conversion_output":true,"text":"prostate cancer cell line), WSU-DLCL2, OCI-Ly7-7D1-luc, and PHTX-22L (3 human","text_display":" prostate cancer cell line), WSU-DLCL2, OCI-Ly7-7D1-luc, and PHTX-22L (3 human","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[318,2393],[1807,2393],[1807,2443],[318,2443]],"region":{"top_left_x":317,"top_left_y":2393,"width":1490,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d02526607dc4114970931d57bec1861","type":"text","conversion_output":true,"text":"lymphoma cell lines). In contrast, bortezomib demonstrated weaker antitumor activity in","text_display":" lymphoma cell lines). In contrast, bortezomib demonstrated weaker antitumor activity in","confidence":1,"confidence_rate":1},{"cnt":[[1072,2587],[1124,2587],[1124,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2586,"width":52,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15634271129a445789554ec129410c6f","type":"page_info","conversion_output":false,"text":"21","text_display":"","confidence":0.89453125,"confidence_rate":0.9457966219013473}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-023","page":23,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e75ac55497e40b8b87cc9244ce27fdc","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9561658590049978529a11371bcaa69","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,251],[1794,251],[1794,303],[318,303]],"region":{"top_left_x":317,"top_left_y":251,"width":1477,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d5dc549fe7947b7bbae13a61b312255","type":"text","conversion_output":true,"text":"these latter 3 lymphoma models, demonstrating that MLN2238 has improved activity in","text_display":"\nthese latter 3 lymphoma models, demonstrating that MLN2238 has improved activity in","confidence":1,"confidence_rate":1},{"cnt":[[320,314],[1712,314],[1712,363],[320,363]],"region":{"top_left_x":320,"top_left_y":313,"width":1393,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc3acfa974364f4284821e6f54bb578f","type":"text","conversion_output":true,"text":"nonclinical models compared to bortezomib. 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\\(2.23- mg / m ^{2}\\) BSA dosing, and \\(5.5 mg \\sim\\) equivalent to \\(2.97- mg / m ^{2}\\) BSA dosing.","text_display":" equivalent to \\(2.23- mg / m ^{2}\\) BSA dosing, and \\(5.5 mg \\sim\\) equivalent to \\(2.97- mg / m ^{2}\\) BSA dosing.","confidence":0.99365234375,"confidence_rate":0.9999498604044118},{"cnt":[[320,1620],[1813,1620],[1813,1671],[320,1671]],"region":{"top_left_x":320,"top_left_y":1619,"width":1494,"height":53},"line":71,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c03a2b88263540d1896a83be24118b01","type":"text","conversion_output":true,"text":"The emerging safety profile indicates that oral MLN9708 is generally well tolerated with","text_display":"\n\nThe emerging safety profile indicates that oral MLN9708 is generally well tolerated 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As noted in Table 1-1, the maximum tolerated dose (MTD) has been established","text_display":" reactions. 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The potential risks reported with oral MLN9708 use, pooled from the enrolling","text_display":" [RRAL]). The potential risks reported with oral MLN9708 use, pooled from the enrolling","confidence":1,"confidence_rate":1},{"cnt":[[320,2183],[1671,2183],[1671,2232],[320,2232]],"region":{"top_left_x":320,"top_left_y":2182,"width":1352,"height":51},"line":80,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc67f95115eb43999c108d8b080c272b","type":"text","conversion_output":true,"text":"5 phase 1 and phase \\(1 / 2\\) clinical studies \\(( N =115)\\) are shown in Table 1-2. As of","text_display":" 5 phase 1 and phase \\(1 / 2\\) clinical studies \\(( N =115)\\) are shown in Table 1-2. 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Reported (> 10\\%) Due to MLN9708 or Disease Under Study & \\begin{tabular}{l}\nFever \\\\\nAnorexia, constipation, dehydration \\\\\nAnemia, neutropenia \\\\\nHeadache \\\\\nUpper respiratory infection, cough \\\\\nDizziness \\\\\nPeripheral neuropathy \\\\\nArthralgia\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 1-2 MLN9708 Potential Risks (Pooled PO Formulation), as of 12 October 2011}\n\\begin{tabular}{|l|l|}\n\\hline Adverse Drug Reactions & \\begin{tabular}{l}\nThrombocytopenia \\\\\nSkin rash (Includes terms: erythematous, generalized, pruritic, macular, macula-papular, papular) \\\\\nNausea, vomiting, diarrhea \\\\\nFatigue\n\\end{tabular} \\\\\n\\hline Potential Risks Reported (> 10\\%) Due to MLN9708 or Disease Under Study & \\begin{tabular}{l}\nFever \\\\\nAnorexia, constipation, dehydration \\\\\nAnemia, neutropenia \\\\\nHeadache \\\\\nUpper respiratory infection, cough \\\\\nDizziness 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After a discussion with the","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[318,2271],[1833,2271],[1833,2322],[318,2322]],"region":{"top_left_x":317,"top_left_y":2270,"width":1516,"height":53},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2538e0275a744fc7b44a5859942bee30","type":"text","conversion_output":true,"text":"participating investigators, an intermediate yet lower dose was evaluated as allowed in the","text_display":" participating investigators, an intermediate yet lower dose was evaluated as allowed in the","confidence":1,"confidence_rate":1},{"cnt":[[318,2333],[1697,2333],[1697,2385],[318,2385]],"region":{"top_left_x":317,"top_left_y":2333,"width":1381,"height":52},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"875f7de527944982aef7f005041a2d4a","type":"text","conversion_output":true,"text":"C16003 protocol and supported by available pharmacokinetic (PK) data to further","text_display":" C16003 protocol and supported by available pharmacokinetic (PK) data to further","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[318,2396],[1796,2396],[1796,2447],[318,2447]],"region":{"top_left_x":317,"top_left_y":2395,"width":1480,"height":53},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f73c291511124aeda8a85b288863b9b3","type":"text","conversion_output":true,"text":"characterize dose-related toxicities. Six patients were treated at the intermediate dose of","text_display":" characterize dose-related toxicities. Six patients were treated at the intermediate dose of","confidence":1,"confidence_rate":1},{"cnt":[[1074,2587],[1126,2587],[1126,2625],[1074,2625]],"region":{"top_left_x":1074,"top_left_y":2586,"width":52,"height":40},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf7d4b50b8be4f1f9d66c97195c3e7a9","type":"page_info","conversion_output":false,"text":"25","text_display":"","confidence":0.771484375,"confidence_rate":0.8783418326596998}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-027","page":27,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5dd7b0d2c524d6dbe65dfb33f6693c1","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86b5407420e247d99a8daf403435f5cc","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,245],[1863,245],[1863,303],[318,303]],"region":{"top_left_x":317,"top_left_y":244,"width":1546,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93bc0a43d62e47a89e2d11dc9fadc27f","type":"text","conversion_output":true,"text":"\\(2.0 mg / m ^{2}\\), a dose approximately half way between the 2 existing dose levels of \\(2.23 mg / m ^{2}\\)","text_display":"\n\\(2.0 mg / m ^{2}\\), a dose approximately half way between the 2 existing dose levels of \\(2.23 mg / m ^{2}\\)","confidence":0.99951171875,"confidence_rate":0.9999959300041316},{"cnt":[[318,305],[1858,305],[1858,363],[318,363]],"region":{"top_left_x":317,"top_left_y":305,"width":1542,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"998d8dea962347168db2b023a77868a8","type":"text","conversion_output":true,"text":"and \\(1.68 mg / m ^{2}\\) (a dose without any DLTs). Given that no patient (0/6) experienced a DLT,","text_display":" and \\(1.68 mg / m ^{2}\\) (a dose without any DLTs). Given that no patient (0/6) experienced a DLT,","confidence":0.8594921892508864,"confidence_rate":0.9985990050725461},{"cnt":[[320,367],[1843,367],[1843,425],[320,425]],"region":{"top_left_x":320,"top_left_y":367,"width":1524,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7072940adce43d491bebe6f9de9b992","type":"text","conversion_output":true,"text":"the MTD of PO MLN9708 administered twice weekly was determined to be \\(2.0 mg / m ^{2}\\).[8]","text_display":" the MTD of PO MLN9708 administered twice weekly was determined to be \\(2.0 mg / m ^{2}\\).[8]","confidence":0.990234375,"confidence_rate":0.9999047266606538},{"cnt":[[320,481],[1869,481],[1869,529],[320,529]],"region":{"top_left_x":320,"top_left_y":481,"width":1550,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"891e0201f39c466e91b0873fdb64b537","type":"text","conversion_output":true,"text":"A summary of the safety profile of patients treated in Study C16003 is outlined in Table 1-3.","text_display":"\n\nA summary of the safety profile of patients treated in Study C16003 is outlined in Table 1-3.","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[322,544],[1790,544],[1790,591],[322,591]],"region":{"top_left_x":322,"top_left_y":543,"width":1468,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9da257eae3dd4a3b8721f22eeb210d91","type":"text","conversion_output":true,"text":"Overall, \\(98 \\%\\) of patients experienced a TEAE of any grade and of any cause. Peripheral","text_display":" Overall, \\(98 \\%\\) of patients experienced a TEAE of any grade and of any cause. Peripheral","confidence":0.81494140625,"confidence_rate":0.9978019991225848},{"cnt":[[320,606],[1846,606],[1846,655],[320,655]],"region":{"top_left_x":320,"top_left_y":605,"width":1526,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f1ec5960b6d4451a903fd9f6bc0f557","type":"text","conversion_output":true,"text":"neuropathy was limited to Grade 1/2 in 10\\% of patients; with all of these patients reporting","text_display":" neuropathy was limited to Grade 1/2 in 10\\% of patients; with all of these patients reporting","confidence":0.9794921875,"confidence_rate":0.999786404076327},{"cnt":[[320,666],[917,666],[917,715],[320,715]],"region":{"top_left_x":320,"top_left_y":666,"width":598,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2486296cf55d4bf0b2e7c4ba61a91eb5","type":"text","conversion_output":true,"text":"baseline Grade 1 PN at study entry.","text_display":" baseline Grade 1 PN at study 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in","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[571,842],[1682,842],[1682,887],[571,887]],"region":{"top_left_x":571,"top_left_y":842,"width":1112,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79e276a6e09945dc823d77d4f7a8ab3d","type":"text","conversion_output":false,"parent_id":"4a707932d39b4c208f04c532fff29b66","text":"RRMM Most Common TEAEs as of 12 October 2011 ( \\(N = 5 6\\) )","text_display":"","confidence":0.53282518289611,"confidence_rate":0.9910465813504891},{"cnt":[[299,920],[1863,920],[1863,1577],[299,1577]],"region":{"top_left_x":298,"top_left_y":919,"width":1565,"height":658},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6cc3ccd2868449a0be8f938a02cb9785","type":"table","conversion_output":true,"children_ids":["92ce36fdc83e4caea57ccc6768fe2225","4616f02b08b44aa8995358daa1102343","09daece011944679992a255d40aa8985","a6e18784477946fba8f59ab7f531bc2d","ff332a8a5b4a4bc3a22c273711e56495"],"selected_labels":["4a707932d39b4c208f04c532fff29b66"],"text":"\\begin{tabular}{|l|l|}\n\\hline Most Common (> 20\\%) Any Grade and Irrespective of Cause & \\begin{tabular}{l}\nFatigue (57\\%) \\\\\nSkin rash (all terms) (50\\%) \\\\\nThrombocytopenia (41\\%) \\\\\nNausea (34\\%). \\\\\nDiarrhea (36\\%) \\\\\nVomiting and fever (30\\% each) \\\\\nCough (25\\%) \\\\\nAnorexia (23\\%) \\\\\nNeutropenia (21\\%) \\\\\nNeutropenia ( \\(n 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(50\\%)","confidence":1,"confidence_rate":1},{"cnt":[[1091,1029],[1461,1029],[1461,1073],[1091,1073]],"region":{"top_left_x":1090,"top_left_y":1029,"width":371,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b012aa164a3a4ba8abc0e32f02cf1378","type":"text","conversion_output":false,"parent_id":"ff332a8a5b4a4bc3a22c273711e56495","text":"Thrombocytopenia (41\\%)","text_display":"\nThrombocytopenia (41\\%)","confidence":1,"confidence_rate":1},{"cnt":[[1091,1079],[1305,1079],[1305,1116],[1091,1116]],"region":{"top_left_x":1090,"top_left_y":1079,"width":215,"height":38},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1a4642d84034e6c98635d38dc088ae0","type":"text","conversion_output":false,"parent_id":"ff332a8a5b4a4bc3a22c273711e56495","text":"Nausea (34\\%).","text_display":"\nNausea 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thrombocytopenia, anemia, neutropenia, febrile neutropenia, nausea, vomiting, abdominal","confidence":1,"confidence_rate":1},{"cnt":[[318,1757],[1790,1757],[1790,1807],[318,1807]],"region":{"top_left_x":317,"top_left_y":1757,"width":1473,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a3a0835c1984e03baff909a68ab66b3","type":"text","conversion_output":true,"text":"pain, chest pain (noncardiac), orthostatic hypotension, hypotension, hypophosphatemia,","text_display":" pain, chest pain (noncardiac), orthostatic hypotension, hypotension, hypophosphatemia,","confidence":1,"confidence_rate":1},{"cnt":[[318,1818],[1777,1818],[1777,1867],[318,1867]],"region":{"top_left_x":317,"top_left_y":1817,"width":1460,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea44a62f48034845954becdd2018f3ab","type":"text","conversion_output":true,"text":"hyperuricemia, febrile neutropenia, fever, chills, rash, pneumonia, hypoxia, pulmonary","text_display":" hyperuricemia, febrile neutropenia, fever, chills, rash, pneumonia, hypoxia, pulmonary","confidence":1,"confidence_rate":1},{"cnt":[[318,1882],[1863,1882],[1863,1931],[318,1931]],"region":{"top_left_x":317,"top_left_y":1882,"width":1546,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9763f1c21dad4085a9f68e51632c4aca","type":"text","conversion_output":true,"text":"hypertension, fall, headache, fatigue, or dehydration. Five patients discontinued therapy due","text_display":" hypertension, fall, headache, fatigue, or dehydration. 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There have been","text_display":" related to disease progression (spinal cord compression and bone pain). 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These patients are heavily pretreated","text_display":" C16004, in which MLN9708 is administered weekly. These patients are heavily pretreated","confidence":1,"confidence_rate":1},{"cnt":[[322,2449],[1725,2449],[1725,2496],[322,2496]],"region":{"top_left_x":322,"top_left_y":2449,"width":1404,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a829da0e7b1942c991cc30cd722f1b80","type":"text","conversion_output":true,"text":"as evidenced by a median number of 5 (range \\(2-15\\) ) prior lines of therapy with \\(59 \\%\\)","text_display":" as evidenced by a median number of 5 (range \\(2-15\\) ) prior lines of therapy with \\(59 \\%\\)","confidence":0.8714911698891115,"confidence_rate":0.9985060133482525},{"cnt":[[1074,2587],[1124,2587],[1124,2628],[1074,2628]],"region":{"top_left_x":1074,"top_left_y":2586,"width":50,"height":42},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7dc9326049e4b55a0700734477f6db2","type":"page_info","conversion_output":false,"text":"26","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-028","page":28,"lines":[{"cnt":[[320,127],[496,127],[496,168],[320,168]],"region":{"top_left_x":320,"top_left_y":126,"width":177,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b46bead5f7854f6d977de6740379356e","type":"section_header","conversion_output":false,"children_ids":["3abe1fb6e66b4896aab8d10ba3d46d18"],"text":"","text_display":""},{"cnt":[[322,129],[492,129],[492,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":170,"height":38},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3abe1fb6e66b4896aab8d10ba3d46d18","type":"text","conversion_output":true,"parent_id":"b46bead5f7854f6d977de6740379356e","text":"MLN9708","text_display":"\n\n\\section*{MLN9708}","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da74ae690ad04b408a679d39a94b42e3","type":"section_header","conversion_output":false,"children_ids":["93349ac47aae407fb7f775fd2efda89c"],"text":"","text_display":""},{"cnt":[[322,174],[1366,172],[1366,215],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1045,"height":47},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93349ac47aae407fb7f775fd2efda89c","type":"text","conversion_output":true,"parent_id":"da74ae690ad04b408a679d39a94b42e3","text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"\n\n\\section*{Clinical Study Protocol C16010 Amendment 8, 08 January 2021}","confidence":1,"confidence_rate":1},{"cnt":[[322,254],[1760,254],[1760,299],[322,299]],"region":{"top_left_x":322,"top_left_y":253,"width":1438,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f7e382d529ab4cf7a88f140f7ee1740c","type":"text","conversion_output":true,"text":"refractory to the last line of therapy.[9] Patients have received a median of 2 cycles of","text_display":"\nrefractory to the last line of therapy.[9] Patients have received a median of 2 cycles of","confidence":0.9960968487430364,"confidence_rate":0.9999596834062305},{"cnt":[[322,318],[1824,318],[1824,363],[322,363]],"region":{"top_left_x":322,"top_left_y":317,"width":1503,"height":47},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"109254988d324ef7908355b3621bc584","type":"text","conversion_output":true,"text":"therapy (range 1-11). Two patients have achieved objective response: 1 achieved a VGPR","text_display":" therapy (range 1-11). Two patients have achieved objective response: 1 achieved a VGPR","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[322,378],[1863,378],[1863,423],[322,423]],"region":{"top_left_x":322,"top_left_y":378,"width":1541,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eaf344d9913c4e308bfb5f4704d260b9","type":"text","conversion_output":true,"text":"and 1 achieved a PR. Additionally 6 patients achieved durable disease stabilization for up to","text_display":" and 1 achieved a PR. Additionally 6 patients achieved durable disease stabilization for up to","confidence":1,"confidence_rate":1},{"cnt":[[322,440],[1854,440],[1854,488],[322,488]],"region":{"top_left_x":322,"top_left_y":440,"width":1533,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9bf8ae84b4484050a579b295d2c16c66","type":"text","conversion_output":true,"text":"9.5 months. At data cut-off, 2 patients remain on treatment; discontinuation was mainly due","text_display":" 9.5 months. At data cut-off, 2 patients remain on treatment; discontinuation was mainly due","confidence":1,"confidence_rate":1},{"cnt":[[322,503],[956,503],[956,548],[322,548]],"region":{"top_left_x":322,"top_left_y":502,"width":635,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e11f761d3c754451ac5b6e7d4bd21e23","type":"text","conversion_output":true,"text":"to progressive disease (PD) (69\\%).[9]","text_display":" to progressive disease (PD) (69\\%).[9]","confidence":1,"confidence_rate":1},{"cnt":[[322,606],[1768,606],[1768,655],[322,655]],"region":{"top_left_x":322,"top_left_y":605,"width":1447,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e31aea904af45c98c9963f64e9aa4cb","type":"text","conversion_output":true,"text":"In Study C16004, 2 of 3 patients experienced protocol-defined DLT (Grade 3 rash and","text_display":"\n\nIn Study C16004, 2 of 3 patients experienced protocol-defined DLT (Grade 3 rash and","confidence":1,"confidence_rate":1},{"cnt":[[322,660],[1693,660],[1693,715],[322,715]],"region":{"top_left_x":322,"top_left_y":659,"width":1371,"height":57},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e4faebdd6bc4eeeb1ee1bd16432e91a","type":"text","conversion_output":true,"text":"Grade 3 nausea, vomiting, and diarrhea) at a dose of \\(3.95 mg / m ^{2}\\). As per protocol,","text_display":" Grade 3 nausea, vomiting, and diarrhea) at a dose of \\(3.95 mg / m ^{2}\\). As per protocol,","confidence":1,"confidence_rate":1},{"cnt":[[322,718],[1824,718],[1824,780],[322,780]],"region":{"top_left_x":322,"top_left_y":717,"width":1503,"height":63},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df27ee1986224b44a90c694723006676","type":"text","conversion_output":true,"text":"subsequent patients were treated at 1 dose level below \\(\\left(2.97 mg / m ^{2}\\right)\\) where 1 of 6 patients","text_display":" subsequent patients were treated at 1 dose level below \\(\\left(2.97 mg / m ^{2}\\right)\\) where 1 of 6 patients","confidence":0.9391138553619385,"confidence_rate":0.9994677810397349},{"cnt":[[322,791],[1781,791],[1781,840],[322,840]],"region":{"top_left_x":322,"top_left_y":790,"width":1460,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9539b4c119a14870b3ebdc462914b016","type":"text","conversion_output":true,"text":"experienced a DLT (Grade 3 nausea, vomiting, and diarrhea). The MTD of weekly oral","text_display":" experienced a DLT (Grade 3 nausea, vomiting, and diarrhea). The MTD of weekly oral","confidence":1,"confidence_rate":1},{"cnt":[[320,846],[1846,846],[1846,904],[320,904]],"region":{"top_left_x":320,"top_left_y":846,"width":1526,"height":59},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8420f098373a4c1dabb056b7ae4f37b6","type":"text","conversion_output":true,"text":"MLN9708 was determined to be \\(2.97 mg / m ^{2}\\). This dose cohort is currently being expanded","text_display":" MLN9708 was determined to be \\(2.97 mg / m ^{2}\\). This dose cohort is currently being expanded","confidence":1,"confidence_rate":1},{"cnt":[[320,915],[1300,915],[1300,965],[320,965]],"region":{"top_left_x":320,"top_left_y":915,"width":980,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e937958515174620aa3dd76a09f06c4d","type":"text","conversion_output":true,"text":"to further evaluate the safety and activity of MLN9708.[9]","text_display":" to further evaluate the safety and activity of MLN9708.[9]","confidence":1,"confidence_rate":1},{"cnt":[[318,1018],[1858,1018],[1858,1068],[318,1068]],"region":{"top_left_x":317,"top_left_y":1018,"width":1542,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3af1a8aad4443b0bc075f5c6a97fdfa","type":"text","conversion_output":true,"text":"A summary of the safety profile of patients treated in Study C16004 (28 patients in the dose","text_display":"\n\nA summary of the safety profile of patients treated in Study C16004 (28 patients in the dose","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[320,1083],[1790,1083],[1790,1132],[320,1132]],"region":{"top_left_x":320,"top_left_y":1082,"width":1470,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9be6f8ebf8a447428f85e9764ca9f6e5","type":"text","conversion_output":true,"text":"escalation phase and 4 in the extension phase) is outlined in Table 1-4. Overall, 97\\% of","text_display":" escalation phase and 4 in the extension phase) is outlined in Table 1-4. Overall, 97\\% of","confidence":0.9396956883974781,"confidence_rate":0.9993523015984849},{"cnt":[[318,1192],[318,1144],[1785,1146],[1785,1195]],"region":{"top_left_x":317,"top_left_y":1143,"width":1469,"height":52},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99804e8cebf74202b7897d0c7b6c9da7","type":"text","conversion_output":true,"text":"patients experienced a TEAE of any grade and of any cause. Peripheral neuropathy was","text_display":" patients experienced a TEAE of any grade and of any cause. 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This study has enrolled 15 patients as of the clinical data cut (12 Oct 2011)","text_display":" phase 2 portion. This study has enrolled 15 patients as of the clinical data cut (12 Oct 2011)","confidence":0.9560546875,"confidence_rate":0.9995720900265613},{"cnt":[[320,765],[1871,765],[1871,819],[320,819]],"region":{"top_left_x":320,"top_left_y":764,"width":1552,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce3e021b8fd340a092c41a0acde1b0b6","type":"text","conversion_output":true,"text":"to 4 dose cohorts. No DLTs were seen at doses up to \\(2.23 mg / m ^{2}\\). Three of 3 patients treated","text_display":" to 4 dose cohorts. No DLTs were seen at doses up to \\(2.23 mg / m ^{2}\\). Three of 3 patients treated","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[320,825],[1824,825],[1824,883],[320,883]],"region":{"top_left_x":320,"top_left_y":825,"width":1505,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82555174da6b46eba27f2c207a9899f3","type":"text","conversion_output":true,"text":"at the \\(3.95 mg / m ^{2}\\) dose cohort experienced Grade 3 nausea and vomiting despite adequate","text_display":" at the \\(3.95 mg / m ^{2}\\) dose cohort experienced Grade 3 nausea and vomiting despite adequate","confidence":1,"confidence_rate":1},{"cnt":[[320,896],[1815,896],[1815,943],[320,943]],"region":{"top_left_x":320,"top_left_y":895,"width":1496,"height":49},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bf1df393dde4440953a0d123509beef","type":"text","conversion_output":true,"text":"anti-emetic therapy; 1 of which additionally experienced Grade 2 syncope and in another","text_display":" anti-emetic therapy; 1 of which additionally experienced Grade 2 syncope and in another","confidence":1,"confidence_rate":1},{"cnt":[[320,958],[1796,958],[1796,1008],[320,1008]],"region":{"top_left_x":320,"top_left_y":958,"width":1477,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"295fbc1e0b19467d9ac4dab220bb96b3","type":"text","conversion_output":true,"text":"patient the dose of lenalidomide was compromised such that they received \\(<80 \\%\\) of the","text_display":" patient the dose of lenalidomide was compromised such that they received \\(<80 \\%\\) of the","confidence":0.9990234375,"confidence_rate":0.99998938006022},{"cnt":[[320,1018],[1768,1018],[1768,1068],[320,1068]],"region":{"top_left_x":320,"top_left_y":1018,"width":1449,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f733a1c9ee6c4d6881ec2f1d60ef3c78","type":"text","conversion_output":true,"text":"planned doses. As per protocol, subsequent patients were treated at 1 dose level below","text_display":" planned doses. As per protocol, subsequent patients were treated at 1 dose level below","confidence":1,"confidence_rate":1},{"cnt":[[322,1074],[1858,1074],[1858,1132],[322,1132]],"region":{"top_left_x":322,"top_left_y":1074,"width":1537,"height":59},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7761a43c598483ab68797b943c2b29c","type":"text","conversion_output":true,"text":"( \\(2.97 mg / m ^{2}\\) ) where 1 of 6 patients experienced a DLT (Grade 3 rash). The MTD of weekly","text_display":" ( \\(2.97 mg / m ^{2}\\) ) where 1 of 6 patients experienced a DLT (Grade 3 rash). The MTD of weekly","confidence":0.998046875,"confidence_rate":0.999983290440155},{"cnt":[[320,1143],[1790,1143],[1790,1192],[320,1192]],"region":{"top_left_x":320,"top_left_y":1142,"width":1470,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c525f992fe134ed09088d56c77841588","type":"text","conversion_output":true,"text":"MLN9708 in combination with a 28-day cycle of lenalidomide and dexamethasone was","text_display":" MLN9708 in combination with a 28-day cycle of lenalidomide and dexamethasone was","confidence":0.83544921875,"confidence_rate":0.9978871092761212},{"cnt":[[320,1199],[1714,1199],[1714,1257],[320,1257]],"region":{"top_left_x":320,"top_left_y":1198,"width":1395,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8311dc20d1484d7a8206a098c4a4243a","type":"text","conversion_output":true,"text":"established at \\(2.97 mg / m ^{2}\\). The recommended phase dose (RP2D) estimation was","text_display":" established at \\(2.97 mg / m ^{2}\\). The recommended phase dose (RP2D) estimation was","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[320,1268],[1820,1268],[1820,1317],[320,1317]],"region":{"top_left_x":320,"top_left_y":1267,"width":1500,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55eb3b29084644a4ac123661f88b2acc","type":"text","conversion_output":true,"text":"established following evaluation of the available data from the phase 1 portion of the trial","text_display":" established following evaluation of the available data from the phase 1 portion of the trial","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[320,1332],[1639,1332],[1639,1381],[320,1381]],"region":{"top_left_x":320,"top_left_y":1332,"width":1320,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e85d24637e4428b9e873cd791cf4cba","type":"text","conversion_output":true,"text":"which included, but was not limited to analyses of efficacy results and toxicity","text_display":" which included, but was not limited to analyses of efficacy results and toxicity","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[320,1394],[1794,1394],[1794,1446],[320,1446]],"region":{"top_left_x":320,"top_left_y":1394,"width":1474,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a1e26bacf6c47bea7422c65999d1cf4","type":"text","conversion_output":true,"text":"characterization (Grade 3/4 AEs, SAEs, all grades peripheral neuropathy, and treatment","text_display":" characterization (Grade 3/4 AEs, SAEs, all grades peripheral neuropathy, and treatment","confidence":0.7383584976196289,"confidence_rate":0.9966722985279076},{"cnt":[[320,1448],[1843,1448],[1843,1506],[320,1506]],"region":{"top_left_x":320,"top_left_y":1448,"width":1524,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"551cf90167934fc7a952551a4ddb4640","type":"text","conversion_output":true,"text":"discontinuation). Based on this review the RP2D dose was determined to be \\(2.23 mg / m ^{2}\\) in","text_display":" discontinuation). Based on this review the RP2D dose was determined to be \\(2.23 mg / m ^{2}\\) in","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[320,1517],[1876,1517],[1876,1571],[320,1571]],"region":{"top_left_x":320,"top_left_y":1516,"width":1556,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd1da900e0734179af28cdad1a47c320","type":"text","conversion_output":true,"text":"this combination schedule. The clinical development of MLN9708 included a population PK","text_display":" this combination schedule. The clinical development of MLN9708 included a population PK","confidence":1,"confidence_rate":1},{"cnt":[[320,1581],[1850,1581],[1850,1631],[320,1631]],"region":{"top_left_x":320,"top_left_y":1581,"width":1530,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4aaaab099084fb599e4fb3c527513cf","type":"text","conversion_output":true,"text":"analysis evaluating the feasibility of switching from body surface area (BSA)-based dosing","text_display":" analysis evaluating the feasibility of switching from body surface area (BSA)-based dosing","confidence":1,"confidence_rate":1},{"cnt":[[318,1644],[1772,1644],[1772,1695],[318,1695]],"region":{"top_left_x":317,"top_left_y":1643,"width":1456,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"679c5d8ea66d4063a2dc0da4e50a7467","type":"text","conversion_output":true,"text":"to fixed dosing.[10] The results of this analysis support the transition from BSA-based","text_display":" to fixed dosing.[10] The results of this analysis support the transition from BSA-based","confidence":1,"confidence_rate":1},{"cnt":[[320,1704],[1755,1704],[1755,1755],[320,1755]],"region":{"top_left_x":320,"top_left_y":1703,"width":1436,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5339e662370458b9fb1b04bc4232d41","type":"text","conversion_output":true,"text":"dosing to fixed dosing, Therefore, in Study C16005, all patients treated in the phase 2","text_display":" dosing to fixed dosing, Therefore, in Study C16005, all patients treated in the phase 2","confidence":1,"confidence_rate":1},{"cnt":[[318,1766],[1850,1766],[1850,1818],[318,1818]],"region":{"top_left_x":317,"top_left_y":1766,"width":1533,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8343c6041c849acb243b910d40cb58e","type":"text","conversion_output":true,"text":"portion of the trial will receive oral MLN9708 at a fixed dose of 4.0 mg (the RP2D dose of","text_display":" portion of the trial will receive oral MLN9708 at a fixed dose of 4.0 mg (the RP2D dose of","confidence":1,"confidence_rate":1},{"cnt":[[318,1822],[1197,1822],[1197,1880],[318,1880]],"region":{"top_left_x":317,"top_left_y":1821,"width":880,"height":59},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18c17c5ebc5547faab4dcfb1b2f64c08","type":"text","conversion_output":true,"text":"\\(2.23 mg / m ^{2} \\times\\) the mean patient BSA of \\(1.86 m^{2}\\).[11]","text_display":" \\(2.23 mg / m ^{2} \\times\\) the mean patient BSA of \\(1.86 m^{2}\\).[11]","confidence":0.9863911935276519,"confidence_rate":0.9998220644679434},{"cnt":[[320,1934],[1779,1934],[1779,1983],[320,1983]],"region":{"top_left_x":320,"top_left_y":1933,"width":1459,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"621e6ec14e764642b370e1212799b5f4","type":"text","conversion_output":true,"text":"As of 12 October 2011, patients in Study C16005 have completed a median of 5 cycles","text_display":"\n\nAs of 12 October 2011, patients in Study C16005 have completed a median of 5 cycles","confidence":1,"confidence_rate":1},{"cnt":[[320,1994],[1777,1994],[1777,2047],[320,2047]],"region":{"top_left_x":320,"top_left_y":1993,"width":1457,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77c2fc350b3548f1a9d60c3c3c6b8968","type":"text","conversion_output":true,"text":"(range 1-9). To date, all 15 response-evaluable patients have achieved a PR or better to","text_display":" (range 1-9). To date, all 15 response-evaluable patients have achieved a PR or better to","confidence":0.9931719303131104,"confidence_rate":0.9999286328840966},{"cnt":[[318,2062],[1811,2062],[1811,2112],[318,2112]],"region":{"top_left_x":317,"top_left_y":2062,"width":1495,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7d7747c55364fdd91b2983bfd7dac36","type":"text","conversion_output":true,"text":"therapy including 4 CRs, 4 VGPRs, and 7 PRs; 14 out of 15 patients achieved \\(\\geq\\) PR after","text_display":" therapy including 4 CRs, 4 VGPRs, and 7 PRs; 14 out of 15 patients achieved \\(\\geq\\) PR after","confidence":0.99658203125,"confidence_rate":0.9999685892699369},{"cnt":[[318,2127],[1201,2127],[1201,2179],[318,2179]],"region":{"top_left_x":317,"top_left_y":2126,"width":884,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"953da7a3d45e464c8d1b5d1029709e9a","type":"text","conversion_output":true,"text":"Cycle 1, and all 15 achieved \\(\\geq\\) PR after Cycle 2.[11]","text_display":" Cycle 1, and all 15 achieved \\(\\geq\\) PR after Cycle 2.[11]","confidence":0.9985356330871582,"confidence_rate":0.9999767393158365},{"cnt":[[320,2230],[1871,2230],[1871,2282],[320,2282]],"region":{"top_left_x":320,"top_left_y":2230,"width":1552,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9cea01964294caebc4b6ef315f245f4","type":"text","conversion_output":true,"text":"A summary of the safety profile of patients treated in Study C16005 is outlined in Table 1-5.","text_display":"\n\nA summary of the safety profile of patients treated in Study C16005 is outlined in Table 1-5.","confidence":1,"confidence_rate":1},{"cnt":[[318,2295],[1813,2295],[1813,2344],[318,2344]],"region":{"top_left_x":317,"top_left_y":2294,"width":1497,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0a5c63d30594fbeab58d13506421a42","type":"text","conversion_output":true,"text":"Overall, \\(100 \\%\\) of patients experienced a TEAE of any grade and of any cause. Peripheral","text_display":" Overall, \\(100 \\%\\) of patients experienced a TEAE of any grade and of any cause. Peripheral","confidence":0.9228515625,"confidence_rate":0.9991462489284806},{"cnt":[[318,2357],[1205,2357],[1205,2408],[318,2408]],"region":{"top_left_x":317,"top_left_y":2356,"width":889,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbce910e26eb451298dc7cc7c82ebb27","type":"text","conversion_output":true,"text":"neuropathy was limited to Grade 1 or 2 in 3 patients.","text_display":" neuropathy was limited to Grade 1 or 2 in 3 patients.","confidence":1,"confidence_rate":1},{"cnt":[[1074,2585],[1126,2585],[1126,2628],[1074,2628]],"region":{"top_left_x":1074,"top_left_y":2584,"width":52,"height":44},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45a34d82deb24e85a96020279ac77a7d","type":"page_info","conversion_output":false,"text":"28","text_display":"","confidence":0.98876953125,"confidence_rate":0.9943689110435825}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-030","page":30,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a890638ef9034d11a46d1d772b8c9dc0","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2840be8903d1442aa54ae2e7ebd2bb2d","type":"page_info","conversion_output":false,"text":"Clinical 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This study is currently enrolling","text_display":" refractory AL amyloidosis after at least 1 prior therapy. 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Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,251],[1815,251],[1815,303],[320,303]],"region":{"top_left_x":320,"top_left_y":251,"width":1496,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddc859dee9cc4e368d5a63f44efbf827","type":"text","conversion_output":true,"text":"and improving drug administration, while building on the efficacy seen with VELCADE.","text_display":"\nand improving drug administration, while building on the efficacy seen with VELCADE.","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[320,314],[1809,314],[1809,365],[320,365]],"region":{"top_left_x":320,"top_left_y":313,"width":1489,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c227029d42b42b381a6b9356717678f","type":"text","conversion_output":true,"text":"Given that MLN9708 has improved binding kinetics and a similar pharmacologic profile","text_display":" Given that MLN9708 has improved binding kinetics and a similar pharmacologic profile","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1867,374],[1867,425],[318,425]],"region":{"top_left_x":317,"top_left_y":373,"width":1550,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3dc8dbacefa47fd9097a1e41e568e08","type":"text","conversion_output":true,"text":"compared with VELCADE, it is expected that these differences will translate into similar, if","text_display":" compared with VELCADE, it is expected that these differences will translate into similar, if","confidence":1,"confidence_rate":1},{"cnt":[[318,438],[1876,438],[1876,488],[318,488]],"region":{"top_left_x":317,"top_left_y":438,"width":1559,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42f65630976244d9b85a78f54c3864db","type":"text","conversion_output":true,"text":"not improved, efficacy and 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The most common TEAEs,","confidence":1,"confidence_rate":1},{"cnt":[[318,915],[1732,915],[1732,967],[318,967]],"region":{"top_left_x":317,"top_left_y":915,"width":1415,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"979668e91f704e41a2b15473b8de5677","type":"text","conversion_output":true,"text":"regardless of causality, of single-agent MLN9708 across all dose level cohorts in all","text_display":" regardless of causality, of single-agent MLN9708 across all dose level cohorts in all","confidence":0.99755859375,"confidence_rate":0.9999728404650293},{"cnt":[[318,975],[1775,975],[1775,1029],[318,1029]],"region":{"top_left_x":317,"top_left_y":975,"width":1458,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f23387a711b94f728af4043bb1caba81","type":"text","conversion_output":true,"text":"phase 1 studies reported to date, as discussed in Section 1.3, were anticipated based on","text_display":" phase 1 studies reported to date, as discussed in Section 1.3, were anticipated based on","confidence":1,"confidence_rate":1},{"cnt":[[318,1040],[1783,1040],[1783,1091],[318,1091]],"region":{"top_left_x":317,"top_left_y":1039,"width":1467,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dff2996c68414408afcfe3a5b5d43709","type":"text","conversion_output":true,"text":"preclinical data and previous experience with bortezomib. Given the available data, the","text_display":" preclinical data and previous experience with bortezomib. Given the available data, the","confidence":1,"confidence_rate":1},{"cnt":[[318,1102],[1811,1102],[1811,1154],[318,1154]],"region":{"top_left_x":317,"top_left_y":1102,"width":1495,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a02270b50b54428bb7525ace76c3ec65","type":"text","conversion_output":true,"text":"similar nonclinical toxicity profile between MLN2238 and bortezomib, and the toxicities","text_display":" similar nonclinical toxicity profile between MLN2238 and bortezomib, and the toxicities","confidence":1,"confidence_rate":1},{"cnt":[[320,1164],[1796,1164],[1796,1214],[320,1214]],"region":{"top_left_x":320,"top_left_y":1164,"width":1477,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bcae890b3954401ad1ebb2e75d9a2dc","type":"text","conversion_output":true,"text":"demonstrated in studies with lenalidomide and dexamethasone and the low potential for","text_display":" demonstrated in studies with lenalidomide and dexamethasone and the low potential for","confidence":1,"confidence_rate":1},{"cnt":[[320,1227],[1824,1227],[1824,1278],[320,1278]],"region":{"top_left_x":320,"top_left_y":1226,"width":1505,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54a6f722d1ec4892bac397decd80b9c3","type":"text","conversion_output":true,"text":"drug-drug interactions, it is anticipated that any potential for overlapping toxicities with a","text_display":" drug-drug interactions, it is anticipated that any potential for overlapping toxicities with a","confidence":1,"confidence_rate":1},{"cnt":[[318,1289],[1863,1289],[1863,1338],[318,1338]],"region":{"top_left_x":317,"top_left_y":1289,"width":1546,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e638d2f65fa24300836eceb0a0f88294","type":"text","conversion_output":true,"text":"combination of MLN9708, lenalidomide, and dexamethasone can be monitored in the clinic","text_display":" combination of MLN9708, lenalidomide, and dexamethasone can be monitored in the clinic","confidence":1,"confidence_rate":1},{"cnt":[[318,1354],[1231,1354],[1231,1403],[318,1403]],"region":{"top_left_x":317,"top_left_y":1353,"width":915,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c702b45054146c4aea29f702e7cb65c","type":"text","conversion_output":true,"text":"with routine clinical observations and laboratory tests.","text_display":" with routine clinical observations and laboratory tests.","confidence":1,"confidence_rate":1},{"cnt":[[318,1457],[1867,1457],[1867,1504],[318,1504]],"region":{"top_left_x":317,"top_left_y":1456,"width":1550,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9998bbbb620c45cc8e53f1db83de0409","type":"text","conversion_output":true,"text":"Patients enrolled in both arms of C 16010 will receive lenalidomide and dexamethasone, one","text_display":"\n\nPatients enrolled in both arms of C 16010 will receive lenalidomide and dexamethasone, one","confidence":0.6843786239624023,"confidence_rate":0.9962147425101842},{"cnt":[[318,1517],[1841,1517],[1841,1571],[318,1571]],"region":{"top_left_x":317,"top_left_y":1516,"width":1525,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fd1bee060194fb18214de1df6b9110e","type":"text","conversion_output":true,"text":"of several regimens recommended by the International Myeloma Working Group (IMWG)","text_display":" of several regimens recommended by the International Myeloma Working Group (IMWG)","confidence":1,"confidence_rate":1},{"cnt":[[320,1581],[1794,1581],[1794,1631],[320,1631]],"region":{"top_left_x":320,"top_left_y":1581,"width":1474,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb5ac38a4e8a4058bbcd2fdb5a91d3ad","type":"text","conversion_output":true,"text":"as well as the NCCN. While initial data from ongoing trials are promising regarding the","text_display":" as well as the NCCN. While initial data from ongoing trials are promising regarding the","confidence":0.9970715045928955,"confidence_rate":0.9999681223359308},{"cnt":[[318,1644],[1876,1644],[1876,1695],[318,1695]],"region":{"top_left_x":317,"top_left_y":1643,"width":1559,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f55dbba148984afc88e50462debba786","type":"text","conversion_output":true,"text":"addition of bortezomib to this regimen, longer follow up and data from randomized phase III","text_display":" addition of bortezomib to this regimen, longer follow up and data from randomized phase III","confidence":1,"confidence_rate":1},{"cnt":[[318,1706],[1669,1706],[1669,1755],[318,1755]],"region":{"top_left_x":317,"top_left_y":1705,"width":1353,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1fbf02208e34c3fbc53775c9d40d69b","type":"text","conversion_output":true,"text":"studies are still needed before bortezomib is broadly incorporated into treatment","text_display":" studies are still needed before bortezomib is broadly incorporated into treatment","confidence":0.99853515625,"confidence_rate":0.999982954590827},{"cnt":[[318,1766],[707,1766],[707,1818],[318,1818]],"region":{"top_left_x":317,"top_left_y":1766,"width":390,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41e112887b464df68c7010acc1d46e7c","type":"text","conversion_output":true,"text":"recommendations.[21]","text_display":" recommendations.[21]","confidence":0.9921910762786865,"confidence_rate":0.9996864662408189},{"cnt":[[318,1869],[1876,1869],[1876,1923],[318,1923]],"region":{"top_left_x":317,"top_left_y":1869,"width":1559,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96dc97b4034e42749bfe075bf5a88a32","type":"text","conversion_output":true,"text":"This study is proposed based on the results of VELCADE in previously treated MM,[22] the","text_display":"\n\nThis study is proposed based on the results of VELCADE in previously treated MM,[22] the","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[318,1934],[1843,1934],[1843,1985],[318,1985]],"region":{"top_left_x":317,"top_left_y":1933,"width":1527,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"464c8cf2046c4a5f9259ff175fd4812d","type":"text","conversion_output":true,"text":"emerging activity seen with MLN9708 in the treatment of previously treated and untreated","text_display":" emerging activity seen with MLN9708 in the treatment of previously treated and untreated","confidence":1,"confidence_rate":1},{"cnt":[[318,1994],[1803,1994],[1803,2047],[318,2047]],"region":{"top_left_x":317,"top_left_y":1993,"width":1486,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71660d0962d942be989b515e32cbf975","type":"text","conversion_output":true,"text":"MM (see Section 1.3), and the urgent need for better treatment options for this incurable","text_display":" MM (see Section 1.3), and the urgent need for better treatment options for this incurable","confidence":0.99609375,"confidence_rate":0.9999583636399967},{"cnt":[[318,2058],[1766,2058],[1766,2110],[318,2110]],"region":{"top_left_x":317,"top_left_y":2058,"width":1450,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f18d7c9191584f538b2c28b9c8ca5619","type":"text","conversion_output":true,"text":"disease. This study is designed to determine the efficacy and safety of MLN9708 with","text_display":" disease. This study is designed to determine the efficacy and safety of MLN9708 with","confidence":1,"confidence_rate":1},{"cnt":[[318,2121],[1865,2121],[1865,2172],[318,2172]],"region":{"top_left_x":317,"top_left_y":2120,"width":1548,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"644f6cc5a19e475e82a13ebfdff9c897","type":"text","conversion_output":true,"text":"lenalidomide and dexamethasone, compared with lenalidomide and dexamethasone alone in","text_display":" lenalidomide and dexamethasone, compared with lenalidomide and dexamethasone alone in","confidence":1,"confidence_rate":1},{"cnt":[[318,2183],[1738,2183],[1738,2237],[318,2237]],"region":{"top_left_x":317,"top_left_y":2182,"width":1422,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3eb13d52fc84878bbbe5de456876c43","type":"text","conversion_output":true,"text":"patients with relapsed and/or refractory MM. The primary purpose of this study is to","text_display":" patients with relapsed and/or refractory MM. The primary purpose of this study is to","confidence":1,"confidence_rate":1},{"cnt":[[318,2243],[1609,2243],[1609,2297],[318,2297]],"region":{"top_left_x":317,"top_left_y":2242,"width":1293,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58e58a8846634b799c6dd8344fb330a7","type":"text","conversion_output":true,"text":"determine the progression-free survival of patients in the 2 treatment groups.","text_display":" determine the progression-free survival of patients in the 2 treatment groups.","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[1074,2582],[1126,2582],[1126,2625],[1074,2625]],"region":{"top_left_x":1074,"top_left_y":2582,"width":52,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de7ec0fb623b48beafdedb96d5deb127","type":"page_info","conversion_output":false,"text":"32","text_display":"","confidence":0.9794921875,"confidence_rate":0.9896929763820697}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-034","page":34,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7dc7652160c9469e94fcab2090e09bcc","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0fbdf158877f4265ba7ce5425b5d0e63","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[316,245],[1755,245],[1755,350],[316,350]],"region":{"top_left_x":315,"top_left_y":244,"width":1441,"height":107},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab7b4cb6a95f48b89ce15c8d37fc71ae","type":"section_header","conversion_output":false,"children_ids":["0d45c622f9424c9dbbce1eb917b3cbc3","c71fcedf3792492cb5a58d69dda61168"],"text":"","text_display":""},{"cnt":[[322,251],[1751,251],[1751,301],[322,301]],"region":{"top_left_x":322,"top_left_y":251,"width":1429,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d45c622f9424c9dbbce1eb917b3cbc3","type":"text","conversion_output":true,"parent_id":"ab7b4cb6a95f48b89ce15c8d37fc71ae","text":"1.4.2 Rationale for MLN9708, Lenalidomide, and Dexamethasone Dose and","text_display":"\n\n\\subsection*{1.4.2 Rationale for MLN9708, Lenalidomide, and Dexamethasone Dose and","confidence":1,"confidence_rate":1},{"cnt":[[494,301],[831,301],[831,342],[494,342]],"region":{"top_left_x":494,"top_left_y":300,"width":338,"height":42},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c71fcedf3792492cb5a58d69dda61168","type":"text","conversion_output":true,"parent_id":"ab7b4cb6a95f48b89ce15c8d37fc71ae","text":"Schedule Selection","text_display":" Schedule Selection}","confidence":1,"confidence_rate":1},{"cnt":[[320,391],[1781,391],[1781,440],[320,440]],"region":{"top_left_x":320,"top_left_y":391,"width":1462,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e77f770ed79f45908c9425211e6398fd","type":"text","conversion_output":true,"text":"MLN9708 administered weekly on Days 1, 8, and 15 of a 28 -day cycle is supported by","text_display":"\n\nMLN9708 administered weekly on Days 1, 8, and 15 of a 28 -day cycle is supported by","confidence":0.8209414679798783,"confidence_rate":0.9979032282647551},{"cnt":[[318,451],[1880,451],[1880,501],[318,501]],"region":{"top_left_x":317,"top_left_y":451,"width":1563,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af319bc532a1430f8e351340ee464b09","type":"text","conversion_output":true,"text":"nonclinical data and clinical trial results in which MLN9708 has been given as a single agent","text_display":" nonclinical data and clinical trial results in which MLN9708 has been given as a single agent","confidence":1,"confidence_rate":1},{"cnt":[[318,511],[1828,511],[1828,563],[318,563]],"region":{"top_left_x":317,"top_left_y":511,"width":1512,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6a9b5bb58db4d6ab6a1da78e8c08a85","type":"text","conversion_output":true,"text":"and in combination with lenalidomide and dexamethasone. The weekly schedule was well","text_display":" and in combination with lenalidomide and dexamethasone. The weekly schedule was well","confidence":1,"confidence_rate":1},{"cnt":[[318,576],[1850,576],[1850,625],[318,625]],"region":{"top_left_x":317,"top_left_y":575,"width":1533,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce82a85913184e46aaf4b646f42aa682","type":"text","conversion_output":true,"text":"tolerated in in vivo toxicology studies and was predicted to allow dosing on a schedule that","text_display":" tolerated in in vivo toxicology studies and was predicted to allow dosing on a schedule that","confidence":1,"confidence_rate":1},{"cnt":[[318,638],[1846,638],[1846,690],[318,690]],"region":{"top_left_x":317,"top_left_y":638,"width":1529,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b25a9957a92d43f490b37170b49baaba","type":"text","conversion_output":true,"text":"produced maximum antitumor activity in mouse models. Study C16004, a phase 1 study in","text_display":" produced maximum antitumor activity in mouse models. Study C16004, a phase 1 study in","confidence":1,"confidence_rate":1},{"cnt":[[318,700],[1807,700],[1807,750],[318,750]],"region":{"top_left_x":317,"top_left_y":700,"width":1490,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54e75001b1c84204b085f4e203824b4f","type":"text","conversion_output":true,"text":"adult patients with RRMM, investigated single-agent MLN9708 in this weekly schedule.","text_display":" adult patients with RRMM, investigated single-agent MLN9708 in this weekly schedule.","confidence":1,"confidence_rate":1},{"cnt":[[318,756],[1766,756],[1766,812],[318,812]],"region":{"top_left_x":317,"top_left_y":756,"width":1450,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5476af65a2644d149baaa3a30eb43fb4","type":"text","conversion_output":true,"text":"The estimated MTD is \\(2.97 mg / m ^{2}\\) with DLTs of transient rash, nausea, and vomiting.","text_display":" The estimated MTD is \\(2.97 mg / m ^{2}\\) with DLTs of transient rash, nausea, and vomiting.","confidence":0.99658203125,"confidence_rate":0.999966433667778},{"cnt":[[318,825],[1807,825],[1807,874],[318,874]],"region":{"top_left_x":317,"top_left_y":825,"width":1490,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d108582950a74d9ba866711e3b9475a8","type":"text","conversion_output":true,"text":"Given that the weekly schedule of MLN9708 combines well with the established 28-day","text_display":" Given that the weekly schedule of MLN9708 combines well with the established 28-day","confidence":0.97607421875,"confidence_rate":0.9997248486376835},{"cnt":[[318,887],[1828,887],[1828,939],[318,939]],"region":{"top_left_x":317,"top_left_y":887,"width":1512,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d18d83aee1e4b33833844155373acb1","type":"text","conversion_output":true,"text":"lenalidomide plus low-dose dexamethasone regimen providing a simple course of therapy","text_display":" lenalidomide plus low-dose dexamethasone regimen providing a simple course of therapy","confidence":1,"confidence_rate":1},{"cnt":[[318,950],[1833,950],[1833,1001],[318,1001]],"region":{"top_left_x":317,"top_left_y":949,"width":1516,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc31f99ab2894d4b9b37182c23c98485","type":"text","conversion_output":true,"text":"for patients, Study C16005, a phase 1/2 study of weekly MLN9708 plus a 28-day cycle of","text_display":" for patients, Study C16005, a phase 1/2 study of weekly MLN9708 plus a 28-day cycle of","confidence":0.9839015007019043,"confidence_rate":0.9998216698823433},{"cnt":[[318,1010],[1815,1010],[1815,1061],[318,1061]],"region":{"top_left_x":317,"top_left_y":1009,"width":1499,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf19ae1839d6448482f1f9c4f39cf59a","type":"text","conversion_output":true,"text":"lenalidomide ( 25 mg on Days 1-21) and dexamethasone ( 40 mg weekly on Days 1, 8, 15,","text_display":" lenalidomide ( 25 mg on Days 1-21) and dexamethasone ( 40 mg weekly on Days 1, 8, 15,","confidence":0.9276648410604397,"confidence_rate":0.9992494340748144},{"cnt":[[318,1074],[685,1074],[685,1124],[318,1124]],"region":{"top_left_x":317,"top_left_y":1074,"width":369,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a0dfcf6e8d24201b0ff38789420542f","type":"text","conversion_output":true,"text":"and 22) was initiated.","text_display":" and 22) was initiated.","confidence":0.9306640625,"confidence_rate":0.9973421715581481},{"cnt":[[318,1177],[1813,1177],[1813,1227],[318,1227]],"region":{"top_left_x":317,"top_left_y":1177,"width":1497,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9161369b156d4c5bb5e17044c67fbd35","type":"text","conversion_output":true,"text":"In the phase 1 portion of Study C16005, 3 evaluable patients were enrolled in each of the","text_display":"\n\nIn the phase 1 portion of Study C16005, 3 evaluable patients were enrolled in each of the","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[318,1233],[1751,1233],[1751,1291],[318,1291]],"region":{"top_left_x":317,"top_left_y":1233,"width":1434,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc7ed41b5e6d41b1a87b8b88a089d83f","type":"text","conversion_output":true,"text":"following dose cohorts: Cohort \\(1\\left(1.68 mg / m ^{2}\\right)\\), Cohort \\(2\\left(2.23 mg / m ^{2}\\right)\\), and Cohort 3","text_display":" following dose cohorts: Cohort \\(1\\left(1.68 mg / m ^{2}\\right)\\), Cohort \\(2\\left(2.23 mg / m ^{2}\\right)\\), and Cohort 3","confidence":0.9839714298955228,"confidence_rate":0.999860713002969},{"cnt":[[318,1296],[1777,1296],[1777,1354],[318,1354]],"region":{"top_left_x":317,"top_left_y":1295,"width":1460,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bf7f09bf83b420fad22403d92037903","type":"text","conversion_output":true,"text":"( \\(2.97 mg / m ^{2}\\) ), respectively. There were no DLTs noted for any of these patients during","text_display":" ( \\(2.97 mg / m ^{2}\\) ), respectively. There were no DLTs noted for any of these patients during","confidence":0.6975116729736328,"confidence_rate":0.9966389690834169},{"cnt":[[318,1358],[1869,1358],[1869,1414],[318,1414]],"region":{"top_left_x":317,"top_left_y":1357,"width":1553,"height":57},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fda16fa9936d46278933e64d2868583c","type":"text","conversion_output":true,"text":"Cycle 1. Three evaluable patients were enrolled in Cohort \\(4\\left(3.95 mg / m ^{2}\\right)\\). DLTs were noted","text_display":" Cycle 1. Three evaluable patients were enrolled in Cohort \\(4\\left(3.95 mg / m ^{2}\\right)\\). DLTs were noted","confidence":0.9016956480641056,"confidence_rate":0.9990511088779942},{"cnt":[[318,1418],[1828,1418],[1828,1476],[318,1476]],"region":{"top_left_x":317,"top_left_y":1417,"width":1512,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fad7480a3a64391870c5df864ad2f9d","type":"text","conversion_output":true,"text":"during Cycle 1 for 3 out of 3 patients in Cohort 4 at the \\(3.95- mg / m ^{2}\\) dose level. The DLTs","text_display":" during Cycle 1 for 3 out of 3 patients in Cohort 4 at the \\(3.95- mg / m ^{2}\\) dose level. The DLTs","confidence":0.9858739242190495,"confidence_rate":0.9998833936969235},{"cnt":[[318,1489],[1826,1489],[1826,1540],[318,1540]],"region":{"top_left_x":317,"top_left_y":1488,"width":1510,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db27ff16af744d84aa009687af3ba91d","type":"text","conversion_output":true,"text":"were Grade 3 fainting/passing out, nausea, vomiting, and diarrhea. Per protocol, dosing at","text_display":" were Grade 3 fainting/passing out, nausea, vomiting, and diarrhea. Per protocol, dosing at","confidence":1,"confidence_rate":1},{"cnt":[[318,1543],[1824,1543],[1824,1601],[318,1601]],"region":{"top_left_x":317,"top_left_y":1542,"width":1508,"height":59},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ba2818f54d74a1aa4db016a338d8edb","type":"text","conversion_output":true,"text":"the \\(3.95- mg / m ^{2}\\) dose level was stopped. Since 6 patients were not enrolled at the previous","text_display":" the \\(3.95- mg / m ^{2}\\) dose level was stopped. Since 6 patients were not enrolled at the previous","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[318,1607],[1826,1607],[1826,1663],[318,1663]],"region":{"top_left_x":317,"top_left_y":1607,"width":1510,"height":56},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91e568998be447b38d1e1b8456ef3cac","type":"text","conversion_output":true,"text":"dose level \\(\\left(2.97 mg / m ^{2}\\right), 3\\) additional patients were enrolled at this lower dose. One of the","text_display":" dose level \\(\\left(2.97 mg / m ^{2}\\right), 3\\) additional patients were enrolled at this lower dose. One of the","confidence":0.6718215942382812,"confidence_rate":0.9963905075859137},{"cnt":[[318,1676],[1781,1676],[1781,1725],[318,1725]],"region":{"top_left_x":317,"top_left_y":1675,"width":1465,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba6dfcc5a9c7465f8bfe18ec2f44204b","type":"text","conversion_output":true,"text":"additional 3 patients had DLT of Grade 3 rash during Cycle 1. Therefore, DLTs were","text_display":" additional 3 patients had DLT of Grade 3 rash during Cycle 1. Therefore, DLTs were","confidence":0.1138656023779136,"confidence_rate":0.9787174958337228},{"cnt":[[318,1732],[1876,1732],[1876,1790],[318,1790]],"region":{"top_left_x":317,"top_left_y":1731,"width":1559,"height":59},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee65b8005aa342a987ec954ba457161e","type":"text","conversion_output":true,"text":"noted for 1 out of 6 patients enrolled at the \\(2.97- mg / m ^{2}\\) dose level; according to the protocol,","text_display":" noted for 1 out of 6 patients enrolled at the \\(2.97- mg / m ^{2}\\) dose level; according to the protocol,","confidence":0.9990234375,"confidence_rate":0.9999919915103647},{"cnt":[[318,1792],[952,1792],[952,1850],[318,1850]],"region":{"top_left_x":317,"top_left_y":1791,"width":635,"height":59},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ec6761634914059a95dc3d0befd89ec","type":"text","conversion_output":true,"text":"\\(2.97 mg / m ^{2}\\) was determined as MTD.","text_display":" \\(2.97 mg / m ^{2}\\) was determined as MTD.","confidence":1,"confidence_rate":1},{"cnt":[[318,1904],[1854,1904],[1854,1953],[318,1953]],"region":{"top_left_x":317,"top_left_y":1903,"width":1538,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40356b5dc15147849628b29ccdecb118","type":"text","conversion_output":true,"text":"The clinical data were evaluated for the available phase 1 data, which included the analyses","text_display":"\n\nThe clinical data were evaluated for the available phase 1 data, which included the analyses","confidence":1,"confidence_rate":1},{"cnt":[[318,1968],[1738,1968],[1738,2017],[318,2017]],"region":{"top_left_x":317,"top_left_y":1967,"width":1422,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"945656943e024c17b24fc9dc6c43b9f8","type":"text","conversion_output":true,"text":"of efficacy results (response rates: PR, VGPR, and CR) and toxicity characterization","text_display":" of efficacy results (response rates: PR, VGPR, and CR) and toxicity characterization","confidence":1,"confidence_rate":1},{"cnt":[[318,2028],[1751,2028],[1751,2082],[318,2082]],"region":{"top_left_x":317,"top_left_y":2028,"width":1434,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77970378b527470fb6848aa6c8eb7bf2","type":"text","conversion_output":true,"text":"(Grade \\(3 / 4 AEs\\), SAEs, all grades peripheral neuropathy, dose holding, and treatment","text_display":" (Grade \\(3 / 4 AEs\\), SAEs, all grades peripheral neuropathy, dose holding, and treatment","confidence":0.8092739880084991,"confidence_rate":0.9977512795691967},{"cnt":[[314,2090],[1781,2090],[1781,2142],[314,2142]],"region":{"top_left_x":313,"top_left_y":2090,"width":1469,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1073b496575846bb8a73f8d8e1859053","type":"text","conversion_output":true,"text":"discontinuation). Cycle 1 data from 15 evaluable patients were reviewed, as well as the","text_display":" discontinuation). Cycle 1 data from 15 evaluable patients were reviewed, as well as the","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[318,2153],[1800,2153],[1800,2202],[318,2202]],"region":{"top_left_x":317,"top_left_y":2152,"width":1484,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"640d22e33aad4833a4819453ec352c15","type":"text","conversion_output":true,"text":"available clinical data supporting tolerance over multiple treatment cycles. AEs that met","text_display":" available clinical data supporting tolerance over multiple treatment cycles. AEs that met","confidence":1,"confidence_rate":1},{"cnt":[[318,2217],[1712,2217],[1712,2267],[318,2267]],"region":{"top_left_x":317,"top_left_y":2217,"width":1396,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"991a89612fd943d89a36ca3ed024ae90","type":"text","conversion_output":true,"text":"DLT criteria in Cycle 2 and beyond were considered, and toxicities leading to dose","text_display":" DLT criteria in Cycle 2 and beyond were considered, and toxicities leading to dose","confidence":1,"confidence_rate":1},{"cnt":[[318,2277],[1296,2277],[1296,2327],[318,2327]],"region":{"top_left_x":317,"top_left_y":2277,"width":979,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36400202291f45caba29205fe3421813","type":"text","conversion_output":true,"text":"modification in Cycle 2 and beyond were also considered.","text_display":" modification in Cycle 2 and beyond were also considered.","confidence":0.998046875,"confidence_rate":0.9999694530472583},{"cnt":[[318,2376],[1854,2376],[1854,2434],[318,2434]],"region":{"top_left_x":317,"top_left_y":2376,"width":1538,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6b018af74a74f5ba1f0ac1efc7396f1","type":"text","conversion_output":true,"text":"Six patients were enrolled at the \\(2.97- mg / m ^{2}\\) dose level. All 6 patients received all doses of","text_display":"\n\nSix patients were enrolled at the \\(2.97- mg / m ^{2}\\) dose level. All 6 patients received all doses of","confidence":1,"confidence_rate":1},{"cnt":[[318,2445],[1876,2445],[1876,2494],[318,2494]],"region":{"top_left_x":317,"top_left_y":2444,"width":1559,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05e29836764a45a6a3ec2a073d211a1b","type":"text","conversion_output":true,"text":"MLN9708 and dexamethasone during Cycle 1. However, 3 out of 6 patients were not able to","text_display":" MLN9708 and dexamethasone during Cycle 1. However, 3 out of 6 patients were not able to","confidence":0.99462890625,"confidence_rate":0.9999450467147566},{"cnt":[[1074,2585],[1124,2585],[1124,2625],[1074,2625]],"region":{"top_left_x":1074,"top_left_y":2584,"width":50,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9e83aad16234d25928324b1534b166f","type":"page_info","conversion_output":false,"text":"33","text_display":"","confidence":0.99853515625,"confidence_rate":0.9992673097074676}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-035","page":35,"lines":[{"cnt":[[320,129],[496,129],[496,165],[320,165]],"region":{"top_left_x":320,"top_left_y":128,"width":177,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16466526ac004e46b271de956fee90b2","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e814ca47613147fa840168e3ad9c9724","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,251],[1755,251],[1755,303],[318,303]],"region":{"top_left_x":317,"top_left_y":251,"width":1439,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d79c4da0ec8c4a008ebf35458b17b402","type":"text","conversion_output":true,"text":"receive all of their lenalidomide doses during Cycle 1 due to Grade 2 or 3 rash. Three","text_display":"\nreceive all of their lenalidomide doses during Cycle 1 due to Grade 2 or 3 rash. Three","confidence":1,"confidence_rate":1},{"cnt":[[318,305],[1785,305],[1785,363],[318,363]],"region":{"top_left_x":317,"top_left_y":305,"width":1469,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3518208ad88d4ba4afc94b1de4a69624","type":"text","conversion_output":true,"text":"patients were enrolled at the \\(2.23- mg / m ^{2}\\) dose level. All 3 patients received all doses of","text_display":" patients were enrolled at the \\(2.23- mg / m ^{2}\\) dose level. All 3 patients received all doses of","confidence":1,"confidence_rate":1},{"cnt":[[320,374],[1824,374],[1824,425],[320,425]],"region":{"top_left_x":320,"top_left_y":373,"width":1505,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f38d9d3c1bc3446fae4c2bff910479f4","type":"text","conversion_output":true,"text":"MLN9708, dexamethasone, and lenalidomide during Cycles 1 through 3, except 1 patient","text_display":" MLN9708, dexamethasone, and lenalidomide during Cycles 1 through 3, except 1 patient","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[318,438],[1824,438],[1824,488],[318,488]],"region":{"top_left_x":317,"top_left_y":438,"width":1508,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab6e9aabdfff4c2bb39c171801d802f5","type":"text","conversion_output":true,"text":"who did not receive 1 dose of dexamethasone during Cycle 2. After 4 cycles of treatment,","text_display":" who did not receive 1 dose of dexamethasone during Cycle 2. After 4 cycles of treatment,","confidence":0.9825031401123852,"confidence_rate":0.9998217154986043},{"cnt":[[318,494],[1861,494],[1861,552],[318,552]],"region":{"top_left_x":317,"top_left_y":494,"width":1544,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23aca6c0f428420f8cb65cf17f0788bf","type":"text","conversion_output":true,"text":"the patients enrolled at \\(2.23 mg / m ^{2}\\) achieved responses of CR, PR, and VGPR, respectively.","text_display":" the patients enrolled at \\(2.23 mg / m ^{2}\\) achieved responses of CR, PR, and VGPR, respectively.","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[318,563],[1830,563],[1830,612],[318,612]],"region":{"top_left_x":317,"top_left_y":562,"width":1514,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b02df532f4344abb9dafbad0f2c44712","type":"text","conversion_output":true,"text":"All 3 patients achieved PR after Cycle 1, 2 of them achieved VGPR after Cycle 2, and CR","text_display":" All 3 patients achieved PR after Cycle 1, 2 of them achieved VGPR after Cycle 2, and CR","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[318,614],[1794,614],[1794,677],[318,677]],"region":{"top_left_x":317,"top_left_y":614,"width":1477,"height":63},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff924315cffd4906b1017a3c0733ecc3","type":"text","conversion_output":true,"text":"after Cycle 4 and Cycle 5. Given that the dose of MLN9708 at \\(2.97 mg / m ^{2}\\) significantly","text_display":" after Cycle 4 and Cycle 5. Given that the dose of MLN9708 at \\(2.97 mg / m ^{2}\\) significantly","confidence":0.9990234375,"confidence_rate":0.9999909533775151},{"cnt":[[318,688],[1826,688],[1826,737],[318,737]],"region":{"top_left_x":317,"top_left_y":687,"width":1510,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d497e1b07024f76a97a2e05c9511ef9","type":"text","conversion_output":true,"text":"compromised the doses of the lenalidomide and dexamethasone background regimen, and","text_display":" compromised the doses of the lenalidomide and dexamethasone background regimen, and","confidence":1,"confidence_rate":1},{"cnt":[[318,743],[1777,743],[1777,799],[318,799]],"region":{"top_left_x":317,"top_left_y":743,"width":1460,"height":57},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03a08c9fd5644a5885994883f19c598f","type":"text","conversion_output":true,"text":"that the dose of \\(2.23 mg / m ^{2}\\) is very tolerable and clinically active, the clinical team has","text_display":" that the dose of \\(2.23 mg / m ^{2}\\) is very tolerable and clinically active, the clinical team has","confidence":1,"confidence_rate":1},{"cnt":[[318,804],[1764,804],[1764,864],[318,864]],"region":{"top_left_x":317,"top_left_y":803,"width":1447,"height":61},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf2195f541204a2d9a458d64ab5cb39e","type":"text","conversion_output":true,"text":"proposed to use \\(2.23 mg / m ^{2}\\) as the dose for the pivotal phase 3 trial. More data will be","text_display":" proposed to use \\(2.23 mg / m ^{2}\\) as the dose for the pivotal phase 3 trial. More data will be","confidence":1,"confidence_rate":1},{"cnt":[[318,872],[1852,872],[1852,924],[318,924]],"region":{"top_left_x":317,"top_left_y":872,"width":1535,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"798a3d655bb54b76be5400f7c1ed0df7","type":"text","conversion_output":true,"text":"gained from the phase 2 cohort of the ongoing C16005 study, in which patients will receive","text_display":" gained from the phase 2 cohort of the ongoing C16005 study, in which patients will receive","confidence":0.99267578125,"confidence_rate":0.9999249908487245},{"cnt":[[318,928],[758,928],[758,986],[318,986]],"region":{"top_left_x":317,"top_left_y":928,"width":442,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3277e61f107048369610177fc56bd96b","type":"text","conversion_output":true,"text":"MLN9708 at \\(2.23 mg / m ^{2}\\).","text_display":" MLN9708 at \\(2.23 mg / m ^{2}\\).","confidence":1,"confidence_rate":1},{"cnt":[[318,1033],[1790,1033],[1790,1091],[318,1091]],"region":{"top_left_x":317,"top_left_y":1033,"width":1473,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e96620503b741d687cbad917908799b","type":"text","conversion_output":true,"text":"This recommended starting dose of \\(2.23 mg / m ^{2}\\) is translated into a fixed dose of 4.0 mg","text_display":"\n\nThis recommended starting dose of \\(2.23 mg / m ^{2}\\) is translated into a fixed dose of 4.0 mg","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[318,1104],[1882,1104],[1882,1154],[318,1154]],"region":{"top_left_x":317,"top_left_y":1104,"width":1566,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d52be6dde75a4cbc9173014943316032","type":"text","conversion_output":true,"text":"based on the results from the population PK analysis. At initiation of clinical development of","text_display":" based on the results from the population PK analysis. At initiation of clinical development of","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[318,1164],[1880,1164],[1880,1214],[318,1214]],"region":{"top_left_x":317,"top_left_y":1164,"width":1563,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"162f9ff5bd0a4431a77cc1e49e822f02","type":"text","conversion_output":true,"text":"MLN9708, early phase 1 clinical studies empirically used a BSA-based dosing approach that","text_display":" MLN9708, early phase 1 clinical studies empirically used a BSA-based dosing approach that","confidence":1,"confidence_rate":1},{"cnt":[[318,1229],[1852,1229],[1852,1278],[318,1278]],"region":{"top_left_x":317,"top_left_y":1228,"width":1535,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69ece4708033451ca18197189a1e5e36","type":"text","conversion_output":true,"text":"has been traditionally used in the development of cytotoxic anticancer agents. Accordingly,","text_display":" has been traditionally used in the development of cytotoxic anticancer agents. Accordingly,","confidence":1,"confidence_rate":1},{"cnt":[[318,1283],[1876,1283],[1876,1338],[318,1338]],"region":{"top_left_x":317,"top_left_y":1282,"width":1559,"height":57},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"facea583020e458f955670d916284188","type":"text","conversion_output":true,"text":"dosing of MLN9708 in individual patients was BSA-scaled (in \\(mg / m ^{2}\\) ) in Study C16005 and","text_display":" dosing of MLN9708 in individual patients was BSA-scaled (in \\(mg / m ^{2}\\) ) in Study C16005 and","confidence":1,"confidence_rate":1},{"cnt":[[318,1351],[1863,1351],[1863,1403],[318,1403]],"region":{"top_left_x":317,"top_left_y":1351,"width":1546,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3e360ceaea044b89a1a376cd3b54475","type":"text","conversion_output":true,"text":"in 4 ongoing single-agent trials (Studies C16001, C16002, C16003, and C16004). However,","text_display":" in 4 ongoing single-agent trials (Studies C16001, C16002, C16003, and C16004). However,","confidence":1,"confidence_rate":1},{"cnt":[[318,1409],[1852,1409],[1852,1463],[318,1463]],"region":{"top_left_x":317,"top_left_y":1409,"width":1535,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7bc75ecae904b3ea9f239d4b02f92fb","type":"text","conversion_output":true,"text":"it is well known that the clearance of small molecule drugs is typically not a linear function","text_display":" it is well known that the clearance of small molecule drugs is typically not a linear function","confidence":1,"confidence_rate":1},{"cnt":[[320,1474],[1858,1474],[1858,1528],[320,1528]],"region":{"top_left_x":320,"top_left_y":1473,"width":1539,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54ee1fdf1f3f48f7acb9d903ff30e71e","type":"text","conversion_output":true,"text":"of BSA and the appropriateness of traditional BSA-scaled approaches for dosing anticancer","text_display":" of BSA and the appropriateness of traditional BSA-scaled approaches for dosing anticancer","confidence":1,"confidence_rate":1},{"cnt":[[320,1538],[1618,1538],[1618,1588],[320,1588]],"region":{"top_left_x":320,"top_left_y":1538,"width":1298,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96861ffe8f824597b691c282a4e54207","type":"text","conversion_output":true,"text":"agents has been critically questioned in the recent scientific literature.[23-26]","text_display":" agents has been critically questioned in the recent scientific literature.[23-26]","confidence":1,"confidence_rate":1},{"cnt":[[318,1644],[1858,1644],[1858,1695],[318,1695]],"region":{"top_left_x":317,"top_left_y":1643,"width":1542,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66b432f75e2548548f2e95dba62f1594","type":"text","conversion_output":true,"text":"Therefore, a preliminary population PK analysis was performed for MLN9708 based on the","text_display":"\n\nTherefore, a preliminary population PK analysis was performed for MLN9708 based on the","confidence":1,"confidence_rate":1},{"cnt":[[320,1706],[1811,1706],[1811,1755],[320,1755]],"region":{"top_left_x":320,"top_left_y":1705,"width":1492,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"207faf75ef384d5b916e48928da1e96b","type":"text","conversion_output":true,"text":"available data from 4 ongoing phase 1 studies to quantitatively assess the contribution of","text_display":" available data from 4 ongoing phase 1 studies to quantitatively assess the contribution of","confidence":0.9931671619415283,"confidence_rate":0.999932118256735},{"cnt":[[320,1766],[1708,1766],[1708,1818],[320,1818]],"region":{"top_left_x":320,"top_left_y":1766,"width":1389,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ceb58305eaf485fb4410b8fbea32dbd","type":"text","conversion_output":true,"text":"interpatient variability in BSA to the overall interpatient variability in clearance of","text_display":" interpatient variability in BSA to the overall interpatient variability in clearance of","confidence":1,"confidence_rate":1},{"cnt":[[320,1828],[1880,1828],[1880,1880],[320,1880]],"region":{"top_left_x":320,"top_left_y":1828,"width":1560,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"322360a41ddc4659ab04275b377e5860","type":"text","conversion_output":true,"text":"MLN9708, and thereby evaluate the feasibility of switching from BSA-based dosing to fixed","text_display":" MLN9708, and thereby evaluate the feasibility of switching from BSA-based dosing to fixed","confidence":1,"confidence_rate":1},{"cnt":[[320,1891],[1807,1891],[1807,1944],[320,1944]],"region":{"top_left_x":320,"top_left_y":1890,"width":1487,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faefceeca0e0463b858296998135c342","type":"text","conversion_output":true,"text":"dosing in future clinical development. A population PK model was built using data from","text_display":" dosing in future clinical development. A population PK model was built using data from","confidence":1,"confidence_rate":1},{"cnt":[[318,1953],[1768,1953],[1768,2004],[318,2004]],"region":{"top_left_x":317,"top_left_y":1952,"width":1452,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04b810abc0444dab9c5db0b47ffa45e0","type":"text","conversion_output":true,"text":"both the twice-weekly and once-weekly IV ( \\(n =86\\) ) and oral ( \\(n =51\\) ) dosing regimens","text_display":" both the twice-weekly and once-weekly IV ( \\(n =86\\) ) and oral ( \\(n =51\\) ) dosing regimens","confidence":0.5538325309753418,"confidence_rate":0.9941084941019843},{"cnt":[[320,2015],[1815,2015],[1815,2067],[320,2067]],"region":{"top_left_x":320,"top_left_y":2015,"width":1496,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e57866007cc8497a9cac1565cd5c19c8","type":"text","conversion_output":true,"text":"( N \\& 137). Population PK analysis showed that MLN9708 PK can be well described by a","text_display":" ( N \\& 137). Population PK analysis showed that MLN9708 PK can be well described by a","confidence":0.23527553879155158,"confidence_rate":0.9848838561224587},{"cnt":[[316,2075],[1850,2075],[1850,2129],[316,2129]],"region":{"top_left_x":315,"top_left_y":2075,"width":1535,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e727a92819644feba146303cf72f3943","type":"text","conversion_output":true,"text":"3-compartment model with linear elimination for IV data and with an additional absorption","text_display":" 3-compartment model with linear elimination for IV data and with an additional absorption","confidence":0.995610237121582,"confidence_rate":0.9999531986890711},{"cnt":[[318,2140],[1706,2140],[1706,2191],[318,2191]],"region":{"top_left_x":317,"top_left_y":2139,"width":1389,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"619b4ff5b2dc4ced8028e6eb2c4481ec","type":"text","conversion_output":true,"text":"compartment (first order absorption) for oral data. Covariate analyses indicate that","text_display":" compartment (first order absorption) for oral data. Covariate analyses indicate that","confidence":1,"confidence_rate":1},{"cnt":[[322,2202],[1809,2202],[1809,2254],[322,2254]],"region":{"top_left_x":322,"top_left_y":2202,"width":1487,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b0b7aaa0e5048458e489acfa55ee00e","type":"text","conversion_output":true,"text":"interpatient variability in BSA, and/or body weight did not significantly contribute to the","text_display":" interpatient variability in BSA, and/or body weight did not significantly contribute to the","confidence":1,"confidence_rate":1},{"cnt":[[320,2264],[1811,2264],[1811,2316],[320,2316]],"region":{"top_left_x":320,"top_left_y":2264,"width":1492,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6222d3cf26a14a5a8ade994d00d85467","type":"text","conversion_output":true,"text":"variability in clearance (CL) and volume of distribution (V2) in the central compartment.","text_display":" variability in clearance (CL) and volume of distribution (V2) in the central compartment.","confidence":1,"confidence_rate":1},{"cnt":[[320,2327],[1876,2327],[1876,2378],[320,2378]],"region":{"top_left_x":320,"top_left_y":2326,"width":1556,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a05ab5cbb83e46eb8b5fdbf5ecea5b28","type":"text","conversion_output":true,"text":"Clearance and volume of distribution in the central compartment (V2) are the PK parameters","text_display":" Clearance and volume of distribution in the central compartment (V2) are the PK parameters","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[320,2389],[1828,2389],[1828,2443],[320,2443]],"region":{"top_left_x":320,"top_left_y":2389,"width":1509,"height":54},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47e82bae667246f9ab422b5d565c8da4","type":"text","conversion_output":true,"text":"that will affect AUC and single-dose maximum (peak) concentration ( \\(C _{\\text {max }}\\) ). The lack of a","text_display":" that will affect AUC and single-dose maximum (peak) concentration ( \\(C _{\\text {max }}\\) ). The lack of a","confidence":0.9951231479644775,"confidence_rate":0.9999563511072518},{"cnt":[[320,2454],[1671,2454],[1671,2503],[320,2503]],"region":{"top_left_x":320,"top_left_y":2453,"width":1352,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d53cfb3112a442f89002854003601077","type":"text","conversion_output":true,"text":"discernable relationship between BSA and MLN9708 clearance based on data in","text_display":" discernable relationship between BSA and MLN9708 clearance based on data in","confidence":1,"confidence_rate":1},{"cnt":[[1072,2582],[1126,2582],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2582,"width":54,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ecd5f0eef1d4afea243ae069f9ed4b0","type":"page_info","conversion_output":false,"text":"34","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-036","page":36,"lines":[{"cnt":[[320,129],[496,129],[496,165],[320,165]],"region":{"top_left_x":320,"top_left_y":128,"width":177,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"55a8f7083455400bb4db4efbb54a1059","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"783bbd51fb2c40eea90faa37cdb6db08","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,245],[1783,245],[1783,303],[322,303]],"region":{"top_left_x":322,"top_left_y":244,"width":1462,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f53e6872ae054db98514f75ac2a210e9","type":"text","conversion_output":true,"text":"137 patients over a relatively wide BSA range (1.4-2.6 \\(m ^{2}\\) ) indicates that total systemic","text_display":"\n\n137 patients over a relatively wide BSA range (1.4-2.6 \\(m ^{2}\\) ) indicates that total systemic","confidence":0.934843846385947,"confidence_rate":0.999364581465294},{"cnt":[[320,314],[1820,314],[1820,363],[320,363]],"region":{"top_left_x":320,"top_left_y":313,"width":1500,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c5ac0b496cf403680f8de7aad577376","type":"text","conversion_output":true,"text":"exposure (AUC) following fixed dosing should be independent of the individual patient's","text_display":" exposure (AUC) following fixed dosing should be independent of the individual patient's","confidence":1,"confidence_rate":1},{"cnt":[[320,374],[1871,374],[1871,423],[320,423]],"region":{"top_left_x":320,"top_left_y":373,"width":1552,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47cbd0636c514db99d3fdd319cbeaf09","type":"text","conversion_output":true,"text":"BSA (see Figure 1-1). Therefore, BSA is not expected to affect \\(C _{\\text {max }}\\) or AUC after IV or oral","text_display":" BSA (see Figure 1-1). Therefore, BSA is not expected to affect \\(C _{\\text {max }}\\) or AUC after IV or oral","confidence":0.7740359306335449,"confidence_rate":0.9977557065477808},{"cnt":[[322,438],[1815,438],[1815,488],[322,488]],"region":{"top_left_x":322,"top_left_y":438,"width":1494,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7634bc73d76948f39f19c99a26e2cd08","type":"text","conversion_output":true,"text":"dosing, and thus fixed dosing is appropriate for both oral and IV routes of administration.","text_display":" dosing, and thus fixed dosing is appropriate for both oral and IV routes of administration.","confidence":1,"confidence_rate":1},{"cnt":[[320,501],[1820,501],[1820,552],[320,552]],"region":{"top_left_x":320,"top_left_y":500,"width":1500,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75e1a26f791d4b9a8a88a2ecb27c4c4a","type":"text","conversion_output":true,"text":"The clinical development of MLN9708 has therefore transitioned from use of BSA-based","text_display":" The clinical development of MLN9708 has therefore transitioned from use of BSA-based","confidence":1,"confidence_rate":1},{"cnt":[[320,563],[1740,563],[1740,612],[320,612]],"region":{"top_left_x":320,"top_left_y":562,"width":1421,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b3b553d25194c088069cb2c4c394f72","type":"text","conversion_output":true,"text":"dosing to fixed dosing in all recently initiated phase 1/2 studies (eg, Studies C16007,","text_display":" dosing to fixed dosing in all recently initiated phase 1/2 studies (eg, Studies C16007,","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[320,623],[707,623],[707,672],[320,672]],"region":{"top_left_x":320,"top_left_y":623,"width":387,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8730d4f352bd4ec5b8cdd49bb9f5d6e8","type":"text","conversion_output":true,"text":"C16008, and C16009).","text_display":" C16008, and C16009).","confidence":1,"confidence_rate":1},{"cnt":[[318,728],[1867,728],[1867,780],[318,780]],"region":{"top_left_x":317,"top_left_y":728,"width":1550,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85e9f61674d3458cae6f1b3286c50dfe","type":"text","conversion_output":true,"text":"Accordingly, the starting dose of MLN9708 in the proposed phase 3 study is a fixed dose of","text_display":"\n\nAccordingly, the starting dose of MLN9708 in the proposed phase 3 study is a fixed dose of","confidence":1,"confidence_rate":1},{"cnt":[[318,784],[1871,784],[1871,844],[318,844]],"region":{"top_left_x":317,"top_left_y":784,"width":1555,"height":61},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c69781e6cc2f475db56bc52afc699020","type":"text","conversion_output":true,"text":"4.0 mg , based on the recommended dose of \\(2.23 mg / m ^{2}\\) (using mean patient BSA of \\(1.86 m^{2}\\)","text_display":" 4.0 mg , based on the recommended dose of \\(2.23 mg / m ^{2}\\) (using mean patient BSA of \\(1.86 m^{2}\\)","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[320,853],[1768,853],[1768,904],[320,904]],"region":{"top_left_x":320,"top_left_y":852,"width":1449,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f0032d375e44cce99f4013efcb0f7ee","type":"text","conversion_output":true,"text":"from the 2208 patients with MM in VELCADE clinical trials for conversion to a fixed","text_display":" from the 2208 patients with MM in VELCADE clinical trials for conversion to a fixed","confidence":1,"confidence_rate":1},{"cnt":[[320,915],[428,915],[428,965],[320,965]],"region":{"top_left_x":320,"top_left_y":915,"width":108,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b991611a04f4d02a68bf5ae774a5671","type":"text","conversion_output":true,"text":"dose).","text_display":" dose).","confidence":1,"confidence_rate":1},{"cnt":[[320,1018],[1760,1018],[1760,1072],[320,1072]],"region":{"top_left_x":320,"top_left_y":1018,"width":1440,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"014f008976c649c393ab103cf0709a95","type":"figure_label","conversion_output":false,"text":"Figure 1-1 No Apparent Relationship Between MLN9708 Clearance and BSA","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,1158],[1579,1155],[1581,1876],[348,1880]],"region":{"top_left_x":346,"top_left_y":1154,"width":1236,"height":726},"line":15,"column":0,"font_size":14,"is_printed":true,"is_handwritten":false,"id":"27d23649361e4e80a30a1a39e21c51be","type":"chart","conversion_output":true,"selected_labels":["014f008976c649c393ab103cf0709a95","36cd38a8836d420ab30501be0d4d3249"],"text":"","text_display":"\n\n\\begin{figure}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 1-1 No Apparent Relationship Between MLN9708 Clearance and BSA}\n\\includegraphics[alt={},max width=\\textwidth]{https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-036.jpg?height=726&width=1236&top_left_y=1154&top_left_x=346}\n\\end{figure}","subtype":"scatter"},{"cnt":[[314,1904],[1841,1904],[1841,2039],[314,2039]],"region":{"top_left_x":313,"top_left_y":1903,"width":1529,"height":136},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36cd38a8836d420ab30501be0d4d3249","type":"figure_label","conversion_output":false,"children_ids":["ff52608a94e946ebb65ddfd9f3d43119","c8029f97f480462e9990900d528f8a68","6f28351f5fdb4240a49444f0660c3984"],"text":"","text_display":""},{"cnt":[[320,1908],[1837,1908],[1837,1953],[320,1953]],"region":{"top_left_x":320,"top_left_y":1907,"width":1517,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff52608a94e946ebb65ddfd9f3d43119","type":"text","conversion_output":true,"parent_id":"36cd38a8836d420ab30501be0d4d3249","text":"Figure 1-1 provides a plot of individual values of MLN9708 clearance across the range of BSA (1.4-2.6 m2)","text_display":"\n\nFigure 1-1 provides a plot of individual values of MLN9708 clearance across the range of BSA (1.4-2.6 m2)","confidence":0.7034574817143948,"confidence_rate":0.9968073995630565},{"cnt":[[357,1951],[1766,1951],[1766,1996],[357,1996]],"region":{"top_left_x":356,"top_left_y":1950,"width":1411,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8029f97f480462e9990900d528f8a68","type":"text","conversion_output":true,"parent_id":"36cd38a8836d420ab30501be0d4d3249","text":"from 4 phase 1 studies \\(( N =137)\\). Each color identifies each study and the blue line represents linear","text_display":" from 4 phase 1 studies \\(( N =137)\\). 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Several clinical studies have shown that tumor biology can be","text_display":" with the biology of the host. 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Additional associations with","text_display":" survival, and/or drug resistance of a given patient's myeloma. 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These data point to","confidence":1,"confidence_rate":1},{"cnt":[[318,501],[1725,501],[1725,552],[318,552]],"region":{"top_left_x":317,"top_left_y":500,"width":1409,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"052cc535aa734ddc829e694126329e20","type":"text","conversion_output":true,"text":"the potential value of further exploring the relationship between predose circulating","text_display":" the potential value of further exploring the relationship between predose circulating","confidence":1,"confidence_rate":1},{"cnt":[[318,563],[1869,563],[1869,614],[318,614]],"region":{"top_left_x":317,"top_left_y":562,"width":1553,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fa8516d573f4bdaad95cb3764543d30","type":"text","conversion_output":true,"text":"proteasome levels and response to MLN9708. In this study, a blood sample will be collected","text_display":" proteasome levels and response to MLN9708. In this study, a blood sample will be collected","confidence":1,"confidence_rate":1},{"cnt":[[318,625],[1747,625],[1747,675],[318,675]],"region":{"top_left_x":317,"top_left_y":625,"width":1430,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a9e28502db942d08674c7db01101929","type":"text","conversion_output":true,"text":"at screening in order to test the levels of circulating proteasome and its association to","text_display":" at screening in order to test the levels of circulating proteasome and its association to","confidence":1,"confidence_rate":1},{"cnt":[[318,688],[657,688],[657,737],[318,737]],"region":{"top_left_x":317,"top_left_y":687,"width":341,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e261a3f050a54d5a8d7baf97ac7a2321","type":"text","conversion_output":true,"text":"MLN9708 efficacy.","text_display":" MLN9708 efficacy.","confidence":1,"confidence_rate":1},{"cnt":[[316,786],[1648,786],[1648,892],[316,892]],"region":{"top_left_x":315,"top_left_y":786,"width":1333,"height":106},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd63cb83aee14c5b94c0131681f0c640","type":"section_header","conversion_output":false,"children_ids":["8f7a8d0a90514f209f3c3f918aca25cd","32c7e7ccb21440beb79a4fdc58c59ae3"],"text":"","text_display":""},{"cnt":[[322,791],[1641,791],[1641,840],[322,840]],"region":{"top_left_x":322,"top_left_y":790,"width":1320,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f7a8d0a90514f209f3c3f918aca25cd","type":"text","conversion_output":true,"parent_id":"bd63cb83aee14c5b94c0131681f0c640","text":"1.4.4 Rationale for the Combination of MLN9708, Lenalidomide, and","text_display":"\n\n\\subsection*{1.4.4 Rationale for the Combination of MLN9708, Lenalidomide, and","confidence":1,"confidence_rate":1},{"cnt":[[494,842],[1396,842],[1396,887],[494,887]],"region":{"top_left_x":494,"top_left_y":842,"width":903,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32c7e7ccb21440beb79a4fdc58c59ae3","type":"text","conversion_output":true,"parent_id":"bd63cb83aee14c5b94c0131681f0c640","text":"Dexamethasone in a High-Risk Patient Population","text_display":" Dexamethasone in a High-Risk Patient Population}","confidence":1,"confidence_rate":1},{"cnt":[[320,928],[1833,928],[1833,978],[320,978]],"region":{"top_left_x":320,"top_left_y":928,"width":1513,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03e6b4e3a08d4589aaf3938a6ad73103","type":"text","conversion_output":true,"text":"The clinical outcome of relapsed myeloma is highly variable and can be related to specific","text_display":"\n\nThe clinical outcome of relapsed myeloma is highly variable and can be related to specific","confidence":1,"confidence_rate":1},{"cnt":[[322,993],[1734,993],[1734,1042],[322,1042]],"region":{"top_left_x":322,"top_left_y":992,"width":1412,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c106663bb4eb4ab79761f31a196aa720","type":"text","conversion_output":true,"text":"cytogenetic subtypes. 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Both del(17) and","text_display":" refractory MM treated with lenalidomide and dexamethasone. 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The","text_display":" high-risk chromosomal aberrations).[39,40] Patients with del(17) had a notable benefit. The","confidence":0.8921944840112701,"confidence_rate":0.9988124646500386},{"cnt":[[320,1551],[1880,1551],[1880,1596],[320,1596]],"region":{"top_left_x":320,"top_left_y":1551,"width":1560,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7af498d09711448aa6a2354a745110a3","type":"text","conversion_output":true,"text":"median PFS time was 26.2 months for the bortezomib arm versus 12 months for the standard","text_display":" median PFS time was 26.2 months for the bortezomib arm versus 12 months for the standard","confidence":1,"confidence_rate":1},{"cnt":[[318,1611],[1751,1611],[1751,1665],[318,1665]],"region":{"top_left_x":317,"top_left_y":1611,"width":1434,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32053f6d183f49cb9f681c2e25961c48","type":"text","conversion_output":true,"text":"arm ( \\(p=0.024\\) ), while the \\(3-\\) year OS rate in this subtype improved from \\(17 \\%\\) to \\(69 \\%\\)","text_display":" arm ( \\(p=0.024\\) ), while the \\(3-\\) year OS rate in this subtype improved from \\(17 \\%\\) to \\(69 \\%\\)","confidence":0.5081615697027002,"confidence_rate":0.9929731811137869},{"cnt":[[320,1676],[1760,1676],[1760,1727],[320,1727]],"region":{"top_left_x":320,"top_left_y":1675,"width":1440,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f4a99ee454c40288e58e4284ded1d85","type":"text","conversion_output":true,"text":"( \\(p =0.028\\) ). After multivariate analysis, del(17) was an independent predictor for PFS","text_display":" ( \\(p =0.028\\) ). After multivariate analysis, del(17) was an independent predictor for PFS","confidence":0.8758618831634521,"confidence_rate":0.9986344706271447},{"cnt":[[318,1738],[1867,1738],[1867,1790],[318,1790]],"region":{"top_left_x":317,"top_left_y":1738,"width":1550,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6dd5cf0c5e147b9b44e7e5bbd22580c","type":"text","conversion_output":true,"text":"( \\(p <0.0001\\) ) and \\(OS ( p <0.0001)\\) only in the bortezomib arm. In light of these observations,","text_display":" ( \\(p <0.0001\\) ) and \\(OS ( p <0.0001)\\) only in the bortezomib arm. 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The patient","text_display":" are treated with lenalidomide and dexamethasone as their standard therapy. The patient","confidence":1,"confidence_rate":1},{"cnt":[[318,715],[1824,715],[1824,771],[318,771]],"region":{"top_left_x":317,"top_left_y":715,"width":1508,"height":57},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c372e903f7b14b96922ee6b3ba49b61e","type":"text","conversion_output":true,"text":"population will consist of adult men and women who have a confirmed diagnosis of MM,","text_display":" population will consist of adult men and women who have a confirmed diagnosis of MM,","confidence":0.9024383791256696,"confidence_rate":0.998847239444192},{"cnt":[[318,782],[1835,782],[1835,836],[318,836]],"region":{"top_left_x":317,"top_left_y":782,"width":1518,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c64d54281b654b45b90781ba2830d259","type":"text","conversion_output":true,"text":"who have received 1 to 3 prior lines of therapy, and who meet other eligibility criteria (see","text_display":" who have received 1 to 3 prior lines of therapy, and who meet other eligibility criteria (see","confidence":0.9728495194576681,"confidence_rate":0.9997353632434658},{"cnt":[[318,844],[1472,844],[1472,896],[318,896]],"region":{"top_left_x":317,"top_left_y":844,"width":1155,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"658e4c46ae4743de82e58ca490c96070","type":"text","conversion_output":true,"text":"Section 5). 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If renal function normalizes (ie, creatinine","text_display":"\nto treatment and is tolerating the treatment. If renal function normalizes (ie, creatinine","confidence":1,"confidence_rate":1},{"cnt":[[382,314],[1880,314],[1880,365],[382,365]],"region":{"top_left_x":382,"top_left_y":313,"width":1498,"height":53},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6dc932b9602b4b0e995a14458c7bbea7","type":"text","conversion_output":true,"text":"clearance \\(>60 mL / min\\) or \\(>50 mL / min\\), according to local label/practice) and the patient","text_display":" clearance \\(>60 mL / min\\) or \\(>50 mL / min\\), according to local label/practice) and the patient","confidence":0.99365234375,"confidence_rate":0.9999410398096767},{"cnt":[[382,374],[1830,374],[1830,425],[382,425]],"region":{"top_left_x":382,"top_left_y":373,"width":1449,"height":53},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ba7ddb72c6a47eab2a7510c6cb56f10","type":"text","conversion_output":true,"text":"continues to tolerate this treatment, lenalidomide may then be escalated to 25 mg once","text_display":" continues to tolerate this treatment, lenalidomide may then be escalated to 25 mg once","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[382,438],[483,438],[483,488],[382,488]],"region":{"top_left_x":382,"top_left_y":438,"width":102,"height":50},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"136d2fbf08134021bf65f97c25d30bd6","type":"text","conversion_output":true,"text":"daily.","text_display":" daily.","confidence":1,"confidence_rate":1},{"cnt":[[382,541],[1775,541],[1775,593],[382,593]],"region":{"top_left_x":382,"top_left_y":541,"width":1393,"height":52},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1442f8890d8045aeba2dd2e2e85058f6","type":"text","conversion_output":true,"text":"Treatment periods will be defined as 28-day cycles. Patients will be seen at regular","text_display":"\n\nTreatment periods will be defined as 28-day cycles. Patients will be seen at regular","confidence":0.6513671875,"confidence_rate":0.9951949324664547},{"cnt":[[382,606],[1783,606],[1783,655],[382,655]],"region":{"top_left_x":382,"top_left_y":605,"width":1402,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"914a95d14e5845609da4fd5adcb82ea1","type":"text","conversion_output":true,"text":"treatment cycle intervals while they are participating in the study: twice a treatment","text_display":" treatment cycle intervals while they are participating in the study: twice a treatment","confidence":1,"confidence_rate":1},{"cnt":[[382,666],[1738,666],[1738,715],[382,715]],"region":{"top_left_x":382,"top_left_y":666,"width":1357,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba19321d9bd44555b2a6c8fc88d8c361","type":"text","conversion_output":true,"text":"cycle for the first 3 cycles, then once a treatment cycle for the remainder of their","text_display":" cycle for the first 3 cycles, then once a treatment cycle for the remainder of their","confidence":1,"confidence_rate":1},{"cnt":[[382,726],[1846,726],[1846,780],[382,780]],"region":{"top_left_x":382,"top_left_y":726,"width":1464,"height":54},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10199fa9b36e4f44ab2804c57ee706ca","type":"text","conversion_output":true,"text":"participation in the active treatment and, if applicable, the PFS (every 4 weeks) and OS","text_display":" participation in the active treatment and, if applicable, the PFS (every 4 weeks) and OS","confidence":1,"confidence_rate":1},{"cnt":[[382,791],[1757,791],[1757,844],[382,844]],"region":{"top_left_x":382,"top_left_y":790,"width":1376,"height":55},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3a705ad06654e55bf8b7072f141a581","type":"text","conversion_output":true,"text":"(every 12 weeks) follow-up phases of the study. As of Amendment 6, the primary","text_display":" (every 12 weeks) follow-up phases of the study. 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However, all patients will continue to be followed for survival.","text_display":" reasons other than PD. However, all patients will continue to be followed for survival.","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[382,1083],[1858,1083],[1858,1132],[382,1132]],"region":{"top_left_x":382,"top_left_y":1082,"width":1477,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f170ceba27db47d1a2010cb66b034cc5","type":"text","conversion_output":true,"text":"Patients will be assessed for disease response and progression by an IRC. Response will","text_display":"\n\nPatients will be assessed for disease response and progression by an IRC. 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Patients will be","text_display":" discontinuation of treatment for reasons other than progression. 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The primary analysis (data cutoff date,","text_display":"\n\nAs of Amendment 8, the 3 IAs have been performed. The primary analysis (data cutoff date,","confidence":1,"confidence_rate":1},{"cnt":[[318,1332],[1867,1332],[1867,1381],[318,1381]],"region":{"top_left_x":317,"top_left_y":1332,"width":1550,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27bd74d73b834bccb7df47ed5db36802","type":"text","conversion_output":true,"text":"30 October 2014) occurred when 286 patients had experienced disease progression or death;","text_display":" 30 October 2014) occurred when 286 patients had experienced disease progression or death;","confidence":0.9960954189300537,"confidence_rate":0.9999592484986185},{"cnt":[[318,1392],[1876,1392],[1876,1446],[318,1446]],"region":{"top_left_x":317,"top_left_y":1392,"width":1559,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b858efaf9e1481eb88ead0190de9f96","type":"text","conversion_output":true,"text":"at this analysis, the primary endpoint of PFS was met. The next analysis (data cutoff date, 12","text_display":" at this analysis, the primary endpoint of PFS was met. The next analysis (data cutoff date, 12","confidence":0.98974609375,"confidence_rate":0.9998948336966145},{"cnt":[[318,1457],[1835,1457],[1835,1506],[318,1506]],"region":{"top_left_x":317,"top_left_y":1456,"width":1518,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa87cf1415994f8d8c43c192121ddb9b","type":"text","conversion_output":true,"text":"July 2015) occurred when 372 patients had experienced disease progression or death. This","text_display":" July 2015) occurred when 372 patients had experienced disease progression or death. 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Per the study design and statistical analysis plan, the","text_display":" OS statistical significance was not met. Per the study design and statistical analysis plan, the","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[318,1644],[1794,1644],[1794,1695],[318,1695]],"region":{"top_left_x":317,"top_left_y":1643,"width":1477,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed794655e3f4404bac9c43ddf6a70aaf","type":"text","conversion_output":true,"text":"study was to continue, following patients for survival. The third IA (data cutoff date, 25","text_display":" study was to continue, following patients for survival. The third IA (data cutoff date, 25","confidence":1,"confidence_rate":1},{"cnt":[[320,1704],[1807,1704],[1807,1755],[320,1755]],"region":{"top_left_x":320,"top_left_y":1703,"width":1487,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6b5c7e654974bc4bd8a8a6e8c55d204","type":"text","conversion_output":true,"text":"October 2017) occurred when 333 deaths had been reported. The threshold for statistical","text_display":" October 2017) occurred when 333 deaths had been reported. The threshold for statistical","confidence":1,"confidence_rate":1},{"cnt":[[318,1766],[1755,1766],[1755,1818],[318,1818]],"region":{"top_left_x":317,"top_left_y":1766,"width":1439,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"497d2095f3514f1f812b6e9691e82f0e","type":"text","conversion_output":true,"text":"significance was not met and the study was to continue to the final analysis. The final","text_display":" significance was not met and the study was to continue to the final analysis. The final","confidence":1,"confidence_rate":1},{"cnt":[[320,1830],[1113,1830],[1113,1880],[320,1880]],"region":{"top_left_x":320,"top_left_y":1830,"width":793,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ef673f8520d4234945da4a4957adca3","type":"text","conversion_output":true,"text":"analysis occurred in the fourth quarter of 2020.","text_display":" analysis occurred in the fourth quarter of 2020.","confidence":1,"confidence_rate":1},{"cnt":[[318,1934],[1848,1934],[1848,1983],[318,1983]],"region":{"top_left_x":317,"top_left_y":1933,"width":1531,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8eeab488e1b64bad9040ecae7aa47db0","type":"text","conversion_output":true,"text":"An independent data monitoring committee (IDMC) will review safety and efficacy data at","text_display":"\n\nAn independent data monitoring committee (IDMC) will review safety and efficacy data at","confidence":1,"confidence_rate":1},{"cnt":[[318,1994],[1102,1994],[1102,2043],[318,2043]],"region":{"top_left_x":317,"top_left_y":1993,"width":786,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"689fa2a1a42b4083bd6f9c7fa76ac1bc","type":"text","conversion_output":true,"text":"the IAs. See Section 9.3 for more information.","text_display":" the IAs. See Section 9.3 for more information.","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[312,2097],[831,2097],[831,2151],[312,2151]],"region":{"top_left_x":311,"top_left_y":2096,"width":521,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7be722240b514760be7fd7ab26a00905","type":"section_header","conversion_output":false,"children_ids":["3765063ae84849e583ae3769daf433cf"],"text":"","text_display":""},{"cnt":[[318,2101],[827,2101],[827,2146],[318,2146]],"region":{"top_left_x":317,"top_left_y":2101,"width":511,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3765063ae84849e583ae3769daf433cf","type":"text","conversion_output":true,"parent_id":"7be722240b514760be7fd7ab26a00905","text":"4.2 Number of Patients","text_display":"\n\n\\subsection*{4.2 Number of Patients}","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[318,2189],[1798,2189],[1798,2241],[318,2241]],"region":{"top_left_x":317,"top_left_y":2189,"width":1482,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"688d681189f841ccbcf3ad94464ce5fd","type":"text","conversion_output":true,"text":"Approximately 703 patients will be enrolled in this study from approximately 150 study","text_display":"\n\nApproximately 703 patients will be enrolled in this study from approximately 150 study","confidence":1,"confidence_rate":1},{"cnt":[[318,2252],[604,2252],[604,2301],[318,2301]],"region":{"top_left_x":317,"top_left_y":2251,"width":287,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0d1cb1ddef147fd8ac688a91fdac0a4","type":"text","conversion_output":true,"text":"centers globally.","text_display":" centers globally.","confidence":1,"confidence_rate":1},{"cnt":[[1072,2582],[1126,2582],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2582,"width":54,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"571f66100c9a4a9ba03e5a70d0022ce0","type":"page_info","conversion_output":false,"text":"46","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-048","page":48,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c4b999e5bc54675a79c6abd2787bdf4","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a9299521e534f04bfc1b4cd2d387400","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[806,249],[806,307],[318,307]],"region":{"top_left_x":317,"top_left_y":249,"width":489,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ddd1565d4db48948f5264b0895f2c16","type":"section_header","conversion_output":false,"children_ids":["8f546f50d56c433c9011e0fac909b20d"],"text":"","text_display":""},{"cnt":[[322,254],[801,254],[801,303],[322,303]],"region":{"top_left_x":322,"top_left_y":253,"width":480,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f546f50d56c433c9011e0fac909b20d","type":"text","conversion_output":true,"parent_id":"1ddd1565d4db48948f5264b0895f2c16","text":"4.3 Duration of Study","text_display":"\n\n\\subsection*{4.3 Duration of Study}","confidence":1,"confidence_rate":1},{"cnt":[[320,339],[1841,339],[1841,389],[320,389]],"region":{"top_left_x":320,"top_left_y":339,"width":1522,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6c6e186eb2f432b987647a7a130f056","type":"text","conversion_output":true,"text":"Patients will be followed up until 486 deaths have been reported. The duration of the study","text_display":"\n\nPatients will be followed up until 486 deaths have been reported. The duration of the study","confidence":1,"confidence_rate":1},{"cnt":[[320,404],[1815,404],[1815,453],[320,453]],"region":{"top_left_x":320,"top_left_y":403,"width":1496,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afdf8304aff74a7ab1ff7b614692d789","type":"text","conversion_output":true,"text":"will be approximately 80 months ( 6 years 8 months), including 20 months for enrollment","text_display":" will be approximately 80 months ( 6 years 8 months), including 20 months for enrollment","confidence":0.9970703125,"confidence_rate":0.9999717889802962},{"cnt":[[322,466],[1248,466],[1248,513],[322,513]],"region":{"top_left_x":322,"top_left_y":466,"width":927,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99186dc12c3146f386c18b7e8e85e25a","type":"text","conversion_output":true,"text":"and 60 months follow-up from the last patient enrolled.","text_display":" and 60 months follow-up from the last patient enrolled.","confidence":1,"confidence_rate":1},{"cnt":[[322,571],[1755,571],[1755,621],[322,621]],"region":{"top_left_x":322,"top_left_y":571,"width":1434,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bf2344c05f04f3a87cdd04b1b4ca688","type":"text","conversion_output":true,"text":"Patients may remain on treatment until the occurrence of PD or unacceptable toxicity.","text_display":"\n\nPatients may remain on treatment until the occurrence of PD or unacceptable toxicity.","confidence":1,"confidence_rate":1},{"cnt":[[320,632],[1807,632],[1807,683],[320,683]],"region":{"top_left_x":320,"top_left_y":631,"width":1487,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed033215045e4754b2eeb61c6a9bdb39","type":"text","conversion_output":true,"text":"Delayed treatment-related AEs will be followed for 30 days after last dose of study drug.","text_display":" Delayed treatment-related AEs will be followed for 30 days after last dose of study drug.","confidence":1,"confidence_rate":1},{"cnt":[[322,696],[1824,696],[1824,746],[322,746]],"region":{"top_left_x":322,"top_left_y":696,"width":1503,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a5c6e773dd34b9ab129ff8220897512","type":"text","conversion_output":true,"text":"Patients who stop treatment for any reason other than disease progression will continue in","text_display":" Patients who stop treatment for any reason other than disease progression will continue in","confidence":0.962890625,"confidence_rate":0.9996020218354136},{"cnt":[[320,756],[1772,756],[1772,806],[320,806]],"region":{"top_left_x":320,"top_left_y":756,"width":1453,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b905cebc79544cda86484fb80241d978","type":"text","conversion_output":true,"text":"PFS follow-up and be seen every 4 weeks until documented disease progression. After","text_display":" PFS follow-up and be seen every 4 weeks until documented disease progression. 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When possible, patients should complete","confidence":0.9931640625,"confidence_rate":0.9999262456280423},{"cnt":[[320,1233],[1674,1233],[1674,1285],[320,1285]],"region":{"top_left_x":320,"top_left_y":1233,"width":1354,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed1a78ef3f954971a7600c34876611f2","type":"text","conversion_output":true,"text":"an End of Treatment (EOT) visit and transition onto an alternative supply of (eg,","text_display":" an End of Treatment (EOT) visit and transition onto an alternative supply of (eg,","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[320,1296],[1712,1296],[1712,1347],[320,1347]],"region":{"top_left_x":320,"top_left_y":1295,"width":1393,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07463e271e654e5a82473b889cbc61b8","type":"text","conversion_output":true,"text":"commercially available) ixazomib and/or LenDex, or onto another standard of care","text_display":" commercially available) ixazomib and/or LenDex, or onto another standard of care","confidence":1,"confidence_rate":1},{"cnt":[[320,1360],[1867,1360],[1867,1412],[320,1412]],"region":{"top_left_x":320,"top_left_y":1359,"width":1547,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ec7b3895b884674bc68e55d7b1b8d37","type":"text","conversion_output":true,"text":"treatment. Discontinued patients will be treated by their physician per local standard of care.","text_display":" treatment. 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Patients with a low creatinine clearance \\(\\leq 60 mL / min\\) (or \\(\\leq 50 mL / min\\),","confidence":0.8560876595998366,"confidence_rate":0.9983657315890531},{"cnt":[[507,1581],[1807,1581],[1807,1635],[507,1635]],"region":{"top_left_x":507,"top_left_y":1581,"width":1300,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68be1054689046c7af9f91f47c81a98a","type":"text","conversion_output":true,"text":"according to local dabel/practice) will receive a reduced lenalidomide dose of","text_display":" according to local dabel/practice) will receive a reduced lenalidomide dose of","confidence":0.982421875,"confidence_rate":0.9997863546936051},{"cnt":[[509,1646],[1878,1646],[1878,1697],[509,1697]],"region":{"top_left_x":509,"top_left_y":1645,"width":1369,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fd8ad676af040d687a2a4ff82558b1c","type":"text","conversion_output":true,"text":"10 mg once daily on Days 1 through 21 of a 28-day cycle. The lenalidomide dose","text_display":" 10 mg once daily on Days 1 through 21 of a 28-day cycle. 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Patients who received prior allogenic transplant must have no active","confidence":1,"confidence_rate":1},{"cnt":[[443,2226],[1038,2226],[1038,2279],[443,2279]],"region":{"top_left_x":442,"top_left_y":2225,"width":596,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03abe5757c814ac68319c625e72b3ee5","type":"text","conversion_output":true,"text":"graft-versus-host disease (GVHD).","text_display":" graft-versus-host disease (GVHD).","confidence":1,"confidence_rate":1},{"cnt":[[382,2329],[810,2329],[810,2383],[382,2383]],"region":{"top_left_x":382,"top_left_y":2328,"width":428,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdf90cfbdef443bc81a311cf8a7070c6","type":"text","conversion_output":true,"text":"8. Female patients who:","text_display":"\n8. Female patients who:","confidence":1,"confidence_rate":1},{"cnt":[[443,2436],[1742,2436],[1742,2490],[443,2490]],"region":{"top_left_x":442,"top_left_y":2436,"width":1301,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f06b039859241b18e083b68e5d45dbe","type":"text","conversion_output":true,"text":"- Are postmenopausal for at least 24 months before the screening visit, OR","text_display":"\n- Are postmenopausal for at least 24 months before the screening visit, OR","confidence":1,"confidence_rate":1},{"cnt":[[1072,2582],[1126,2582],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2582,"width":54,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a7ce2b66fff489ea18e356f672b1226","type":"page_info","conversion_output":false,"text":"49","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-051","page":51,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"633a75e5d6714d9b81f0cfc0ec0f66a4","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b409fb5f1344ae5811890312658cc0e","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[447,254],[947,254],[947,303],[447,303]],"region":{"top_left_x":446,"top_left_y":253,"width":502,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2af1561e14d4b7eae82ff4ee28c0069","type":"text","conversion_output":true,"text":"- Are surgically sterile, OR","text_display":"\n- Are surgically sterile, OR","confidence":1,"confidence_rate":1},{"cnt":[[443,361],[1841,361],[1841,410],[443,410]],"region":{"top_left_x":442,"top_left_y":360,"width":1400,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96ec8df5a9184beaa643f5dc5f3b2c6d","type":"text","conversion_output":true,"text":"- Females of childbearing potential (FCBP - see Section 6.9 for definition) must:","text_display":"\n- Females of childbearing potential (FCBP - see Section 6.9 for definition) must:","confidence":1,"confidence_rate":1},{"cnt":[[571,466],[1837,466],[1837,513],[571,513]],"region":{"top_left_x":571,"top_left_y":466,"width":1266,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f85d83016aae451e9b29dc54edf7d59a","type":"text","conversion_output":true,"text":"1. Have a negative pregnancy test with a sensitivity of at least \\(25 mIU / mL\\)","text_display":"\n1. 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Either agree to practice true abstinence, when this is in line with the","text_display":"\n2. Either agree to practice true abstinence, when this is in line with the","confidence":0.99853515625,"confidence_rate":0.9999814442521284},{"cnt":[[632,756],[1777,756],[1777,806],[632,806]],"region":{"top_left_x":631,"top_left_y":756,"width":1146,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b3b4055bae4445c987d1661817f262c","type":"text","conversion_output":true,"text":"preferred and usual lifestyle of the patient. (Periodic abstinence [eg,","text_display":" preferred and usual lifestyle of the patient. 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Placebo capsules will be identical in shape,","text_display":" containing 4.0, 3.0, and 2.3 mg of MLN9708. Placebo capsules will be identical in shape,","confidence":0.9636680623862048,"confidence_rate":0.9996224347927066},{"cnt":[[320,1695],[1833,1695],[1833,1747],[320,1747]],"region":{"top_left_x":320,"top_left_y":1695,"width":1513,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1bb97ede3f245898eb7e276828faa2b","type":"text","conversion_output":true,"text":"size, and color to the MLN9708 active capsules. Both the active and placebo capsules will","text_display":" size, and color to the MLN9708 active capsules. Both the active and placebo capsules will","confidence":1,"confidence_rate":1},{"cnt":[[318,1762],[788,1762],[788,1809],[318,1809]],"region":{"top_left_x":317,"top_left_y":1761,"width":472,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25ac016b04f8423b93450e8e58c320ec","type":"text","conversion_output":true,"text":"be provided by the sponsor.","text_display":" be provided by the sponsor.","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[320,1865],[1755,1865],[1755,1914],[320,1914]],"region":{"top_left_x":320,"top_left_y":1864,"width":1436,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6723b5cb2b7a49e8af18975877d926ac","type":"text","conversion_output":true,"text":"The final analysis data cutoff has been conducted and as such, the study is considered","text_display":"\n\nThe final analysis data cutoff has been conducted and as such, the study is considered","confidence":0.99609375,"confidence_rate":0.9999569910422619},{"cnt":[[322,1927],[1760,1927],[1760,1974],[322,1974]],"region":{"top_left_x":322,"top_left_y":1927,"width":1438,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b259a883a27b4b52847f9aa3c0aa882e","type":"text","conversion_output":true,"text":"complete for statistical analysis purposes. Upon implementation of Amendment 8 , the","text_display":" complete for statistical analysis purposes. Upon implementation of Amendment 8 , the","confidence":0.8740234375,"confidence_rate":0.998537504324082},{"cnt":[[320,1989],[1850,1989],[1850,2039],[320,2039]],"region":{"top_left_x":320,"top_left_y":1989,"width":1530,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d35c9fd52894faaa484cade725fcd77","type":"text","conversion_output":true,"text":"investigator will unblind all patients remaining on study treatment Patients continuing their","text_display":" investigator will unblind all patients remaining on study treatment Patients continuing their","confidence":1,"confidence_rate":1},{"cnt":[[318,2050],[1790,2050],[1790,2099],[318,2099]],"region":{"top_left_x":317,"top_left_y":2049,"width":1473,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a4cd43123eb444ba95db0c9b17819e9","type":"text","conversion_output":true,"text":"current study treatment may do so until such time as other means of accessing the study","text_display":" current study treatment may do so until such time as other means of accessing the study","confidence":1,"confidence_rate":1},{"cnt":[[320,2114],[1803,2114],[1803,2163],[320,2163]],"region":{"top_left_x":320,"top_left_y":2114,"width":1483,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a20d0b6ad6ea47cbae8e02a43aae5878","type":"text","conversion_output":true,"text":"drugs are arranged. When possible, patients should complete an EOT visit and transition","text_display":" drugs are arranged. When possible, patients should complete an EOT visit and transition","confidence":1,"confidence_rate":1},{"cnt":[[322,2174],[1861,2174],[1861,2224],[322,2224]],"region":{"top_left_x":322,"top_left_y":2174,"width":1539,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef8b21942f6b4dd187f32e775aa93346","type":"text","conversion_output":true,"text":"onto an alternative supply of (eg, commercially available) ixazomib and/or LenDex, or onto","text_display":" onto an alternative supply of (eg, commercially available) ixazomib and/or LenDex, or onto","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[320,2239],[1837,2239],[1837,2288],[320,2288]],"region":{"top_left_x":320,"top_left_y":2238,"width":1517,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fe7123462e74928bda8d99d2f847e58","type":"text","conversion_output":true,"text":"another standard of care treatment. Discontinued patients will be treated by their physician","text_display":" another standard of care treatment. Discontinued patients will be treated by their physician","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[318,2299],[1876,2299],[1876,2348],[318,2348]],"region":{"top_left_x":317,"top_left_y":2298,"width":1559,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d747729e0e94c28859e74b3c80b45be","type":"text","conversion_output":true,"text":"per local standard of care. Patients who are receiving ixazomib plus LenDex will continue to","text_display":" per local standard of care. Patients who are receiving ixazomib plus LenDex will continue to","confidence":1,"confidence_rate":1},{"cnt":[[320,2363],[1749,2363],[1749,2413],[320,2413]],"region":{"top_left_x":320,"top_left_y":2363,"width":1429,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a9c2c55a9f04bd8997968603c5efd0d","type":"text","conversion_output":true,"text":"receive ixazomib plus LenDex. Patients who are receiving placebo plus LenDex will","text_display":" receive ixazomib plus LenDex. Patients who are receiving placebo plus LenDex will","confidence":1,"confidence_rate":1},{"cnt":[[1074,2587],[1124,2587],[1124,2628],[1074,2628]],"region":{"top_left_x":1074,"top_left_y":2586,"width":50,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b665e4def8545dcb12d6f916ec12f11","type":"page_info","conversion_output":false,"text":"53","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-055","page":55,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"03e7257a4a284703b76e8ce94621c2fe","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a87458f4446b448394421f6732b6770a","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,251],[1757,251],[1757,303],[318,303]],"region":{"top_left_x":317,"top_left_y":251,"width":1441,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c71af0d492342889b55ec7073883d74","type":"text","conversion_output":true,"text":"receive LenDex only; the placebo capsule will no longer be administered and patients","text_display":"\nreceive LenDex only; the placebo capsule will no longer be administered and patients","confidence":1,"confidence_rate":1},{"cnt":[[320,314],[1463,314],[1463,363],[320,363]],"region":{"top_left_x":320,"top_left_y":313,"width":1144,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec93649c812e4a6b86bda1a4897fa276","type":"text","conversion_output":true,"text":"receiving placebo will not be crossed over to ixazomib in this study.","text_display":" receiving placebo will not be crossed over to ixazomib in this study.","confidence":1,"confidence_rate":1},{"cnt":[[322,417],[1790,417],[1790,466],[322,466]],"region":{"top_left_x":322,"top_left_y":416,"width":1468,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75bd8b1f562245a88a39107671c39cbc","type":"text","conversion_output":true,"text":"Study drug will be given as a single, oral dose of 4.0 mg weekly (Days 1, 8, and 15) for","text_display":"\n\nStudy drug will be given as a single, oral dose of 4.0 mg weekly (Days 1, 8, and 15) for","confidence":0.9727058410644531,"confidence_rate":0.9997176565590279},{"cnt":[[320,477],[1760,477],[1760,529],[320,529]],"region":{"top_left_x":320,"top_left_y":476,"width":1440,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50e69a496cdf4763a87703dc896e7efc","type":"text","conversion_output":true,"text":"3 weeks, followed by 1 week without study drug in a 28 -day cycle. Patients should be","text_display":" 3 weeks, followed by 1 week without study drug in a 28 -day cycle. Patients should be","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[320,541],[1863,541],[1863,591],[320,591]],"region":{"top_left_x":320,"top_left_y":541,"width":1543,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dc96706c4cb48c0911cd754eec785f6","type":"text","conversion_output":true,"text":"instructed to swallow MLN9708/placebo capsules whole with water and not to break, chew,","text_display":" instructed to swallow MLN9708/placebo capsules whole with water and not to break, chew,","confidence":1,"confidence_rate":1},{"cnt":[[320,606],[1768,606],[1768,655],[320,655]],"region":{"top_left_x":320,"top_left_y":605,"width":1449,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec1cbcbb994a4a3b95107c96735ab0d4","type":"text","conversion_output":true,"text":"or open the capsules. Study drug should be taken on an empty stomach, at least 1 hour","text_display":" or open the capsules. Study drug should be taken on an empty stomach, at least 1 hour","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[318,666],[1848,666],[1848,715],[318,715]],"region":{"top_left_x":317,"top_left_y":666,"width":1531,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcd026a8dac341889839ac5ad52e267e","type":"text","conversion_output":true,"text":"before or no sooner than 2 hours after food. The capsule should be swallowed with a sip of","text_display":" before or no sooner than 2 hours after food. The capsule should be swallowed with a sip of","confidence":0.9970715045928955,"confidence_rate":0.9999700740004459},{"cnt":[[318,728],[1727,722],[1728,779],[318,786]],"region":{"top_left_x":317,"top_left_y":721,"width":1411,"height":65},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53a4a8ec55194ae9975870af38023a19","type":"text","conversion_output":true,"text":"water. A total of approximately 240 mL of water should be taken with the capsules.","text_display":" water. A total of approximately 240 mL of water should be taken with the capsules.","confidence":1,"confidence_rate":1},{"cnt":[[318,834],[1826,834],[1826,883],[318,883]],"region":{"top_left_x":317,"top_left_y":833,"width":1510,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2c521fa9cc448bab2eb420d2f05074a","type":"text","conversion_output":true,"text":"Missed doses can be taken as soon as the patient remembers as long as the next scheduled","text_display":"\n\nMissed doses can be taken as soon as the patient remembers as long as the next scheduled","confidence":1,"confidence_rate":1},{"cnt":[[320,896],[1846,896],[1846,943],[320,943]],"region":{"top_left_x":320,"top_left_y":895,"width":1526,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff107bf35fb54d8fa603e05d4ff68813","type":"text","conversion_output":true,"text":"dose is 72 hours or more away. A double dose should not be taken to make up for a missed","text_display":" dose is 72 hours or more away. A double dose should not be taken to make up for a missed","confidence":0.9975600242614746,"confidence_rate":0.9999745528515933},{"cnt":[[320,958],[1790,958],[1790,1008],[320,1008]],"region":{"top_left_x":320,"top_left_y":958,"width":1470,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db4e4408f9bc44199a97e95f3d3d0f42","type":"text","conversion_output":true,"text":"dose. If the patient vomits after taking a dose, the patient should not repeat the dose but","text_display":" dose. If the patient vomits after taking a dose, the patient should not repeat the dose but","confidence":0.98876953125,"confidence_rate":0.999882361017729},{"cnt":[[320,1018],[1338,1018],[1338,1068],[320,1068]],"region":{"top_left_x":320,"top_left_y":1018,"width":1019,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a441eb80d8884b87938ae275392cd664","type":"text","conversion_output":true,"text":"should resume dosing at the time of the next scheduled dose.","text_display":" should resume dosing at the time of the next scheduled dose.","confidence":1,"confidence_rate":1},{"cnt":[[316,1119],[982,1119],[982,1179],[316,1179]],"region":{"top_left_x":315,"top_left_y":1119,"width":667,"height":61},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be40228ccee548c990de898101454a7d","type":"section_header","conversion_output":false,"children_ids":["279049c18db548b5b2c78a8ba11843e1"],"text":"","text_display":""},{"cnt":[[322,1126],[978,1126],[978,1175],[322,1175]],"region":{"top_left_x":322,"top_left_y":1125,"width":656,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"279049c18db548b5b2c78a8ba11843e1","type":"text","conversion_output":true,"parent_id":"be40228ccee548c990de898101454a7d","text":"6.2 Standard of Care Therapies","text_display":"\n\n\\subsection*{6.2 Standard of Care Therapies}","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[316,1207],[1038,1207],[1038,1261],[316,1261]],"region":{"top_left_x":315,"top_left_y":1207,"width":723,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9612d8341ece44259027ece6e4fbee8b","type":"section_header","conversion_output":false,"children_ids":["acdea084de204b169dc47eb680edafba"],"text":"","text_display":""},{"cnt":[[322,1214],[1033,1214],[1033,1257],[322,1257]],"region":{"top_left_x":322,"top_left_y":1213,"width":712,"height":44},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acdea084de204b169dc47eb680edafba","type":"text","conversion_output":true,"parent_id":"9612d8341ece44259027ece6e4fbee8b","text":"6.2.1 Lenalidomide Administration","text_display":"\n\n\\subsection*{6.2.1 Lenalidomide Administration}","confidence":1,"confidence_rate":1},{"cnt":[[320,1302],[1869,1302],[1869,1354],[320,1354]],"region":{"top_left_x":320,"top_left_y":1301,"width":1550,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a81f9f343a242a29f9a7673ff69ebce","type":"text","conversion_output":true,"text":"Lenalidomide will be given as a single, daily oral dose of 25 mg for a total of 21 days out of","text_display":"\n\nLenalidomide will be given as a single, daily oral dose of 25 mg for a total of 21 days out of","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[320,1369],[1781,1369],[1781,1420],[320,1420]],"region":{"top_left_x":320,"top_left_y":1368,"width":1462,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15b3a71098ba4d75b8485d71588063b4","type":"text","conversion_output":true,"text":"a 28-day cycle. Patients with a low creatinine clearance \\(\\leq 60 mL / min\\) (or \\(\\leq 50 mL / min\\),","text_display":" a 28-day cycle. Patients with a low creatinine clearance \\(\\leq 60 mL / min\\) (or \\(\\leq 50 mL / min\\),","confidence":0.576866626739502,"confidence_rate":0.9947742336101899},{"cnt":[[320,1431],[1818,1431],[1818,1480],[320,1480]],"region":{"top_left_x":320,"top_left_y":1430,"width":1498,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6ccc65c58d44e45a47b23813dc7c20c","type":"text","conversion_output":true,"text":"according to local label/practice) will receive a reduced lenalidomide dose of 10 mg once","text_display":" according to local label/practice) will receive a reduced lenalidomide dose of 10 mg once","confidence":1,"confidence_rate":1},{"cnt":[[320,1491],[1824,1491],[1824,1545],[320,1545]],"region":{"top_left_x":320,"top_left_y":1491,"width":1505,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cf370169a5b483da365db9a9960b9a7","type":"text","conversion_output":true,"text":"daily on Days 1 through 21 of a 28 -day cycle. The lenalidomide dose may be escalated to","text_display":" daily on Days 1 through 21 of a 28 -day cycle. The lenalidomide dose may be escalated to","confidence":0.8474044799804688,"confidence_rate":0.9983780114155865},{"cnt":[[322,1555],[1858,1555],[1858,1607],[322,1607]],"region":{"top_left_x":322,"top_left_y":1555,"width":1537,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d39ba3c0c8b041f481ae04f1a2733bb0","type":"text","conversion_output":true,"text":"15 mg once daily after 2 cycles if the patient is not responding to treatment and is tolerating","text_display":" 15 mg once daily after 2 cycles if the patient is not responding to treatment and is tolerating","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[318,1618],[1721,1618],[1721,1669],[318,1669]],"region":{"top_left_x":317,"top_left_y":1617,"width":1404,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e3a4ba800f84cfcabd41653f04a7060","type":"text","conversion_output":true,"text":"the treatment. If renal function normalizes (ie, creatinine clearance \\(>60 mL / min\\) or","text_display":" the treatment. 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Patients","text_display":"\n\nAdministration of lenalidomide will be at approximately the same time each day. 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Dose reduction of multiple agents may be considered after consultation","text_display":" to 1 of the agents. Dose reduction of multiple agents may be considered after consultation","confidence":0.9965853681787848,"confidence_rate":0.9999650978031597},{"cnt":[[318,1573],[1809,1573],[1809,1622],[318,1622]],"region":{"top_left_x":317,"top_left_y":1572,"width":1492,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8908b710561438b9ce73cd80f9e4985","type":"text","conversion_output":true,"text":"with the Millennium clinician/Study clinician designee. Guidelines for dose modification","text_display":" with the Millennium clinician/Study clinician designee. 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Prior to beginning the next cycle of","confidence":1,"confidence_rate":1},{"cnt":[[320,1697],[1124,1697],[1124,1747],[320,1747]],"region":{"top_left_x":320,"top_left_y":1697,"width":804,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63e4798e3563448394c4f6bfe98e9a65","type":"text","conversion_output":true,"text":"treatment, refer to the guidelines in Section 6.5.","text_display":" treatment, refer to the guidelines in Section 6.5.","confidence":0.99609375,"confidence_rate":0.9999288407261024},{"cnt":[[320,1800],[1803,1800],[1803,1850],[320,1850]],"region":{"top_left_x":320,"top_left_y":1800,"width":1483,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f692ca0c9c2d48d4afdff0cfe1b77db5","type":"text","conversion_output":true,"text":"Further clarification can be obtained in consultation with the Millennium clinician/study","text_display":"\n\nFurther clarification can be obtained in consultation with the Millennium clinician/study","confidence":1,"confidence_rate":1},{"cnt":[[320,1865],[1878,1865],[1878,1914],[320,1914]],"region":{"top_left_x":320,"top_left_y":1864,"width":1558,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db3d664e03ba45918ca7f10335b60e50","type":"text","conversion_output":true,"text":"clinician designee. If multiple toxicities are noted, the dose adjustments and/or delays should","text_display":" clinician designee. If multiple toxicities are noted, the dose adjustments and/or delays should","confidence":1,"confidence_rate":1},{"cnt":[[318,1925],[1285,1925],[1285,1974],[318,1974]],"region":{"top_left_x":317,"top_left_y":1925,"width":968,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"307eb7198bc14e7596ccb16aa8f67384","type":"text","conversion_output":true,"text":"be made according to the most severe toxicity guidelines.","text_display":" be made according to the most severe toxicity guidelines.","confidence":1,"confidence_rate":1},{"cnt":[[318,2030],[1848,2030],[1848,2082],[318,2082]],"region":{"top_left_x":317,"top_left_y":2030,"width":1531,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61b8794c332d4ca589d7154ca615cec5","type":"text","conversion_output":true,"text":"Alternative dose modifications may be recommended after discussion with the investigator","text_display":"\n\nAlternative dose 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3.0 mg & 2.3 mg & Discontinue study drug \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.9878386906348169,"confidence_rate":0.9999375740753532},{"cnt":[[318,962],[1680,962],[1680,1063],[318,1063]],"region":{"top_left_x":317,"top_left_y":962,"width":1364,"height":102},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7380eedfd02f456690c8c70ca8e90fc8","type":"figure_label","conversion_output":false,"children_ids":["26c0345bdc3e4e1b86b85a74b4dd6a78","db9248cb95f944f2b654a29f2a1cdc26"],"text":"","text_display":""},{"cnt":[[322,967],[1676,967],[1676,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":966,"width":1354,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26c0345bdc3e4e1b86b85a74b4dd6a78","type":"text","conversion_output":false,"parent_id":"7380eedfd02f456690c8c70ca8e90fc8","text":"Table 6-5 Study Drug Treatment Modification (Delays, Reductions, 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be related to study drug & Hold study drug until resolution to Grade < 1 or baseline & Symptomatic recommendations noted in Section 6.10 \\\\\n\\hline If does not recover to < Grade 1 or baseline within 4 weeks & Reduce study drug to next lower dose upon return to < Grade 1 or baseline & \\\\\n\\hline - Subsequent recurrence Grade 3 that does not recover to < Grade 1 or baseline within 4 weeks & \\begin{tabular}{l}\nHold study drug until resolution to Grade < 1 or baseline \\\\\nReduce study drug to next lower dose\n\\end{tabular} & Monitor closely, take appropriate medical precautions, and provide appropriate symptomatic care \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 6-5 Study Drug Treatment Modification (Delays, Reductions, and Discontinuations) Due to Adverse Events}\n\\begin{tabular}{|l|l|l|}\n\\hline Adverse Event (Severity) & Action on Study Drug/Placebo & Further Considerations \\\\\n\\hline Grade 1 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Modification}","confidence":1,"confidence_rate":1},{"cnt":[[322,1835],[1846,1835],[1846,1884],[322,1884]],"region":{"top_left_x":322,"top_left_y":1834,"width":1524,"height":51},"line":80,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5088833ef6c4df3997d5c785f04f155","type":"text","conversion_output":true,"text":"Dosage adjustments for dexamethasone are outlined in Table 6-8. Treatment modifications","text_display":"\n\nDosage adjustments for dexamethasone are outlined in Table 6-8. Treatment modifications","confidence":1,"confidence_rate":1},{"cnt":[[320,1895],[1343,1895],[1343,1944],[320,1944]],"region":{"top_left_x":320,"top_left_y":1894,"width":1023,"height":51},"line":81,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8bcbdc98f5745979c56629d5f87589c","type":"text","conversion_output":true,"text":"due to dexamethasone-related AEs are outlined in Table 6-9.","text_display":" due to dexamethasone-related AEs are outlined in Table 6-9.","confidence":0.9990234375,"confidence_rate":0.9999847338720312},{"cnt":[[322,2024],[1317,2024],[1317,2073],[322,2073]],"region":{"top_left_x":322,"top_left_y":2023,"width":995,"height":51},"line":82,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2b74214fa2b400c907383c3ccc281b9","type":"figure_label","conversion_output":false,"text":"Table 6-8 Dose Reduction Steps for 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\\\\\n\\hline 40 mg & 20 mg & 8 mg & \\begin{tabular}{c} \nDiscontinue \\\\\ndexamethasone\n\\end{tabular} 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\\multicolumn{2}{|l|}{Adverse Event (Severity)} & Action on Dexamethasone \\\\\n\\hline Gastrointestinal & Dyspepsia, gastric, or duodenal ulcer, gastritis Grade 1-2 (requiring medical management) & Treat with histamine-2 blockers, sucralfate, or omeprazole. If symptoms persist despite these measures, decrease dexamethasone by 1 dose level. \\\\\n\\hline & \\(\\geq\\) Grade 3 (requiring hospitalization or surgery) & Hold dexamethasone until symptoms adequately controlled. Restart and decrease 1 dose level of current dose along with concurrent therapy with histamine-2 blockers, sucralfate, or omeprazole. If symptoms persist despite these measures, discontinue dexamethasone and do not resume. \\\\\n\\hline & Acute pancreatitis & Discontinue dexamethasone and do not resume. \\\\\n\\hline Cardiovascular & Edema \\(>\\) Grade 2 (limiting function and unresponsive to therapy or anasarca) & Diuretics as needed and decrease dexamethasone by 1 dose level. If edema persists despite these measures, decrease dose another level. Discontinue dexamethasone and do not resume if symptoms persist despite second reduction. \\\\\n\\hline Neurological & Confusion or mood alteration > Grade 2 & Hold dexamethasone until symptoms resolve. Restart with 1 dose level reduction. If symptoms persist despite these measures, discontinue dexamethasone and do not resume. \\\\\n\\hline Musculoskeletal & Muscle weakness > Grade 2 (interfering with function + interfering with activities of daily living) & Decrease dexamethasone dose by 1 dose level. If weakness persists despite these measures, decrease dose by 1 dose level. Discontinue dexamethasone and do not resume if symptoms persist. \\\\\n\\hline Metabolic & Hyperglycemia \\(\\geq\\) Grade 3 & Treatment with insulin or oral hypoglycemics as needed. If uncontrolled despite these measures, decrease dose by 1 dose level until levels are satisfactory. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 6-9 Dexamethasone-Related Treatment Modification (Delays, Reductions, and Discontinuations) Guidelines Due to Adverse Events[44]}\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{Adverse Event (Severity)} & Action on Dexamethasone \\\\\n\\hline Gastrointestinal & Dyspepsia, gastric, or duodenal ulcer, gastritis Grade 1-2 (requiring medical management) & Treat with histamine-2 blockers, sucralfate, or omeprazole. If symptoms persist despite these measures, decrease dexamethasone by 1 dose level. \\\\\n\\hline & \\(\\geq\\) Grade 3 (requiring hospitalization or surgery) & Hold dexamethasone until symptoms adequately controlled. Restart and decrease 1 dose level of current dose along with concurrent therapy with histamine-2 blockers, sucralfate, or omeprazole. If symptoms persist despite these measures, discontinue dexamethasone and do not resume. \\\\\n\\hline & Acute pancreatitis & Discontinue dexamethasone and do not resume. \\\\\n\\hline Cardiovascular & Edema \\(>\\) Grade 2 (limiting function and unresponsive to therapy or anasarca) & Diuretics as needed and decrease dexamethasone by 1 dose level. If edema persists despite these measures, decrease dose another level. Discontinue dexamethasone and do not resume if symptoms persist despite second reduction. \\\\\n\\hline Neurological & Confusion or mood alteration > Grade 2 & Hold dexamethasone until symptoms resolve. Restart with 1 dose level reduction. If symptoms persist despite these measures, discontinue dexamethasone and do not resume. \\\\\n\\hline Musculoskeletal & Muscle weakness > Grade 2 (interfering with function + interfering with activities of daily living) & Decrease dexamethasone dose by 1 dose level. 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At the end of that time, the patient","text_display":" initiation of the next cycle should be delayed for 1 week. At the end of that time, the patient","confidence":1,"confidence_rate":1},{"cnt":[[318,546],[1781,546],[1781,593],[318,593]],"region":{"top_left_x":317,"top_left_y":545,"width":1465,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"367bd63d8243497c8430519252c42653","type":"text","conversion_output":true,"text":"should be re-evaluated to determine whether the criteria for retreatment have been met.","text_display":" should be re-evaluated to determine whether the criteria for retreatment have been met.","confidence":1,"confidence_rate":1},{"cnt":[[318,649],[1794,649],[1794,703],[318,703]],"region":{"top_left_x":317,"top_left_y":648,"width":1477,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1738a9041f5146e594ca0d535fde11f1","type":"text","conversion_output":true,"text":"See Section 6.4 for recommended dose reduction because of incomplete recovery from","text_display":"\n\nSee Section 6.4 for recommended dose reduction because of incomplete recovery from","confidence":1,"confidence_rate":1},{"cnt":[[318,711],[1798,711],[1798,763],[318,763]],"region":{"top_left_x":317,"top_left_y":711,"width":1482,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae07c190b093452a81a77110c66f4f09","type":"text","conversion_output":true,"text":"treatment-related toxicity. The maximum delay before treatment should be discontmued","text_display":" treatment-related toxicity. The maximum delay before treatment should be discontmued","confidence":0.74951171875,"confidence_rate":0.9967655418727659},{"cnt":[[320,773],[1749,773],[1749,823],[320,823]],"region":{"top_left_x":320,"top_left_y":773,"width":1429,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3bf236522d34d98ad88a506ffd3707c","type":"text","conversion_output":true,"text":"(except in the case of investigator determined clinical benefit and discussion with the","text_display":" (except in the case of investigator determined clinical benefit and discussion with the","confidence":1,"confidence_rate":1},{"cnt":[[318,836],[1008,836],[1008,887],[318,887]],"region":{"top_left_x":317,"top_left_y":835,"width":691,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b16f8bb4d40444789af10e6d82abe71f","type":"text","conversion_output":true,"text":"MPI/designee clinician) will be 3 weeks.","text_display":" MPI/designee clinician) will be 3 weeks.","confidence":0.9970703125,"confidence_rate":0.999938877129854},{"cnt":[[314,932],[1412,932],[1412,990],[314,990]],"region":{"top_left_x":313,"top_left_y":932,"width":1099,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c7c827621e84db3a4e30ebca8a5c56e","type":"section_header","conversion_output":false,"children_ids":["167f0c7096a54bea9d5ce744a14ac04d"],"text":"","text_display":""},{"cnt":[[318,937],[1405,937],[1405,986],[318,986]],"region":{"top_left_x":317,"top_left_y":936,"width":1089,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"167f0c7096a54bea9d5ce744a14ac04d","type":"text","conversion_output":true,"parent_id":"5c7c827621e84db3a4e30ebca8a5c56e","text":"6.6 Excluded Concomitant Medications and Procedures","text_display":"\n\n\\subsection*{6.6 Excluded Concomitant Medications and Procedures}","confidence":1,"confidence_rate":1},{"cnt":[[318,1027],[1807,1027],[1807,1081],[318,1081]],"region":{"top_left_x":317,"top_left_y":1026,"width":1490,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2552d4b8853478eb9a7af9d8f4be58b","type":"text","conversion_output":true,"text":"The following medications and procedures are prohibited during the study. Note that the","text_display":"\n\nThe following medications and procedures are prohibited during the study. Note that the","confidence":1,"confidence_rate":1},{"cnt":[[318,1091],[1824,1091],[1824,1141],[318,1141]],"region":{"top_left_x":317,"top_left_y":1091,"width":1508,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca46dad7fb864cb9900ea59cad23317b","type":"text","conversion_output":true,"text":"excluded concomitant medication information has been updated to reflect the available in","text_display":" excluded concomitant medication information has been updated to reflect the available in","confidence":1,"confidence_rate":1},{"cnt":[[318,1152],[1858,1152],[1858,1205],[318,1205]],"region":{"top_left_x":317,"top_left_y":1151,"width":1542,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ac4d17519064f71b1d00f00725b37b6","type":"text","conversion_output":true,"text":"vitro metabolism and clinical drug-drug interaction information as of Amendment 6. Please","text_display":" vitro metabolism and clinical drug-drug interaction information as of Amendment 6. Please","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[318,1216],[930,1216],[930,1263],[318,1263]],"region":{"top_left_x":317,"top_left_y":1216,"width":614,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf5def0d20f24daea2bdd1aace575d74","type":"text","conversion_output":true,"text":"refer to the IB for additional details.","text_display":" refer to the IB for additional details.","confidence":1,"confidence_rate":1},{"cnt":[[318,1319],[1777,1319],[1777,1373],[318,1373]],"region":{"top_left_x":317,"top_left_y":1319,"width":1460,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cf3cd0ca87a411086e4825a0b6df64d","type":"text","conversion_output":true,"text":"Systemic treatment with any of the following metabolizing enzyme inducers should be","text_display":"\n\nSystemic treatment with any of the following metabolizing enzyme inducers should 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Lenalidomide interruption or","confidence":1,"confidence_rate":1},{"cnt":[[1074,2582],[1126,2582],[1126,2628],[1074,2628]],"region":{"top_left_x":1074,"top_left_y":2582,"width":52,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1963b8b44f449ff82d9752494124ea0","type":"page_info","conversion_output":false,"text":"68","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-070","page":70,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a237993f662b44ee90eb825b3c726285","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f5c9c5514d148798df621d02f619ba9","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,251],[1820,251],[1820,303],[320,303]],"region":{"top_left_x":320,"top_left_y":251,"width":1500,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72056ebce4fe41a5aa9aef59a6b8222a","type":"text","conversion_output":true,"text":"discontinuation should be considered as described in the package insert (PI)/ summary of","text_display":"\ndiscontinuation should be considered as described in the package insert (PI)/ summary of","confidence":0.8620170895010233,"confidence_rate":0.9984047127169977},{"cnt":[[318,314],[930,314],[930,365],[318,365]],"region":{"top_left_x":317,"top_left_y":313,"width":614,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ff03466bee14e6abb0d4899f6468f02","type":"text","conversion_output":true,"text":"product characteristics (SmPC).[43]","text_display":" product characteristics (SmPC).[43]","confidence":1,"confidence_rate":1},{"cnt":[[318,417],[1861,417],[1861,466],[318,466]],"region":{"top_left_x":317,"top_left_y":416,"width":1544,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17303eba28a7436da6826a4e07fbb2d3","type":"text","conversion_output":true,"text":"Rash may range from limited erythematous areas, macular or small papular bumps that may","text_display":"\n\nRash may range from limited erythematous areas, macular or small papular bumps that may","confidence":1,"confidence_rate":1},{"cnt":[[318,477],[1815,477],[1815,529],[318,529]],"region":{"top_left_x":317,"top_left_y":476,"width":1499,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc2938dfdba74d4fbe1320fb0c236368","type":"text","conversion_output":true,"text":"or may not be pruritic over a few areas of the body, to a more generalized eruption that is","text_display":" or may not be pruritic over a few areas of the body, to a more generalized eruption that is","confidence":1,"confidence_rate":1},{"cnt":[[318,541],[1841,541],[1841,593],[318,593]],"region":{"top_left_x":317,"top_left_y":541,"width":1525,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dc70cb04d9b479dadea38b47644c54f","type":"text","conversion_output":true,"text":"predominantly on the trunk or extremities. Rash has been most commonly characterized as","text_display":" predominantly on the trunk or extremities. Rash has been most commonly characterized as","confidence":1,"confidence_rate":1},{"cnt":[[318,604],[1811,604],[1811,655],[318,655]],"region":{"top_left_x":317,"top_left_y":603,"width":1495,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5ba1a0c52514cf4bd160195c597bebc","type":"text","conversion_output":true,"text":"maculopapular or macular. To date, when it does occur, rash is most commonly reported","text_display":" maculopapular or macular. To date, when it does occur, rash is most commonly reported","confidence":1,"confidence_rate":1},{"cnt":[[318,666],[1764,666],[1764,715],[318,715]],"region":{"top_left_x":317,"top_left_y":666,"width":1447,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"937c16e4b568493ea262b8b6c0c5150a","type":"text","conversion_output":true,"text":"within the first 3 cycles of therapy. The rash is often transient and self-limiting and is","text_display":" within the first 3 cycles of therapy. The rash is often transient and self-limiting and is","confidence":1,"confidence_rate":1},{"cnt":[[318,726],[1766,726],[1766,780],[318,780]],"region":{"top_left_x":317,"top_left_y":726,"width":1450,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ff15f2b6ca941b183eb19909846e3ea","type":"text","conversion_output":true,"text":"typically Grade 1 or 2 in severity. As in many other oncology trials, rash may occur in","text_display":" typically Grade 1 or 2 in severity. As in many other oncology trials, rash may occur in","confidence":1,"confidence_rate":1},{"cnt":[[318,791],[1863,791],[1863,844],[318,844]],"region":{"top_left_x":317,"top_left_y":790,"width":1546,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cff94080e7654d1da7c82687f7247fdd","type":"text","conversion_output":true,"text":"patients receiving placebo and in patients receiving MLN9708. If rash occurs,consideration","text_display":" patients receiving placebo and in patients receiving MLN9708. If rash occurs,consideration","confidence":0.9990236759185791,"confidence_rate":0.9999897179371111},{"cnt":[[318,851],[1850,851],[1850,904],[318,904]],"region":{"top_left_x":317,"top_left_y":850,"width":1533,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87131a50028d47198605bef47f5fce6b","type":"text","conversion_output":true,"text":"should be given to alternate causes of the rash such as concomitant medications, infections,","text_display":" should be given to alternate causes of the rash such as concomitant medications, infections,","confidence":1,"confidence_rate":1},{"cnt":[[318,915],[1843,915],[1843,965],[318,965]],"region":{"top_left_x":317,"top_left_y":915,"width":1527,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c916e5d1f6945d4a56600508df86c49","type":"text","conversion_output":true,"text":"etc; these other causative agents should be discontinued and alterative agents considered if","text_display":" etc; these other causative agents should be discontinued and alterative agents considered if","confidence":1,"confidence_rate":1},{"cnt":[[318,975],[672,975],[672,1029],[318,1029]],"region":{"top_left_x":317,"top_left_y":975,"width":356,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8232b577b9914280a3f60a7144ec1d8b","type":"text","conversion_output":true,"text":"medically necessary.","text_display":" medically necessary.","confidence":1,"confidence_rate":1},{"cnt":[[320,1083],[1850,1083],[1850,1132],[320,1132]],"region":{"top_left_x":320,"top_left_y":1082,"width":1530,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c43273583e6741dd8b1b27c18218a1e0","type":"text","conversion_output":true,"text":"Symptomatic measures such as antihistamines or corticosteroids (oral or topical) have been","text_display":"\n\nSymptomatic measures such as antihistamines or corticosteroids (oral or topical) have been","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[320,1143],[1858,1143],[1858,1197],[320,1197]],"region":{"top_left_x":320,"top_left_y":1142,"width":1539,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86d7235ae7344f91baaf171f0103d9c9","type":"text","conversion_output":true,"text":"successfully used to manage rash and have been used prophylactically in subsequent cycles.","text_display":" successfully used to manage rash and have been used prophylactically in subsequent cycles.","confidence":1,"confidence_rate":1},{"cnt":[[318,1207],[1835,1207],[1835,1261],[318,1261]],"region":{"top_left_x":317,"top_left_y":1207,"width":1518,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9b9b1086d3f4ed7b45344bffa794bff","type":"text","conversion_output":true,"text":"The use of a topical, IV, or oral steroid (eg, prednisone \\(\\leq 10 mg\\) per day or equivalent [see","text_display":" The use of a topical, IV, or oral steroid (eg, prednisone \\(\\leq 10 mg\\) per day or equivalent [see","confidence":1,"confidence_rate":1},{"cnt":[[318,1272],[784,1272],[784,1326],[318,1326]],"region":{"top_left_x":317,"top_left_y":1271,"width":468,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15ccdb8895b24aaf9d65432125d3c248","type":"text","conversion_output":true,"text":"Section 15.5]) is permitted.","text_display":" Section 15.5]) is permitted.","confidence":0.99951171875,"confidence_rate":0.9999852000944255},{"cnt":[[318,1377],[1669,1377],[1669,1429],[318,1429]],"region":{"top_left_x":317,"top_left_y":1377,"width":1353,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e65d309091a40349f0ddc2300c96154","type":"text","conversion_output":true,"text":"Management of a Grade 3 rash may require IV antihistamines or corticosteroids.","text_display":"\n\nManagement of a Grade 3 rash may require IV antihistamines or corticosteroids.","confidence":1,"confidence_rate":1},{"cnt":[[318,1439],[1841,1439],[1841,1489],[318,1489]],"region":{"top_left_x":317,"top_left_y":1439,"width":1525,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34899ecbc9134a11a5f6756f0bfa1991","type":"text","conversion_output":true,"text":"Administration of MLN9708 (and/or other causative agent if given in combination) should","text_display":" Administration of MLN9708 (and/or other causative agent if given in combination) should","confidence":1,"confidence_rate":1},{"cnt":[[318,1500],[1871,1500],[1871,1553],[318,1553]],"region":{"top_left_x":317,"top_left_y":1499,"width":1555,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ab868b13cce4a86ba4524879715c1c1","type":"text","conversion_output":true,"text":"be modified per protocol and re-initiated at a reduced level from where rash was noted (also,","text_display":" be modified per protocol and re-initiated at a reduced level from where rash was noted (also,","confidence":1,"confidence_rate":1},{"cnt":[[318,1560],[1824,1560],[1824,1613],[318,1613]],"region":{"top_left_x":317,"top_left_y":1559,"width":1508,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cdfd9f870534997b8edf8014d492f66","type":"text","conversion_output":true,"text":"per protocol). In line with clinical practice, dermatology consult and biopsy of Grade 3 or","text_display":" per protocol). In line with clinical practice, dermatology consult and biopsy of Grade 3 or","confidence":1,"confidence_rate":1},{"cnt":[[318,1624],[1850,1624],[1850,1678],[318,1678]],"region":{"top_left_x":317,"top_left_y":1624,"width":1533,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ed4a2acb3b14efe8aa2201ca0ddfee6","type":"text","conversion_output":true,"text":"higher rash or any SAE involving rash is recommended. Prophylactic measures should also","text_display":" higher rash or any SAE involving rash is recommended. Prophylactic measures should also","confidence":1,"confidence_rate":1},{"cnt":[[318,1689],[1811,1689],[1811,1738],[318,1738]],"region":{"top_left_x":317,"top_left_y":1688,"width":1495,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"261c9b1378e5444dbd46cf356694910a","type":"text","conversion_output":true,"text":"be considered if a patient has previously developed a rash (eg, using a thick, alcohol-free","text_display":" be considered if a patient has previously developed a rash (eg, using a thick, alcohol-free","confidence":1,"confidence_rate":1},{"cnt":[[318,1749],[1577,1749],[1577,1803],[318,1803]],"region":{"top_left_x":317,"top_left_y":1748,"width":1260,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bb94f4945684b4898dbd2671ec0c266","type":"text","conversion_output":true,"text":"emollient cream on-dry areas of the body or oral or topical antihistamines).","text_display":" emollient cream on-dry areas of the body or oral or topical antihistamines).","confidence":0.6123046875,"confidence_rate":0.9939624323376414},{"cnt":[[318,1852],[1858,1852],[1858,1906],[318,1906]],"region":{"top_left_x":317,"top_left_y":1851,"width":1542,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7376ad935e4645fbbdab9fed523e35fc","type":"text","conversion_output":true,"text":"The rare risks of Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with","text_display":"\n\nThe rare risks of Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with","confidence":1,"confidence_rate":1},{"cnt":[[318,1916],[1794,1916],[1794,1970],[318,1970]],"region":{"top_left_x":317,"top_left_y":1916,"width":1477,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12bbd88697b747e3bbaa67f80eca09aa","type":"text","conversion_output":true,"text":"eosinophidia and systemic symptoms (DRESS syndrome), and pemphigus vulgaris have","text_display":" eosinophidia and systemic symptoms (DRESS syndrome), and pemphigus vulgaris have","confidence":0.7434196472167969,"confidence_rate":0.9965179049256535},{"cnt":[[318,1977],[1871,1977],[1871,2030],[318,2030]],"region":{"top_left_x":317,"top_left_y":1976,"width":1555,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f829ff8820dc4d1fbb72b98ef040b1b3","type":"text","conversion_output":true,"text":"been reported in oncology studies when MLN9708 (or placebo) was given with concomitant","text_display":" been reported in oncology studies when MLN9708 (or placebo) was given with concomitant","confidence":1,"confidence_rate":1},{"cnt":[[318,2041],[1852,2041],[1852,2093],[318,2093]],"region":{"top_left_x":317,"top_left_y":2041,"width":1535,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed61bb155ae14d1a8709d5be7385d34f","type":"text","conversion_output":true,"text":"medications that are known to cause rash (eg, Bactrim, lenalidomide, aspirin), and/or in the","text_display":" medications that are known to cause rash (eg, Bactrim, lenalidomide, aspirin), and/or in the","confidence":1,"confidence_rate":1},{"cnt":[[316,2103],[1708,2103],[1708,2155],[316,2155]],"region":{"top_left_x":315,"top_left_y":2103,"width":1394,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e21121dbfbd422ea2ab2be5c4aab99b","type":"text","conversion_output":true,"text":"setting of confounding TEAEs. These severe, potentially life-threatening or deadly","text_display":" setting of confounding TEAEs. These severe, potentially life-threatening or deadly","confidence":1,"confidence_rate":1},{"cnt":[[320,2166],[1790,2166],[1790,2219],[320,2219]],"region":{"top_left_x":320,"top_left_y":2165,"width":1470,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adb1fdb798174ff8b6a53c533f455176","type":"text","conversion_output":true,"text":"conditions may involve rash with skin peeling and mouth sores and should be clinically","text_display":" conditions may involve rash with skin peeling and mouth sores and should be clinically","confidence":1,"confidence_rate":1},{"cnt":[[318,2228],[1760,2228],[1760,2279],[318,2279]],"region":{"top_left_x":317,"top_left_y":2227,"width":1443,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4df144722fa8484183b0e495e76db2bb","type":"text","conversion_output":true,"text":"managed according to standard medical practice. Punch biopsies for histopathological","text_display":" managed according to standard medical practice. Punch biopsies for histopathological","confidence":1,"confidence_rate":1},{"cnt":[[318,2290],[1818,2290],[1818,2342],[318,2342]],"region":{"top_left_x":317,"top_left_y":2290,"width":1501,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1abbc8d23b4f4cac97358362ea68a683","type":"text","conversion_output":true,"text":"analysis are encouraged at the discretion of the investigator. Study medications should be","text_display":" analysis are encouraged at the discretion of the investigator. Study medications should be","confidence":1,"confidence_rate":1},{"cnt":[[318,2350],[1863,2350],[1863,2404],[318,2404]],"region":{"top_left_x":317,"top_left_y":2350,"width":1546,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9314818cef6049b1b4be47fbbdb0c3cd","type":"text","conversion_output":true,"text":"discontinued in the event of severe, potentially life-threatening rash. Additional information","text_display":" discontinued in the event of severe, potentially life-threatening rash. 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Thrombocytopenia may be severe","text_display":" testing obtained according to standard clinical practice. Thrombocytopenia may be severe","confidence":1,"confidence_rate":1},{"cnt":[[320,464],[1828,464],[1828,518],[320,518]],"region":{"top_left_x":320,"top_left_y":464,"width":1509,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dff160f134e041cc8d215e305af9a9f2","type":"text","conversion_output":true,"text":"but has been manageable with platelet transfusions according to standard clinical practice.","text_display":" but has been manageable with platelet transfusions according to standard clinical practice.","confidence":1,"confidence_rate":1},{"cnt":[[320,529],[1798,529],[1798,578],[320,578]],"region":{"top_left_x":320,"top_left_y":528,"width":1479,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ee57fe96ba8427da113a372df3f8d95","type":"text","conversion_output":true,"text":"Lenalidomide or study drug administration should be modified as per dose modification","text_display":" Lenalidomide or study drug administration should be modified as per dose modification","confidence":1,"confidence_rate":1},{"cnt":[[320,589],[1837,589],[1837,642],[320,642]],"region":{"top_left_x":320,"top_left_y":588,"width":1517,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d13a605cf904748a00b7b1459bad774","type":"text","conversion_output":true,"text":"recommendations in the protocol when thrombocytopenia occurs (see Table 6-1). 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Symptoms may include fatigue,","text_display":" blood cells and result in blood clots in small blood vessels. Symptoms may include fatigue,","confidence":0.9990236759185791,"confidence_rate":0.999989825041388},{"cnt":[[318,902],[1858,902],[1858,952],[318,952]],"region":{"top_left_x":317,"top_left_y":902,"width":1542,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10d960193608436faf0dc62fd625a840","type":"text","conversion_output":true,"text":"fever, bruising, nose bleeds, and decreased urination. These disorders, including fatal cases,","text_display":" fever, bruising, nose bleeds, and decreased urination. These disorders, including fatal cases,","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[318,965],[1708,965],[1708,1016],[318,1016]],"region":{"top_left_x":317,"top_left_y":964,"width":1392,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4158f2fc7fe452894e142d0dc57a393","type":"text","conversion_output":true,"text":"have been reported in patients receiving MLN9708. If TMA is suspected, consider","text_display":" have been reported in patients receiving MLN9708. If TMA is suspected, consider","confidence":1,"confidence_rate":1},{"cnt":[[318,1025],[1785,1025],[1785,1076],[318,1076]],"region":{"top_left_x":317,"top_left_y":1024,"width":1469,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"825e59bdd1fd46369f0a08ecb7c9fc28","type":"text","conversion_output":true,"text":"withdrawal of the suspected causative agent and manage according to standard medical","text_display":" withdrawal of the suspected causative agent and manage according to standard medical","confidence":1,"confidence_rate":1},{"cnt":[[318,1091],[471,1091],[471,1141],[318,1141]],"region":{"top_left_x":317,"top_left_y":1091,"width":154,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec8bb91265ba4b688b18914a9fadedf0","type":"text","conversion_output":true,"text":"practice.","text_display":" practice.","confidence":1,"confidence_rate":1},{"cnt":[[318,1190],[556,1190],[556,1248],[318,1248]],"region":{"top_left_x":317,"top_left_y":1190,"width":240,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"268c7c5ee27142ac8523bc38df3c0932","type":"section_header","conversion_output":false,"children_ids":["27cc5f6e79664b99b3490a5402d0cce8"],"text":"","text_display":""},{"cnt":[[322,1195],[552,1195],[552,1244],[322,1244]],"region":{"top_left_x":322,"top_left_y":1194,"width":231,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27cc5f6e79664b99b3490a5402d0cce8","type":"text","conversion_output":true,"parent_id":"268c7c5ee27142ac8523bc38df3c0932","text":"Neutropenia","text_display":"\n\n\\section*{Neutropenia}","confidence":1,"confidence_rate":1},{"cnt":[[318,1283],[1772,1283],[1772,1334],[318,1334]],"region":{"top_left_x":317,"top_left_y":1282,"width":1456,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"750e38af0ccc401da378fafd1dee0518","type":"text","conversion_output":true,"text":"Blood counts should be monitored regularly as outlined in the protocol with additional","text_display":"\n\nBlood counts should be monitored regularly as outlined in the protocol with additional","confidence":1,"confidence_rate":1},{"cnt":[[320,1345],[1846,1345],[1846,1396],[320,1396]],"region":{"top_left_x":320,"top_left_y":1344,"width":1526,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc0741ce0e7a4615a82198dea9f9cf2c","type":"text","conversion_output":true,"text":"testing obtained according to standard clinical practice. 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Fluid deficit should be promptly corrected before","text_display":" gastrointestinal toxicities and dehydration. Fluid deficit should be promptly corrected before","confidence":1,"confidence_rate":1},{"cnt":[[312,2097],[1678,2097],[1678,2151],[312,2151]],"region":{"top_left_x":311,"top_left_y":2096,"width":1367,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c721686fbbb4f4dad20ed542619c5d3","type":"text","conversion_output":true,"text":"initiation of study drug and as needed during treatment to avoid dehydration (see","text_display":" initiation of study drug and as needed during treatment to avoid dehydration (see","confidence":0.9921875,"confidence_rate":0.9999088044206508},{"cnt":[[322,2161],[539,2161],[539,2211],[322,2211]],"region":{"top_left_x":322,"top_left_y":2161,"width":218,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e48f9ec60a6b42bda623a1484b3b06fa","type":"text","conversion_output":true,"text":"Section 6.8).","text_display":" Section 6.8).","confidence":1,"confidence_rate":1},{"cnt":[[314,2262],[561,2262],[561,2322],[314,2322]],"region":{"top_left_x":313,"top_left_y":2262,"width":248,"height":61},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de2e06b792f846118a8f6f0018ecb28b","type":"section_header","conversion_output":false,"children_ids":["15252c20d2654dd487f869cbb2ec1081"],"text":"","text_display":""},{"cnt":[[320,2269],[556,2269],[556,2318],[320,2318]],"region":{"top_left_x":320,"top_left_y":2268,"width":237,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15252c20d2654dd487f869cbb2ec1081","type":"text","conversion_output":true,"parent_id":"de2e06b792f846118a8f6f0018ecb28b","text":"Hypotension","text_display":"\n\n\\section*{Hypotension}","confidence":1,"confidence_rate":1},{"cnt":[[320,2355],[1830,2355],[1830,2408],[320,2408]],"region":{"top_left_x":320,"top_left_y":2354,"width":1511,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84dec31476b54f279d0a399c742d1557","type":"text","conversion_output":true,"text":"Symptomatic hypotension and orthostatic hypotension with or without syncope have been","text_display":"\n\nSymptomatic hypotension and orthostatic hypotension with or without syncope have been","confidence":1,"confidence_rate":1},{"cnt":[[318,2417],[1880,2417],[1880,2469],[318,2469]],"region":{"top_left_x":317,"top_left_y":2416,"width":1563,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64408369350d4bb7ac4cf73e205e5eff","type":"text","conversion_output":true,"text":"reported with MLN9708. Blood pressure should be closely monitored as per standard of care","text_display":" reported with MLN9708. 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Fluid deficit should be corrected before initiation of study drug","text_display":" during the course of the trial. Fluid deficit should be corrected before initiation of study drug","confidence":1,"confidence_rate":1},{"cnt":[[318,623],[1214,623],[1214,675],[318,675]],"region":{"top_left_x":317,"top_left_y":623,"width":897,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f98f24f7f12c41f18c4034c33c5c3635","type":"text","conversion_output":true,"text":"and as needed during treatment to avoid dehydration.","text_display":" and as needed during treatment to avoid dehydration.","confidence":1,"confidence_rate":1},{"cnt":[[316,726],[1190,726],[1190,784],[316,784]],"region":{"top_left_x":315,"top_left_y":726,"width":876,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc619d381c9547ceb526062fa4ca3f27","type":"section_header","conversion_output":false,"children_ids":["05a28e389f80496db95480be25d1cd4c"],"text":"","text_display":""},{"cnt":[[320,730],[1188,730],[1188,780],[320,780]],"region":{"top_left_x":320,"top_left_y":730,"width":869,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05a28e389f80496db95480be25d1cd4c","type":"text","conversion_output":true,"parent_id":"bc619d381c9547ceb526062fa4ca3f27","text":"Posterior Reversible Encephalopathy Syndrome","text_display":"\n\n\\section*{Posterior Reversible Encephalopathy Syndrome}","confidence":1,"confidence_rate":1},{"cnt":[[320,816],[1824,816],[1824,870],[320,870]],"region":{"top_left_x":320,"top_left_y":816,"width":1505,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b3b088bcdff421b881406c81bd25056","type":"text","conversion_output":true,"text":"Posterior reversible encephalopathy syndrome (PRES) has been reported with MLN9708.","text_display":"\n\nPosterior reversible encephalopathy syndrome (PRES) has been reported with MLN9708.","confidence":1,"confidence_rate":1},{"cnt":[[320,881],[1841,881],[1841,930],[320,930]],"region":{"top_left_x":320,"top_left_y":880,"width":1522,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"376f21d4631841c78f5b4c38d7a65f74","type":"text","conversion_output":true,"text":"This condition is usually transient and reversible. It is characterized by headache, seizures,","text_display":" This condition is usually transient and reversible. It is characterized by headache, seizures,","confidence":1,"confidence_rate":1},{"cnt":[[318,941],[1871,941],[1871,995],[318,995]],"region":{"top_left_x":317,"top_left_y":941,"width":1555,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0532203bdf364a05b32af5b4a81cca8d","type":"text","conversion_output":true,"text":"and visual loss, as well as abrupt increase in blood pressure. Diagnosis may be confirmed by","text_display":" and visual loss, as well as abrupt increase in blood pressure. Diagnosis may be confirmed by","confidence":1,"confidence_rate":1},{"cnt":[[318,1005],[1768,1005],[1768,1055],[318,1055]],"region":{"top_left_x":317,"top_left_y":1005,"width":1452,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6a26bc35b4541a8b8c8cc4c42a63955","type":"text","conversion_output":true,"text":"magnetic resonance imaging (MRI) or computed tomography (CD). If the syndrome is","text_display":" magnetic resonance imaging (MRI) or computed tomography (CD). If the syndrome is","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[320,1068],[1725,1068],[1725,1119],[320,1119]],"region":{"top_left_x":320,"top_left_y":1067,"width":1406,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f72d82a2af64788bce426777f1929a5","type":"text","conversion_output":true,"text":"diagnosed or suspected, symptom-directed treatment should be maintained until the","text_display":" diagnosed or suspected, symptom-directed treatment should be maintained until the","confidence":1,"confidence_rate":1},{"cnt":[[318,1128],[1588,1128],[1588,1179],[318,1179]],"region":{"top_left_x":317,"top_left_y":1127,"width":1271,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6dcf5427ace4c189e9c24085f3485b3","type":"text","conversion_output":true,"text":"condition is reversed by control of hypertension or other instigating factors.","text_display":" condition is reversed by control of hypertension or other instigating factors.","confidence":0.99853515625,"confidence_rate":0.9999823384971409},{"cnt":[[314,1229],[690,1229],[690,1291],[314,1291]],"region":{"top_left_x":313,"top_left_y":1228,"width":377,"height":64},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34627595c625471e9dd2d48e17797d7b","type":"section_header","conversion_output":false,"children_ids":["72dbcb5eeb9146039089bdb84ee42ddf"],"text":"","text_display":""},{"cnt":[[318,1233],[685,1233],[685,1285],[318,1285]],"region":{"top_left_x":317,"top_left_y":1233,"width":369,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72dbcb5eeb9146039089bdb84ee42ddf","type":"text","conversion_output":true,"parent_id":"34627595c625471e9dd2d48e17797d7b","text":"Transverse Myelitis","text_display":"\n\n\\section*{Transverse Myelitis}","confidence":1,"confidence_rate":1},{"cnt":[[320,1323],[1833,1323],[1833,1373],[320,1373]],"region":{"top_left_x":320,"top_left_y":1323,"width":1513,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7e3b5497b434cd586313132482d9fb7","type":"text","conversion_output":true,"text":"Transverse myelitis has been reported with MDN9708. It is not known whether MLN9708","text_display":"\n\nTransverse myelitis has been reported with MDN9708. It is not known whether MLN9708","confidence":0.409423828125,"confidence_rate":0.9899035376396785},{"cnt":[[318,1386],[1841,1386],[1841,1437],[318,1437]],"region":{"top_left_x":317,"top_left_y":1385,"width":1525,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abc517d42d3447fa81154807a75c96bf","type":"text","conversion_output":true,"text":"causes transverse myelitis; however, because it happened to a patient receiving MLN9708,","text_display":" causes transverse myelitis; however, because it happened to a patient receiving MLN9708,","confidence":0.99853515625,"confidence_rate":0.9999842375685026},{"cnt":[[318,1448],[1734,1448],[1734,1497],[318,1497]],"region":{"top_left_x":317,"top_left_y":1448,"width":1417,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f55f0de2cb7947eabd8634775b1fb514","type":"text","conversion_output":true,"text":"the possibility that MLN9708 may have contributed to transverse myelitis cannot be","text_display":" the possibility that MLN9708 may have contributed to transverse myelitis cannot be","confidence":1,"confidence_rate":1},{"cnt":[[318,1508],[1824,1508],[1824,1562],[318,1562]],"region":{"top_left_x":317,"top_left_y":1508,"width":1508,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59898c9d648244869424cdfa711d9e98","type":"text","conversion_output":true,"text":"excluded. Transverse myelitis should be managed according to standard medical practice.","text_display":" excluded. Transverse myelitis should be managed according to standard medical practice.","confidence":1,"confidence_rate":1},{"cnt":[[314,1611],[509,1611],[509,1671],[314,1671]],"region":{"top_left_x":313,"top_left_y":1611,"width":197,"height":61},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16dbce274479421fa5983a594c078007","type":"section_header","conversion_output":false,"children_ids":["1bf22aafe82f4f608b57cf08e4b7afe7"],"text":"","text_display":""},{"cnt":[[318,1616],[501,1616],[501,1665],[318,1665]],"region":{"top_left_x":317,"top_left_y":1615,"width":184,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bf22aafe82f4f608b57cf08e4b7afe7","type":"text","conversion_output":true,"parent_id":"16dbce274479421fa5983a594c078007","text":"Overdose","text_display":"\n\n\\section*{Overdose}","confidence":1,"confidence_rate":1},{"cnt":[[318,1719],[1863,1719],[1863,1768],[318,1768]],"region":{"top_left_x":317,"top_left_y":1718,"width":1546,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03d141c0af184ca892d9f2f5f5dadf86","type":"text","conversion_output":true,"text":"An overdose is defined as a known deliberate or accidental administration of investigational","text_display":"\n\nAn overdose is defined as a known deliberate or accidental administration of investigational","confidence":1,"confidence_rate":1},{"cnt":[[318,1779],[1764,1779],[1764,1833],[318,1833]],"region":{"top_left_x":317,"top_left_y":1778,"width":1447,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bbe3d4d1789407a84509dd42939cb9d","type":"text","conversion_output":true,"text":"drug, to or by a study subject, at a dose above that which is assigned to that individual","text_display":" drug, to or by a study subject, at a dose above that which is assigned to that individual","confidence":1,"confidence_rate":1},{"cnt":[[318,1843],[1766,1843],[1766,1893],[318,1893]],"region":{"top_left_x":317,"top_left_y":1843,"width":1450,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"110e37476f5440bdbc84f1ff7f410fe0","type":"text","conversion_output":true,"text":"subject according to the study protocol. If overdose occurs, consider close observation","text_display":" subject according to the study protocol. If overdose occurs, consider close observation","confidence":1,"confidence_rate":1},{"cnt":[[318,1904],[1807,1904],[1807,1957],[318,1957]],"region":{"top_left_x":317,"top_left_y":1903,"width":1490,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80cf51334caa483891e34ed2f9de29cb","type":"text","conversion_output":true,"text":"including hospitalization for hemodynamic support. Gastric lavage may be considered if","text_display":" including hospitalization for hemodynamic support. Gastric lavage may be considered if","confidence":1,"confidence_rate":1},{"cnt":[[320,1968],[1330,1968],[1330,2017],[320,2017]],"region":{"top_left_x":320,"top_left_y":1967,"width":1010,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a14f676ca1364cfba04ed9bc1aaf2eac","type":"text","conversion_output":true,"text":"instituted within 1 hour of ingestion of MLN9708 overdose.","text_display":" instituted within 1 hour of ingestion of MLN9708 overdose.","confidence":1,"confidence_rate":1},{"cnt":[[314,2065],[930,2065],[930,2129],[314,2129]],"region":{"top_left_x":313,"top_left_y":2064,"width":618,"height":66},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62643a0270314c569ade5f2adc8b2a64","type":"section_header","conversion_output":false,"children_ids":["ca089723b6c04f8cb8c863a377bacafe"],"text":"","text_display":""},{"cnt":[[322,2071],[924,2071],[924,2125],[322,2125]],"region":{"top_left_x":322,"top_left_y":2071,"width":602,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca089723b6c04f8cb8c863a377bacafe","type":"text","conversion_output":true,"parent_id":"62643a0270314c569ade5f2adc8b2a64","text":"6.11 Blinding and Unblinding","text_display":"\n\n\\subsection*{6.11 Blinding and Unblinding}","confidence":1,"confidence_rate":1},{"cnt":[[320,2161],[1841,2161],[1841,2211],[320,2211]],"region":{"top_left_x":320,"top_left_y":2161,"width":1522,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3aaed9c2ad0f4f5bb94f76730340a1ef","type":"text","conversion_output":true,"text":"To maintain the blind, all study personnel including the investigators, site personnel, study","text_display":"\n\nTo maintain the blind, all study personnel including the investigators, site personnel, study","confidence":1,"confidence_rate":1},{"cnt":[[320,2221],[1841,2221],[1841,2275],[320,2275]],"region":{"top_left_x":320,"top_left_y":2221,"width":1522,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a94dfddb95df44209bdd17e91d607925","type":"text","conversion_output":true,"text":"clinicians, and the sponsor will be blinded to the treatment assignments for the duration of","text_display":" clinicians, and the sponsor will be blinded to the treatment assignments for the duration of","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[318,2286],[488,2286],[488,2335],[318,2335]],"region":{"top_left_x":317,"top_left_y":2285,"width":171,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b3d15dd666549ea879e82c97c6a58ea","type":"text","conversion_output":true,"text":"the study.","text_display":" the study.","confidence":1,"confidence_rate":1},{"cnt":[[320,2389],[1781,2389],[1781,2443],[320,2443]],"region":{"top_left_x":320,"top_left_y":2389,"width":1462,"height":54},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"578016d57ca64bd6bbd6a9d5ff9fa165","type":"text","conversion_output":true,"text":"Kit assignments will be obtained through the interactive voice response system (IVRS)","text_display":"\n\nKit assignments will be obtained through the interactive voice response system (IVRS)","confidence":1,"confidence_rate":1},{"cnt":[[320,2454],[1790,2454],[1790,2503],[320,2503]],"region":{"top_left_x":320,"top_left_y":2453,"width":1470,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eacc8ed9c4d04ae4a7205248422b8bc0","type":"text","conversion_output":true,"text":"according to the procedures outlines in the Study Manual. Information regarding the kit","text_display":" according to the procedures outlines in the Study Manual. Information regarding the kit","confidence":1,"confidence_rate":1},{"cnt":[[1072,2585],[1124,2585],[1124,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2584,"width":52,"height":44},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"314d25399dcc4627b929f9214cdeb2c8","type":"page_info","conversion_output":false,"text":"71","text_display":"","confidence":0.998046875,"confidence_rate":0.9990229601966113}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-073","page":73,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2487f2aaaac457793cbb970903fda31","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3acaef7e0b6a4ddea8a2c2b52fdf1593","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,254],[1781,254],[1781,303],[320,303]],"region":{"top_left_x":320,"top_left_y":253,"width":1462,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"823de6860bff452d91232ede8ff83a0e","type":"text","conversion_output":true,"text":"assignments will be kept securely at Millennium or designee, per its standard operating","text_display":"\nassignments will be kept securely at Millennium or designee, per its standard operating","confidence":1,"confidence_rate":1},{"cnt":[[318,314],[1687,314],[1687,365],[318,365]],"region":{"top_left_x":317,"top_left_y":313,"width":1370,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c197ce3997c4638b02ace4924c5a900","type":"text","conversion_output":true,"text":"procedures. Emergency unblinding, if necessary, will be conducted via the IVRS.","text_display":" procedures. Emergency unblinding, if necessary, will be conducted via the IVRS.","confidence":1,"confidence_rate":1},{"cnt":[[320,417],[1815,417],[1815,466],[320,466]],"region":{"top_left_x":320,"top_left_y":416,"width":1496,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb1c6034a27945aa89dfde5492aa6ad8","type":"text","conversion_output":true,"text":"Records of the patient number, the date study drug was dispensed, and the kit assignment","text_display":"\n\nRecords of the patient number, the date study drug was dispensed, and the kit assignment","confidence":1,"confidence_rate":1},{"cnt":[[318,477],[1811,477],[1811,529],[318,529]],"region":{"top_left_x":317,"top_left_y":476,"width":1495,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c3fba6635c1402eb630bc7bda5bb138","type":"text","conversion_output":true,"text":"will be maintained by the study site. If the treatment assignment must be revealed for the","text_display":" will be maintained by the study site. If the treatment assignment must be revealed for the","confidence":1,"confidence_rate":1},{"cnt":[[322,541],[1865,541],[1865,591],[322,591]],"region":{"top_left_x":322,"top_left_y":541,"width":1543,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8c4b9681f3f4c40aaa9488a8c9df142","type":"text","conversion_output":true,"text":"safety of the patient or to treat an AE, the investigator will contact the Millennium clinician/","text_display":" safety of the patient or to treat an AE, the investigator will contact the Millennium clinician/","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[320,604],[1830,604],[1830,655],[320,655]],"region":{"top_left_x":320,"top_left_y":603,"width":1511,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7de08e9b9ad48abb243cddd44e6aaf6","type":"text","conversion_output":true,"text":"study clinician designee (contact information is in the Study Manual). A decision to break","text_display":" study clinician designee (contact information is in the Study Manual). A decision to break","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[320,666],[1777,666],[1777,715],[320,715]],"region":{"top_left_x":320,"top_left_y":666,"width":1457,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"209e5abfc41849a9a0ffb282b5639390","type":"text","conversion_output":true,"text":"the blind must be reached by the Millennium clinician/study clinician designee and the","text_display":" the blind must be reached by the Millennium clinician/study clinician designee and the","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[320,726],[1691,717],[1691,779],[320,788]],"region":{"top_left_x":320,"top_left_y":717,"width":1372,"height":72},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fd61a52b3d14f14ba64fe8bcaf24677","type":"text","conversion_output":true,"text":"investigator. The investigator, or designee, may break the blind through the IVRS","text_display":" investigator. The investigator, or designee, may break the blind through the IVRS","confidence":1,"confidence_rate":1},{"cnt":[[320,791],[1850,791],[1850,844],[320,844]],"region":{"top_left_x":320,"top_left_y":790,"width":1530,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e08e16efb9fd4cba9f9f445e71b2d9eb","type":"text","conversion_output":true,"text":"independent of the Millennium clinician/ study clinician designee only if it is considered to","text_display":" independent of the Millennium clinician/ study clinician designee only if it is considered to","confidence":0.9941482543945312,"confidence_rate":0.9999401147099615},{"cnt":[[318,851],[1826,851],[1826,904],[318,904]],"region":{"top_left_x":317,"top_left_y":850,"width":1510,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03cd4ebb09544279a52596fe59192192","type":"text","conversion_output":true,"text":"be an emergency by the investigator that requires specific knowledge of the blinded study","text_display":" be an emergency by the investigator that requires specific knowledge of the blinded study","confidence":0.9970703125,"confidence_rate":0.9999687878548241},{"cnt":[[318,915],[1811,915],[1811,965],[318,965]],"region":{"top_left_x":317,"top_left_y":915,"width":1495,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e734c85484f4a82b593060cc0394a88","type":"text","conversion_output":true,"text":"treatment in order to properly treat the \\(AE /\\) safety issue. If the treatment of the \\(AE /\\) safety","text_display":" treatment in order to properly treat the \\(AE /\\) safety issue. If the treatment of the \\(AE /\\) safety","confidence":0.5493431073217536,"confidence_rate":0.9945690551505477},{"cnt":[[318,975],[1815,975],[1815,1029],[318,1029]],"region":{"top_left_x":317,"top_left_y":975,"width":1499,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98e3e6006e454f27b1b81b08c9f8213f","type":"text","conversion_output":true,"text":"issue is the same regardless of the study drug assignment, the blind should not be broken.","text_display":" issue is the same regardless of the study drug assignment, the blind should not be broken.","confidence":1,"confidence_rate":1},{"cnt":[[318,1040],[1798,1040],[1798,1089],[318,1089]],"region":{"top_left_x":317,"top_left_y":1039,"width":1482,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22ce18b8b6174c1c9ebbe840ace2fb25","type":"text","conversion_output":true,"text":"The event requiring breaking the blind must be documented in the electronic case report","text_display":" The event requiring breaking the blind must be documented in the electronic case report","confidence":1,"confidence_rate":1},{"cnt":[[318,1100],[1747,1100],[1747,1154],[318,1154]],"region":{"top_left_x":317,"top_left_y":1100,"width":1430,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f82b45c008424c219a6963e660e26226","type":"text","conversion_output":true,"text":"form (eCRF), including the date the blind was broken. In addition, the patient will be","text_display":" form (eCRF), including the date the blind was broken. 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When possible, patients should","confidence":1,"confidence_rate":1},{"cnt":[[318,1704],[1747,1704],[1747,1755],[318,1755]],"region":{"top_left_x":317,"top_left_y":1703,"width":1430,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20b3c93e188d4d15bff510ff19c6c991","type":"text","conversion_output":true,"text":"complete an EOT visit and transition onto an alternative supply of (eg, commercially","text_display":" complete an EOT visit and transition onto an alternative supply of (eg, commercially","confidence":0.9990234375,"confidence_rate":0.9999890220866866},{"cnt":[[318,1766],[1652,1766],[1652,1815],[318,1815]],"region":{"top_left_x":317,"top_left_y":1766,"width":1336,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13267e33f9604eb29fbe822a0cee0351","type":"text","conversion_output":true,"text":"available) ixazomiband/or LenDex, or onto another standard of care treatment.","text_display":" available) ixazomiband/or LenDex, or onto another standard of care treatment.","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[318,1828],[1833,1828],[1833,1882],[318,1882]],"region":{"top_left_x":317,"top_left_y":1828,"width":1516,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"644361729ec642f497160fca085a0f88","type":"text","conversion_output":true,"text":"Discontinued patients will be treated by their physician per local standard of care. Patients","text_display":" Discontinued patients will be treated by their physician per local standard of care. 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The MLN9708","text_display":"\n\nMLN9708 and matching placebo capsules are manufactured by Millennium. The MLN9708","confidence":1,"confidence_rate":1},{"cnt":[[320,2333],[1867,2333],[1867,2385],[320,2385]],"region":{"top_left_x":320,"top_left_y":2333,"width":1547,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9e32b1e2f9b4918bda6fd1f72e87a3a","type":"text","conversion_output":true,"text":"drug product is provided in strengths of \\(4.0-, 3.0-\\), and \\(2.3- mg\\) capsules as the active boronic","text_display":" drug product is provided in strengths of \\(4.0-, 3.0-\\), and \\(2.3- mg\\) capsules as the active boronic","confidence":0.879578560884019,"confidence_rate":0.998812627759836},{"cnt":[[1072,2585],[1126,2585],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2584,"width":54,"height":44},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fe4ef986cf3473dbd33f495dac18220","type":"page_info","conversion_output":false,"text":"72","text_display":"","confidence":0.998046875,"confidence_rate":0.9990229601966113}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-074","page":74,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f373b3167c3a4af7bf153ecf59c0150d","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d03fb928ab74bc6afbe856b7002625a","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1824,249],[1824,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1508,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39f0e02d01c64791b931e8ecdb75354a","type":"text","conversion_output":true,"text":"acid. 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Patients should be instructed not","text_display":" caution should be exercised when handling the study drug. Patients should be instructed not","confidence":1,"confidence_rate":1},{"cnt":[[320,1706],[1764,1706],[1764,1755],[320,1755]],"region":{"top_left_x":320,"top_left_y":1705,"width":1444,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e08842c614884908a253ac492d4d3688","type":"text","conversion_output":true,"text":"to chew, break, or open capsules. In case of contact with broken capsules, raising dust","text_display":" to chew, break, or open capsules. In case of contact with broken capsules, raising dust","confidence":0.9956073760986328,"confidence_rate":0.999952150059853},{"cnt":[[318,1766],[1871,1766],[1871,1818],[318,1818]],"region":{"top_left_x":317,"top_left_y":1766,"width":1555,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd7b4a70653f4d058372cbd836483121","type":"text","conversion_output":true,"text":"should be avoided during the clean-up operation. The product may be harmful by inhalation,","text_display":" should be avoided during the clean-up operation. The product may be harmful by inhalation,","confidence":1,"confidence_rate":1},{"cnt":[[320,1830],[1876,1830],[1876,1880],[320,1880]],"region":{"top_left_x":320,"top_left_y":1830,"width":1556,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef1353d1c68742f485b85d5664356ae7","type":"text","conversion_output":true,"text":"ingestion, or skin absorption. 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The area should","confidence":1,"confidence_rate":1},{"cnt":[[318,1955],[1878,1955],[1878,2004],[318,2004]],"region":{"top_left_x":317,"top_left_y":1955,"width":1561,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc30f2c7a2da494a88ebbb1c933b1187","type":"text","conversion_output":true,"text":"be ventilated and the site washed with soap and water after material pick up is complete. The","text_display":" be ventilated and the site washed with soap and water after material pick up is complete. 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If the study schedule is shifted,","confidence":1,"confidence_rate":1},{"cnt":[[322,438],[1800,438],[1800,488],[322,488]],"region":{"top_left_x":322,"top_left_y":438,"width":1479,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c238e4a61ee64ef1a1a44eac1dbac82f","type":"text","conversion_output":true,"text":"assessments must be shifted to ensure that collection of assessments is completed before","text_display":" assessments must be shifted to ensure that collection of assessments is completed before","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[322,503],[449,503],[449,548],[322,548]],"region":{"top_left_x":322,"top_left_y":502,"width":128,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77365a1b0dbe4012a2b6ba8253d962d8","type":"text","conversion_output":true,"text":"dosing.","text_display":" dosing.","confidence":1,"confidence_rate":1},{"cnt":[[320,606],[1512,606],[1512,655],[320,655]],"region":{"top_left_x":320,"top_left_y":605,"width":1193,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d08767d061d46338fe6299d53b819fb","type":"text","conversion_output":true,"text":"Additional details are provided as necessary in the sections that follow.","text_display":"\n\nAdditional details are provided as necessary in the sections that follow.","confidence":1,"confidence_rate":1},{"cnt":[[318,705],[834,705],[834,754],[318,754]],"region":{"top_left_x":317,"top_left_y":704,"width":517,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1ad51137cbc4e71a0233a789adb47f3","type":"section_header","conversion_output":false,"children_ids":["ca9bc92ef77a429ba8dde3682fc223cc"],"text":"","text_display":""},{"cnt":[[322,709],[827,709],[827,750],[322,750]],"region":{"top_left_x":322,"top_left_y":708,"width":506,"height":42},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca9bc92ef77a429ba8dde3682fc223cc","type":"text","conversion_output":true,"parent_id":"d1ad51137cbc4e71a0233a789adb47f3","text":"7.4.1 Informed Consent","text_display":"\n\n\\subsection*{7.4.1 Informed Consent}","confidence":1,"confidence_rate":1},{"cnt":[[320,799],[1828,799],[1828,849],[320,849]],"region":{"top_left_x":320,"top_left_y":799,"width":1509,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47c8c22bde624f74a435bb30ad1cdf4c","type":"text","conversion_output":true,"text":"Each patient must provide written informed consent before any study-required procedures","text_display":"\n\nEach patient must provide written informed consent before any study-required procedures","confidence":1,"confidence_rate":1},{"cnt":[[322,862],[1843,862],[1843,909],[322,909]],"region":{"top_left_x":322,"top_left_y":861,"width":1522,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32931fc6fb134832a8d0d972bea2f16c","type":"text","conversion_output":true,"text":"are conducted, unless those procedures are performed as part of the patient's standard care.","text_display":" are conducted, unless those procedures are performed as part of the patient's standard care.","confidence":1,"confidence_rate":1},{"cnt":[[322,965],[1846,965],[1846,1012],[322,1012]],"region":{"top_left_x":322,"top_left_y":964,"width":1524,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d79ae1277a334a3db931f4bd92028475","type":"text","conversion_output":true,"text":"Patients remaining on study treatment will need to be reconsented. Reconsenting should be","text_display":"\n\nPatients remaining on study treatment will need to be reconsented. Reconsenting should be","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[320,1010],[1785,1010],[1785,1059],[320,1059]],"region":{"top_left_x":320,"top_left_y":1009,"width":1466,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed7ecde257a841d19ca2687f563464d7","type":"text","conversion_output":true,"text":"done in person. Remote reconsenting is permitted as long as the process adheres to site,","text_display":" done in person. Remote reconsenting is permitted as long as the process adheres to site,","confidence":1,"confidence_rate":1},{"cnt":[[322,1059],[1182,1059],[1182,1106],[322,1106]],"region":{"top_left_x":322,"top_left_y":1059,"width":860,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7556cc859c6141a58e03c454b21a1cdc","type":"text","conversion_output":true,"text":"IRB/IEC, and GCP standards and local regulations.","text_display":" IRB/IEC, and GCP standards and local regulations.","confidence":1,"confidence_rate":1},{"cnt":[[318,1126],[902,1126],[902,1184],[318,1184]],"region":{"top_left_x":317,"top_left_y":1125,"width":586,"height":59},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aac27ddaf2484633808be4c80ef9fa15","type":"section_header","conversion_output":false,"children_ids":["8901f74bf487489d8dd52de1e09dfc7b"],"text":"","text_display":""},{"cnt":[[322,1130],[896,1130],[896,1179],[322,1179]],"region":{"top_left_x":322,"top_left_y":1130,"width":574,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8901f74bf487489d8dd52de1e09dfc7b","type":"text","conversion_output":true,"parent_id":"aac27ddaf2484633808be4c80ef9fa15","text":"7.4.2 Patient Demographics","text_display":"\n\n\\subsection*{7.4.2 Patient Demographics}","confidence":1,"confidence_rate":1},{"cnt":[[320,1216],[1850,1216],[1850,1268],[320,1268]],"region":{"top_left_x":320,"top_left_y":1216,"width":1530,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfb87ac02a2d4a35a578b53efec788ae","type":"text","conversion_output":true,"text":"The date of birth, race, ethnicity, and sex of the patient are to be recorded during screening.","text_display":"\n\nThe date of birth, race, ethnicity, and sex of the patient are to be recorded during screening.","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[318,1319],[797,1319],[797,1377],[318,1377]],"region":{"top_left_x":317,"top_left_y":1319,"width":481,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"977db2007ccf40e7ae2c4fcaed292200","type":"section_header","conversion_output":false,"children_ids":["b605ba887ad94ff886141ac6440338fa"],"text":"","text_display":""},{"cnt":[[322,1323],[793,1323],[793,1373],[322,1373]],"region":{"top_left_x":322,"top_left_y":1323,"width":471,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b605ba887ad94ff886141ac6440338fa","type":"text","conversion_output":true,"parent_id":"977db2007ccf40e7ae2c4fcaed292200","text":"7.4.3 Medical History","text_display":"\n\n\\subsection*{7.4.3 Medical History}","confidence":1,"confidence_rate":1},{"cnt":[[320,1414],[1843,1414],[1843,1463],[320,1463]],"region":{"top_left_x":320,"top_left_y":1413,"width":1524,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"981e8fce37164239b086008880dcf923","type":"text","conversion_output":true,"text":"During the Screening period, a complete medical history will be compiled for each patient,","text_display":"\n\nDuring the Screening period, a complete medical history will be compiled for each patient,","confidence":0.9951171875,"confidence_rate":0.9999484774075793},{"cnt":[[322,1474],[1820,1474],[1820,1523],[322,1523]],"region":{"top_left_x":322,"top_left_y":1473,"width":1498,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e46f647bedc4897a075367d489facb4","type":"text","conversion_output":true,"text":"including diagnosis (Section 15.2) and current staging (Section 15.4) of MM. The history","text_display":" including diagnosis (Section 15.2) and current staging (Section 15.4) of MM. The history","confidence":0.93359375,"confidence_rate":0.9992614138294855},{"cnt":[[320,1536],[1854,1536],[1854,1588],[320,1588]],"region":{"top_left_x":320,"top_left_y":1536,"width":1535,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df697bc23b4d43d4ab50e7b0026e2961","type":"text","conversion_output":true,"text":"should include a review of all current medications, prior radiation or antineoplastic therapy,","text_display":" should include a review of all current medications, prior radiation or antineoplastic therapy,","confidence":1,"confidence_rate":1},{"cnt":[[320,1598],[1001,1598],[1001,1648],[320,1648]],"region":{"top_left_x":320,"top_left_y":1598,"width":682,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"068fbb118fb0458e9985890cdba75ded","type":"text","conversion_output":true,"text":"and the patient's current smoking status.","text_display":" and the patient's current smoking status.","confidence":0.9546117782592773,"confidence_rate":0.9989907154084239},{"cnt":[[318,1702],[896,1702],[896,1755],[318,1755]],"region":{"top_left_x":317,"top_left_y":1701,"width":579,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61334b408ee94615aad6679f5bb159df","type":"section_header","conversion_output":false,"children_ids":["21dfb3de6aa44baeb5e70ce319d39473"],"text":"","text_display":""},{"cnt":[[322,1706],[892,1706],[892,1751],[322,1751]],"region":{"top_left_x":322,"top_left_y":1705,"width":570,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21dfb3de6aa44baeb5e70ce319d39473","type":"text","conversion_output":true,"parent_id":"61334b408ee94615aad6679f5bb159df","text":"7.4.4 Physical Examination","text_display":"\n\n\\subsection*{7.4.4 Physical Examination}","confidence":1,"confidence_rate":1},{"cnt":[[318,1792],[1869,1792],[1869,1841],[318,1841]],"region":{"top_left_x":317,"top_left_y":1791,"width":1553,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03c957182f2c417890548640a8d22205","type":"text","conversion_output":true,"text":"A complete physical examination and symptom-directed physical exam will be conducted at","text_display":"\n\nA complete physical examination and symptom-directed physical exam will be conducted at","confidence":0.9912109375,"confidence_rate":0.9999040490152906},{"cnt":[[320,1852],[1858,1852],[1858,1906],[320,1906]],"region":{"top_left_x":320,"top_left_y":1851,"width":1539,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e3b58afe2ea43c2894dc9b648004ae2","type":"text","conversion_output":true,"text":"the time points specified in the Schedule of Events. Symptom-directed examinations should","text_display":" the time points specified in the Schedule of Events. Symptom-directed examinations should","confidence":0.7212924957275391,"confidence_rate":0.9965303889811532},{"cnt":[[320,1916],[1807,1916],[1807,1968],[320,1968]],"region":{"top_left_x":320,"top_left_y":1916,"width":1487,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a32cd5f4a9948a48fd87bb056916ecc","type":"text","conversion_output":true,"text":"include examination of organ systems related to patient symptoms to document potential","text_display":" include examination of organ systems related to patient symptoms to document potential","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[320,1977],[952,1977],[952,2030],[320,2030]],"region":{"top_left_x":320,"top_left_y":1976,"width":632,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f30a08b8a2a84420a8a1e02174d27b2f","type":"text","conversion_output":true,"text":"AEs, AE severity, and AE resolution.","text_display":" 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the time points specified in the Schedules of Events in Section 15.12 and Section 15.13.","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[320,2299],[1740,2299],[1740,2348],[320,2348]],"region":{"top_left_x":320,"top_left_y":2298,"width":1421,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83975ce0ee1f423fa43da7bd4ad6220c","type":"text","conversion_output":true,"text":"Upon implementation of Amendment 8, ECOG performance status will no longer be","text_display":" Upon implementation of Amendment 8, ECOG performance status will no longer be","confidence":1,"confidence_rate":1},{"cnt":[[320,2359],[488,2359],[488,2404],[320,2404]],"region":{"top_left_x":320,"top_left_y":2358,"width":168,"height":47},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3bd93314f9c440f942b8866657da7ad","type":"text","conversion_output":true,"text":"collected.","text_display":" 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Females","text_display":" discontinuation of study treatment, and atDay 28 after the last dose of study drug. Females","confidence":0.9965848922729492,"confidence_rate":0.9999654455210774},{"cnt":[[318,1448],[1867,1448],[1867,1500],[318,1500]],"region":{"top_left_x":317,"top_left_y":1448,"width":1550,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f19413c0adde48d1955ed7a1a6e4ba1c","type":"text","conversion_output":true,"text":"with irregular menstruation must have a pregnancy test weekly for the first 28 days and then","text_display":" with irregular menstruation must have a pregnancy test weekly for the first 28 days and then","confidence":1,"confidence_rate":1},{"cnt":[[318,1508],[1852,1508],[1852,1562],[318,1562]],"region":{"top_left_x":317,"top_left_y":1508,"width":1535,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3aae451656643d4a150d9a65711e0fc","type":"text","conversion_output":true,"text":"every 14 days while on study (including breaks in therapy), at discontinuation of treatment,","text_display":" every 14 days while on study (including breaks in therapy), at discontinuation of treatment,","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[318,1573],[1854,1573],[1854,1624],[318,1624]],"region":{"top_left_x":317,"top_left_y":1572,"width":1538,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b93039da7edb45adbb387ef9bb46c72d","type":"text","conversion_output":true,"text":"and at Days 14 and 28 after thelast dose of treatment. All patients must be counseled about","text_display":" and at Days 14 and 28 after thelast dose of treatment. All patients must be counseled about","confidence":0.921875,"confidence_rate":0.9992028116544474},{"cnt":[[318,1633],[1747,1633],[1747,1687],[318,1687]],"region":{"top_left_x":317,"top_left_y":1632,"width":1430,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6dc1f04a330472aa757d55dd7d4d6cd","type":"text","conversion_output":true,"text":"pregnancy precautions, risks of fetal exposure, and other risks in accordance with the","text_display":" pregnancy precautions, risks of fetal exposure, and other risks in accordance with the","confidence":1,"confidence_rate":1},{"cnt":[[318,1693],[1798,1693],[1798,1749],[318,1749]],"region":{"top_left_x":317,"top_left_y":1692,"width":1482,"height":57},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a080782e08c24980ae645104a46f4fd5","type":"text","conversion_output":true,"text":"RevAssist program (US participants), RevAid program (Canadian participants), iAccess","text_display":" RevAssist program (US participants), RevAid program (Canadian participants), iAccess","confidence":1,"confidence_rate":1},{"cnt":[[318,1757],[1734,1757],[1734,1811],[318,1811]],"region":{"top_left_x":317,"top_left_y":1757,"width":1417,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9b91c1433e94368b909cc85b668bdf2","type":"text","conversion_output":true,"text":"program (Australian participants), RevMate program (Japanese participants), or The","text_display":" program (Australian participants), RevMate program (Japanese participants), or The","confidence":0.99755859375,"confidence_rate":0.9999719039424972},{"cnt":[[318,1822],[1858,1822],[1858,1871],[318,1871]],"region":{"top_left_x":317,"top_left_y":1821,"width":1542,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba5c44035b4347a6b111132612b965ec","type":"text","conversion_output":true,"text":"Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the Study Manual (all other","text_display":" Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the Study Manual (all other","confidence":1,"confidence_rate":1},{"cnt":[[318,1886],[1210,1886],[1210,1936],[318,1936]],"region":{"top_left_x":317,"top_left_y":1886,"width":893,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"daaec5efd42048b8a12453c36eb7f1e6","type":"text","conversion_output":true,"text":"participants who are not using commercial supplies).","text_display":" participants who are not using commercial supplies).","confidence":1,"confidence_rate":1},{"cnt":[[318,1987],[1775,1987],[1775,2039],[318,2039]],"region":{"top_left_x":317,"top_left_y":1987,"width":1458,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2029092df5ea4191ba48f44df2f06c15","type":"text","conversion_output":true,"text":"The Cycle 1, Day 1 pregnancy test may be collected up to 24 hours before dosing. The","text_display":"\n\nThe Cycle 1, Day 1 pregnancy test may be collected up to 24 hours before dosing. The","confidence":1,"confidence_rate":1},{"cnt":[[316,2050],[1809,2050],[1809,2099],[316,2099]],"region":{"top_left_x":315,"top_left_y":2049,"width":1494,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bf71d0f416e4de4ac3097485270e383","type":"text","conversion_output":true,"text":"results must be available and negative before the first dose of study drug is administered.","text_display":" results must be available and negative before the first dose of study drug is administered.","confidence":1,"confidence_rate":1},{"cnt":[[318,2153],[1777,2153],[1777,2206],[318,2206]],"region":{"top_left_x":317,"top_left_y":2152,"width":1460,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0266ac1573094badb84daa5939472c86","type":"text","conversion_output":true,"text":"Pregnancy tests may also be repeated during the study as per request of IEC/IRBs or if","text_display":"\n\nPregnancy tests may also be repeated during the study as per request of IEC/IRBs or if","confidence":1,"confidence_rate":1},{"cnt":[[318,2217],[814,2217],[814,2267],[318,2267]],"region":{"top_left_x":317,"top_left_y":2217,"width":498,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57b357385f77492bac89f4b6a1846896","type":"text","conversion_output":true,"text":"required by local regulations.","text_display":" required by local regulations.","confidence":1,"confidence_rate":1},{"cnt":[[1074,2587],[1126,2587],[1126,2628],[1074,2628]],"region":{"top_left_x":1074,"top_left_y":2586,"width":52,"height":42},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f247ef1ef1e34a05b4a9584ccf51c009","type":"page_info","conversion_output":false,"text":"79","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-081","page":81,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fe828b3b8d34d8aa259a0afea80c960","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b89c8fb9e2747c295a0822782c288b4","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[316,249],[844,249],[844,307],[316,307]],"region":{"top_left_x":315,"top_left_y":249,"width":530,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df9b6711739c450bb1313f4305fae74b","type":"section_header","conversion_output":false,"children_ids":["900d35a1f6fa4c1ca3574987af660d10"],"text":"","text_display":""},{"cnt":[[322,254],[840,254],[840,301],[322,301]],"region":{"top_left_x":322,"top_left_y":253,"width":519,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"900d35a1f6fa4c1ca3574987af660d10","type":"text","conversion_output":true,"parent_id":"df9b6711739c450bb1313f4305fae74b","text":"7.4.8 Electrocardiogram","text_display":"\n\n\\subsection*{7.4.8 Electrocardiogram}","confidence":1,"confidence_rate":1},{"cnt":[[320,339],[1858,339],[1858,389],[320,389]],"region":{"top_left_x":320,"top_left_y":339,"width":1539,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bc864324a3a409c868099c8fe69c3ee","type":"text","conversion_output":true,"text":"A 12-lead ECG will be conducted at screening and at the times outlined in the Schedules of","text_display":"\n\nA 12-lead ECG will be conducted at screening and at the times outlined in the Schedules of","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[322,404],[1858,404],[1858,453],[322,453]],"region":{"top_left_x":322,"top_left_y":403,"width":1537,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79f3fb36c2784c789b59b597e431f0a2","type":"text","conversion_output":true,"text":"Events in Section 15.12 and Section 15.13. It may be repeated as clinically indicated during","text_display":" Events in Section 15.12 and Section 15.13. It may be repeated as clinically indicated during","confidence":1,"confidence_rate":1},{"cnt":[[320,466],[1843,466],[1843,518],[320,518]],"region":{"top_left_x":320,"top_left_y":466,"width":1524,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"754a05489aca42e0857328ac918c554b","type":"text","conversion_output":true,"text":"the study at the discretion of the investigator. ECG data to be obtained include PR interval,","text_display":" the study at the discretion of the investigator. 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At the unscheduled visits, pain assessments should be completed and appropriate","text_display":" the future. At the unscheduled visits, pain assessments should be completed and appropriate","confidence":1,"confidence_rate":1},{"cnt":[[320,924],[1820,924],[1820,973],[320,973]],"region":{"top_left_x":320,"top_left_y":923,"width":1500,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c736b39e17de475f8ee9ee7bb5c1a600","type":"text","conversion_output":true,"text":"management instituted. In addition, patients who report new or worsening pain at either a","text_display":" management instituted. In addition, patients who report new or worsening pain at either a","confidence":1,"confidence_rate":1},{"cnt":[[318,984],[1876,984],[1876,1036],[318,1036]],"region":{"top_left_x":317,"top_left_y":983,"width":1559,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f2ab7a5c7db4ff1a70c2aa1d4f12dba","type":"text","conversion_output":true,"text":"regularly scheduled visit or are seen for pain at an unscheduled visit should have a follow-up","text_display":" regularly scheduled visit or are seen for pain at an unscheduled visit should have a follow-up","confidence":1,"confidence_rate":1},{"cnt":[[320,1044],[1796,1044],[1796,1098],[320,1098]],"region":{"top_left_x":320,"top_left_y":1044,"width":1477,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be00692481ea4539952e33b7f2c76078","type":"text","conversion_output":true,"text":"visit 3 to 5 weeks later for confirmation of the pain progression and for appropriate pain","text_display":" visit 3 to 5 weeks later for confirmation of the pain progression and for appropriate pain","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[318,1113],[552,1113],[552,1158],[318,1158]],"region":{"top_left_x":317,"top_left_y":1112,"width":236,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"253157784afa4a7c918bedd188c09345","type":"text","conversion_output":true,"text":"management.","text_display":" management.","confidence":1,"confidence_rate":1},{"cnt":[[318,1212],[1876,1212],[1876,1265],[318,1265]],"region":{"top_left_x":317,"top_left_y":1211,"width":1559,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc90c333b82c4b9fb38beb8c87731498","type":"text","conversion_output":true,"text":"The Brief Pain Inventory-Short Form (BPI-SF) will be the principal pain assessment tool for","text_display":"\n\nThe Brief Pain Inventory-Short Form (BPI-SF) will be the principal pain assessment tool for","confidence":1,"confidence_rate":1},{"cnt":[[318,1272],[1798,1272],[1798,1326],[318,1326]],"region":{"top_left_x":317,"top_left_y":1271,"width":1482,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b448bfbae8dc4ec0afaa31cd21bc3016","type":"text","conversion_output":true,"text":"this study. The BPI-SF contains 15 items designed to capture the pain severity (\"worst,\"","text_display":" this study. The BPI-SF contains 15 items designed to capture the pain severity (\"worst,\"","confidence":1,"confidence_rate":1},{"cnt":[[318,1336],[1846,1336],[1846,1390],[318,1390]],"region":{"top_left_x":317,"top_left_y":1336,"width":1529,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"419bbee3d16a4f4da861b79a0d81376e","type":"text","conversion_output":true,"text":"\"least,\" \"average,\" and \"now\" [current pain]), pain location, medication to relieve the pain,","text_display":" \"least,\" \"average,\" and \"now\" [current pain]), pain location, medication to relieve the pain,","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[320,1401],[1824,1401],[1824,1450],[320,1450]],"region":{"top_left_x":320,"top_left_y":1400,"width":1505,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6faa7aca2f584209bb4abf4dea10696e","type":"text","conversion_output":true,"text":"and the interference of pain with various daily activities including general activity, mood,","text_display":" and the interference of pain with various daily activities including general activity, mood,","confidence":1,"confidence_rate":1},{"cnt":[[318,1461],[1794,1461],[1794,1515],[318,1515]],"region":{"top_left_x":317,"top_left_y":1460,"width":1477,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8b189ed95a447a3a5cdeb49e4b264e1","type":"text","conversion_output":true,"text":"walking activity, normal work, relations with other people, sleep, and enjoyment of life.","text_display":" walking activity, normal work, relations with other people, sleep, and enjoyment of life.","confidence":1,"confidence_rate":1},{"cnt":[[320,1566],[1820,1566],[1820,1618],[320,1618]],"region":{"top_left_x":320,"top_left_y":1566,"width":1500,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd156106230e4f2180ae564d9505a462","type":"text","conversion_output":true,"text":"The questionnaire employs a 24 -hour recall period. The pain severity items are rated on a","text_display":"\n\nThe questionnaire employs a 24 -hour recall period. The pain severity items are rated on a","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[320,1629],[1876,1629],[1876,1680],[320,1680]],"region":{"top_left_x":320,"top_left_y":1628,"width":1556,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ffaa7ac08fe4231acb1e59f6993d4f3","type":"text","conversion_output":true,"text":"0 to 10 scale, with \\(0=\\) no pain and \\(10=\\) pain as bad as you can imagine. The PRO secondary","text_display":" 0 to 10 scale, with \\(0=\\) no pain and \\(10=\\) pain as bad as you can imagine. The PRO secondary","confidence":0.994140625,"confidence_rate":0.9999418174502049},{"cnt":[[320,1693],[1798,1693],[1798,1742],[320,1742]],"region":{"top_left_x":320,"top_left_y":1692,"width":1479,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8295578c214449ff92579bea839b189e","type":"text","conversion_output":true,"text":"endpoint will be \"pain response rate\" as measured by the worst pain item (Item 3) in the","text_display":" endpoint will be \"pain response rate\" as measured by the worst pain item (Item 3) in the","confidence":1,"confidence_rate":1},{"cnt":[[320,1753],[1878,1753],[1878,1807],[320,1807]],"region":{"top_left_x":320,"top_left_y":1753,"width":1558,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14c343a32661470eb7239cbdf14486d2","type":"text","conversion_output":true,"text":"BPI-SF or analgesie use. The use of the single item, worst pain, is supported by the Initiative","text_display":" BPI-SF or analgesie use. The use of the single item, worst pain, is supported by the Initiative","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[320,1813],[1674,1813],[1674,1867],[320,1867]],"region":{"top_left_x":320,"top_left_y":1813,"width":1354,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"145c1a95219f4780946dbd142c5072ba","type":"text","conversion_output":true,"text":"on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)","text_display":" on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)","confidence":1,"confidence_rate":1},{"cnt":[[318,1878],[1740,1878],[1740,1929],[318,1929]],"region":{"top_left_x":317,"top_left_y":1877,"width":1424,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"147f43797a5c4c50945057a6bc013cfa","type":"text","conversion_output":true,"text":"recommendations for assessing pain in clinical trials and by the European Medicines","text_display":" recommendations for assessing pain in clinical trials and by the European Medicines","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[318,1938],[1798,1938],[1798,1992],[318,1992]],"region":{"top_left_x":317,"top_left_y":1937,"width":1482,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"349d71bc54ec4b5db018a25fa9d23e39","type":"text","conversion_output":true,"text":"Agency 2003 Guidance on Clinical Investigation of Medicinal Products for Nociceptive","text_display":" Agency 2003 Guidance on Clinical Investigation of Medicinal Products for Nociceptive","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[318,2002],[1807,2002],[1807,2054],[318,2054]],"region":{"top_left_x":317,"top_left_y":2002,"width":1490,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f8a82ca49d0424497b493b939a2d514","type":"text","conversion_output":true,"text":"Pain issued by the Committee for Proprietary Medicinal Products. In addition, the newly","text_display":" Pain issued by the Committee for Proprietary Medicinal Products. In addition, the newly","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[318,2065],[1676,2065],[1676,2116],[318,2116]],"region":{"top_left_x":317,"top_left_y":2064,"width":1359,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35ca31d36a5349f98d9b8fb75b1e5f9a","type":"text","conversion_output":true,"text":"released FDA Guidance uses the following example while discussing conceptual","text_display":" released FDA Guidance uses the following example while discussing conceptual","confidence":0.98388671875,"confidence_rate":0.9997994705805813},{"cnt":[[318,2127],[1835,2127],[1835,2179],[318,2179]],"region":{"top_left_x":317,"top_left_y":2126,"width":1518,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46a8729008ab433880bd3a5e8501a6d6","type":"text","conversion_output":true,"text":"frameworks: \"The conceptual framework of a PRO instrument may be straightforward if a","text_display":" frameworks: \"The conceptual framework of a PRO instrument may be straightforward if a","confidence":0.63671875,"confidence_rate":0.9949967001481825},{"cnt":[[320,2187],[1807,2187],[1807,2241],[320,2241]],"region":{"top_left_x":320,"top_left_y":2187,"width":1487,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7503b792839d4fbe8042358922133ab7","type":"text","conversion_output":true,"text":"single item is a reliable and valid measure of the concept of interest (eg, pain intensity).\"","text_display":" single item is a reliable and valid measure of the concept of interest (eg, pain intensity).\"","confidence":1,"confidence_rate":1},{"cnt":[[320,2292],[1869,2292],[1869,2344],[320,2344]],"region":{"top_left_x":320,"top_left_y":2292,"width":1550,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aed79d462b4041c0aec9f6874da0e8bc","type":"text","conversion_output":true,"text":"At the time of each pain assessment including unscheduled visits, the patient will be queried","text_display":"\n\nAt the time of each pain assessment including unscheduled visits, the patient will be queried","confidence":1,"confidence_rate":1},{"cnt":[[318,2355],[1854,2355],[1854,2404],[318,2404]],"region":{"top_left_x":317,"top_left_y":2354,"width":1538,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d589a2d113e453b943597ccce0b80db","type":"text","conversion_output":true,"text":"regarding concomitant use of analgesics, if any, as specified in the Schedule of Events. The","text_display":" regarding concomitant use of analgesics, if any, as specified in the Schedule of Events. The","confidence":0.998046875,"confidence_rate":0.9999798452048033},{"cnt":[[1072,2585],[1126,2585],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2584,"width":54,"height":44},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bb2a7c7c46d4fd29d86e23695372161","type":"page_info","conversion_output":false,"text":"83","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-085","page":85,"lines":[{"cnt":[[322,129],[492,129],[492,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":170,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27e64d0f1dae45deb42b287971958ef5","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d45dca23674543e69b0229f9e792a21c","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,251],[1871,251],[1871,303],[318,303]],"region":{"top_left_x":317,"top_left_y":251,"width":1555,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21317f8e2cc44457b7f018a6c49d89e3","type":"text","conversion_output":true,"text":"patient-recalled amount of analgesic use during the 24 hours prior to pain assessment will be","text_display":"\npatient-recalled amount of analgesic use during the 24 hours prior to pain assessment will be","confidence":1,"confidence_rate":1},{"cnt":[[320,314],[1682,314],[1682,363],[320,363]],"region":{"top_left_x":320,"top_left_y":313,"width":1363,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9af83f377d834f1080458564a2e3f646","type":"text","conversion_output":true,"text":"recorded on both the 24 hour analgesic form and concomitant medication eCRFs.","text_display":" recorded on both the 24 hour analgesic form and concomitant medication eCRFs.","confidence":0.9965834617614746,"confidence_rate":0.9999597374231135},{"cnt":[[318,417],[1755,417],[1755,466],[318,466]],"region":{"top_left_x":317,"top_left_y":416,"width":1439,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d771a6c2844641c0a2d1a6a740cd9f75","type":"text","conversion_output":true,"text":"Upon implementation of Amendment 8, pain assessments will no longer be collected.","text_display":"\n\nUpon implementation of Amendment 8, pain assessments will no longer be collected.","confidence":1,"confidence_rate":1},{"cnt":[[314,518],[879,518],[879,578],[314,578]],"region":{"top_left_x":313,"top_left_y":517,"width":566,"height":61},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8491343dd525499284eb839493210eb8","type":"section_header","conversion_output":false,"children_ids":["6babd555959c479697326befdbbf34fd"],"text":"","text_display":""},{"cnt":[[320,524],[874,524],[874,571],[320,571]],"region":{"top_left_x":320,"top_left_y":524,"width":555,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6babd555959c479697326befdbbf34fd","type":"text","conversion_output":true,"parent_id":"8491343dd525499284eb839493210eb8","text":"7.4.14 Utility Measurement","text_display":"\n\n\\subsection*{7.4.14 Utility Measurement}","confidence":1,"confidence_rate":1},{"cnt":[[318,610],[1867,610],[1867,662],[318,662]],"region":{"top_left_x":317,"top_left_y":610,"width":1550,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2c334b9259643fc95f0ce59b5800057","type":"text","conversion_output":true,"text":"Because oncology therapies may positively or negatively affect a subject's QOL, a common","text_display":"\n\nBecause oncology therapies may positively or negatively affect a subject's QOL, a common","confidence":1,"confidence_rate":1},{"cnt":[[318,675],[1785,675],[1785,724],[318,724]],"region":{"top_left_x":317,"top_left_y":674,"width":1469,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38329503088a4a8fb402954da369aa05","type":"text","conversion_output":true,"text":"methodologic approach is used to quantify this effect by \"quality-adjusting\" survival in","text_display":" methodologic approach is used to quantify this effect by \"quality-adjusting\" survival in","confidence":1,"confidence_rate":1},{"cnt":[[320,735],[1867,735],[1867,784],[320,784]],"region":{"top_left_x":320,"top_left_y":734,"width":1547,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5992c776a6c649b1a3c4b9479d9cf30a","type":"text","conversion_output":true,"text":"comparative treatment groups. The result, quality-adjusted life years (QALYs), is a measure","text_display":" comparative treatment groups. The result, quality-adjusted life years (QALYs), is a measure","confidence":1,"confidence_rate":1},{"cnt":[[318,801],[1766,801],[1766,853],[318,853]],"region":{"top_left_x":317,"top_left_y":801,"width":1450,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"070b6f52e04c44bc8738e9c1f01f4127","type":"text","conversion_output":true,"text":"of both the length and quality of life and is used as a measure of benefit in cost-utility","text_display":" of both the length and quality of life and is used as a measure of benefit in cost-utility","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[318,864],[1762,864],[1762,915],[318,915]],"region":{"top_left_x":317,"top_left_y":863,"width":1445,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38ca140e958042278a702cc6f740a869","type":"text","conversion_output":true,"text":"analysis. General PRO instruments such as the EORTC QLQ-C30 are not specifically","text_display":" analysis. General PRO instruments such as the EORTC QLQ-C30 are not specifically","confidence":0.994145393371582,"confidence_rate":0.9999309222445126},{"cnt":[[318,924],[1867,924],[1867,978],[318,978]],"region":{"top_left_x":317,"top_left_y":923,"width":1550,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcb55b4a8031462f89ff5b620ee6b3ee","type":"text","conversion_output":true,"text":"designed to measure subject preferences (or utilities) in a way that is suitable for calculating","text_display":" designed to measure subject preferences (or utilities) in a way that is suitable for calculating","confidence":1,"confidence_rate":1},{"cnt":[[318,988],[1837,988],[1837,1038],[318,1038]],"region":{"top_left_x":317,"top_left_y":988,"width":1520,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84e4652b5fa24a19afc0c6fefba6c165","type":"text","conversion_output":true,"text":"QALYs. Therefore, a separate validated instrument, in this case the EuroQoL EQ-5D, will","text_display":" QALYs. Therefore, a separate validated instrument, in this case the EuroQoL EQ-5D, will","confidence":1,"confidence_rate":1},{"cnt":[[318,1053],[1558,1053],[1558,1104],[318,1104]],"region":{"top_left_x":317,"top_left_y":1052,"width":1241,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d2a3aa075904addb0d1c77c9d22a5d2","type":"text","conversion_output":true,"text":"be used to quantify utilities to calculate QALYs for a cost-utidity analysis","text_display":" be used to quantify utilities to calculate QALYs for a cost-utidity analysis","confidence":0.57240275060758,"confidence_rate":0.9931358588521467},{"cnt":[[318,1212],[318,1155],[1841,1158],[1841,1215]],"region":{"top_left_x":317,"top_left_y":1155,"width":1525,"height":60},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da7bc9e9f1c4459d842e7ba434ad11d0","type":"text","conversion_output":true,"text":"The EQ-5D consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue","text_display":"\n\nThe EQ-5D consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[318,1220],[1852,1220],[1852,1274],[318,1274]],"region":{"top_left_x":317,"top_left_y":1220,"width":1535,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cea59b1617947189c1f3bef155de978","type":"text","conversion_output":true,"text":"scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual","text_display":" scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual","confidence":0.7913761812014855,"confidence_rate":0.9975907229828509},{"cnt":[[318,1280],[1846,1280],[1846,1334],[318,1334]],"region":{"top_left_x":317,"top_left_y":1280,"width":1529,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3c5b7382d73428883696596fc8edfaf","type":"text","conversion_output":true,"text":"activities, pain/discomfort, and anxiety/depression). The EQ VAS records the respondent's","text_display":" activities, pain/discomfort, and anxiety/depression). 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This","text_display":" bone marrow aspirate sample is obtained to assess CR or to investigate suspected PD. This","confidence":1,"confidence_rate":1},{"cnt":[[318,2423],[1687,2423],[1687,2473],[318,2473]],"region":{"top_left_x":317,"top_left_y":2423,"width":1370,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9215038731ae4c7e8f8f821318e5f814","type":"text","conversion_output":true,"text":"evaluation will be performed locally. Determination of the kappa/lambda ratio by","text_display":" evaluation will be performed locally. 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Investigators may continue to take bone marrow aspirate","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[318,606],[1076,606],[1076,655],[318,655]],"region":{"top_left_x":317,"top_left_y":605,"width":760,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89bcbdc6c27a4deead550b17dc80360b","type":"text","conversion_output":true,"text":"per standard of care for response assessment.","text_display":" per standard of care for response assessment.","confidence":1,"confidence_rate":1},{"cnt":[[318,705],[559,705],[559,763],[318,763]],"region":{"top_left_x":317,"top_left_y":704,"width":242,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"357394231f6641698d6b2d1216b76ddd","type":"section_header","conversion_output":false,"children_ids":["727b0291561449ffb47b631041290d0d"],"text":"","text_display":""},{"cnt":[[322,709],[556,709],[556,758],[322,758]],"region":{"top_left_x":322,"top_left_y":708,"width":235,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"727b0291561449ffb47b631041290d0d","type":"text","conversion_output":true,"parent_id":"357394231f6641698d6b2d1216b76ddd","text":"Cytogenetics","text_display":"\n\n\\section*{Cytogenetics}","confidence":1,"confidence_rate":1},{"cnt":[[318,799],[1777,799],[1777,849],[318,849]],"region":{"top_left_x":317,"top_left_y":799,"width":1460,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f3d5dfcd60445babeafdc8fa988ba45","type":"text","conversion_output":true,"text":"An additional bone marrow aspirate or bone marrow sample may also be submitted for","text_display":"\n\nAn additional bone marrow aspirate or bone marrow sample may also be submitted for","confidence":1,"confidence_rate":1},{"cnt":[[320,862],[1858,862],[1858,913],[320,913]],"region":{"top_left_x":320,"top_left_y":861,"width":1539,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c492f76b9124e9a9b3ca03e416190c2","type":"text","conversion_output":true,"text":"cytogenetics to be analyzed locally, according to local standards, if the site has capability to","text_display":" cytogenetics to be analyzed locally, according to local standards, if the site has capability to","confidence":1,"confidence_rate":1},{"cnt":[[320,924],[1858,924],[1858,973],[320,973]],"region":{"top_left_x":320,"top_left_y":923,"width":1539,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b95ebc3690646a2aa438c8c14c16090","type":"text","conversion_output":true,"text":"perform analysis and there is sufficient sample available. The central daboratory cytogenetic","text_display":" perform analysis and there is sufficient sample available. The central daboratory cytogenetic","confidence":0.9609375,"confidence_rate":0.999593491743337},{"cnt":[[320,984],[1755,984],[1755,1033],[320,1033]],"region":{"top_left_x":320,"top_left_y":983,"width":1436,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"187bca7b4ba04f34ab0b3f39e6fbeeb7","type":"text","conversion_output":true,"text":"results will be utilized for study analysis, whereas local laboratory cytogenetic results","text_display":" results will be utilized for study analysis, whereas local laboratory cytogenetic results","confidence":1,"confidence_rate":1},{"cnt":[[322,1044],[1824,1044],[1824,1098],[322,1098]],"region":{"top_left_x":322,"top_left_y":1044,"width":1503,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af4d6959de8d45bb982546e0c1e03d9d","type":"text","conversion_output":true,"text":"(where available) will only be utilized in instances when central laboratory results are not","text_display":" (where available) will only be utilized in instances when central laboratory results are not","confidence":1,"confidence_rate":1},{"cnt":[[322,1109],[488,1109],[488,1154],[322,1154]],"region":{"top_left_x":322,"top_left_y":1108,"width":166,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52674f0dfa094b9f9363f8cdb398c7e7","type":"text","conversion_output":true,"text":"available.","text_display":" available.","confidence":1,"confidence_rate":1},{"cnt":[[322,1212],[1678,1212],[1678,1265],[322,1265]],"region":{"top_left_x":322,"top_left_y":1211,"width":1356,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce4f8a1a003e419d877c4bafeb440e7e","type":"text","conversion_output":true,"text":"Upon implementation of Amendment 8, a bone marrow sample for evaluation of","text_display":"\n\nUpon implementation of Amendment 8, a bone marrow sample for evaluation of","confidence":1,"confidence_rate":1},{"cnt":[[322,1276],[1867,1276],[1867,1326],[322,1326]],"region":{"top_left_x":322,"top_left_y":1276,"width":1545,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42fb0ce2c82343408003c0ebe32d4838","type":"text","conversion_output":true,"text":"cytogenetics is no longer needed. Investigators should follow local standard of care for bone","text_display":" cytogenetics is no longer needed. Investigators should follow local standard of care for bone","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[320,1341],[750,1341],[750,1390],[320,1390]],"region":{"top_left_x":320,"top_left_y":1340,"width":430,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fe70f871e014f399e846cf9ffed2555","type":"text","conversion_output":true,"text":"marrow aspirate samples.","text_display":" marrow aspirate samples.","confidence":1,"confidence_rate":1},{"cnt":[[316,1439],[889,1439],[889,1497],[316,1497]],"region":{"top_left_x":315,"top_left_y":1439,"width":575,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6ac644d7bf54d36aa54e0b5677e684b","type":"section_header","conversion_output":false,"children_ids":["664fbe574b0049b29c95a842543dd0ea"],"text":"","text_display":""},{"cnt":[[322,1444],[883,1444],[883,1493],[322,1493]],"region":{"top_left_x":322,"top_left_y":1443,"width":562,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"664fbe574b0049b29c95a842543dd0ea","type":"text","conversion_output":true,"parent_id":"f6ac644d7bf54d36aa54e0b5677e684b","text":"7.4.24 Response Assessment","text_display":"\n\n\\subsection*{7.4.24 Response Assessment}","confidence":1,"confidence_rate":1},{"cnt":[[322,1532],[1876,1532],[1876,1583],[322,1583]],"region":{"top_left_x":322,"top_left_y":1531,"width":1554,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"867fda5a6f3d485ba0cd3251969e6cbc","type":"text","conversion_output":true,"text":"Patients will be assessed for disease response according to the IMWG criteria, versions 2006","text_display":"\n\nPatients will be assessed for disease response according to the IMWG criteria, versions 2006","confidence":1,"confidence_rate":1},{"cnt":[[322,1594],[947,1594],[947,1644],[322,1644]],"region":{"top_left_x":322,"top_left_y":1594,"width":626,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26f29b148e9e4379b0252001a6ba9db9","type":"text","conversion_output":true,"text":"and 2011 (see Section 15.11).[49,50]","text_display":" and 2011 (see Section 15.11).[49,50]","confidence":0.998046875,"confidence_rate":0.9999555683772091},{"cnt":[[322,1697],[1745,1697],[1745,1749],[322,1749]],"region":{"top_left_x":322,"top_left_y":1697,"width":1423,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3410e3dfd83d41cc9a1a0321edccbf04","type":"text","conversion_output":true,"text":"Response assessments should occur every cycle until progression. The MPI/designee","text_display":"\n\nResponse assessments should occur every cycle until progression. The MPI/designee","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[320,1760],[1841,1760],[1841,1811],[320,1811]],"region":{"top_left_x":320,"top_left_y":1759,"width":1522,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bb0a68dbac74619b559b71ac466b8cb","type":"text","conversion_output":true,"text":"clinician will confirm the investigator assessment of PD prior to the investigator taking the","text_display":" clinician will confirm the investigator assessment of PD prior to the investigator taking the","confidence":1,"confidence_rate":1},{"cnt":[[318,1822],[677,1822],[677,1876],[318,1876]],"region":{"top_left_x":317,"top_left_y":1821,"width":360,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78fdddc285414392aa80431444a005e1","type":"text","conversion_output":true,"text":"patient off treatment.","text_display":" patient off 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Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,271],[960,271],[960,324],[320,324]],"region":{"top_left_x":320,"top_left_y":270,"width":641,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ca7d67cd6ca456fa49b6b1b0870e2b9","type":"figure_label","conversion_output":false,"text":"Table 7-1 Response 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Blood samples for the determination of plasma","text_display":" are provided in the Study Manual. 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Polymorphisms in mechanism","text_display":" relationship to response or resistance to MLN9708 therapy. 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Polymorphisms ofNFKB","confidence":0.90478515625,"confidence_rate":0.9988372142357637},{"cnt":[[318,756],[1848,756],[1848,806],[318,806]],"region":{"top_left_x":317,"top_left_y":756,"width":1531,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36c98ef42f74407e8ffa5d6cc7e89fde","type":"text","conversion_output":true,"text":"family genes are associated with development of multiple myeloma and treatment outcome","text_display":" family genes are associated with development of multiple myeloma and treatment outcome","confidence":1,"confidence_rate":1},{"cnt":[[318,869],[318,816],[1803,819],[1803,872]],"region":{"top_left_x":317,"top_left_y":816,"width":1486,"height":56},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"545e7c6510724b67bca8f1337ee36a0b","type":"text","conversion_output":true,"text":"in patients receiving bortezomib-based regimens and may be relevant for the efficacy of","text_display":" in patients receiving bortezomib-based regimens and may be relevant for the efficacy of","confidence":1,"confidence_rate":1},{"cnt":[[318,881],[1695,881],[1695,932],[318,932]],"region":{"top_left_x":317,"top_left_y":880,"width":1379,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13220d67862c4decb252848048fc455c","type":"text","conversion_output":true,"text":"proteasome inhibitors generally. 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See Section 6.6 for a list of prohibited concomitant medications and","text_display":" Schedule of Events). See Section 6.6 for a list of prohibited concomitant medications and","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[318,1676],[1751,1676],[1751,1727],[318,1727]],"region":{"top_left_x":317,"top_left_y":1675,"width":1434,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e58b5261545441ba1d6037aedcb2050","type":"text","conversion_output":true,"text":"therapies and Section 6.7for a list of allowed concomitant medications and therapies.","text_display":" therapies and Section 6.7for a list of allowed concomitant medications and therapies.","confidence":0.985358476638794,"confidence_rate":0.9998361271136877},{"cnt":[[318,1779],[784,1779],[784,1828],[318,1828]],"region":{"top_left_x":317,"top_left_y":1778,"width":468,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ab5270a95fb4cb2a43ab0d08bdeeb1e","type":"section_header","conversion_output":false,"children_ids":["d8872244956e4fff81e98569f0adf1cd"],"text":"","text_display":""},{"cnt":[[322,1783],[780,1783],[780,1824],[322,1824]],"region":{"top_left_x":322,"top_left_y":1783,"width":458,"height":42},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8872244956e4fff81e98569f0adf1cd","type":"text","conversion_output":true,"parent_id":"0ab5270a95fb4cb2a43ab0d08bdeeb1e","text":"7.4.28 Adverse Events","text_display":"\n\n\\subsection*{7.4.28 Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[320,1869],[1850,1869],[1850,1923],[320,1923]],"region":{"top_left_x":320,"top_left_y":1869,"width":1530,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7295f0f26b54ceab5011a554b49996a","type":"text","conversion_output":true,"text":"Monitoring of AEs, both nonserious and serious, will be conducted throughout the study as","text_display":"\n\nMonitoring of AEs, both nonserious and serious, will be conducted throughout the study as","confidence":1,"confidence_rate":1},{"cnt":[[320,1929],[1732,1929],[1732,1983],[320,1983]],"region":{"top_left_x":320,"top_left_y":1929,"width":1412,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd5034bc8ac749819e190e3bcf51074c","type":"text","conversion_output":true,"text":"specified in the Schedule of Events. See Section 10 for details regarding definitions,","text_display":" specified in the Schedule of Events. See Section 10 for details regarding definitions,","confidence":1,"confidence_rate":1},{"cnt":[[320,1994],[1491,1994],[1491,2043],[320,2043]],"region":{"top_left_x":320,"top_left_y":1993,"width":1172,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76d9208b0ade4487a133b16f88562f07","type":"text","conversion_output":true,"text":"documentation, and reporting of pretreatment events, AEs, and SAEs.","text_display":" documentation, and reporting of pretreatment events, AEs, and SAEs.","confidence":1,"confidence_rate":1},{"cnt":[[314,2093],[1175,2093],[1175,2155],[314,2155]],"region":{"top_left_x":313,"top_left_y":2092,"width":863,"height":63},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5001f77ae2904f99ace592771f7fc180","type":"section_header","conversion_output":false,"children_ids":["171473075cb147c2a022a577ea9e6dda"],"text":"","text_display":""},{"cnt":[[318,2099],[1171,2099],[1171,2151],[318,2151]],"region":{"top_left_x":317,"top_left_y":2099,"width":854,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"171473075cb147c2a022a577ea9e6dda","type":"text","conversion_output":true,"parent_id":"5001f77ae2904f99ace592771f7fc180","text":"7.4.29 Follow-up Assessments (PFS and OS)","text_display":"\n\n\\subsection*{7.4.29 Follow-up Assessments (PFS and OS)}","confidence":1,"confidence_rate":1},{"cnt":[[318,2187],[1811,2187],[1811,2239],[318,2239]],"region":{"top_left_x":317,"top_left_y":2187,"width":1495,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"151dacaeb3ae4c0a8cd85cc275381088","type":"text","conversion_output":true,"text":"Prior to implementation of Amendment 6, patients who stopped treatment for any reason","text_display":"\n\nPrior to implementation of Amendment 6, patients who stopped treatment for any reason","confidence":1,"confidence_rate":1},{"cnt":[[320,2252],[1824,2252],[1824,2301],[320,2301]],"region":{"top_left_x":320,"top_left_y":2251,"width":1505,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"098c7cbc19954d019661973a84f58180","type":"text","conversion_output":true,"text":"had PFS follow-up visits. 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The","text_display":"\n\nThe total sample size was calculated based on maintaining \\(80 \\%\\) power to test the OS. The","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[320,2329],[1772,2329],[1772,2378],[320,2378]],"region":{"top_left_x":320,"top_left_y":2328,"width":1453,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dd37bee426248d295225bb89df66fa0","type":"text","conversion_output":true,"text":"study is also adequately powered to test PFS. Assuming a hazard ratio of 0.77 (median","text_display":" study is also adequately powered to test PFS. Assuming a hazard ratio of 0.77 (median","confidence":1,"confidence_rate":1},{"cnt":[[320,2389],[1803,2389],[1803,2438],[320,2438]],"region":{"top_left_x":320,"top_left_y":2389,"width":1483,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56d7ea281d4446d29b9f87ce91af5683","type":"text","conversion_output":true,"text":"survival of 30 months in control arm versus 39 months in treatment arm), the number of","text_display":" survival of 30 months in control arm versus 39 months in treatment arm), the number of","confidence":1,"confidence_rate":1},{"cnt":[[320,2449],[1867,2449],[1867,2503],[320,2503]],"region":{"top_left_x":320,"top_left_y":2449,"width":1547,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f6d61b061634e9e99d1efc81f275f9e","type":"text","conversion_output":true,"text":"death events needed is \\(486(80 \\%\\) power and 2 -sided alpha of 0.05\\()\\). A total of approximately","text_display":" death events needed is \\(486(80 \\%\\) power and 2 -sided alpha of 0.05\\()\\). A total of approximately","confidence":0.9469635486602783,"confidence_rate":0.9994811377230413},{"cnt":[[1072,2585],[1126,2585],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2584,"width":54,"height":44},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66c0f1b10ab745558624a319b523a565","type":"page_info","conversion_output":false,"text":"94","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-096","page":96,"lines":[{"cnt":[[320,125],[496,123],[497,168],[320,170]],"region":{"top_left_x":319,"top_left_y":122,"width":178,"height":48},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5c0367d979d40b8b3048483ecdd17d1","type":"section_header","conversion_output":false,"children_ids":["f8e3f869904b445dac0a8d14cf82ea35"],"text":"","text_display":""},{"cnt":[[322,129],[492,129],[492,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":170,"height":38},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8e3f869904b445dac0a8d14cf82ea35","type":"text","conversion_output":true,"parent_id":"a5c0367d979d40b8b3048483ecdd17d1","text":"MLN9708","text_display":"\n\n\\section*{MLN9708}","confidence":1,"confidence_rate":1},{"cnt":[[318,168],[1371,168],[1371,221],[318,221]],"region":{"top_left_x":317,"top_left_y":167,"width":1054,"height":55},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d43bb6ea1f44916b78ab49dc171e026","type":"section_header","conversion_output":false,"children_ids":["42e691bb6c1948f298cc5828f6dbb546"],"text":"","text_display":""},{"cnt":[[322,172],[1366,172],[1366,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1045,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42e691bb6c1948f298cc5828f6dbb546","type":"text","conversion_output":true,"parent_id":"0d43bb6ea1f44916b78ab49dc171e026","text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"\n\n\\section*{Clinical Study Protocol C16010 Amendment 8, 08 January 2021}","confidence":1,"confidence_rate":1},{"cnt":[[322,254],[1740,254],[1740,301],[322,301]],"region":{"top_left_x":322,"top_left_y":253,"width":1419,"height":48},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3cf7de4c1803406e8d51e267fd640aaf","type":"text","conversion_output":true,"text":"703 patients will need to be randomized in a \\(1: 1\\) ratio into those 2 arms, assuming an","text_display":"\n\n703 patients will need to be randomized in a \\(1: 1\\) ratio into those 2 arms, assuming an","confidence":0.822265625,"confidence_rate":0.9979422065727368},{"cnt":[[320,314],[1699,314],[1699,363],[320,363]],"region":{"top_left_x":320,"top_left_y":313,"width":1380,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f466dac81ef645b5a814d14928435496","type":"text","conversion_output":true,"text":"average enrollment rate of approximately 13 patients/month for the first 6 months,","text_display":" average enrollment rate of approximately 13 patients/month for the first 6 months,","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[318,374],[1837,374],[1837,423],[318,423]],"region":{"top_left_x":317,"top_left_y":373,"width":1520,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49e34cdbc44e417998bac102aee3b46d","type":"text","conversion_output":true,"text":"approximately 45 patients/month thereafter, and approximately \\(10 \\%\\) dropout rate at month","text_display":" approximately 45 patients/month thereafter, and approximately \\(10 \\%\\) dropout rate at month","confidence":0.9980475902557373,"confidence_rate":0.9999800581765897},{"cnt":[[320,438],[1738,438],[1738,488],[320,488]],"region":{"top_left_x":320,"top_left_y":438,"width":1419,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b3fd1ce1d584f76aa5e0c53c04ab58e","type":"text","conversion_output":true,"text":"35. The final analysis of OS is estimated to occur approximately 80 months from the","text_display":" 35. The final analysis of OS is estimated to occur approximately 80 months from the","confidence":0.8480222225189209,"confidence_rate":0.9983019748485177},{"cnt":[[322,501],[1798,501],[1798,552],[322,552]],"region":{"top_left_x":322,"top_left_y":500,"width":1477,"height":53},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d1d8a332cbe48f5a64df82755763300","type":"text","conversion_output":true,"text":"enrollment of first patient, including a \\(20-\\) month randomization period and an additional","text_display":" enrollment of first patient, including a \\(20-\\) month randomization period and an additional","confidence":0.6950383186340332,"confidence_rate":0.996256629099608},{"cnt":[[322,563],[1824,563],[1824,612],[322,612]],"region":{"top_left_x":322,"top_left_y":562,"width":1503,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4bd85e04bc74f21aca4686063f68f78","type":"text","conversion_output":true,"text":"60-month follow up from the last patient enrolled. With an observed hazard ratio of 0.833","text_display":" 60-month follow up from the last patient enrolled. With an observed hazard ratio of 0.833","confidence":0.9970703125,"confidence_rate":0.9999684522456539},{"cnt":[[320,623],[1635,623],[1635,675],[320,675]],"region":{"top_left_x":320,"top_left_y":623,"width":1315,"height":52},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93397c29736148e2890d402729b11ee2","type":"text","conversion_output":true,"text":"(eg, median OS of 30 months for control versus 36 months for treatment, 20\\%","text_display":" (eg, median OS of 30 months for control versus 36 months for treatment, 20\\%","confidence":1,"confidence_rate":1},{"cnt":[[318,688],[1807,688],[1807,737],[318,737]],"region":{"top_left_x":317,"top_left_y":687,"width":1490,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23365922350b461899d19fc7a49836ae","type":"text","conversion_output":true,"text":"improvement), statistical significance can be claimed at the final analysis with 486 death","text_display":" improvement), statistical significance can be claimed at the final analysis with 486 death","confidence":1,"confidence_rate":1},{"cnt":[[320,756],[445,756],[445,793],[320,793]],"region":{"top_left_x":320,"top_left_y":756,"width":125,"height":37},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d089ef496dba4c25be3855d62d954598","type":"text","conversion_output":true,"text":"events.","text_display":" events.","confidence":1,"confidence_rate":1},{"cnt":[[318,855],[1704,855],[1704,904],[318,904]],"region":{"top_left_x":317,"top_left_y":855,"width":1387,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"03305d3b85f24c34b423bd62228f1c6c","type":"text","conversion_output":true,"text":"Assuming a hazard ratio of 0.728 (median PFS of 15 months in control arm versus","text_display":"\n\nAssuming a hazard ratio of 0.728 (median PFS of 15 months in control arm versus","confidence":0.998046875,"confidence_rate":0.9999782776266475},{"cnt":[[318,915],[1785,915],[1785,965],[318,965]],"region":{"top_left_x":317,"top_left_y":915,"width":1469,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e11711c1bfd4400ba6faa259c841d8a2","type":"text","conversion_output":true,"text":"20.6 months in treatment arm), 365 PFS events will be needed ( \\(85 \\%\\) power and 2 -sided","text_display":" 20.6 months in treatment arm), 365 PFS events will be needed ( \\(85 \\%\\) power and 2 -sided","confidence":0.8977584874191962,"confidence_rate":0.9989000524085704},{"cnt":[[318,975],[1837,975],[1837,1027],[318,1027]],"region":{"top_left_x":317,"top_left_y":975,"width":1520,"height":52},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"607b7766fb1a467dbd87a0da379eac71","type":"text","conversion_output":true,"text":"alpha of 0.05 ) with 2 planned IAs and the second IA as the final PFS analysis. The first IA","text_display":" alpha of 0.05 ) with 2 planned IAs and the second IA as the final PFS analysis. The first IA","confidence":1,"confidence_rate":1},{"cnt":[[318,1040],[1852,1040],[1852,1089],[318,1089]],"region":{"top_left_x":317,"top_left_y":1039,"width":1535,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d2a1048f2e28414e9fe98758bf578db4","type":"text","conversion_output":true,"text":"will be performed when approximately 262 PFS events have occurred. This will be the first","text_display":" will be performed when approximately 262 PFS events have occurred. This will be the first","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[318,1104],[1781,1104],[1781,1154],[318,1154]],"region":{"top_left_x":317,"top_left_y":1104,"width":1465,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c609846f32724f72af574e697fbf13a5","type":"text","conversion_output":true,"text":"analysis for PFS for statistical testing purpose. Based on the O'Brien-Fleming stopping","text_display":" analysis for PFS for statistical testing purpose. Based on the O'Brien-Fleming stopping","confidence":0.984906868905,"confidence_rate":0.9998347072317557},{"cnt":[[318,1164],[1861,1164],[1861,1214],[318,1214]],"region":{"top_left_x":317,"top_left_y":1164,"width":1544,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4691eaf954474c80b9e07353c9590a16","type":"text","conversion_output":true,"text":"boundary, the alpha level at the first IA and second IA on PFS would be 0.0163 and 0.0337,","text_display":" boundary, the alpha level at the first IA and second IA on PFS would be 0.0163 and 0.0337,","confidence":0.9980475902557373,"confidence_rate":0.9999800581765897},{"cnt":[[318,1229],[1869,1229],[1869,1278],[318,1278]],"region":{"top_left_x":317,"top_left_y":1228,"width":1553,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51426ad656da43ffbb8424ab895e9d7b","type":"text","conversion_output":true,"text":"respectively, if the number of PFS events at the first IA is exactly 262.[41] Correspondingly,","text_display":" respectively, if the number of PFS events at the first IA is exactly 262.[41] Correspondingly,","confidence":0.6852020835503936,"confidence_rate":0.9961886808596119},{"cnt":[[318,1289],[1777,1289],[1777,1338],[318,1338]],"region":{"top_left_x":317,"top_left_y":1289,"width":1460,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07a1e168e1d144a799f40f9ea1fd8033","type":"text","conversion_output":true,"text":"if the observed p value is less than 0.0163 and 0.0451 at the first IA and the second IA,","text_display":" if the observed p value is less than 0.0163 and 0.0451 at the first IA and the second IA,","confidence":0.80322265625,"confidence_rate":0.9978111657693587},{"cnt":[[318,1354],[1708,1354],[1708,1403],[318,1403]],"region":{"top_left_x":317,"top_left_y":1353,"width":1392,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ed3df167b7a434db25a850b484a4e6f","type":"text","conversion_output":true,"text":"respectively, the test for PFS will be claimed to be statistically significant. With an","text_display":" respectively, the test for PFS will be claimed to be statistically significant. With an","confidence":0.9619324207305908,"confidence_rate":0.9995782294103981},{"cnt":[[318,1414],[1807,1414],[1807,1463],[318,1463]],"region":{"top_left_x":317,"top_left_y":1413,"width":1490,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a64bb26fe9440e7b3b161eaf69f9f15","type":"text","conversion_output":true,"text":"assumption of approximately 13 patients/month for the first 6 months, 45 patients/month","text_display":" assumption of approximately 13 patients/month for the first 6 months, 45 patients/month","confidence":1,"confidence_rate":1},{"cnt":[[318,1474],[1830,1474],[1830,1525],[318,1525]],"region":{"top_left_x":317,"top_left_y":1473,"width":1514,"height":53},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"160a357cc7f34863ba300df34f04d9e2","type":"text","conversion_output":true,"text":"thereafter, and approximately \\(10 \\%\\) dropout rate over 30 -month follow-up period, 262 PFS","text_display":" thereafter, and approximately \\(10 \\%\\) dropout rate over 30 -month follow-up period, 262 PFS","confidence":0.9907479118555784,"confidence_rate":0.999907973001537},{"cnt":[[320,1538],[1820,1538],[1820,1588],[320,1588]],"region":{"top_left_x":320,"top_left_y":1538,"width":1500,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eae97fed898e4949b83c0d519f7edd77","type":"text","conversion_output":true,"text":"events is expected to occur at approximately 24.5 months after the first patient is enrolled","text_display":" events is expected to occur at approximately 24.5 months after the first patient is enrolled","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[318,1603],[1858,1603],[1858,1652],[318,1652]],"region":{"top_left_x":317,"top_left_y":1602,"width":1542,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3d52ca6b9984afc84e740d71e24b456","type":"text","conversion_output":true,"text":"and approximately 703 patients have been enrolled. This is the first IA of the study with the","text_display":" and approximately 703 patients have been enrolled. This is the first IA of the study with the","confidence":1,"confidence_rate":1},{"cnt":[[320,1663],[1833,1663],[1833,1712],[320,1712]],"region":{"top_left_x":320,"top_left_y":1662,"width":1513,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e1c230706f94cb3bfd1d525fbe5d53d","type":"text","conversion_output":true,"text":"opportunity to claim PES benefit. With an observed hazard ratio of 0.743 (eg, median PFS","text_display":" opportunity to claim PES benefit. 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If the test for PFS","text_display":" can be claimed at the analysis for PFS with 262 progression/death events. 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An","text_display":" occurred, which will also be the final analysis of PFS for statistical testing purpose. An","confidence":1,"confidence_rate":1},{"cnt":[[322,2204],[1869,2204],[1869,2249],[322,2249]],"region":{"top_left_x":322,"top_left_y":2204,"width":1548,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3adeeed30a9a451c97c364c71e9a2340","type":"text","conversion_output":true,"text":"observed hazard ratio 0.810 (median PFS of 15 months in control arm versus 18.5 months in","text_display":" observed hazard ratio 0.810 (median PFS of 15 months in control arm versus 18.5 months in","confidence":1,"confidence_rate":1},{"cnt":[[320,2264],[1837,2264],[1837,2314],[320,2314]],"region":{"top_left_x":320,"top_left_y":2264,"width":1517,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd96e1b732474ce7b00024f968b1f142","type":"text","conversion_output":true,"text":"treatment arm) or better will lead to statistical significance for the PFS endpoint. If the test","text_display":" treatment arm) or better will lead to statistical significance for the PFS endpoint. If the test","confidence":1,"confidence_rate":1},{"cnt":[[322,2329],[1876,2329],[1876,2378],[322,2378]],"region":{"top_left_x":322,"top_left_y":2328,"width":1554,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3942aeedb63e4f828789e6f387af8954","type":"text","conversion_output":true,"text":"for PFS is not statistically significant at second IA, the study will be claimed as unsuccessful","text_display":" for PFS is not statistically significant at second IA, the study will be claimed as unsuccessful","confidence":1,"confidence_rate":1},{"cnt":[[322,2389],[1811,2389],[1811,2438],[322,2438]],"region":{"top_left_x":322,"top_left_y":2389,"width":1490,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"000531a39f3943a1907c641b055b7268","type":"text","conversion_output":true,"text":"and no further testing will be conducted. If the test for PFS is significant at an IA, the OS","text_display":" and no further testing will be conducted. If the test for PFS is significant at an IA, the OS","confidence":0.556523323059082,"confidence_rate":0.9943807875631514},{"cnt":[[320,2454],[1850,2454],[1850,2503],[320,2503]],"region":{"top_left_x":320,"top_left_y":2453,"width":1530,"height":50},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b61842174d745dc9a9928e3ef524684","type":"text","conversion_output":true,"text":"will be tested; however, the trial will not be stopped for overwhelming evidence of efficacy","text_display":" will be tested; however, the trial will not be stopped for overwhelming evidence of efficacy","confidence":1,"confidence_rate":1},{"cnt":[[1072,2587],[1124,2587],[1124,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2586,"width":52,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"135af826c523430f9fd5b81aee2c9a37","type":"page_info","conversion_output":false,"text":"95","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-097","page":97,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6527e1862c264615969d3e9eb39400ae","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17157383015a4bd3868a18c1f0fc2d28","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,251],[1678,251],[1678,303],[320,303]],"region":{"top_left_x":320,"top_left_y":251,"width":1358,"height":52},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e8ea1c081af4db3a38e22bae280319f","type":"text","conversion_output":true,"text":"or futility at the first IA. The third IA will be for OS and will be performed when","text_display":"\nor futility at the first IA. The third IA will be for OS and will be performed when","confidence":1,"confidence_rate":1},{"cnt":[[320,314],[1837,314],[1837,363],[320,363]],"region":{"top_left_x":320,"top_left_y":313,"width":1517,"height":51},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c491af145271462280785d65e19a2290","type":"text","conversion_output":true,"text":"approximately 322 deaths (two-thirds of the total expected deaths) have occurred, with the","text_display":" approximately 322 deaths (two-thirds of the total expected deaths) have occurred, with the","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1824,374],[1824,425],[318,425]],"region":{"top_left_x":317,"top_left_y":373,"width":1508,"height":53},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d49cf76a1ec4922a2a167cae88b3de5","type":"text","conversion_output":true,"text":"opportunity to stop the study for overwhelming evidence of efficacy or futility. This IA is","text_display":" opportunity to stop the study for overwhelming evidence of efficacy or futility. This IA is","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[318,438],[1601,438],[1601,488],[318,488]],"region":{"top_left_x":317,"top_left_y":438,"width":1284,"height":50},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6158e633f2e415990417f78c93ca73d","type":"text","conversion_output":true,"text":"expected to occur approximately 44 months after the first patient is enrolled.","text_display":" expected to occur approximately 44 months after the first patient is enrolled.","confidence":1,"confidence_rate":1},{"cnt":[[320,541],[1854,541],[1854,591],[320,591]],"region":{"top_left_x":320,"top_left_y":541,"width":1535,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b5b09a986dd4a47badfa17194cdd3ab","type":"text","conversion_output":true,"text":"Based on the O'Brien-Fleming stopping boundary, the alpha levels at the 3 planned OS IAs","text_display":"\n\nBased on the O'Brien-Fleming stopping boundary, the alpha levels at the 3 planned OS IAs","confidence":0.99462890625,"confidence_rate":0.9999439018867602},{"cnt":[[320,604],[1727,604],[1727,655],[320,655]],"region":{"top_left_x":320,"top_left_y":603,"width":1408,"height":53},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a33b3062acb84cd89f8778c21b6668ac","type":"text","conversion_output":true,"text":"and final analysis would be \\(0.00014,0.0017,0.0100\\), and 0.0382 , respectively if the","text_display":" and final analysis would be \\(0.00014,0.0017,0.0100\\), and 0.0382 , respectively if the","confidence":1,"confidence_rate":1},{"cnt":[[318,662],[1794,662],[1794,715],[318,715]],"region":{"top_left_x":317,"top_left_y":661,"width":1477,"height":55},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc73790df5a94484a51e8c0f8acb1038","type":"text","conversion_output":true,"text":"numbers of events at these analysis time points are exactly \\(154,222,322\\), and 486 .[41]","text_display":" numbers of events at these analysis time points are exactly \\(154,222,322\\), and 486 .[41]","confidence":0.8927126579485829,"confidence_rate":0.9988426037543748},{"cnt":[[322,726],[1800,726],[1800,778],[322,778]],"region":{"top_left_x":322,"top_left_y":726,"width":1479,"height":52},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c6a9601cc256475286cd2b1624fd2be7","type":"text","conversion_output":true,"text":"Correspondingly, if the nominal p value is less than \\(0.0001,0.0018,0.0112\\), and 0.0462 ,","text_display":" Correspondingly, if the nominal p value is less than \\(0.0001,0.0018,0.0112\\), and 0.0462 ,","confidence":0.9990236759185791,"confidence_rate":0.9999906971766409},{"cnt":[[318,791],[1858,791],[1858,840],[318,840]],"region":{"top_left_x":317,"top_left_y":790,"width":1542,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"316e02c7ffc54763a5c14927c292bbc0","type":"text","conversion_output":true,"text":"respectively, at the first, second, and third IAs, and the final analysis, the test for OS will be","text_display":" respectively, at the first, second, and third IAs, and the final analysis, the test for OS will be","confidence":1,"confidence_rate":1},{"cnt":[[320,853],[1841,853],[1841,904],[320,904]],"region":{"top_left_x":320,"top_left_y":852,"width":1522,"height":53},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a242a12cfa54e54b7f1ce4b8f7caf21","type":"text","conversion_output":true,"text":"claimed to be statistically significant. However, the study will not be stopped after the first","text_display":" claimed to be statistically significant. However, the study will not be stopped after the first","confidence":1,"confidence_rate":1},{"cnt":[[320,915],[1815,915],[1815,965],[320,965]],"region":{"top_left_x":320,"top_left_y":915,"width":1496,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d8cfbaed38943efa620d36721ef33f0","type":"text","conversion_output":true,"text":"IA based on the test for OS. However, the actual boundary could be adjusted if the actual","text_display":" IA based on the test for OS. However, the actual boundary could be adjusted if the actual","confidence":1,"confidence_rate":1},{"cnt":[[318,980],[1858,980],[1858,1029],[318,1029]],"region":{"top_left_x":317,"top_left_y":979,"width":1542,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e892bf96fcc4777bbb5edb6bf5e4830","type":"text","conversion_output":true,"text":"number of events does not correspond to the projected number of events in the IAs or in the","text_display":" number of events does not correspond to the projected number of events in the IAs or in the","confidence":1,"confidence_rate":1},{"cnt":[[318,1042],[389,1042],[389,1085],[318,1085]],"region":{"top_left_x":317,"top_left_y":1041,"width":72,"height":44},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1b4378407f942bd8ea39b5409363cdd","type":"text","conversion_output":true,"text":"FA.","text_display":" FA.","confidence":0.99951171875,"confidence_rate":0.9999389518012535},{"cnt":[[314,1139],[1106,1137],[1107,1195],[314,1197]],"region":{"top_left_x":313,"top_left_y":1136,"width":794,"height":61},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65e481538de5450b9ed6a9d3a6b0b05c","type":"section_header","conversion_output":false,"children_ids":["dc8f09fdb80545c3a12ee1ea9a41f0c6"],"text":"","text_display":""},{"cnt":[[322,1145],[1102,1145],[1102,1188],[322,1188]],"region":{"top_left_x":322,"top_left_y":1145,"width":781,"height":44},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc8f09fdb80545c3a12ee1ea9a41f0c6","type":"text","conversion_output":true,"parent_id":"65e481538de5450b9ed6a9d3a6b0b05c","text":"8.1.2 Randomization and Stratification","text_display":"\n\n\\subsection*{8.1.2 Randomization and Stratification}","confidence":1,"confidence_rate":1},{"cnt":[[320,1233],[1850,1233],[1850,1283],[320,1283]],"region":{"top_left_x":320,"top_left_y":1233,"width":1530,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6d99b73687d40d493db2c330141a86a","type":"text","conversion_output":true,"text":"Randomization scheme will be generated by an independent statistician at Millennium who","text_display":"\n\nRandomization scheme will be generated by an independent statistician at Millennium who","confidence":1,"confidence_rate":1},{"cnt":[[320,1298],[1833,1298],[1833,1347],[320,1347]],"region":{"top_left_x":320,"top_left_y":1297,"width":1513,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68d3cbc0a68e47a298a7a53cc3d2f0b6","type":"text","conversion_output":true,"text":"is not on the study team. Prior to dosing, a randomization number will be assigned to each","text_display":" is not on the study team. Prior to dosing, a randomization number will be assigned to each","confidence":1,"confidence_rate":1},{"cnt":[[318,1358],[1545,1358],[1545,1407],[318,1407]],"region":{"top_left_x":317,"top_left_y":1357,"width":1228,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca97bc0fa5b7400987c07296361cfa67","type":"text","conversion_output":true,"text":"patient. The randomization assignment will be implemented by an IVRS.","text_display":" patient. The randomization assignment will be implemented by an IVRS.","confidence":1,"confidence_rate":1},{"cnt":[[320,1461],[1850,1461],[1850,1515],[320,1515]],"region":{"top_left_x":320,"top_left_y":1460,"width":1530,"height":55},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b60291126fd848849c2a6fc50f95965a","type":"text","conversion_output":true,"text":"Eligible patients will be randomized in a \\(1: 1\\) ratio into those 2 treatment arms, stratified by:","text_display":"\n\nEligible patients will be randomized in a \\(1: 1\\) ratio into those 2 treatment arms, stratified by:","confidence":0.986328125,"confidence_rate":0.9998701386613538},{"cnt":[[322,1525],[1751,1525],[1751,1575],[322,1575]],"region":{"top_left_x":322,"top_left_y":1525,"width":1429,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97a246de17104b48844a19ad1b397154","type":"text","conversion_output":true,"text":"1) 1 versus 2 or 3 prior therapies, 2) proteasome inhibitor exposed versus proteasome","text_display":"\n1) 1 versus 2 or 3 prior therapies, 2) proteasome inhibitor exposed versus proteasome","confidence":0.9902389049530029,"confidence_rate":0.9999009236272598},{"cnt":[[322,1588],[1485,1588],[1485,1637],[322,1637]],"region":{"top_left_x":322,"top_left_y":1587,"width":1163,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1997aec8ebc84efa94e6939ffdc7798c","type":"text","conversion_output":true,"text":"inhibitor naïve, and 3) ISS stage at screening of 1 or 2 versus stage 3.","text_display":" inhibitor naïve, and 3) ISS stage at screening of 1 or 2 versus stage 3.","confidence":1,"confidence_rate":1},{"cnt":[[314,1687],[947,1687],[947,1749],[314,1749]],"region":{"top_left_x":313,"top_left_y":1686,"width":635,"height":63},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"727de85b0c0649adbb3e92615e0b95db","type":"section_header","conversion_output":false,"children_ids":["d6c8d1f0e610402f9923ec24879d4a0a"],"text":"","text_display":""},{"cnt":[[320,1693],[939,1693],[939,1742],[320,1742]],"region":{"top_left_x":320,"top_left_y":1692,"width":619,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6c8d1f0e610402f9923ec24879d4a0a","type":"text","conversion_output":true,"parent_id":"727de85b0c0649adbb3e92615e0b95db","text":"8.1.3 Populations for Analysis","text_display":"\n\n\\subsection*{8.1.3 Populations for Analysis}","confidence":0.9990234375,"confidence_rate":0.9999720849711223},{"cnt":[[320,1781],[1343,1781],[1343,1833],[320,1833]],"region":{"top_left_x":320,"top_left_y":1781,"width":1023,"height":52},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5266f0e77646459aaecb418640c17c02","type":"text","conversion_output":true,"text":"The populations used for analysis will include the following:","text_display":"\n\nThe populations used for analysis will include the following:","confidence":1,"confidence_rate":1},{"cnt":[[320,1884],[1783,1884],[1783,1936],[320,1936]],"region":{"top_left_x":320,"top_left_y":1884,"width":1464,"height":52},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d4f67728a4d4b9f9abe9135b68a0754","type":"text","conversion_output":true,"text":"Safety population: The safety population is defined as all patients who receive at least","text_display":"\n\nSafety population: The safety population is defined as all patients who receive at least","confidence":1,"confidence_rate":1},{"cnt":[[322,1946],[1766,1946],[1766,1998],[322,1998]],"region":{"top_left_x":322,"top_left_y":1946,"width":1445,"height":53},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1972dbe9b6bb4ea187afa7373f11ced4","type":"text","conversion_output":true,"text":"1 dose of any study drug. Patients will be analyzed according to the treatment actually","text_display":" 1 dose of any study drug. Patients will be analyzed according to the treatment actually","confidence":1,"confidence_rate":1},{"cnt":[[318,2007],[1772,2007],[1772,2058],[318,2058]],"region":{"top_left_x":317,"top_left_y":2006,"width":1456,"height":53},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0eb057173e1642988fbe02514dd0c22f","type":"text","conversion_output":true,"text":"received. That is, those patients who are randomized to the active arm but received the","text_display":" received. 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Patients will be analyzed according to the treatment they were randomized to","text_display":" randomized. 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The PP","text_display":"\n\nPer-Protocol (PP) population: The PP population is a subset of the ITT population. The PP","confidence":1,"confidence_rate":1},{"cnt":[[318,314],[1854,314],[1854,363],[318,363]],"region":{"top_left_x":317,"top_left_y":313,"width":1538,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de89a3fa88934ad6b3d59852a21e77ed","type":"text","conversion_output":true,"text":"population consists of all patients who do not violate the terms of the protocol in a way that","text_display":" population consists of all patients who do not violate the terms of the protocol in a way that","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1824,374],[1824,425],[318,425]],"region":{"top_left_x":317,"top_left_y":373,"width":1508,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f9670786e0b48368dd042e1c38dca6d","type":"text","conversion_output":true,"text":"would affect the study outcome significantly, as determined by the study clinician, who is","text_display":" would affect the study outcome significantly, as determined by the study clinician, who is","confidence":1,"confidence_rate":1},{"cnt":[[318,438],[1843,438],[1843,488],[318,488]],"region":{"top_left_x":317,"top_left_y":438,"width":1527,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61fc2ff99ae244a1bd59c7d14ae95200","type":"text","conversion_output":true,"text":"blinded to study drug assignment. All decisions to exclude patients from the PP population","text_display":" blinded to study drug assignment. All decisions to exclude patients from the PP population","confidence":1,"confidence_rate":1},{"cnt":[[318,501],[1128,501],[1128,552],[318,552]],"region":{"top_left_x":317,"top_left_y":500,"width":811,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2372e47dc5c349d89d1cfd49ed1ad9de","type":"text","conversion_output":true,"text":"will be made before the unblinding of the study.","text_display":" will be made before the unblinding of the study.","confidence":1,"confidence_rate":1},{"cnt":[[314,602],[1609,602],[1609,660],[314,660]],"region":{"top_left_x":313,"top_left_y":601,"width":1297,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1f8a25f84a54a8eb883d89aac25bd65","type":"section_header","conversion_output":false,"children_ids":["1b9d647c5771415aace1aecf22908799"],"text":"","text_display":""},{"cnt":[[318,606],[1605,606],[1605,655],[318,655]],"region":{"top_left_x":317,"top_left_y":605,"width":1288,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b9d647c5771415aace1aecf22908799","type":"text","conversion_output":true,"parent_id":"a1f8a25f84a54a8eb883d89aac25bd65","text":"8.1.4 Procedures for Handling Missing, Unused, and Spurious Data","text_display":"\n\n\\subsection*{8.1.4 Procedures for Handling Missing, Unused, and Spurious Data}","confidence":1,"confidence_rate":1},{"cnt":[[318,696],[1815,696],[1815,746],[318,746]],"region":{"top_left_x":317,"top_left_y":696,"width":1499,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c066365e30f5410eb8e3d013f1277733","type":"text","conversion_output":true,"text":"All available efficacy and safety data will be included in data listings and tabulations. No","text_display":"\n\nAll available efficacy and safety data will be included in data listings and tabulations. No","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[318,756],[1807,756],[1807,806],[318,806]],"region":{"top_left_x":317,"top_left_y":756,"width":1490,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"681ae010de9d49d58840f0e3a4edf78a","type":"text","conversion_output":true,"text":"imputation of values for missing data will be performed, unless specified otherwise. The","text_display":" imputation of values for missing data will be performed, unless specified otherwise. 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The analysis will be performed on summary","text_display":" will be analyzed using the ITT population. The analysis will be performed on summary","confidence":1,"confidence_rate":1},{"cnt":[[318,1255],[1265,1255],[1265,1304],[318,1304]],"region":{"top_left_x":317,"top_left_y":1254,"width":949,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d270db26d6a4ac296deefec6c6b63e7","type":"text","conversion_output":true,"text":"scores as well as on subscales and individual symptoms.","text_display":" scores as well as on subscales and individual symptoms.","confidence":1,"confidence_rate":1},{"cnt":[[318,1354],[1837,1354],[1837,1407],[318,1407]],"region":{"top_left_x":317,"top_left_y":1353,"width":1520,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c025e7d8a39f4c6aad4c42c27712162c","type":"text","conversion_output":true,"text":"Differences between treatment groups in the EORTC QLQ-C30 and MY-20 scores will be","text_display":"\n\nDifferences between treatment groups in the EORTC QLQ-C30 and MY-20 scores will be","confidence":1,"confidence_rate":1},{"cnt":[[318,1418],[1824,1418],[1824,1472],[318,1472]],"region":{"top_left_x":317,"top_left_y":1417,"width":1508,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d48a1c627ec43e38a5455bf0def8b97","type":"text","conversion_output":true,"text":"evaluated using published minimally important difference (MID) values. Specific interest","text_display":" evaluated using published minimally important difference (MID) values. Specific interest","confidence":1,"confidence_rate":1},{"cnt":[[318,1482],[1837,1482],[1837,1532],[318,1532]],"region":{"top_left_x":317,"top_left_y":1482,"width":1520,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fca48646f6e345e48d9a481706522b37","type":"text","conversion_output":true,"text":"centers on physical functioning, global quality of life summary scores, and individual item","text_display":" centers on physical functioning, global quality of life summary scores, and individual item","confidence":1,"confidence_rate":1},{"cnt":[[320,1543],[1846,1543],[1846,1596],[320,1596]],"region":{"top_left_x":320,"top_left_y":1542,"width":1526,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"209b1ac4c2074cfa8164db12d08716bd","type":"text","conversion_output":true,"text":"scores for fatigue, nausea/vomiting, pain, dyspnea, appetite loss, and constipation/diarrhea.","text_display":" scores for fatigue, nausea/vomiting, pain, dyspnea, appetite loss, and constipation/diarrhea.","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[320,1646],[1757,1646],[1757,1699],[320,1699]],"region":{"top_left_x":320,"top_left_y":1645,"width":1438,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb7dd35bd28544bfadf229951ad92856","type":"text","conversion_output":true,"text":"The main endpoint for the PRO analysis will be the global health status/quality of life","text_display":"\n\nThe main endpoint for the PRO analysis will be the global health status/quality of life","confidence":1,"confidence_rate":1},{"cnt":[[322,1708],[1867,1708],[1867,1760],[322,1760]],"region":{"top_left_x":322,"top_left_y":1708,"width":1545,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be5010c086964bdd9b53b43ef3ca2def","type":"text","conversion_output":true,"text":"subscale of the EORTC QLQ-C30 and MY-20. The change in PRO scores between baseline","text_display":" subscale of the EORTC QLQ-C30 and MY-20. The change in PRO scores between baseline","confidence":1,"confidence_rate":1},{"cnt":[[320,1772],[1858,1772],[1858,1824],[320,1824]],"region":{"top_left_x":320,"top_left_y":1772,"width":1539,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d00fde80e8864bd5a63f56d617a6b1f1","type":"text","conversion_output":true,"text":"and each postbaseline assessment will be described overall and according to the response to","text_display":" and each postbaseline assessment will be described overall and according to the response to","confidence":1,"confidence_rate":1},{"cnt":[[318,1835],[1837,1835],[1837,1886],[318,1886]],"region":{"top_left_x":317,"top_left_y":1834,"width":1520,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e763bcea748e4381af202893c77d036e","type":"text","conversion_output":true,"text":"treatment. The other PRO endpoints include the remaining EORTC QLQ-C30 and MY-20","text_display":" treatment. The other PRO endpoints include the remaining EORTC QLQ-C30 and MY-20","confidence":0.94775390625,"confidence_rate":0.9993689003684879},{"cnt":[[320,1897],[1687,1897],[1687,1949],[320,1949]],"region":{"top_left_x":320,"top_left_y":1897,"width":1367,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7511f63d1b643caaf0b8ccea31817d7","type":"text","conversion_output":true,"text":"subscale and individual item scores. The change in scores will be presented using","text_display":" subscale and individual item scores. The change in scores will be presented using","confidence":1,"confidence_rate":1},{"cnt":[[320,1959],[1029,1959],[1029,2009],[320,2009]],"region":{"top_left_x":320,"top_left_y":1959,"width":710,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e36f3b96cf814316b882ea1762681f14","type":"text","conversion_output":true,"text":"cumulative frequency distribution figures.","text_display":" cumulative frequency distribution figures.","confidence":1,"confidence_rate":1},{"cnt":[[316,2065],[1790,2065],[1790,2116],[316,2116]],"region":{"top_left_x":315,"top_left_y":2064,"width":1475,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c63b5723e0a14aa5ba0779bb5b706954","type":"text","conversion_output":true,"text":"The analysis of PRO scores will be performed as a repeated-measures analysis using all","text_display":"\n\nThe analysis of PRO scores will be performed as a repeated-measures analysis using all","confidence":1,"confidence_rate":1},{"cnt":[[316,2127],[1626,2127],[1626,2176],[316,2176]],"region":{"top_left_x":315,"top_left_y":2126,"width":1312,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c48fb78dba164deba1e83b438ae9caf7","type":"text","conversion_output":true,"text":"available time points. The analysis will use mixed model analysis of variance.","text_display":" available time points. The analysis will use mixed model analysis of variance.","confidence":0.99853515625,"confidence_rate":0.9999823384971409},{"cnt":[[318,2226],[1016,2226],[1016,2284],[318,2284]],"region":{"top_left_x":317,"top_left_y":2225,"width":700,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e11e3144dd341ddad25e1812856ed6a","type":"section_header","conversion_output":false,"children_ids":["430fd52e627940fd9c4a355777e09973"],"text":"","text_display":""},{"cnt":[[322,2230],[1012,2230],[1012,2279],[322,2279]],"region":{"top_left_x":322,"top_left_y":2230,"width":690,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"430fd52e627940fd9c4a355777e09973","type":"text","conversion_output":true,"parent_id":"1e11e3144dd341ddad25e1812856ed6a","text":"8.1.7.2 Health Economics Analysis","text_display":"\n\n\\subsection*{8.1.7.2 Health Economics 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or","text_display":" (length of stay, inpatient, outpatient, and reason), number of missing days from work or","confidence":1,"confidence_rate":1},{"cnt":[[322,374],[1328,374],[1328,423],[322,423]],"region":{"top_left_x":322,"top_left_y":373,"width":1006,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4182ce3819a7498ba7764c6e8b6eda65","type":"text","conversion_output":true,"text":"other activities by patient and care-giver for treatment arms.","text_display":" other activities by patient and care-giver for treatment 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Pain Response Rate is the proportion of patients who have a pain response and","text_display":" population. Pain Response Rate is the proportion of patients who have a pain response and","confidence":0.9936552047729492,"confidence_rate":0.9999322894308992},{"cnt":[[318,694],[1729,694],[1729,743],[318,743]],"region":{"top_left_x":317,"top_left_y":693,"width":1413,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a11f492971c84d589106527d7d0180fb","type":"text","conversion_output":true,"text":"will be summarized by treatment groups. The CMH test will be used to compare the","text_display":" will be summarized by treatment groups. The CMH test will be used to compare the","confidence":1,"confidence_rate":1},{"cnt":[[318,756],[1850,756],[1850,806],[318,806]],"region":{"top_left_x":317,"top_left_y":756,"width":1533,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0bf0442601c4ea784b9496f0b00982f","type":"text","conversion_output":true,"text":"2 treatment groups by stratification factors. In addition, the absolute treatment difference in","text_display":" 2 treatment groups by stratification factors. In addition, the absolute treatment difference in","confidence":1,"confidence_rate":1},{"cnt":[[318,819],[1259,819],[1259,870],[318,870]],"region":{"top_left_x":317,"top_left_y":818,"width":942,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28e277f271674ce48b584361f93b1e79","type":"text","conversion_output":true,"text":"pain response rate will be provided, along with \\(95 \\% CI\\).","text_display":" pain response rate will be provided, along with \\(95 \\% CI\\).","confidence":0.5447232723236084,"confidence_rate":0.9908380264288554},{"cnt":[[318,924],[1809,924],[1809,973],[318,973]],"region":{"top_left_x":317,"top_left_y":923,"width":1492,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9169ca362fb4557974355f981f43b05","type":"text","conversion_output":true,"text":"Pain response is defined as the occurrence of a \\(\\geq 30 \\%\\) reduction from baseline in BPI-SF","text_display":"\n\nPain response is defined as the occurrence of a \\(\\geq 30 \\%\\) reduction from baseline in BPI-SF","confidence":0.5330282197475134,"confidence_rate":0.9933289370512941},{"cnt":[[320,988],[1858,988],[1858,1038],[320,1038]],"region":{"top_left_x":320,"top_left_y":988,"width":1539,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d6dd0444df84b61baf1b2fc6270e78a","type":"text","conversion_output":true,"text":"worst pain score over the last 24 hours without an increase in analgesic use at 2 consecutive","text_display":" worst pain score over the last 24 hours without an increase in analgesic use at 2 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An unadjusted stratified Cox model will be","text_display":" log-rank test between the 2 treatment groups. An unadjusted stratified Cox model will be","confidence":1,"confidence_rate":1},{"cnt":[[318,1723],[1699,1723],[1699,1772],[318,1772]],"region":{"top_left_x":317,"top_left_y":1723,"width":1383,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fed0713ea224e5d9a76a7461356b1fc","type":"text","conversion_output":true,"text":"used to estimate the hazard ratio and its 95\\% CIs for the treatment effect using the","text_display":" used to estimate the hazard ratio and its 95\\% CIs for the treatment effect using the","confidence":0.9751424789428711,"confidence_rate":0.9997172120548431},{"cnt":[[318,1783],[1850,1783],[1850,1835],[318,1835]],"region":{"top_left_x":317,"top_left_y":1783,"width":1533,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b95578ebdbea4a8fae6d45a7a225614d","type":"text","conversion_output":true,"text":"stratification factors. The K-M survival curves and K-M medians (if estimable), along with","text_display":" stratification factors. The K-M survival curves and K-M medians (if estimable), along with","confidence":1,"confidence_rate":1},{"cnt":[[318,1846],[1846,1846],[1846,1897],[318,1897]],"region":{"top_left_x":317,"top_left_y":1845,"width":1529,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f11b3a880f140f3b89f0d93a9ffb4e8","type":"text","conversion_output":true,"text":"their 2-sided \\(95 \\%\\) CIs, will also be provided for each treatment arm. Time to pain response","text_display":" their 2-sided \\(95 \\%\\) CIs, will also be provided for each treatment arm. Time to pain response","confidence":0.6338439515130858,"confidence_rate":0.9953582300586283},{"cnt":[[318,1910],[1480,1910],[1480,1962],[318,1962]],"region":{"top_left_x":317,"top_left_y":1909,"width":1164,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f4c0cf7c6c4405f95487c6b57455444","type":"text","conversion_output":true,"text":"will be summarized descriptively among patients with pain response.","text_display":" will be summarized descriptively among patients with pain response.","confidence":0.9975595474243164,"confidence_rate":0.99996606397398},{"cnt":[[320,2013],[1740,2013],[1740,2065],[320,2065]],"region":{"top_left_x":320,"top_left_y":2013,"width":1421,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ced8dfd094d4cea9d42aac2d0fc6eb8","type":"text","conversion_output":true,"text":"Pain progression is defined as the occurrence of 1 of the following and confirmed by","text_display":"\n\nPain progression is defined as the occurrence of 1 of the following and confirmed by","confidence":0.747439204511636,"confidence_rate":0.9968408451341878},{"cnt":[[316,2071],[1848,2071],[1848,2129],[316,2129]],"region":{"top_left_x":315,"top_left_y":2071,"width":1533,"height":59},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5582c09a15e64e32b86bde25e9997e20","type":"text","conversion_output":true,"text":"2 consecutive evaluations. To qualify as progression, the patient must have a BPI-SF worst","text_display":" 2 consecutive evaluations. To qualify as progression, the patient must have a BPI-SF worst","confidence":0.99267578125,"confidence_rate":0.9999217990947539},{"cnt":[[318,2140],[896,2140],[896,2191],[318,2191]],"region":{"top_left_x":317,"top_left_y":2139,"width":579,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a038748d4d241f0a6f192e00862f216","type":"text","conversion_output":true,"text":"pain score \\(\\geq 4\\) during progression.","text_display":" pain score \\(\\geq 4\\) during progression.","confidence":1,"confidence_rate":1},{"cnt":[[382,2247],[1837,2247],[1837,2299],[382,2299]],"region":{"top_left_x":382,"top_left_y":2247,"width":1455,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91f5049fa02443b284a8636a86da1ea9","type":"text","conversion_output":true,"text":"- \\(A \\geq 2\\) point and \\(30 \\%\\) increase from baseline in BPI-SF worst pain score without an","text_display":"\n- \\(A \\geq 2\\) point and \\(30 \\%\\) increase from baseline in BPI-SF worst pain score without an","confidence":0.9298849105834961,"confidence_rate":0.9992269537144292},{"cnt":[[443,2312],[922,2312],[922,2361],[443,2361]],"region":{"top_left_x":442,"top_left_y":2311,"width":480,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d607c69d3a5412fa1675f7f019ed1fa","type":"text","conversion_output":true,"text":"increase in analgesic use, or","text_display":" increase in analgesic use, or","confidence":1,"confidence_rate":1},{"cnt":[[1070,2585],[1134,2585],[1134,2628],[1070,2628]],"region":{"top_left_x":1069,"top_left_y":2584,"width":66,"height":44},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdd5f80cb049480892bc9878cb140b95","type":"page_info","conversion_output":false,"text":"101","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-103","page":103,"lines":[{"cnt":[[320,129],[494,129],[494,165],[320,165]],"region":{"top_left_x":320,"top_left_y":128,"width":175,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4fdefff7974479db22777198f2c9f7a","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,172],[1369,172],[1369,217],[320,217]],"region":{"top_left_x":320,"top_left_y":171,"width":1049,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9d569d8bfa649d7a527be5e034d078b","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[382,254],[1871,254],[1871,303],[382,303]],"region":{"top_left_x":382,"top_left_y":253,"width":1490,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf04b48fbeb2428baeb969c804351bff","type":"text","conversion_output":true,"text":"- A \\(25 \\%\\) or more increase in analgesic use from baseline without a decrease in BPI-SF","text_display":"\n- A \\(25 \\%\\) or more increase in analgesic use from baseline without a decrease in BPI-SF","confidence":0.9345703125,"confidence_rate":0.999264744192395},{"cnt":[[443,318],[965,318],[965,367],[443,367]],"region":{"top_left_x":442,"top_left_y":317,"width":523,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8397a9857ac64c99a2c2e00f80e951c6","type":"text","conversion_output":true,"text":"worst pain score from baseline","text_display":" worst pain score from baseline","confidence":1,"confidence_rate":1},{"cnt":[[318,421],[1652,421],[1652,471],[318,471]],"region":{"top_left_x":317,"top_left_y":421,"width":1336,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9046d0d8ec2843daa99c4bdbb728268c","type":"text","conversion_output":true,"text":"Analgesic use can be stable or increased according to the following definitions:","text_display":"\n\nAnalgesic use can be stable or increased according to the following definitions:","confidence":1,"confidence_rate":1},{"cnt":[[382,529],[1760,529],[1760,578],[382,578]],"region":{"top_left_x":382,"top_left_y":528,"width":1378,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e660be9bab44dc2b5af1c925f51078d","type":"text","conversion_output":true,"text":"- Stable analgesic use is defined as less than a \\(25 \\%\\) change of the oral morphine","text_display":"\n- Stable analgesic use is defined as less than a \\(25 \\%\\) change of the oral morphine","confidence":1,"confidence_rate":1},{"cnt":[[443,589],[1085,589],[1085,640],[443,640]],"region":{"top_left_x":442,"top_left_y":588,"width":643,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6707b8d697234823b07c037cb7f9dbbd","type":"text","conversion_output":true,"text":"equivalent (OME) dose from baseline","text_display":" equivalent (OME) dose from baseline","confidence":1,"confidence_rate":1},{"cnt":[[382,696],[1772,696],[1772,748],[382,748]],"region":{"top_left_x":382,"top_left_y":696,"width":1391,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dde9915a91f4019a82342284ceb8d7a","type":"text","conversion_output":true,"text":"- Increased analgesic use is defined as an increase of \\(25 \\%\\) or more in OME from","text_display":"\n- Increased analgesic use is defined as an increase of \\(25 \\%\\) or more in OME 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The PK","text_display":"\nAs of Amendment 6, PK sample collection has been completed for all patients. 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be evaluated by the incidence of AEs, severity and type of AEs, and by changes","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[320,1109],[1807,1109],[1807,1158],[320,1158]],"region":{"top_left_x":320,"top_left_y":1108,"width":1487,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c452d11a7add4cd685aa0eef993993ff","type":"text","conversion_output":true,"text":"from baseline in the patient's vital signs, weight, and clinical laboratory results using the","text_display":" from baseline in the patient's vital signs, weight, and clinical laboratory results using the","confidence":1,"confidence_rate":1},{"cnt":[[320,1171],[1858,1171],[1858,1222],[320,1222]],"region":{"top_left_x":320,"top_left_y":1170,"width":1539,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2c0941731a94b2a8894d7e2fcf4a59a","type":"text","conversion_output":true,"text":"safety population. Exposure to study drug and reasons for discontinuation will be tabulated.","text_display":" safety population. Exposure to study drug and reasons for discontinuation will be tabulated.","confidence":0.99609375,"confidence_rate":0.9999596513364917},{"cnt":[[320,1276],[1841,1276],[1841,1326],[320,1326]],"region":{"top_left_x":320,"top_left_y":1276,"width":1522,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e385f151d1ed4772a68beb9418fccb1a","type":"text","conversion_output":true,"text":"Treatment-emergent AEs that occur after administration of the first dose of study drug and","text_display":"\n\nTreatment-emergent AEs that occur after administration of the first dose of study drug and","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[318,1336],[1749,1336],[1749,1390],[318,1390]],"region":{"top_left_x":317,"top_left_y":1336,"width":1432,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"100bb8227ea84551bba8ce4054ca33ba","type":"text","conversion_output":true,"text":"through 30 days after the last dose of study medication will be tabulated. AEs will be","text_display":" through 30 days after the last dose of study medication will be tabulated. AEs will be","confidence":0.5234375,"confidence_rate":0.9931370874025822},{"cnt":[[320,1401],[1871,1401],[1871,1450],[320,1450]],"region":{"top_left_x":320,"top_left_y":1400,"width":1552,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90da798e712b4f4c9e84c7ead006716e","type":"text","conversion_output":true,"text":"tabulated according to the Medical Dictionary for Regulatory Activities (MedDRA) and will","text_display":" tabulated according to the Medical Dictionary for Regulatory Activities (MedDRA) and will","confidence":1,"confidence_rate":1},{"cnt":[[320,1461],[874,1461],[874,1515],[320,1515]],"region":{"top_left_x":320,"top_left_y":1460,"width":555,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dce98a284494c8f918ed2608149d384","type":"text","conversion_output":true,"text":"include the following categories:","text_display":" include the following 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Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1843,249],[1843,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1527,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"520b550128444998bd04d3f98249e010","type":"text","conversion_output":true,"text":"Development of new or worsening of existing selected SREs (eg, new fractures [excluding","text_display":"\n\nDevelopment of new or worsening of existing selected SREs (eg, new fractures [excluding","confidence":1,"confidence_rate":1},{"cnt":[[318,314],[1785,314],[1785,363],[318,363]],"region":{"top_left_x":317,"top_left_y":313,"width":1469,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9616fa8992b496e913eff2ea3d4a322","type":"text","conversion_output":true,"text":"vertebral compression or rib fractures], irradiation of or surgery on bone, or spinal 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laboratory parameters) will be presented for all scheduled","confidence":1,"confidence_rate":1},{"cnt":[[320,666],[1699,666],[1699,715],[320,715]],"region":{"top_left_x":320,"top_left_y":666,"width":1380,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd58fbea2c5b483ba3b7dd7ffeccff65","type":"text","conversion_output":true,"text":"measurements over time. Mean laboratory values over time will be plotted for key","text_display":" measurements over time. Mean laboratory values over time will be plotted for key","confidence":1,"confidence_rate":1},{"cnt":[[320,730],[703,730],[703,780],[320,780]],"region":{"top_left_x":320,"top_left_y":730,"width":383,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e27e773fc5284fee8871ea0bd871df98","type":"text","conversion_output":true,"text":"laboratory parameters.","text_display":" laboratory parameters.","confidence":1,"confidence_rate":1},{"cnt":[[318,834],[1772,834],[1772,883],[318,883]],"region":{"top_left_x":317,"top_left_y":833,"width":1456,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8ee9d1bbf84484480f36b710c3d085e","type":"text","conversion_output":true,"text":"Descriptive statistics for the actual values and changes from baseline of vital signs and","text_display":"\n\nDescriptive statistics for the actual values and changes from baseline of vital signs and","confidence":1,"confidence_rate":1},{"cnt":[[320,896],[1734,896],[1734,947],[320,947]],"region":{"top_left_x":320,"top_left_y":895,"width":1414,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fac8548cf28448d8b654dfadd5480f3d","type":"text","conversion_output":true,"text":"weight will be tabulated by scheduled time point. ECOG performance scores will be","text_display":" weight will be tabulated by scheduled time point. ECOG performance scores will be","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[320,958],[846,958],[846,1008],[320,1008]],"region":{"top_left_x":320,"top_left_y":958,"width":527,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f2fed0d9cc1456cb8ca08f35212086e","type":"text","conversion_output":true,"text":"summarized using a shift table.","text_display":" summarized using a shift table.","confidence":1,"confidence_rate":1},{"cnt":[[322,1061],[1824,1061],[1824,1111],[322,1111]],"region":{"top_left_x":322,"top_left_y":1061,"width":1503,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68dc8961c10a4a8ab5739f8809a6936b","type":"text","conversion_output":true,"text":"Shift tables for laboratory parameters will be generated based on changes in NCI CTCAE","text_display":"\n\nShift tables for laboratory parameters will be generated based on changes in NCI CTCAE","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[320,1124],[1762,1124],[1762,1175],[320,1175]],"region":{"top_left_x":320,"top_left_y":1123,"width":1442,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b60b29e04a04b9da939db1a3c81fd94","type":"text","conversion_output":true,"text":"Grade from baseline to the worst post baseline value. Graphical displays of key safety","text_display":" Grade from baseline to the worst post baseline value. 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The first IA will be performed when approximately 262 of the","text_display":"\n\nThere are 3 planned IAs. The first IA will be performed when approximately 262 of the","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[318,1899],[1861,1899],[1861,1949],[318,1949]],"region":{"top_left_x":317,"top_left_y":1899,"width":1544,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0a6928c725b4ee48a6e0491a2d92c2c","type":"text","conversion_output":true,"text":"disease progression/death events have occurred. This IA is expected to occur approximately","text_display":" disease progression/death events have occurred. This IA is expected to occur approximately","confidence":1,"confidence_rate":1},{"cnt":[[318,1962],[1852,1962],[1852,2013],[318,2013]],"region":{"top_left_x":317,"top_left_y":1961,"width":1535,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bfc10a8eb9946bea9897d86307f56b4","type":"text","conversion_output":true,"text":"24.5 months after the first patient is enrolled. This is the first analysis for PFS for statistical","text_display":" 24.5 months after the first patient is enrolled. This is the first analysis for PFS for statistical","confidence":1,"confidence_rate":1},{"cnt":[[318,2024],[1858,2024],[1858,2073],[318,2073]],"region":{"top_left_x":317,"top_left_y":2023,"width":1542,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59630bf8e2d04af398bb78d3abd838bc","type":"text","conversion_output":true,"text":"testing purpose and first IA for OS. During this IA, enrollment to the study will continue. If","text_display":" testing purpose and first IA for OS. During this IA, enrollment to the study will continue. If","confidence":1,"confidence_rate":1},{"cnt":[[316,2084],[1858,2084],[1858,2138],[316,2138]],"region":{"top_left_x":315,"top_left_y":2083,"width":1544,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3edfc5aac3dc464f8a5210fcfa944e7e","type":"text","conversion_output":true,"text":"the test for PFS is not statistically significant at 2 sided alpha level of 0.0163 , the study will","text_display":" the test for PFS is not statistically significant at 2 sided alpha level of 0.0163 , the study will","confidence":1,"confidence_rate":1},{"cnt":[[320,2148],[1790,2148],[1790,2198],[320,2198]],"region":{"top_left_x":320,"top_left_y":2148,"width":1470,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47add10900c34f71b51778bc20402457","type":"text","conversion_output":true,"text":"continue and PFS testing will be conducted again at the second IA when approximately","text_display":" continue and PFS testing will be conducted again at the second IA when approximately","confidence":1,"confidence_rate":1},{"cnt":[[318,2211],[1807,2211],[1807,2260],[318,2260]],"region":{"top_left_x":317,"top_left_y":2210,"width":1490,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c0e6d33fc9c42b78354dc2ca650b3ff","type":"text","conversion_output":true,"text":"365 PFS events have occurred, which will also be the final analysis of PFS for statistical","text_display":" 365 PFS events have occurred, which will also be the final analysis of PFS for statistical","confidence":1,"confidence_rate":1},{"cnt":[[318,2273],[1867,2273],[1867,2322],[318,2322]],"region":{"top_left_x":317,"top_left_y":2273,"width":1550,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83bab0ef6f03493e8e3d4ab4f37d661f","type":"text","conversion_output":true,"text":"testing purpose. Based on the projected number of PFS events, the statistical significance of","text_display":" testing purpose. Based on the projected number of PFS events, the statistical significance of","confidence":1,"confidence_rate":1},{"cnt":[[318,2333],[1854,2333],[1854,2385],[318,2385]],"region":{"top_left_x":317,"top_left_y":2333,"width":1538,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c24d8a2dfd44441a956e423d146ed41a","type":"text","conversion_output":true,"text":"PFS could be claimed if the observed p value is less than 0.0451 (corresponding to nominal","text_display":" PFS could be claimed if the observed p value is less than 0.0451 (corresponding to nominal","confidence":0.9286149073159322,"confidence_rate":0.9992881270596774},{"cnt":[[318,2398],[1869,2398],[1869,2449],[318,2449]],"region":{"top_left_x":317,"top_left_y":2397,"width":1553,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4759f3e26ccb44f7b919a00b64ce7e9e","type":"text","conversion_output":true,"text":"alpha of 0.0337 ). The trial will not be stopped due to the test for OS at the first IA. The third","text_display":" alpha of 0.0337 ). The trial will not be stopped due to the test for OS at the first IA. The third","confidence":0.9717318823095411,"confidence_rate":0.9997295143820003},{"cnt":[[1070,2587],[1141,2587],[1141,2628],[1070,2628]],"region":{"top_left_x":1069,"top_left_y":2586,"width":72,"height":42},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee5d42e30a5f429bbe85eeabd669cdf1","type":"page_info","conversion_output":false,"text":"104","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-106","page":106,"lines":[{"cnt":[[322,129],[492,129],[492,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":170,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e82b9bfa85ce4e5b80eb0831073a6b52","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a4482df7f814686aefeb3d216096a30","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1772,249],[1772,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1456,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f0f1f380bc648909e4b805dc404498f","type":"text","conversion_output":true,"text":"IA will be performed when approximately 322 deaths (two-thirds of the total expected","text_display":"\n\nIA will be performed when approximately 322 deaths (two-thirds of the total expected","confidence":1,"confidence_rate":1},{"cnt":[[318,314],[1796,314],[1796,365],[318,365]],"region":{"top_left_x":317,"top_left_y":313,"width":1480,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd0b3ffbaf824c0382cb51a89ef2bbbe","type":"text","conversion_output":true,"text":"deaths) have been observed. The third IA is expected to occur approximately 44 months","text_display":" deaths) have been observed. The third IA is expected to occur approximately 44 months","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1609,374],[1609,425],[318,425]],"region":{"top_left_x":317,"top_left_y":373,"width":1293,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdcb3515dc444e54a6461481c9163537","type":"text","conversion_output":true,"text":"after the first patient is enrolled. At that time, all patients have been enrolled.","text_display":" after the first patient is enrolled. At that time, all patients have been enrolled.","confidence":1,"confidence_rate":1},{"cnt":[[318,477],[1766,477],[1766,531],[318,531]],"region":{"top_left_x":317,"top_left_y":476,"width":1450,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd089a8770ac448893c9196c4a4a3f9d","type":"text","conversion_output":true,"text":"The test significance for the interim and final analyses of OS will be determined using","text_display":"\n\nThe test significance for the interim and final analyses of OS will be determined using","confidence":0.9892673492431641,"confidence_rate":0.9998827170836556},{"cnt":[[318,541],[1848,541],[1848,591],[318,591]],"region":{"top_left_x":317,"top_left_y":541,"width":1531,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e07d69ada89427dac0039abea946041","type":"text","conversion_output":true,"text":"O'Brien-Fleming boundaries (the Lan-DeMets method). Based on the projected number of","text_display":" O'Brien-Fleming boundaries (the Lan-DeMets method). Based on the projected number of","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[318,604],[1835,604],[1835,655],[318,655]],"region":{"top_left_x":317,"top_left_y":603,"width":1518,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55882b4b67144802b2d7e77d49b0387b","type":"text","conversion_output":true,"text":"death events, the trial will be stopped for overwhelming efficacy if the observed \\(p\\) value is","text_display":" death events, the trial will be stopped for overwhelming efficacy if the observed \\(p\\) value is","confidence":0.96240234375,"confidence_rate":0.9996168466319402},{"cnt":[[320,666],[1850,666],[1850,715],[320,715]],"region":{"top_left_x":320,"top_left_y":666,"width":1530,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25c05f16094a42e5b8a050cbf1f8ee8e","type":"text","conversion_output":true,"text":"less than 0.0018 and 0.0112 at the second and third IA, respectively. The final analysis will","text_display":" less than 0.0018 and 0.0112 at the second and third IA, respectively. The final analysis will","confidence":1,"confidence_rate":1},{"cnt":[[318,724],[1757,724],[1757,780],[318,780]],"region":{"top_left_x":317,"top_left_y":724,"width":1441,"height":56},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c3ce0c9af864f82913bca37b65b7ff6","type":"text","conversion_output":true,"text":"be tested at 2 -sided alpha level of 0.0462 (corresponding to nominal alpha of 0.0382 ).","text_display":" be tested at 2 -sided alpha level of 0.0462 (corresponding to nominal alpha of 0.0382 ).","confidence":0.99755859375,"confidence_rate":0.9999760356661515},{"cnt":[[314,829],[902,829],[902,883],[314,883]],"region":{"top_left_x":313,"top_left_y":829,"width":590,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8337166e8094daf9270a8c56b47399c","type":"section_header","conversion_output":false,"children_ids":["3524710846ed4c94b2362e477c6fa248"],"text":"","text_display":""},{"cnt":[[318,834],[896,834],[896,879],[318,879]],"region":{"top_left_x":317,"top_left_y":833,"width":579,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3524710846ed4c94b2362e477c6fa248","type":"text","conversion_output":true,"parent_id":"c8337166e8094daf9270a8c56b47399c","text":"9. 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Data from the IRC","text_display":" from the study and determined disease status (response and progression). Data from the IRC","confidence":1,"confidence_rate":1},{"cnt":[[318,1452],[1717,1452],[1717,1506],[318,1506]],"region":{"top_left_x":317,"top_left_y":1452,"width":1400,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e83d7e17aa1435d94238589fa03b8e4","type":"text","conversion_output":true,"text":"will not be provided back to the investigator during the conduct of the study. As of","text_display":" will not be provided back to the investigator during the conduct of the study. 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The IDMC will communicate major safety","text_display":" Records of all meetings will be archived. 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any organism, virus, or infectious particle (eg, prion protein transmitting","text_display":" drug abuse; any organism, virus, or infectious particle (eg, prion protein transmitting","confidence":1,"confidence_rate":1},{"cnt":[[443,2187],[1717,2187],[1717,2239],[443,2239]],"region":{"top_left_x":442,"top_left_y":2187,"width":1275,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97485f8e1c3d482e806799594ac78386","type":"text","conversion_output":true,"text":"transmissible spongiform encephalopathy), pathogenic or nonpathogenic, is","text_display":" transmissible spongiform encephalopathy), pathogenic or nonpathogenic, is","confidence":1,"confidence_rate":1},{"cnt":[[443,2247],[971,2247],[971,2301],[443,2301]],"region":{"top_left_x":442,"top_left_y":2247,"width":530,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60de4ee4cf0448c6bc0e4c9b4b7c2f31","type":"text","conversion_output":true,"text":"considered an infectious agent.","text_display":" considered an infectious agent.","confidence":1,"confidence_rate":1},{"cnt":[[318,2350],[1867,2350],[1867,2404],[318,2404]],"region":{"top_left_x":317,"top_left_y":2350,"width":1550,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c04858f360ee4304acc61e1e8c83412e","type":"text","conversion_output":true,"text":"In this study, intensity for each AE, including any lab abnormality, will be determined using","text_display":"\n\nIn this study, intensity for each AE, including any lab abnormality, will be determined using","confidence":1,"confidence_rate":1},{"cnt":[[318,2415],[1798,2415],[1798,2464],[318,2464]],"region":{"top_left_x":317,"top_left_y":2414,"width":1482,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21cda668c713421fa381ba2a9d671a15","type":"text","conversion_output":true,"text":"the NCI CTCAE, Version 4.03, effective date 14 June 2010.[51] Clarification should be","text_display":" the NCI CTCAE, Version 4.03, effective date 14 June 2010.[51] Clarification should be","confidence":0.943359375,"confidence_rate":0.9993732290687446},{"cnt":[[1070,2582],[1141,2582],[1141,2628],[1070,2628]],"region":{"top_left_x":1069,"top_left_y":2582,"width":72,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"744fab55cf534061be5b7911b9c1c84d","type":"page_info","conversion_output":false,"text":"107","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-109","page":109,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c857f1d3b36477187af3c0155044c6a","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f0b3ea658a14c2c8f75fcdd61884b5f","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,251],[1867,251],[1867,303],[320,303]],"region":{"top_left_x":320,"top_left_y":251,"width":1547,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b85158d153e94f8d9a885c9bd8b2e854","type":"text","conversion_output":true,"text":"made between a serious AE (SAE) and an AE that is considered severe in intensity (Grade 3","text_display":"\nmade between a serious AE (SAE) and an AE that is considered severe in intensity (Grade 3","confidence":0.76611328125,"confidence_rate":0.9971393121316368},{"cnt":[[318,314],[1841,314],[1841,363],[318,363]],"region":{"top_left_x":317,"top_left_y":313,"width":1525,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97452bbbd8434ee291a7d5d75760507a","type":"text","conversion_output":true,"text":"or 4), because the terms serious and severe are NOT synonymous. The general term severe","text_display":" or 4), because the terms serious and severe are NOT synonymous. The general term severe","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1871,374],[1871,423],[318,423]],"region":{"top_left_x":317,"top_left_y":373,"width":1555,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f462492530a48bd8045f55af4aab574","type":"text","conversion_output":true,"text":"is often used to describe the intensity (severity) of a specific event; the event itself, however,","text_display":" is often used to describe the intensity (severity) of a specific event; the event itself, however,","confidence":1,"confidence_rate":1},{"cnt":[[318,438],[1854,438],[1854,488],[318,488]],"region":{"top_left_x":317,"top_left_y":438,"width":1538,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67db4384e2964e5e933b78740a6a0401","type":"text","conversion_output":true,"text":"may be of relatively minor medical significance (such as a Grade 3 headache). This is NOT","text_display":" may be of relatively minor medical significance (such as a Grade 3 headache). This is NOT","confidence":1,"confidence_rate":1},{"cnt":[[318,501],[1807,501],[1807,548],[318,548]],"region":{"top_left_x":317,"top_left_y":500,"width":1490,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad7160311dca4daca7439e25f309f605","type":"text","conversion_output":true,"text":"the same as serious, which is based on patient/event outcome or action criteria described","text_display":" the same as serious, which is based on patient/event outcome or action criteria described","confidence":1,"confidence_rate":1},{"cnt":[[318,563],[1863,563],[1863,612],[318,612]],"region":{"top_left_x":317,"top_left_y":562,"width":1546,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09bb114d3d304c8396d71cf723b0d1a9","type":"text","conversion_output":true,"text":"above, and is usually associated with events that pose a threat to a patient's life or ability to","text_display":" above, and is usually associated with events that pose a threat to a patient's life or ability to","confidence":0.8755488395690918,"confidence_rate":0.9986978647496865},{"cnt":[[318,623],[1876,623],[1876,672],[318,672]],"region":{"top_left_x":317,"top_left_y":623,"width":1559,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5741e7a998c1445f8fa61f9a3ee40cd2","type":"text","conversion_output":true,"text":"function. A severe AE (Grade 3 or 4) does not necessarily need to be considered serious. For","text_display":" function. A severe AE (Grade 3 or 4) does not necessarily need to be considered serious. For","confidence":0.9917163848876953,"confidence_rate":0.999916822310395},{"cnt":[[318,679],[1785,679],[1785,737],[318,737]],"region":{"top_left_x":317,"top_left_y":678,"width":1469,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae70b782cdbd4c92866ac61b8759c53b","type":"text","conversion_output":true,"text":"example, a white blood cell count of \\(1000 / mm ^{3}\\) to less than 2000 is considered Grade 3","text_display":" example, a white blood cell count of \\(1000 / mm ^{3}\\) to less than 2000 is considered Grade 3","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[318,750],[1858,748],[1858,799],[318,801]],"region":{"top_left_x":317,"top_left_y":747,"width":1542,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0ca6b3e85304bf2923588317f83a3f8","type":"text","conversion_output":true,"text":"(severe) but may not be considered serious. Seriousness (not intensity) serves as a guide for","text_display":" (severe) but may not be considered serious. Seriousness (not intensity) serves as a guide for","confidence":1,"confidence_rate":1},{"cnt":[[318,812],[1016,812],[1016,862],[318,862]],"region":{"top_left_x":317,"top_left_y":812,"width":700,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2abbdc9d46d4ed692baddc4ad39dd03","type":"text","conversion_output":true,"text":"defining regulatory reporting obligations.","text_display":" defining regulatory reporting obligations.","confidence":1,"confidence_rate":1},{"cnt":[[314,913],[1721,913],[1721,1012],[314,1012]],"region":{"top_left_x":313,"top_left_y":913,"width":1408,"height":99},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0e4437c917446bf886c95ce23bd6185","type":"section_header","conversion_output":false,"children_ids":["ad861c30a10846699dc2d93975ecaaf1","498b4a230a49472cac5e8948cd060187"],"text":"","text_display":""},{"cnt":[[322,965],[322,913],[1715,916],[1714,967]],"region":{"top_left_x":322,"top_left_y":913,"width":1393,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad861c30a10846699dc2d93975ecaaf1","type":"text","conversion_output":true,"parent_id":"c0e4437c917446bf886c95ce23bd6185","text":"10.2 Procedures for Recording and Reporting Adverse Events and Serious","text_display":"\n\n\\subsection*{10.2 Procedures for Recording and Reporting Adverse Events and Serious","confidence":1,"confidence_rate":1},{"cnt":[[468,967],[754,967],[754,1008],[468,1008]],"region":{"top_left_x":468,"top_left_y":966,"width":287,"height":42},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"498b4a230a49472cac5e8948cd060187","type":"text","conversion_output":true,"parent_id":"c0e4437c917446bf886c95ce23bd6185","text":"Adverse Events","text_display":" Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[318,1053],[1843,1053],[1843,1102],[318,1102]],"region":{"top_left_x":317,"top_left_y":1052,"width":1527,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a899890d3c6f431f94c1ccc4e74801a2","type":"text","conversion_output":true,"text":"All AEs spontaneously reported by the patient and/or in response to an open question from","text_display":"\n\nAll AEs spontaneously reported by the patient and/or in response to an open question from","confidence":1,"confidence_rate":1},{"cnt":[[318,1113],[1755,1113],[1755,1164],[318,1164]],"region":{"top_left_x":317,"top_left_y":1112,"width":1439,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9f5e7e3279d4799bb0c8ff68b34bf9f","type":"text","conversion_output":true,"text":"study personnel or revealed by observation, physical examination, or other diagnostic","text_display":" study personnel or revealed by observation, physical examination, or other diagnostic","confidence":1,"confidence_rate":1},{"cnt":[[318,1177],[1826,1177],[1826,1227],[318,1227]],"region":{"top_left_x":317,"top_left_y":1177,"width":1510,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c38fb09b9b2c49629bec9adf9928d715","type":"text","conversion_output":true,"text":"procedures will be recorded on the appropriate page of the eCRF (see Section 10.3 for the","text_display":" procedures will be recorded on the appropriate page of the eCRF (see Section 10.3 for the","confidence":1,"confidence_rate":1},{"cnt":[[318,1240],[1807,1240],[1807,1291],[318,1291]],"region":{"top_left_x":317,"top_left_y":1239,"width":1490,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b7d41b5639b4d85958f19c95420d547","type":"text","conversion_output":true,"text":"period of observation). Any clinically relevant deterioration in laboratory assessments or","text_display":" period of observation). Any clinically relevant deterioration in laboratory assessments or","confidence":1,"confidence_rate":1},{"cnt":[[318,1302],[1858,1302],[1858,1351],[318,1351]],"region":{"top_left_x":317,"top_left_y":1301,"width":1542,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1aa90af1e69e4d4d9b7a63dc64bfeda9","type":"text","conversion_output":true,"text":"other clinical finding is considered an AE. When possible, signs and symptoms indicating a","text_display":" other clinical finding is considered an AE. When possible, signs and symptoms indicating a","confidence":1,"confidence_rate":1},{"cnt":[[318,1364],[1566,1364],[1566,1414],[318,1414]],"region":{"top_left_x":317,"top_left_y":1364,"width":1250,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e00271539a81441dad8eb7bdbe4796b9","type":"text","conversion_output":true,"text":"common underlying pathology should be noted as 1 comprehensive event.","text_display":" common underlying pathology should be noted as 1 comprehensive event.","confidence":1,"confidence_rate":1},{"cnt":[[318,1470],[1837,1470],[1837,1519],[318,1519]],"region":{"top_left_x":317,"top_left_y":1469,"width":1520,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07b8cee0cafe48f3a05033d5fed30559","type":"text","conversion_output":true,"text":"Regardless of causality, SAEs and serious pretreatment events (as defined in Section 10.1)","text_display":"\n\nRegardless of causality, SAEs and serious pretreatment events (as defined in Section 10.1)","confidence":1,"confidence_rate":1},{"cnt":[[318,1530],[1833,1530],[1833,1579],[318,1579]],"region":{"top_left_x":317,"top_left_y":1529,"width":1516,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96f078c9699945d6b58fa69ad9942779","type":"text","conversion_output":true,"text":"must be reported (see Section 10.3 for the period of observation) by the investigator to the","text_display":" must be reported (see Section 10.3 for the period of observation) by the investigator to the","confidence":0.9975595474243164,"confidence_rate":0.999974810262278},{"cnt":[[318,1592],[1820,1592],[1820,1644],[318,1644]],"region":{"top_left_x":317,"top_left_y":1591,"width":1503,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0e1b4f062e347489557c526357b727a","type":"text","conversion_output":true,"text":"Millennium Department of Pharmacovigilance or designee (contact information provided","text_display":" Millennium Department of Pharmacovigilance or designee (contact information provided","confidence":1,"confidence_rate":1},{"cnt":[[318,1654],[1803,1654],[1803,1704],[318,1704]],"region":{"top_left_x":317,"top_left_y":1654,"width":1486,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27c7cf737a8b41afa448189dc03011a8","type":"text","conversion_output":true,"text":"below) by faxing the SAE Form within 24 hours after becoming aware of the event. The","text_display":" below) by faxing the SAE Form within 24 hours after becoming aware of the event. The","confidence":0.9858884811401367,"confidence_rate":0.9998455333109033},{"cnt":[[318,1714],[1846,1714],[1846,1768],[318,1768]],"region":{"top_left_x":317,"top_left_y":1714,"width":1529,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2d5c6c887bc4f9da30150167c48265e","type":"text","conversion_output":true,"text":"SAE Form, created specifically by Millennium, will be provided to each clinical study site.","text_display":" SAE Form, created specifically by Millennium, will be provided to each clinical study site.","confidence":1,"confidence_rate":1},{"cnt":[[318,1779],[1828,1779],[1828,1830],[318,1830]],"region":{"top_left_x":317,"top_left_y":1778,"width":1512,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccf49237359540b4984c28cba0941b5c","type":"text","conversion_output":true,"text":"A sample of the SAE Form may be found in the Study Manual. Follow-up information on","text_display":" A sample of the SAE Form may be found in the Study Manual. Follow-up information on","confidence":1,"confidence_rate":1},{"cnt":[[318,1841],[1738,1841],[1738,1893],[318,1893]],"region":{"top_left_x":317,"top_left_y":1841,"width":1422,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a8cc84e8d2c446c92142bfe874fa7f9","type":"text","conversion_output":true,"text":"the SAE or serious pretreatment event may be requested by Millennium. SAE report","text_display":" the SAE or serious pretreatment event may be requested by Millennium. SAE report","confidence":1,"confidence_rate":1},{"cnt":[[318,1904],[1459,1904],[1459,1953],[318,1953]],"region":{"top_left_x":317,"top_left_y":1903,"width":1142,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40fa6061989243f1a2f5194306ea7e23","type":"text","conversion_output":true,"text":"information must be consistent with the data provided on the eCRF.","text_display":" information must be consistent with the data provided on the eCRF.","confidence":0.99951171875,"confidence_rate":0.9999931211434043},{"cnt":[[318,2007],[1878,2007],[1878,2058],[318,2058]],"region":{"top_left_x":317,"top_left_y":2006,"width":1561,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d078c31794534206bd6698e897b3cc36","type":"text","conversion_output":true,"text":"The paper SAE forms must be submitted via fax (see fax numbers below) within 24 hours of","text_display":"\n\nThe paper SAE forms must be submitted via fax (see fax numbers below) within 24 hours of","confidence":1,"confidence_rate":1},{"cnt":[[318,2071],[1837,2071],[1837,2121],[318,2121]],"region":{"top_left_x":317,"top_left_y":2071,"width":1520,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"754a13bca97844ab93e0ea5cd68c93f0","type":"text","conversion_output":true,"text":"awareness. In case of fax, site personnel must confirm successful transmission of all pages","text_display":" awareness. In case of fax, site personnel must confirm successful transmission of all pages","confidence":1,"confidence_rate":1},{"cnt":[[318,2133],[1837,2133],[1837,2185],[318,2185]],"region":{"top_left_x":317,"top_left_y":2133,"width":1520,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29a650dc2c3b47e6a7f3cdfcb28075f4","type":"text","conversion_output":true,"text":"and include an e-mail address on the fax cover sheet so that an acknowledgment of receipt","text_display":" and include an e-mail address on the fax cover sheet so that an acknowledgment of receipt","confidence":1,"confidence_rate":1},{"cnt":[[320,2196],[1811,2196],[1811,2245],[320,2245]],"region":{"top_left_x":320,"top_left_y":2195,"width":1492,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d33f87b170e3453d92952950abc93926","type":"text","conversion_output":true,"text":"can be returned via e-mail within 1 business day. E-mail submission of paper SAE forms","text_display":" can be returned via e-mail within 1 business day. 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For serious","text_display":" the event and the relationship of the event to study drug administration. For serious","confidence":1,"confidence_rate":1},{"cnt":[[318,1830],[1841,1830],[1841,1880],[318,1880]],"region":{"top_left_x":317,"top_left_y":1830,"width":1525,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e66abdba5f174bbe8990a19ae5d50d48","type":"text","conversion_output":true,"text":"pretreatment events, the investigator must determine both the intensity of the event and the","text_display":" pretreatment events, the investigator must determine both the intensity of the event and the","confidence":1,"confidence_rate":1},{"cnt":[[318,1895],[1072,1895],[1072,1944],[318,1944]],"region":{"top_left_x":317,"top_left_y":1894,"width":756,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b10656cb78e449398466c4306c21d69d","type":"text","conversion_output":true,"text":"relationship of the event to study procedures","text_display":" relationship of the event to study 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version 4.03, effective date 14 June 2010.[51] The criteria are provided in the","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[318,2123],[574,2123],[574,2172],[318,2172]],"region":{"top_left_x":317,"top_left_y":2122,"width":257,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0dcb454d2b324a17a65a44b736e9decb","type":"text","conversion_output":true,"text":"Study Manual.","text_display":" Study Manual.","confidence":1,"confidence_rate":1},{"cnt":[[318,2226],[1876,2226],[1876,2275],[318,2275]],"region":{"top_left_x":317,"top_left_y":2225,"width":1559,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"997866a8d46c4789b18bd476366c6835","type":"text","conversion_output":true,"text":"Relationship to study drug administration will be determined by the investigator responding","text_display":"\n\nRelationship to study drug administration will be determined by the investigator 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All rightsreserved. 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IMWG uniform response criteria by response subcategory for multiple myeloma \\({ }^{7}\\)}\n\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline CR* & Stringent complete response (sCR) † & VGPR* & PR & SD & PD † \\\\\n\\hline Negative immunofixation of serum and urine, and & CR as defined, plus & Serum and urine M-component detectable by immunofixation but not on electrophoresis, or & \\(\\geq 50 \\%\\) reduction of serum M-protein and reduction in 24 -hour urinary M-protein by \\(\\geq 90 \\%\\) or to \\(<200 mg / 24\\) hours & Not meeting criteria for CR, VGPR, PR, or PD & Increase of 25\\% from lowest response value in any of the following: \\\\\n\\hline Disappearance of any soft tissue plasmacytomas, and & Normal FLC ratio and & \\(\\geq 90 \\%\\) reduction in serum Mcomponent plus urine M-component \\(<100 mg / 24 h\\) & If the serum and urine M-protein are not measurable, a decrease \\(\\geq 50 \\%\\) in the difference between involved and uninvolved FLC levels is required in place of the 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calcium","text_display":" (corrected serum calcium","confidence":0.99853515625,"confidence_rate":0.9999494523919701},{"cnt":[[1593,2053],[1826,2053],[1826,2078],[1593,2078]],"region":{"top_left_x":1593,"top_left_y":2052,"width":234,"height":27},"line":141,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"63a30b69f16446e282f9e55ad5c8d44a","type":"text","conversion_output":false,"parent_id":"1afbcf67fc824d6d80ef79482cf459ba","text":"\\(>11.5 mg / dL\\) ) that can be","text_display":" \\(>11.5 mg / dL\\) ) that can be","confidence":0.99951171875,"confidence_rate":0.9999856353826395},{"cnt":[[1593,2083],[1824,2083],[1824,2110],[1593,2110]],"region":{"top_left_x":1593,"top_left_y":2082,"width":231,"height":28},"line":142,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"c08a90e3c3c94fdbad0eb1c48bbc0e6d","type":"text","conversion_output":false,"parent_id":"1afbcf67fc824d6d80ef79482cf459ba","text":"attributed solely to the PC","text_display":" attributed solely to the PC","confidence":1,"confidence_rate":1},{"cnt":[[1593,2114],[1777,2114],[1777,2141],[1593,2141]],"region":{"top_left_x":1593,"top_left_y":2113,"width":185,"height":29},"line":143,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"b108e6f99057407eaa47c829971e03dd","type":"text","conversion_output":false,"parent_id":"1afbcf67fc824d6d80ef79482cf459ba","text":"proliferative disorder","text_display":" proliferative disorder","confidence":1,"confidence_rate":1},{"cnt":[[391,2161],[1858,2161],[1858,2189],[391,2189]],"region":{"top_left_x":391,"top_left_y":2161,"width":1468,"height":29},"line":144,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"404aee2473294199a18ae582dc87c76c","type":"text","conversion_output":true,"text":"Adapted from Durie et al \\({ }^{7}\\) and Kyle et al \\({ }^{13}\\) with permission. All response categories (CR, sCR, VGPR, PR, and PD) require 2 consecutive assessments made at any time","text_display":"\n\nAdapted from Durie et al \\({ }^{7}\\) and Kyle et al \\({ }^{13}\\) with permission. All response categories (CR, sCR, VGPR, PR, and PD) require 2 consecutive assessments made at any time","confidence":0.7994577316020252,"confidence_rate":0.9988349416214107},{"cnt":[[354,2187],[1858,2187],[1858,2215],[354,2215]],"region":{"top_left_x":354,"top_left_y":2187,"width":1505,"height":29},"line":145,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"d4271414f1174301b6a4d41e082c9710","type":"text","conversion_output":true,"text":"before the institution of any new therapy; CR, sCR, VGPR, PR, and SD categories also require no known evidence of progressive or new bone lesions if radiographic studies","text_display":" before the institution of any new therapy; CR, sCR, VGPR, PR, and SD categories also require no known evidence of progressive or new bone lesions if radiographic studies","confidence":1,"confidence_rate":1},{"cnt":[[354,2213],[1858,2213],[1858,2241],[354,2241]],"region":{"top_left_x":354,"top_left_y":2212,"width":1505,"height":29},"line":146,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"1f11d766fa2d4d52ac92bbe9365da058","type":"text","conversion_output":true,"text":"were performed. VGPR and CR categories require serum and urine studies regardess of whether disease at baseline was measurable on serum, urine, both, or neither.","text_display":" were performed. VGPR and CR categories require serum and urine studies regardess of whether disease at baseline was measurable on serum, urine, both, or neither.","confidence":0.72509765625,"confidence_rate":0.9980654343220838},{"cnt":[[354,2239],[1858,2239],[1858,2267],[354,2267]],"region":{"top_left_x":354,"top_left_y":2238,"width":1505,"height":29},"line":147,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"8a7aff4198d44d8d86ed1b8f9530a207","type":"text","conversion_output":true,"text":"Radiographic studies are not required to satisfy these response requirements. Bone marrow assessments need not be confirmed. For PD, serum M-component increases of","text_display":" Radiographic studies are not required to satisfy these response requirements. Bone marrow assessments need not be confirmed. For PD, serum M-component increases of","confidence":0.98681640625,"confidence_rate":0.9999210074727182},{"cnt":[[352,2264],[1184,2264],[1184,2292],[352,2292]],"region":{"top_left_x":352,"top_left_y":2264,"width":832,"height":29},"line":148,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"63ece442afae4a72b72665d09ef008e6","type":"text","conversion_output":true,"text":"more than or equal to \\(1 g / dL\\) are sufficient to define relapse if starting M -component is \\(\\geq 5 g / dL\\).","text_display":" more than or equal to \\(1 g / dL\\) are sufficient to define relapse if starting M -component is \\(\\geq 5 g / dL\\).","confidence":0.9922053688205779,"confidence_rate":0.9999378974196892},{"cnt":[[391,2290],[625,2290],[625,2318],[391,2318]],"region":{"top_left_x":391,"top_left_y":2290,"width":235,"height":29},"line":149,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"98da7285aa1645d590dffef74bd96218","type":"text","conversion_output":true,"text":"PCs indicate plasma cells.","text_display":"\n\nPCs indicate plasma cells.","confidence":0.9912109375,"confidence_rate":0.9997152691201923},{"cnt":[[391,2316],[1858,2316],[1858,2344],[391,2344]],"region":{"top_left_x":391,"top_left_y":2316,"width":1468,"height":28},"line":150,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"2aeb0d4c2cd0494882dc40e6647a69c7","type":"text","conversion_output":true,"text":"*Clarifications to IMWG criteria for coding CR and VGPR in patients in whom the only measurable disease is by serum FLC levels: CR in such patients indicates a normal","text_display":"\n*Clarifications to IMWG criteria for coding CR and VGPR in patients in whom the only measurable disease is by serum FLC levels: CR in such patients indicates a normal","confidence":0.9902536764275283,"confidence_rate":0.9999427260269922},{"cnt":[[352,2342],[1858,2342],[1858,2368],[352,2368]],"region":{"top_left_x":352,"top_left_y":2341,"width":1507,"height":27},"line":151,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"34d775c1df974ce7969baa4e20ab13b5","type":"text","conversion_output":true,"text":"FLC ratio of 0.26 to 1.65 in addition to CR criteria listed above. VGPR in such patients requires a \\(>90 \\%\\) decrease in the difference between involved and uninvolved FLC","text_display":" FLC ratio of 0.26 to 1.65 in addition to CR criteria listed above. VGPR in such patients requires a \\(>90 \\%\\) decrease in the difference between involved and uninvolved FLC","confidence":0.9166638267925009,"confidence_rate":0.9995193725823629},{"cnt":[[352,2368],[421,2368],[421,2393],[352,2393]],"region":{"top_left_x":352,"top_left_y":2367,"width":70,"height":27},"line":152,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"e430c52d98c0480aae8bd6f11688fdd4","type":"text","conversion_output":true,"text":"levels.","text_display":" levels.","confidence":1,"confidence_rate":1},{"cnt":[[391,2393],[1858,2393],[1858,2421],[391,2421]],"region":{"top_left_x":391,"top_left_y":2393,"width":1468,"height":29},"line":153,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"381677a73fca4bbb94aa18dfb101cb98","type":"text","conversion_output":true,"text":"†Clarifications to IMWG criteria for coding PD: Bone marrow criteria for PD are to be used only in patients without measurable disease by M protein and by FLC levels;","text_display":"\n†Clarifications to IMWG criteria for coding PD: Bone marrow criteria for PD are to be used only in patients without measurable disease by M protein and by FLC levels;","confidence":0.9844357967376709,"confidence_rate":0.9999082697214555},{"cnt":[[352,2419],[1858,2419],[1858,2447],[352,2447]],"region":{"top_left_x":352,"top_left_y":2419,"width":1507,"height":29},"line":154,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"c10a08bad9e446909862c5b9326bb528","type":"text","conversion_output":true,"text":"\"25\\% increase\" refers to M protein, FLC, and bone marrow results, and does not refer to bone lesions, soft tissue plasmacytomas, or hypercalcemia and the \"lowest response","text_display":" \"25\\% increase\" refers to M protein, FLC, and bone marrow results, and does not refer to bone lesions, soft tissue plasmacytomas, or hypercalcemia and the \"lowest 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Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[316,271],[1695,271],[1695,376],[316,376]],"region":{"top_left_x":315,"top_left_y":270,"width":1381,"height":106},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3454c48c4234398aeba9255e21164eb","type":"section_header","conversion_output":false,"children_ids":["24c667dcd9544beeb3fe15c475bd95f1","ad5e780d353745f4bb1c7df219bb76de"],"text":"","text_display":""},{"cnt":[[322,275],[1691,275],[1691,322],[322,322]],"region":{"top_left_x":322,"top_left_y":275,"width":1369,"height":48},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24c667dcd9544beeb3fe15c475bd95f1","type":"text","conversion_output":true,"parent_id":"b3454c48c4234398aeba9255e21164eb","text":"International Myeloma Working Group Uniform Response Criteria: Disease","text_display":"\n\n\\section*{International Myeloma Working Group Uniform Response Criteria: Disease","confidence":1,"confidence_rate":1},{"cnt":[[322,322],[844,322],[844,372],[322,372]],"region":{"top_left_x":322,"top_left_y":322,"width":523,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad5e780d353745f4bb1c7df219bb76de","type":"text","conversion_output":true,"parent_id":"b3454c48c4234398aeba9255e21164eb","text":"Progression and Relapse [58]","text_display":" Progression and Relapse [58]}","confidence":1,"confidence_rate":1},{"cnt":[[303,402],[1867,402],[1867,1184],[303,1184]],"region":{"top_left_x":302,"top_left_y":401,"width":1565,"height":783},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40cbc4ae89a24c84a3e7699f7b7ff8bd","type":"table","conversion_output":true,"children_ids":["a7e25f10ce02476faf8ef09ce2af99e4","361bc36f59f74a328fcf922637fae0a8","514867ecc82848c0ac9da128728cc010","d5cd4b0262584811a0beca9fa6d08355","18ad831732754f8991d8858f735b3d91","e419d02ceb314ee9b8fd607dac12325b","8928a37bdcfc46c494f0410dd1945628","0414b5de6ba343149b39fede3796b562"],"text":"\\begin{tabular}{|l|l|}\n\\hline Relapse Subcategory & Relapse Criteria \\\\\n\\hline \\begin{tabular}{l}\nProgressive disease (PD) \\({ }^{ a }\\) \\\\\nTo be used for calculation of time to progression and PFS endpoints for all subjects, including those in CR (includes primary progressive disease and disease progression on or off therapy)\n\\end{tabular} & \\begin{tabular}{l}\nProgressive Disease: requires any 1 or more of the following: \\\\\nIncrease of \\(\\geq 25 \\%\\) from nadir in \\\\\nSerum M-component and/or (the absolute increase must be \\(\\geq 0.5 g / dL )^{ b }\\) \\\\\nUrine M-component and/or (the absolute increase must be \\(\\geq 200 mg / 24 h\\) \\\\\nOnly in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \\(>10 mg / dL\\) \\\\\nBone marrow plasma cell percentage: the absolute \\% must be \\(\\geq 10 \\%\\) \\\\\nDefinite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas \\({ }^{\\text {c }}\\) \\\\\nDevelopment of hypercalcemia (corrected serum calcium \\(>11.5 mg / dL\\) or \\(2.85 mmol / L\\) ) that can be attributed solely to the plasma cell proliferative disorder\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Relapse Subcategory & Relapse Criteria \\\\\n\\hline \\begin{tabular}{l}\nProgressive disease (PD) \\({ }^{ a }\\) \\\\\nTo be used for calculation of time to progression and PFS endpoints for all subjects, including those in CR (includes primary progressive disease and disease progression on or off therapy)\n\\end{tabular} & \\begin{tabular}{l}\nProgressive Disease: requires any 1 or more of the following: \\\\\nIncrease of \\(\\geq 25 \\%\\) from nadir in \\\\\nSerum M-component and/or (the absolute increase must be \\(\\geq 0.5 g / dL )^{ b }\\) \\\\\nUrine M-component and/or (the absolute increase must be \\(\\geq 200 mg / 24 h\\) \\\\\nOnly in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \\(>10 mg / dL\\) \\\\\nBone marrow plasma cell percentage: the absolute \\% must be \\(\\geq 10 \\%\\) \\\\\nDefinite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas \\({ }^{\\text {c }}\\) \\\\\nDevelopment of hypercalcemia (corrected serum calcium \\(>11.5 mg / dL\\) or \\(2.85 mmol / L\\) ) that can be attributed solely to the plasma cell proliferative disorder\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.986328125,"confidence_rate":0.9999884623400861},{"cnt":[[306,401],[776,401],[776,1185],[306,1185]],"region":{"top_left_x":306,"top_left_y":401,"width":471,"height":784},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7e25f10ce02476faf8ef09ce2af99e4","type":"table_column","conversion_output":false,"parent_id":"40cbc4ae89a24c84a3e7699f7b7ff8bd","text":"","text_display":""},{"cnt":[[794,401],[1852,401],[1852,1185],[794,1185]],"region":{"top_left_x":793,"top_left_y":401,"width":1060,"height":784},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"361bc36f59f74a328fcf922637fae0a8","type":"table_column","conversion_output":false,"parent_id":"40cbc4ae89a24c84a3e7699f7b7ff8bd","text":"","text_display":""},{"cnt":[[302,412],[1868,412],[1868,464],[302,464]],"region":{"top_left_x":302,"top_left_y":411,"width":1566,"height":53},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"514867ecc82848c0ac9da128728cc010","type":"table_row","conversion_output":false,"parent_id":"40cbc4ae89a24c84a3e7699f7b7ff8bd","text":"","text_display":""},{"cnt":[[302,462],[1868,462],[1868,1183],[302,1183]],"region":{"top_left_x":302,"top_left_y":461,"width":1566,"height":722},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5cd4b0262584811a0beca9fa6d08355","type":"table_row","conversion_output":false,"parent_id":"40cbc4ae89a24c84a3e7699f7b7ff8bd","text":"","text_display":""},{"cnt":[[324,420],[638,420],[638,459],[324,459]],"region":{"top_left_x":323,"top_left_y":420,"width":315,"height":40},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18ad831732754f8991d8858f735b3d91","type":"simple_cell","conversion_output":false,"parent_id":"40cbc4ae89a24c84a3e7699f7b7ff8bd","text":"Relapse 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therapy)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nProgressive disease (PD) \\({ }^{ a }\\) \\\\\nTo be used for calculation of time to progression and PFS endpoints for all subjects, including those in CR (includes primary progressive disease and disease progression on or off therapy)\n\\end{tabular}","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,466],[759,466],[759,516],[324,516]],"region":{"top_left_x":323,"top_left_y":465,"width":436,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a398b6b4e1ec437fbce946b5d53ea79b","type":"text","conversion_output":false,"parent_id":"8928a37bdcfc46c494f0410dd1945628","text":"Progressive disease (PD) \\({ }^{ a }\\)","text_display":"Progressive disease (PD) \\({ }^{ a 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\\multirow[b]{2}{*}{Study Procedures} & \\multirow{3}{*}{Screening} & \\multicolumn{12}{|c|}{Treatment Period} & \\multirow{4}{*}{![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-150.jpg?height=282\\&width=42\\&top_left_y=355\\&top_left_x=2125)} & \\multicolumn{2}{|c|}{Follow-up} \\\\\n\\hline & & \\multicolumn{12}{|c|}{28-Day Cycles} & & PFS & OS \\\\\n\\hline Cycle & & C1 & C1 & C1 & C1 & C2 & C2 & C2 & C2 & C3 & C3 & C4 Through 12 & C13 and Beyond & & & \\\\\n\\hline Days & to -1 & 1 & 7 & 14 & 21 & 1 & 7 & 14 & 21 & 1 & 14 & 1 & 1 & & Every 4 weeks & Every 12 weeks \\\\\n\\hline Window & \\multicolumn{16}{|r|}{\\begin{tabular}{l}\n\\(\\pm 1\\) wk \\\\\n\\(\\pm 1 ~ w k\\) \\\\\n± \\(1\\) wk\n\\end{tabular}} \\\\\n\\hline EORTC-QLQ-C30 and MY-20 \\({ }^{ h }\\) & X & X & & & & X & & & & & C & X \\({ }^{ i }\\) & X \\({ }^{ i }\\) & X & X & \\\\\n\\hline EQ-5D \\({ }^{\\text {h }}\\) & X & X & & & & X & & & & X & & X & X & X & X & X \\\\\n\\hline BPI-SF \\& 24 hour analgesic form (also for unscheduled visit) \\({ }^{\\text {h }}\\) & X & X & & & & X & & & & X & & X & X & X & X & \\\\\n\\hline HU Asssessment \\({ }^{ h }\\) & & X & & & & X & & & & X & & X & X & X & X & X \\\\\n\\hline Skeletal Survey \\({ }^{ j }\\) & X & & & & & & & & & & & X & X & & X & \\\\\n\\hline Radiographic Disease Assessment \\({ }^{ k }\\) & X & & & & & X & & & & & & X & X & X & X & \\\\\n\\hline \\(\\beta 2\\)-microglobulin & X & & & & & & & & & & & & & & & \\\\\n\\hline M-protein Measurements (SPEP) & X & X \\({ }^{1}\\) & & & & X & & & & X & & X & X & X & X & \\\\\n\\hline M-protein Measurements (UPEP [24hr Urine collection]) & X & \\(X ^{1}\\) & & \\(C ^{ S }\\) & & X & & & & X & & X & X & X & X & \\\\\n\\hline Serum Free Light Chain Assay & X & ![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-150.jpg?height=72\\&width=50\\&top_left_y=1531\\&top_left_x=821) & ![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-150.jpg?height=63\\&width=40\\&top_left_y=1534\\&top_left_x=840) & & & X & & & & X & & X & X & X & X & \\\\\n\\hline Immunofixation - serum and urine & X & ![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-150.jpg?height=53\\&width=77\\&top_left_y=1618\\&top_left_x=794) & & & & X & & & & X & & X & X & X & X & \\\\\n\\hline Quantification of Ig & \\(\\partial^{ X }\\) & X \\({ }^{1}\\) & & & & X & & & & X & & X & X & X & X & \\\\\n\\hline \\multicolumn{17}{|l|}{Bone Marrow Aspiration} \\\\\n\\hline Disease Assessment & X \\({ }^{ m }\\) & & & & & \\(X ^{ m }\\) & & & & X & & X \\({ }^{\\text {m }}\\) & X \\({ }^{\\text {m }}\\) & X \\({ }^{\\text {m }}\\) & \\(X ^{ m }\\) & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multirow[b]{2}{*}{Study Procedures} & \\multirow{3}{*}{Screening} & \\multicolumn{12}{|c|}{Treatment Period} & \\multirow{4}{*}{![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-150.jpg?height=282\\&width=42\\&top_left_y=355\\&top_left_x=2125)} & \\multicolumn{2}{|c|}{Follow-up} \\\\\n\\hline & & \\multicolumn{12}{|c|}{28-Day Cycles} & & PFS & OS \\\\\n\\hline Cycle & & C1 & C1 & C1 & C1 & C2 & C2 & C2 & C2 & C3 & C3 & C4 Through 12 & C13 and Beyond & & & \\\\\n\\hline Days & to -1 & 1 & 7 & 14 & 21 & 1 & 7 & 14 & 21 & 1 & 14 & 1 & 1 & & Every 4 weeks & Every 12 weeks \\\\\n\\hline Window & \\multicolumn{16}{|r|}{\\begin{tabular}{l}\n\\(\\pm 1\\) wk \\\\\n\\(\\pm 1 ~ w k\\) \\\\\n± \\(1\\) wk\n\\end{tabular}} \\\\\n\\hline EORTC-QLQ-C30 and MY-20 \\({ }^{ h }\\) & X & X & & & & X & & & & & C & X \\({ }^{ i }\\) & X \\({ }^{ i }\\) & X & X & \\\\\n\\hline EQ-5D \\({ }^{\\text {h }}\\) & X & X & & & & X & & & & X & & X & X & X & X & X \\\\\n\\hline BPI-SF \\& 24 hour analgesic form (also for unscheduled visit) \\({ }^{\\text {h }}\\) & X & X & & & & X & & & & X & 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\\multirow[b]{2}{*}{Study Procedures} & \\multirow{3}{*}{Screening} & \\multicolumn{12}{|c|}{Treatment Period} & \\multicolumn{2}{|c|}{\\multirow[b]{2}{*}{\\begin{tabular}{l}\nPFS \\\\\nPFS\n\\end{tabular}}} & \\\\\n\\hline & & \\multicolumn{12}{|c|}{\\begin{tabular}{l}\n28-Day Cycles \\\\\n18\n\\end{tabular}} & & & \\begin{tabular}{l}\nOS \\\\\nOS\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nCycle \\\\\nyele\n\\end{tabular} & & \\multicolumn{2}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nC1 \\\\\nC1\n\\end{tabular}}} & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nC1 \\\\\n14\n\\end{tabular}} & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nC1 \\\\\n21\n\\end{tabular}} & \\begin{tabular}{l}\nC2 \\\\\nC2\n\\end{tabular} & ![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-151.jpg?height=149\\&width=53\\&top_left_y=436\\&top_left_x=1262) & C2 & C2 & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nC4 \\\\\nC4 Through Through \\\\\nC3 \\\\\nC3 \\\\\n\\begin{tabular}{|c|}\n\\hline C4 \\\\\nThrough \\\\\n\\(1 2\\)\n\\end{tabular} 12 12\n\\end{tabular}} & and and Beyond & \\multirow{2}{*}{} & & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nEvery\n12 weeks \\\\\nEvery \\\\\nEvery 12 weeks 12 weeks\n\\end{tabular}} \\\\\n\\hline Days & -28 to -1 & 1 & 7 & & & 1 & 7 & 14 & 21 & 1 & 14 & a & 1 & & Every 4 weeks & \\\\\n\\hline Window & \\multicolumn{16}{|c|}{\\begin{tabular}{l}\n\\(\\pm 2\\) days \\({ }^{ b }\\) \\\\\n\\(\\pm 1 ~ w k\\) \\\\\n± \\(1\\) wk \\\\\n± \\(1\\) wk\n\\end{tabular}} \\\\\n\\hline Molecular analysis and high-risk cytogenetic assessment & Xn & & & & & \\multicolumn{2}{|c|}{} & & ![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-151.jpg?height=135\\&width=62\\&top_left_y=717\\&top_left_x=1454) & & & & & X \\({ }^{\\text {n }}\\) & & \\\\\n\\hline Cytogenetics & \\(X ^{ o }\\) & & & & & & & & & & & & & & & \\\\\n\\hline Blood samples for biomarker analysis & \\multicolumn{16}{|c|}{} \\\\\n\\hline Plasma biomarker (proteasome level) & X & & & & & & & & & & & & & & & \\\\\n\\hline Blood samples for germline DNA & X & & & & & & & & & & & & & & & \\\\\n\\hline \\multirow{2}{*}{Adverse Event Reporting} & \\multicolumn{14}{|c|}{Recorded from the first dose of study drug through 30 days after last dose of study drug} & & \\\\\n\\hline & \\multicolumn{14}{|l|}{Serious adverse events and serious pretreatment events will be collected from signing of the informed consent form through 30 days after the last dose of any study drug} & & \\\\\n\\hline Concomitant Medications/Procedures & \\multicolumn{14}{|c|}{Recorded from the first dose of study drug through 30 days after last dose of study drug} & & \\\\\n\\hline Skeletal-related Events & \\multicolumn{16}{|c|}{Continuous from the start of study drug administration until death or termination of the study by the sponsor} \\\\\n\\hline New Primary Malignancy Assessment & \\multicolumn{16}{|c|}{Continuous from the start of study drug administration until death or termination of the study by the sponsor} \\\\\n\\hline Survival & \\multicolumn{2}{|c|}{10} & \\multicolumn{2}{|c|}{} & \\multicolumn{3}{|c|}{} & & & \\multicolumn{2}{|c|}{} & \\multicolumn{2}{|c|}{} & & & X \\\\\n\\hline \\multicolumn{17}{|c|}{Study Drug Administration} \\\\\n\\hline MLN9708/Placebo & o & \\multicolumn{12}{|c|}{Days 1, 8, and 15 of each cycle} & & & \\\\\n\\hline Lenalidomide & & \\multicolumn{12}{|c|}{Continuous D1-21 of each cycle} & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multirow[b]{2}{*}{Study Procedures} & \\multirow{3}{*}{Screening} & \\multicolumn{12}{|c|}{Treatment Period} & \\multicolumn{2}{|c|}{\\multirow[b]{2}{*}{\\begin{tabular}{l}\nPFS \\\\\nPFS\n\\end{tabular}}} & \\\\\n\\hline & & \\multicolumn{12}{|c|}{\\begin{tabular}{l}\n28-Day Cycles \\\\\n18\n\\end{tabular}} & & & \\begin{tabular}{l}\nOS \\\\\nOS\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nCycle \\\\\nyele\n\\end{tabular} & & \\multicolumn{2}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nC1 \\\\\nC1\n\\end{tabular}}} & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nC1 \\\\\n14\n\\end{tabular}} & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nC1 \\\\\n21\n\\end{tabular}} & \\begin{tabular}{l}\nC2 \\\\\nC2\n\\end{tabular} & ![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-151.jpg?height=149\\&width=53\\&top_left_y=436\\&top_left_x=1262) & C2 & C2 & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nC4 \\\\\nC4 Through Through \\\\\nC3 \\\\\nC3 \\\\\n\\begin{tabular}{|c|}\n\\hline C4 \\\\\nThrough \\\\\n\\(1 2\\)\n\\end{tabular} 12 12\n\\end{tabular}} & and and Beyond & \\multirow{2}{*}{} & & \\multirow[b]{2}{*}{\\begin{tabular}{l}\nEvery\n12 weeks \\\\\nEvery \\\\\nEvery 12 weeks 12 weeks\n\\end{tabular}} \\\\\n\\hline Days & -28 to -1 & 1 & 7 & & & 1 & 7 & 14 & 21 & 1 & 14 & a & 1 & & Every 4 weeks & \\\\\n\\hline Window & \\multicolumn{16}{|c|}{\\begin{tabular}{l}\n\\(\\pm 2\\) days \\({ }^{ b }\\) \\\\\n\\(\\pm 1 ~ w k\\) \\\\\n± \\(1\\) wk \\\\\n± \\(1\\) wk\n\\end{tabular}} \\\\\n\\hline Molecular analysis and high-risk cytogenetic assessment & Xn & & & & & \\multicolumn{2}{|c|}{} & & ![](https://cdn.mathpix.com/cropped/d6e5225d-d7a1-4e2c-b412-132ff953cb04-151.jpg?height=135\\&width=62\\&top_left_y=717\\&top_left_x=1454) & & & & & X \\({ }^{\\text {n }}\\) & & \\\\\n\\hline Cytogenetics & \\(X ^{ o }\\) & & & & & & & & & & & & & & & \\\\\n\\hline Blood samples for biomarker analysis & \\multicolumn{16}{|c|}{} \\\\\n\\hline Plasma biomarker (proteasome level) & X & & & & & & & & & & & & & & & \\\\\n\\hline Blood samples for germline DNA & X & & & & & & & & & & & & & & & \\\\\n\\hline \\multirow{2}{*}{Adverse Event Reporting} & \\multicolumn{14}{|c|}{Recorded from the first dose of study drug through 30 days after last dose of study drug} & & \\\\\n\\hline & \\multicolumn{14}{|l|}{Serious adverse 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The first pregnancy test must be","confidence":1,"confidence_rate":1},{"cnt":[[346,1268],[2576,1268],[2576,1317],[346,1317]],"region":{"top_left_x":345,"top_left_y":1267,"width":2231,"height":50},"line":104,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b124ce1ad26b4a3ca377dbd0390dc9de","type":"text","conversion_output":true,"text":"performed within 10 to 14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug.","text_display":" performed within 10 to 14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug.","confidence":1,"confidence_rate":1},{"cnt":[[284,1317],[2469,1317],[2469,1364],[284,1364]],"region":{"top_left_x":283,"top_left_y":1316,"width":2186,"height":49},"line":105,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ecc5f8a907b4783b3d41a96e2110ef1","type":"text","conversion_output":true,"text":"- On-Treatment: Pregnancy tests for FCBP to be collected weekly during Cycle 1 and then within 24 hours before the first dose of each subsequent cycle.","text_display":"\n- On-Treatment: Pregnancy tests for FCBP to be collected weekly during Cycle 1 and then within 24 hours before the first dose of each subsequent cycle.","confidence":1,"confidence_rate":1},{"cnt":[[348,1358],[2572,1358],[2572,1403],[348,1403]],"region":{"top_left_x":348,"top_left_y":1357,"width":2224,"height":46},"line":106,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4df7db856d6e424d99c3890362890088","type":"text","conversion_output":true,"text":"Lenalidomide package insert must be followed while patients remain on therapy. If menstrual cycles are irregular, the pregnancy testing must occur weekly for","text_display":" Lenalidomide package insert must be followed while patients remain on therapy. If menstrual cycles are irregular, the pregnancy testing must occur weekly for","confidence":1,"confidence_rate":1},{"cnt":[[348,1399],[1158,1399],[1158,1446],[348,1446]],"region":{"top_left_x":348,"top_left_y":1398,"width":811,"height":48},"line":107,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f333b35b9a6443018fb27eb140830475","type":"text","conversion_output":true,"text":"the first 28 days and then every 14 days while on therapy.","text_display":" the first 28 days and then every 14 days while on therapy.","confidence":0.99951171875,"confidence_rate":0.9999929217569623},{"cnt":[[286,1448],[2570,1448],[2570,1493],[286,1493]],"region":{"top_left_x":285,"top_left_y":1448,"width":2285,"height":46},"line":108,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adc7b90d4698489ead5a8385119a73f5","type":"text","conversion_output":true,"text":"- End of Treatment: Pregnancy tests for FCBP to be collected at treatment discontinuation and at Day 28 following therapy. If menstrual cycles are irregular, the","text_display":"\n- End of Treatment: Pregnancy tests for FCBP to be collected at treatment discontinuation and at Day 28 following therapy. If menstrual cycles are irregular, the","confidence":1,"confidence_rate":1},{"cnt":[[348,1489],[1858,1489],[1858,1532],[348,1532]],"region":{"top_left_x":348,"top_left_y":1488,"width":1511,"height":44},"line":109,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d2f314bfe9441d4adfd4e1a3fadd1f4","type":"text","conversion_output":true,"text":"pregnancy testing must occur at drug discontinuation and at Days 14 and 28 following drug discontinuation.","text_display":" pregnancy testing must occur at drug discontinuation and at Days 14 and 28 following drug discontinuation.","confidence":1,"confidence_rate":1},{"cnt":[[245,1534],[2512,1534],[2512,1579],[245,1579]],"region":{"top_left_x":244,"top_left_y":1533,"width":2268,"height":47},"line":110,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"409d836506a548c0843b579f4e9e5847","type":"text","conversion_output":true,"text":"f Clinical laboratory evaluations will be performed by a central laboratory. For dosing decisions, local hematology and chemistry laboratory results may be used;","text_display":"\nf Clinical laboratory evaluations will be performed by a central laboratory. For dosing decisions, local hematology and chemistry laboratory results may be used;","confidence":0.99951171875,"confidence_rate":0.9999970578326528},{"cnt":[[284,1577],[2585,1577],[2585,1620],[284,1620]],"region":{"top_left_x":283,"top_left_y":1576,"width":2302,"height":44},"line":111,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f01be2dbc4dd4b1e9fab9f99992a3c11","type":"text","conversion_output":true,"text":"however, samples must still be sent to central labs as well. Hematology and chemistry panels may be collected up to 3 days before Day 1 dosing and 24 hours before","text_display":" however, samples must still be sent to central labs as well. Hematology and chemistry panels may be collected up to 3 days before Day 1 dosing and 24 hours before","confidence":0.99853515625,"confidence_rate":0.9999916709569452},{"cnt":[[284,1616],[2535,1616],[2535,1661],[284,1661]],"region":{"top_left_x":283,"top_left_y":1615,"width":2253,"height":46},"line":112,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a6a1ebfaf1b49c69488e5b5411c778e","type":"text","conversion_output":true,"text":"Days 8, 15 and 22 dosing, where required. Local laboratory evaluations may be done more frequently at the investigators discretion, ie, for acute management of","text_display":" Days 8, 15 and 22 dosing, where required. Local laboratory evaluations may be done more frequently at the investigators discretion, ie, for acute management of","confidence":0.9716796875,"confidence_rate":0.9998310197585292},{"cnt":[[284,1654],[730,1654],[730,1699],[284,1699]],"region":{"top_left_x":283,"top_left_y":1654,"width":448,"height":46},"line":113,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cf15a404cbb42e39ad5ff9751c1e0fc","type":"text","conversion_output":true,"text":"TEAEs (refer to Section 7.4.9).","text_display":" TEAEs (refer to Section 7.4.9).","confidence":1,"confidence_rate":1},{"cnt":[[245,1705],[1033,1702],[1034,1749],[245,1751]],"region":{"top_left_x":244,"top_left_y":1702,"width":790,"height":50},"line":114,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4182e03af5704bf58da6c6d33d4540d8","type":"text","conversion_output":true,"text":"g Thyroid testing required every 4 cycles on treatment.","text_display":"\ng Thyroid testing required every 4 cycles on treatment.","confidence":0.99853515625,"confidence_rate":0.9999767317360675},{"cnt":[[245,1749],[2557,1749],[2557,1794],[245,1794]],"region":{"top_left_x":244,"top_left_y":1748,"width":2313,"height":46},"line":115,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0db8067487bc4e39995e549372eb69b0","type":"text","conversion_output":true,"text":"h Patient-reported outcomes and HU assessment should be completed before any other study procedures are performed or study drug is administered. During the OS","text_display":"\nh Patient-reported outcomes and HU assessment should be completed before any other study procedures are performed or study drug is administered. During the OS","confidence":1,"confidence_rate":1},{"cnt":[[284,1790],[1970,1790],[1970,1833],[284,1833]],"region":{"top_left_x":283,"top_left_y":1789,"width":1688,"height":44},"line":116,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e41f61d41e14380bd5838970a0ab1b5","type":"text","conversion_output":true,"text":"follow-up, assessments can be made over the phone and do not require a clinic visit. (Refer to Sections 7.4.11 to 7.4.14.)","text_display":" follow-up, assessments can be made over the phone and do not require a clinic visit. (Refer to Sections 7.4.11 to 7.4.14.)","confidence":0.9970722198486328,"confidence_rate":0.9999769130658488},{"cnt":[[1345,1959],[1409,1959],[1409,1998],[1345,1998]],"region":{"top_left_x":1344,"top_left_y":1959,"width":66,"height":40},"line":117,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5587cd8bc1254e33b0de152f184191aa","type":"page_info","conversion_output":false,"text":"151","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-153","page":153,"lines":[{"cnt":[[243,125],[423,125],[423,170],[243,170]],"region":{"top_left_x":242,"top_left_y":124,"width":182,"height":46},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a3e650d20ab4bf78ce7fd6371bf69e6","type":"section_header","conversion_output":false,"children_ids":["409458dd4d5e4f75b7741cc5f0597aa1"],"text":"","text_display":""},{"cnt":[[247,129],[419,129],[419,165],[247,165]],"region":{"top_left_x":247,"top_left_y":128,"width":172,"height":38},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"409458dd4d5e4f75b7741cc5f0597aa1","type":"text","conversion_output":true,"parent_id":"3a3e650d20ab4bf78ce7fd6371bf69e6","text":"MLN9708","text_display":"\n\n\\section*{MLN9708}","confidence":1,"confidence_rate":1},{"cnt":[[245,172],[1291,172],[1291,217],[245,217]],"region":{"top_left_x":244,"top_left_y":171,"width":1048,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"385d2f2913ce4561a9b86f6f9a33c931","type":"text","conversion_output":true,"text":"Clinical 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Patients who stop treatment for any reason will continue to have OS follow-up","text_display":"\n```\nInitial Patients who stop treatment for any reason will continue to have OS follow-up","confidence":1,"confidence_rate":1},{"cnt":[[322,309],[1824,309],[1824,354],[322,354]],"region":{"top_left_x":322,"top_left_y":309,"width":1503,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e253e62dfbc04c80afc1cb0b38f969bb","type":"code","conversion_output":true,"parent_id":"76e6992356b64783bd5179260dd17629","text":"wording: visits. See the Schedule of Events for appropriate assessments. All subsequent","text_display":"\nwording: visits. See the Schedule of Events for appropriate assessments. 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During the OS follow-up, assessments can be made over the","text_display":"\n    visits/assessments. During the OS follow-up, assessments can be made over the","confidence":1,"confidence_rate":1},{"cnt":[[511,836],[1824,836],[1824,883],[511,883]],"region":{"top_left_x":511,"top_left_y":835,"width":1314,"height":49},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe563062a9e54b11865f2ce2a2e52447","type":"code","conversion_output":true,"parent_id":"76e6992356b64783bd5179260dd17629","text":"phone and do not require a clinic visit. Data may be collected bymethods that","text_display":"\n    phone and do not require a clinic visit. 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As of Amendment 6, however, the","text_display":"\n    including the PFS and OS follow-up periods. 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All patients","text_display":"\n    discontinued for patients currently receiving study therapy. 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Fluid deficit should be corrected before","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[511,1506],[1253,1506],[1253,1558],[511,1558]],"region":{"top_left_x":511,"top_left_y":1506,"width":742,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b6bdd58a0ea47a2bfba8040042436fd","type":"text","conversion_output":true,"text":"initiation of treatment and during treatment.","text_display":" initiation of treatment and during treatment.","confidence":1,"confidence_rate":1},{"cnt":[[509,1573],[1349,1573],[1349,1629],[509,1629]],"region":{"top_left_x":509,"top_left_y":1572,"width":841,"height":57},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dccc79ec97540e0a865ab1025bac69e","type":"section_header","conversion_output":false,"children_ids":["ce649dda4f48447bb5ff170e936efd27"],"text":"","text_display":""},{"cnt":[[511,1577],[1343,1577],[1343,1622],[511,1622]],"region":{"top_left_x":511,"top_left_y":1576,"width":832,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce649dda4f48447bb5ff170e936efd27","type":"text","conversion_output":true,"parent_id":"9dccc79ec97540e0a865ab1025bac69e","text":"Erythematous Rash With or Without Pruritus","text_display":"\n\n\\section*{Erythematous Rash With or Without Pruritus}","confidence":1,"confidence_rate":1},{"cnt":[[511,1732],[1820,1732],[1820,1783],[511,1783]],"region":{"top_left_x":511,"top_left_y":1731,"width":1309,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0520eae8ddca4c91b3445a4957816d16","type":"text","conversion_output":true,"text":"Rash may range from some erythematous areas, macular and/or small papular","text_display":"\n\nRash may range from some erythematous areas, macular and/or small papular","confidence":0.98291015625,"confidence_rate":0.9997790300518201},{"cnt":[[511,1781],[1824,1781],[1824,1833],[511,1833]],"region":{"top_left_x":511,"top_left_y":1781,"width":1314,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95c0300ff04a40578c7d6e85884df8cd","type":"text","conversion_output":true,"text":"bumps that may or may not be pruritic over a few areas of the body, to a more","text_display":" bumps that may or may not be pruritic over a few areas of the body, to a more","confidence":1,"confidence_rate":1},{"cnt":[[511,1830],[1850,1830],[1850,1880],[511,1880]],"region":{"top_left_x":511,"top_left_y":1830,"width":1339,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1fca2d7b6a548a3ae5358796d42e311","type":"text","conversion_output":true,"text":"generalized eruption that is predominantly on the trunk or extremities. Rash has","text_display":" generalized eruption that is predominantly on the trunk or extremities. Rash has","confidence":1,"confidence_rate":1},{"cnt":[[511,1878],[1863,1878],[1863,1927],[511,1927]],"region":{"top_left_x":511,"top_left_y":1877,"width":1352,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32e26bd57f7743bc93f40a82849f513f","type":"text","conversion_output":true,"text":"been most commonly characterized as maculopapular or macular. To date, when","text_display":" been most commonly characterized as maculopapular or macular. To date, when","confidence":1,"confidence_rate":1},{"cnt":[[511,1925],[1747,1925],[1747,1974],[511,1974]],"region":{"top_left_x":511,"top_left_y":1925,"width":1236,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dbd000b29c846f3894ff5382daab128","type":"text","conversion_output":true,"text":"it does occur, rash is most commonly reported within the first 3 cycles of","text_display":" it does occur, rash is most commonly reported within the first 3 cycles of","confidence":1,"confidence_rate":1},{"cnt":[[511,1972],[1869,1972],[1869,2022],[511,2022]],"region":{"top_left_x":511,"top_left_y":1972,"width":1359,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7694166108ff4db2b936dcabbf2c0de7","type":"text","conversion_output":true,"text":"therapy. The rash is often transient and self-limiting and is typically Grade 1 to 2","text_display":" therapy. The rash is often transient and self-limiting and is typically Grade 1 to 2","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[511,2020],[1725,2020],[1725,2069],[511,2069]],"region":{"top_left_x":511,"top_left_y":2019,"width":1215,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c3d8886355f49c693855fb734e288d7","type":"text","conversion_output":true,"text":"in severity. As in many other oncology trials, rash may occur in patients","text_display":" in severity. As in many other oncology trials, rash may occur in patients","confidence":1,"confidence_rate":1},{"cnt":[[511,2067],[1680,2067],[1680,2118],[511,2118]],"region":{"top_left_x":511,"top_left_y":2066,"width":1170,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02182f9e646e45d799a5ff7400d3a366","type":"text","conversion_output":true,"text":"receiving placebo and in patients receiving MLN9708. If rash occurs,","text_display":" receiving placebo and in patients receiving MLN9708. If rash occurs,","confidence":1,"confidence_rate":1},{"cnt":[[511,2118],[1871,2118],[1871,2168],[511,2168]],"region":{"top_left_x":511,"top_left_y":2118,"width":1361,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"768b4713612b49ccaa73560018482fb1","type":"text","conversion_output":true,"text":"consideration should be given to alternate causes of the rash such as concomitant","text_display":" consideration should be given to alternate causes of the rash such as concomitant","confidence":1,"confidence_rate":1},{"cnt":[[511,2161],[986,2161],[986,2213],[511,2213]],"region":{"top_left_x":511,"top_left_y":2161,"width":476,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e566dd5338994bca8e4654dbb517ff8d","type":"text","conversion_output":true,"text":"medications, infections, etc.","text_display":" medications, infections, etc.","confidence":1,"confidence_rate":1},{"cnt":[[511,2299],[1820,2299],[1820,2353],[511,2353]],"region":{"top_left_x":511,"top_left_y":2298,"width":1309,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d24d595f19341c2a70eb5ad618892d4","type":"text","conversion_output":true,"text":"The rare risks of Stevens-Johnson syndrome, toxic epidermal necrolysis, drug","text_display":"\n\nThe rare risks of Stevens-Johnson syndrome, toxic epidermal necrolysis, drug","confidence":1,"confidence_rate":1},{"cnt":[[511,2350],[1790,2350],[1790,2400],[511,2400]],"region":{"top_left_x":511,"top_left_y":2350,"width":1279,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66cd1f94368f473c80f6620292372520","type":"text","conversion_output":true,"text":"reaction with eosinophilia and systemic symptoms (DRESS syndrome), and","text_display":" reaction with eosinophilia and systemic symptoms (DRESS syndrome), and","confidence":1,"confidence_rate":1},{"cnt":[[511,2398],[1861,2398],[1861,2447],[511,2447]],"region":{"top_left_x":511,"top_left_y":2397,"width":1350,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"425369546a2b46ea9bb60f2e7e261d92","type":"text","conversion_output":true,"text":"pemphigus vulgaris have been reported in oncology studies when MLN9708 (or","text_display":" pemphigus vulgaris have been reported in oncology studies when MLN9708 (or","confidence":1,"confidence_rate":1},{"cnt":[[511,2445],[1841,2445],[1841,2494],[511,2494]],"region":{"top_left_x":511,"top_left_y":2444,"width":1331,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfcda36b0c594800a7818f024820c38c","type":"text","conversion_output":true,"text":"placebo) was given with concomitant medications that are known to cause rash","text_display":" placebo) was given with concomitant medications that are known to cause rash","confidence":1,"confidence_rate":1},{"cnt":[[1070,2587],[1134,2587],[1134,2625],[1070,2625]],"region":{"top_left_x":1069,"top_left_y":2586,"width":66,"height":40},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d247267ccfb14d70a43a60ed43de05e4","type":"page_info","conversion_output":false,"text":"177","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-179","page":179,"lines":[{"cnt":[[322,129],[494,129],[494,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":173,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed813c91faa646959d4cab5954eb531f","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83faf6eae852466d8f3e7098313a0d04","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[511,258],[1738,258],[1738,312],[511,312]],"region":{"top_left_x":511,"top_left_y":257,"width":1228,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d8eb077f219437b908801d66ae4972e","type":"text","conversion_output":true,"text":"(eg, Bactrim, lenalidomide, aspirin), and/or in the setting of confounding","text_display":"\n(eg, Bactrim, lenalidomide, aspirin), and/or in the setting of confounding","confidence":1,"confidence_rate":1},{"cnt":[[511,305],[1781,305],[1781,359],[511,359]],"region":{"top_left_x":511,"top_left_y":305,"width":1271,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c5b269e296b4ca9997105c2ad59c074","type":"text","conversion_output":true,"text":"TEAEs. These severe, potentially life-threatening or deadly conditions may","text_display":" TEAEs. These severe, potentially life-threatening or deadly conditions may","confidence":1,"confidence_rate":1},{"cnt":[[511,352],[1878,352],[1878,406],[511,406]],"region":{"top_left_x":511,"top_left_y":352,"width":1367,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0b46d81388c4563a26c7a4b5cec9434","type":"text","conversion_output":true,"text":"involve rash with skin peeling and mouth sores and should be clinically managed","text_display":" involve rash with skin peeling and mouth sores and should be clinically managed","confidence":1,"confidence_rate":1},{"cnt":[[511,402],[1794,402],[1794,453],[511,453]],"region":{"top_left_x":511,"top_left_y":401,"width":1283,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11ddabfed7144d0b9c7bb29a5a15c856","type":"text","conversion_output":true,"text":"according to standard medical practice. Punch biopsies for histopathological","text_display":" according to standard medical practice. Punch biopsies for histopathological","confidence":1,"confidence_rate":1},{"cnt":[[511,451],[1710,451],[1710,501],[511,501]],"region":{"top_left_x":511,"top_left_y":451,"width":1200,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3daf9540fb104febb26075194b9ec7c2","type":"text","conversion_output":true,"text":"analysis are encouraged at the discretion of the investigator. Additional","text_display":" analysis are encouraged at the discretion of the investigator. Additional","confidence":1,"confidence_rate":1},{"cnt":[[511,498],[1536,498],[1536,548],[511,548]],"region":{"top_left_x":511,"top_left_y":498,"width":1026,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26116fbc9e8341fd9ad82aab75042dbb","type":"text","conversion_output":true,"text":"information regarding these reactions can be found in the IB.","text_display":" information regarding these reactions can be found in the IB.","confidence":1,"confidence_rate":1},{"cnt":[[507,567],[866,567],[866,621],[507,621]],"region":{"top_left_x":507,"top_left_y":567,"width":359,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bcab0b780a34d739a6fc9f2e5a2a4df","type":"section_header","conversion_output":false,"children_ids":["72e1335fa2e04930a2c78fa7f42245fa"],"text":"","text_display":""},{"cnt":[[511,571],[862,571],[862,617],[511,617]],"region":{"top_left_x":511,"top_left_y":571,"width":351,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72e1335fa2e04930a2c78fa7f42245fa","type":"text","conversion_output":true,"parent_id":"6bcab0b780a34d739a6fc9f2e5a2a4df","text":"Thrombocytopenia","text_display":"\n\n\\section*{Thrombocytopenia}","confidence":1,"confidence_rate":1},{"cnt":[[511,657],[1794,657],[1794,711],[511,711]],"region":{"top_left_x":511,"top_left_y":657,"width":1283,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc1d4bef089b4ceaa8b3fc8642b13798","type":"text","conversion_output":true,"text":"Blood counts should be monitored regularly as outlined in the protocol with","text_display":"\n\nBlood counts should be monitored regularly as outlined in the protocol with","confidence":0.99853515625,"confidence_rate":0.9999816761968517},{"cnt":[[511,707],[1618,707],[1618,754],[511,754]],"region":{"top_left_x":511,"top_left_y":706,"width":1107,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"497c5177c41e423dbadd2ab8e95376fa","type":"text","conversion_output":true,"text":"additional testing obtained according to standard clinical practice.","text_display":" additional testing obtained according to standard clinical practice.","confidence":1,"confidence_rate":1},{"cnt":[[511,752],[1738,752],[1738,801],[511,801]],"region":{"top_left_x":511,"top_left_y":751,"width":1228,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"762f045bef3e435ea8d3d4863314ac70","type":"text","conversion_output":true,"text":"Thrombocytopenia may be severe but has been manageable with platelet","text_display":" Thrombocytopenia may be severe but has been manageable with platelet","confidence":1,"confidence_rate":1},{"cnt":[[511,799],[1854,799],[1854,851],[511,851]],"region":{"top_left_x":511,"top_left_y":799,"width":1344,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80be3871fa094197a73643bf06edc6b8","type":"text","conversion_output":true,"text":"transfusions according to standard clinical practice. Lenalidomide or study drug","text_display":" transfusions according to standard clinical practice. Lenalidomide or study drug","confidence":1,"confidence_rate":1},{"cnt":[[511,849],[1863,849],[1863,900],[511,900]],"region":{"top_left_x":511,"top_left_y":848,"width":1352,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87a565e4152143cd95dab42b5b4b9ddf","type":"text","conversion_output":true,"text":"administration should be modified as per dose modification recommendations in","text_display":" administration should be modified as per dose modification recommendations in","confidence":1,"confidence_rate":1},{"cnt":[[511,896],[1794,896],[1794,947],[511,947]],"region":{"top_left_x":511,"top_left_y":895,"width":1283,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c82bf1525bc415c8de2a4595d62ed0a","type":"text","conversion_output":true,"text":"the protocol when thrombocytopenia occurs (see Table 6-1). Therapy can be","text_display":" the protocol when thrombocytopenia occurs (see Table 6-1). Therapy can be","confidence":0.97119140625,"confidence_rate":0.9996253047375354},{"cnt":[[511,941],[1781,941],[1781,995],[511,995]],"region":{"top_left_x":511,"top_left_y":941,"width":1271,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b5dd3208fce4d8d9cc32a75c4b52402","type":"text","conversion_output":true,"text":"reinitiated at a reduced level upon recovery of platelet counts. A rare risk is","text_display":" reinitiated at a reduced level upon recovery of platelet counts. A rare risk is","confidence":1,"confidence_rate":1},{"cnt":[[511,993],[1833,993],[1833,1042],[511,1042]],"region":{"top_left_x":511,"top_left_y":992,"width":1322,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a40f26686363480dacdad7bddcaca581","type":"text","conversion_output":true,"text":"thrombotic thrombocytopenic purpura, a rare blood disorder where blood clots","text_display":" thrombotic thrombocytopenic purpura, a rare blood disorder where blood clots","confidence":1,"confidence_rate":1},{"cnt":[[511,1040],[1618,1040],[1618,1089],[511,1089]],"region":{"top_left_x":511,"top_left_y":1039,"width":1107,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c6fe71f100d4e62a4b1eb640079c79c","type":"text","conversion_output":true,"text":"form in small blood vessels throughout the body characterized by","text_display":" form in small blood vessels throughout the body characterized by","confidence":1,"confidence_rate":1},{"cnt":[[511,1087],[1706,1087],[1706,1139],[511,1139]],"region":{"top_left_x":511,"top_left_y":1087,"width":1195,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b64793b51b5a47288a0678baa9f764fd","type":"text","conversion_output":true,"text":"thrombocytopenia, petechiae, fever, or possibly more serious signs and","text_display":" thrombocytopenia, petechiae, fever, or possibly more serious signs and","confidence":1,"confidence_rate":1},{"cnt":[[511,1137],[1699,1137],[1699,1188],[511,1188]],"region":{"top_left_x":511,"top_left_y":1136,"width":1189,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d10a241702d1454684c05014b98f9981","type":"text","conversion_output":true,"text":"symptoms. Thrombotic thrombocytopenic purpura should be managed","text_display":" symptoms. 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Acute","text_display":" kidney, and MLN9708 may cause vomiting, diarrhea, and dehydration. Acute","confidence":1,"confidence_rate":1},{"cnt":[[511,1437],[1850,1437],[1850,1489],[511,1489]],"region":{"top_left_x":511,"top_left_y":1437,"width":1339,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"932edacee7ed460f96f8c541a65263cb","type":"text","conversion_output":true,"text":"renal failure has been reported in patients treated with MLN9708, commonly in","text_display":" renal failure has been reported in patients treated with MLN9708, commonly in","confidence":1,"confidence_rate":1},{"cnt":[[511,1487],[1809,1487],[1809,1536],[511,1536]],"region":{"top_left_x":511,"top_left_y":1486,"width":1298,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6a3265976cc458ea6c002ebb921f11b","type":"text","conversion_output":true,"text":"the setting of the previously noted gastrointestinal toxicities and dehydration.","text_display":" the setting of the previously noted gastrointestinal toxicities and dehydration.","confidence":1,"confidence_rate":1},{"cnt":[[511,1534],[1867,1534],[1867,1583],[511,1583]],"region":{"top_left_x":511,"top_left_y":1533,"width":1356,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1680810f404a450aa683fd2c45db51a2","type":"text","conversion_output":true,"text":"Fluid deficit should be corrected before initiation of study drug as needed during","text_display":" Fluid deficit should be corrected before initiation of study drug as needed during","confidence":0.7482921478804201,"confidence_rate":0.9966726536140175},{"cnt":[[511,1581],[1334,1581],[1334,1635],[511,1635]],"region":{"top_left_x":511,"top_left_y":1581,"width":824,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a9921ff04684b5c86aa794365402b64","type":"text","conversion_output":true,"text":"treatment to avoid dehydration (see Section 6.8).","text_display":" treatment to avoid dehydration (see Section 6.8).","confidence":1,"confidence_rate":1},{"cnt":[[507,1650],[754,1650],[754,1704],[507,1704]],"region":{"top_left_x":507,"top_left_y":1650,"width":248,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e208542dc614deca56328110a3bc6bd","type":"section_header","conversion_output":false,"children_ids":["c95f17ea19ce4febafa03eec7f2315c6"],"text":"","text_display":""},{"cnt":[[511,1654],[750,1654],[750,1699],[511,1699]],"region":{"top_left_x":511,"top_left_y":1654,"width":239,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c95f17ea19ce4febafa03eec7f2315c6","type":"text","conversion_output":true,"parent_id":"8e208542dc614deca56328110a3bc6bd","text":"Hypotension","text_display":"\n\n\\section*{Hypotension}","confidence":1,"confidence_rate":1},{"cnt":[[511,1740],[1846,1740],[1846,1790],[511,1790]],"region":{"top_left_x":511,"top_left_y":1740,"width":1335,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4da3dfa80d0487ebd84a5be0c245c0a","type":"text","conversion_output":true,"text":"Symptomatic hypotension and orthostatic hypotension with or without syncope","text_display":"\n\nSymptomatic hypotension and orthostatic hypotension with or without syncope","confidence":1,"confidence_rate":1},{"cnt":[[511,1788],[1865,1788],[1865,1841],[511,1841]],"region":{"top_left_x":511,"top_left_y":1787,"width":1354,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dfd20523e8840bca915b0f8f04ba583","type":"text","conversion_output":true,"text":"have been reported with MLN9708. Blood pressure should be closely monitored","text_display":" have been reported with MLN9708. Blood pressure should be closely monitored","confidence":1,"confidence_rate":1},{"cnt":[[511,1835],[1820,1835],[1820,1886],[511,1886]],"region":{"top_left_x":511,"top_left_y":1834,"width":1309,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c27060a700d64decb8bf0e595eef8360","type":"text","conversion_output":true,"text":"while the patient is on study treatment and fluid deficit should be corrected as","text_display":" while the patient is on study treatment and fluid deficit should be corrected as","confidence":0.9931671619415283,"confidence_rate":0.9999193410321587},{"cnt":[[511,1884],[1764,1884],[1764,1936],[511,1936]],"region":{"top_left_x":511,"top_left_y":1884,"width":1253,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c514d0466b14fad85ce84e3b495bbb4","type":"text","conversion_output":true,"text":"needed, especially in the setting of concomitant symptoms such as nausea,","text_display":" needed, especially in the setting of concomitant symptoms such as nausea,","confidence":1,"confidence_rate":1},{"cnt":[[511,1931],[1803,1931],[1803,1983],[511,1983]],"region":{"top_left_x":511,"top_left_y":1931,"width":1292,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11d39a7532814a1ca76c021ada544df5","type":"text","conversion_output":true,"text":"vomiting, diarrhea, or decreased appetite. Patients taking medications and/or","text_display":" vomiting, diarrhea, or decreased appetite. Patients taking medications and/or","confidence":1,"confidence_rate":1},{"cnt":[[511,1981],[1762,1981],[1762,2030],[511,2030]],"region":{"top_left_x":511,"top_left_y":1980,"width":1251,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfcaed1c2ef0465bb1aeabe61e9615c4","type":"text","conversion_output":true,"text":"diuretics to manage their blood pressure (for either hypo- or hypertension)","text_display":" diuretics to manage their blood pressure (for either hypo- or hypertension)","confidence":1,"confidence_rate":1},{"cnt":[[511,2028],[1669,2028],[1669,2082],[511,2082]],"region":{"top_left_x":511,"top_left_y":2028,"width":1159,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa27b0ce171f45f9a3e96433bf546cc2","type":"text","conversion_output":true,"text":"should be managed according to standard clinical practice, including","text_display":" should be managed according to standard clinical practice, including","confidence":1,"confidence_rate":1},{"cnt":[[511,2075],[1861,2075],[1861,2125],[511,2125]],"region":{"top_left_x":511,"top_left_y":2075,"width":1350,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e219aee6d96a4acab465f0f712c5c9c0","type":"text","conversion_output":true,"text":"considerations for dose adjustments of their concomitant medications during the","text_display":" considerations for dose adjustments of their concomitant medications during the","confidence":1,"confidence_rate":1},{"cnt":[[511,2123],[1803,2123],[1803,2174],[511,2174]],"region":{"top_left_x":511,"top_left_y":2122,"width":1292,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c982bdec21fa41e4ba0a5474cca3b069","type":"text","conversion_output":true,"text":"course of the trial. Fluid deficit should be corrected before initiation of study","text_display":" course of the trial. Fluid deficit should be corrected before initiation of study","confidence":1,"confidence_rate":1},{"cnt":[[511,2170],[1493,2170],[1493,2224],[511,2224]],"region":{"top_left_x":511,"top_left_y":2169,"width":983,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e611b9f935b448e997df96ffc53ae70","type":"text","conversion_output":true,"text":"drug and as needed during treatment to avoid dehydration.","text_display":" drug and as needed during treatment to avoid dehydration.","confidence":1,"confidence_rate":1},{"cnt":[[507,2239],[1386,2239],[1386,2297],[507,2297]],"region":{"top_left_x":507,"top_left_y":2238,"width":879,"height":59},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbbc64ca6cff4a1c9a0fb7ed4e1748e9","type":"section_header","conversion_output":false,"children_ids":["1681bbf7f5234b4cab1e66abdb0a74b3"],"text":"","text_display":""},{"cnt":[[511,2243],[1381,2243],[1381,2292],[511,2292]],"region":{"top_left_x":511,"top_left_y":2242,"width":871,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1681bbf7f5234b4cab1e66abdb0a74b3","type":"text","conversion_output":true,"parent_id":"dbbc64ca6cff4a1c9a0fb7ed4e1748e9","text":"Posterior Reversible Encephalopathy Syndrome","text_display":"\n\n\\section*{Posterior Reversible Encephalopathy Syndrome}","confidence":1,"confidence_rate":1},{"cnt":[[511,2329],[1760,2329],[1760,2378],[511,2378]],"region":{"top_left_x":511,"top_left_y":2328,"width":1249,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9a66a9e061e40c383d246027a1066b9","type":"text","conversion_output":true,"text":"One case of posterior reversible encephalopathy syndrome (PRES), which","text_display":"\n\nOne case of posterior reversible encephalopathy syndrome (PRES), which","confidence":1,"confidence_rate":1},{"cnt":[[511,2376],[1729,2376],[1729,2428],[511,2428]],"region":{"top_left_x":511,"top_left_y":2376,"width":1219,"height":52},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c76d9c1c6964dfcb5f1ecf624766f3b","type":"text","conversion_output":true,"text":"ultimately resolved, has been reported with MLN9708. This condition is","text_display":" ultimately resolved, has been reported with MLN9708. This condition is","confidence":1,"confidence_rate":1},{"cnt":[[511,2426],[1876,2426],[1876,2477],[511,2477]],"region":{"top_left_x":511,"top_left_y":2425,"width":1365,"height":53},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1158db924bb4e788964363aea5a3a28","type":"text","conversion_output":true,"text":"characterized by headache, seizures, and visual loss, as well as abrupt increase in","text_display":" characterized by headache, seizures, and visual loss, as well as abrupt increase in","confidence":1,"confidence_rate":1},{"cnt":[[1070,2585],[1141,2585],[1141,2628],[1070,2628]],"region":{"top_left_x":1069,"top_left_y":2584,"width":72,"height":44},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c1295eef2ad44e19c3874c82876e87c","type":"page_info","conversion_output":false,"text":"178","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-180","page":180,"lines":[{"cnt":[[322,129],[492,129],[492,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":170,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1dd061e7d8a4619b1c499e12a9c2191","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19a09885130f428fa1defaa8c43f8d03","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[511,258],[1807,258],[1807,312],[511,312]],"region":{"top_left_x":511,"top_left_y":257,"width":1296,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca9f97991221425aa3415ceac795745f","type":"text","conversion_output":true,"text":"blood pressure. Diagnosis may be confirmed by magnetic resonance imaging","text_display":"\nblood pressure. Diagnosis may be confirmed by magnetic resonance imaging","confidence":1,"confidence_rate":1},{"cnt":[[511,309],[1841,309],[1841,359],[511,359]],"region":{"top_left_x":511,"top_left_y":309,"width":1331,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7088666c4d54aec8d9a21a0bd8600a9","type":"text","conversion_output":true,"text":"(MRI). If the syndrome is diagnosed or suspected, symptom-directed treatment","text_display":" (MRI). If the syndrome is diagnosed or suspected, symptom-directed treatment","confidence":1,"confidence_rate":1},{"cnt":[[511,354],[1837,354],[1837,406],[511,406]],"region":{"top_left_x":511,"top_left_y":354,"width":1326,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8754e149e72e45ce8841d97462512e01","type":"text","conversion_output":true,"text":"should be maintained until the condition is reversed by control of hypertension","text_display":" should be maintained until the condition is reversed by control of hypertension","confidence":0.9990234375,"confidence_rate":0.9999883686432659},{"cnt":[[511,404],[973,404],[973,453],[511,453]],"region":{"top_left_x":511,"top_left_y":403,"width":463,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"652f2bb3204e4ca8893ea345b8c528c5","type":"text","conversion_output":true,"text":"or other instigating factors.","text_display":" or other instigating factors.","confidence":1,"confidence_rate":1},{"cnt":[[507,468],[883,468],[883,526],[507,526]],"region":{"top_left_x":507,"top_left_y":468,"width":377,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"138e84df94404ffe825ecae3735f5334","type":"section_header","conversion_output":false,"children_ids":["fb1cf80c83844df59cd3acbc2c4f4910"],"text":"","text_display":""},{"cnt":[[511,473],[879,473],[879,522],[511,522]],"region":{"top_left_x":511,"top_left_y":472,"width":368,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb1cf80c83844df59cd3acbc2c4f4910","type":"text","conversion_output":true,"parent_id":"138e84df94404ffe825ecae3735f5334","text":"Transverse Myelitis","text_display":"\n\n\\section*{Transverse Myelitis}","confidence":1,"confidence_rate":1},{"cnt":[[511,563],[1768,563],[1768,612],[511,612]],"region":{"top_left_x":511,"top_left_y":562,"width":1258,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c6c57f4d6d7441398f4977933ef678a","type":"text","conversion_output":true,"text":"One case of transverse myelitis has been reported with MLN9708. It is not","text_display":"\n\nOne case of transverse myelitis has been reported with MLN9708. It is not","confidence":1,"confidence_rate":1},{"cnt":[[511,610],[1766,610],[1766,660],[511,660]],"region":{"top_left_x":511,"top_left_y":610,"width":1256,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3332a03ce23e4a938982c1ba65f8a2d9","type":"text","conversion_output":true,"text":"known whether MLN9708 causes transverse myelitis; however, because it","text_display":" known whether MLN9708 causes transverse myelitis; however, because it","confidence":1,"confidence_rate":1},{"cnt":[[511,657],[1828,657],[1828,709],[511,709]],"region":{"top_left_x":511,"top_left_y":657,"width":1318,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7658e739a0034f0b9c5a28704198bf92","type":"text","conversion_output":true,"text":"happened to a patient receiving MLN9708, the possibility that MLN9708 may","text_display":" happened to a patient receiving MLN9708, the possibility that MLN9708 may","confidence":1,"confidence_rate":1},{"cnt":[[511,705],[1850,705],[1850,754],[511,754]],"region":{"top_left_x":511,"top_left_y":704,"width":1339,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11c37382437043b899c32ab19c817285","type":"text","conversion_output":true,"text":"have contributed to transverse myelitis cannot be excluded. Transversemyelitis","text_display":" have contributed to transverse myelitis cannot be excluded. Transversemyelitis","confidence":0.98095703125,"confidence_rate":0.9997683807875777},{"cnt":[[511,752],[1506,752],[1506,806],[511,806]],"region":{"top_left_x":511,"top_left_y":751,"width":996,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69a17184e6434a23b6a9f9f484101a51","type":"text","conversion_output":true,"text":"should be managed according to standard medical practice.","text_display":" should be managed according to standard medical practice.","confidence":1,"confidence_rate":1},{"cnt":[[507,816],[698,816],[698,879],[507,879]],"region":{"top_left_x":507,"top_left_y":816,"width":192,"height":63},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"692f5cc5349a4239a01b46ab83ae3bff","type":"section_header","conversion_output":false,"children_ids":["34b7943192f44fccbe48489cd41a37be"],"text":"","text_display":""},{"cnt":[[511,821],[694,821],[694,872],[511,872]],"region":{"top_left_x":511,"top_left_y":820,"width":183,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34b7943192f44fccbe48489cd41a37be","type":"text","conversion_output":true,"parent_id":"692f5cc5349a4239a01b46ab83ae3bff","text":"Overdose","text_display":"\n\n\\section*{Overdose}","confidence":1,"confidence_rate":1},{"cnt":[[511,924],[1807,924],[1807,973],[511,973]],"region":{"top_left_x":511,"top_left_y":923,"width":1296,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f3a92f12f004b218df19de8ef785252","type":"text","conversion_output":true,"text":"An overdose is defined as a known deliberate or accidental administration of","text_display":"\n\nAn overdose is defined as a known deliberate or accidental administration of","confidence":0.9518909454345703,"confidence_rate":0.9993914839387283},{"cnt":[[511,973],[1764,973],[1764,1025],[511,1025]],"region":{"top_left_x":511,"top_left_y":973,"width":1253,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"231d2fb50a984073a30e80f0b3a4d1e7","type":"text","conversion_output":true,"text":"investigational drug, to or by a study subject, at a dose above that which is","text_display":" investigational drug, to or by a study subject, at a dose above that which is","confidence":1,"confidence_rate":1},{"cnt":[[511,1023],[1828,1023],[1828,1072],[511,1072]],"region":{"top_left_x":511,"top_left_y":1022,"width":1318,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff9bee2237e540eeaaa7e85848505d82","type":"text","conversion_output":true,"text":"assigned to that individual subject according to the study protocol. 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However, dDiarrhea","confidence":0.99853515625,"confidence_rate":0.999982954590827},{"cnt":[[511,400],[1876,400],[1876,445],[511,445]],"region":{"top_left_x":511,"top_left_y":399,"width":1365,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2480f06b854e4a6cb89b0c96992025a8","type":"text","conversion_output":true,"parent_id":"b44e4a9a1b2c420ebd755d9e9a2746d7","text":"should be managed according to clinical practice, including the administration of","text_display":" should be managed according to clinical practice, including the administration of","confidence":1,"confidence_rate":1},{"cnt":[[511,447],[1747,447],[1747,488],[511,488]],"region":{"top_left_x":511,"top_left_y":446,"width":1236,"height":42},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ec3d7d805864d9d9aee017fd5fe35e5","type":"text","conversion_output":true,"parent_id":"b44e4a9a1b2c420ebd755d9e9a2746d7","text":"antidiarrheals once infectious causes are excluded. Fluid intake should be","text_display":" antidiarrheals once infectious causes are excluded. Fluid intake should be","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[511,494],[1841,494],[1841,541],[511,541]],"region":{"top_left_x":511,"top_left_y":494,"width":1331,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a05effdaeec449eb0b6ea9803f208c7","type":"text","conversion_output":true,"parent_id":"b44e4a9a1b2c420ebd755d9e9a2746d7","text":"maintained to avoid dehydration. Any Ffluid deficit should be corrected before","text_display":" maintained to avoid dehydration. 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To","text_display":" Rash has been most commonly characterized as maculopapular or macular. To","confidence":1,"confidence_rate":1},{"cnt":[[511,1008],[1768,1008],[1768,1057],[511,1057]],"region":{"top_left_x":511,"top_left_y":1007,"width":1258,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22a0d903197f449a97f1b2a60fe582d1","type":"text","conversion_output":true,"text":"date, when it does occur, rash is most commonly reported within the first 3","text_display":" date, when it does occur, rash is most commonly reported within the first 3","confidence":1,"confidence_rate":1},{"cnt":[[511,1057],[1811,1057],[1811,1104],[511,1104]],"region":{"top_left_x":511,"top_left_y":1057,"width":1301,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc133f6962a84ddea1b2f3e6a30b93a2","type":"text","conversion_output":true,"text":"cycles of therapy. The rash is often transient and self-limiting and is typically","text_display":" cycles of therapy. The rash is often transient and self-limiting and is typically","confidence":1,"confidence_rate":1},{"cnt":[[511,1104],[1841,1104],[1841,1154],[511,1154]],"region":{"top_left_x":511,"top_left_y":1104,"width":1331,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62981a34015e4dad8b7647cd4900ef6a","type":"text","conversion_output":true,"text":"Grade 1 toor 2 in severity. As in many other oncology trials, rash may occur in","text_display":" Grade 1 toor 2 in severity. As in many other oncology trials, rash may occur in","confidence":0.9685401932347304,"confidence_rate":0.9996448931043206},{"cnt":[[511,1152],[1820,1152],[1820,1201],[511,1201]],"region":{"top_left_x":511,"top_left_y":1151,"width":1309,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3130e7f986ba4ea8a38c8a66f0c07e9c","type":"text","conversion_output":true,"text":"patients receiving placebo and in patients receiving MLN9708. If rash occurs,","text_display":" patients receiving placebo and in patients receiving MLN9708. If rash occurs,","confidence":1,"confidence_rate":1},{"cnt":[[511,1199],[1871,1199],[1871,1248],[511,1248]],"region":{"top_left_x":511,"top_left_y":1198,"width":1361,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f17207e503824342b366c86096c1e884","type":"text","conversion_output":true,"text":"consideration should be given to alternate causes of the rash such as concomitant","text_display":" consideration should be given to alternate causes of the rash such as concomitant","confidence":1,"confidence_rate":1},{"cnt":[[511,1246],[1678,1246],[1678,1300],[511,1300]],"region":{"top_left_x":511,"top_left_y":1246,"width":1167,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35c03403ef904a468130a03c2158d66a","type":"text","conversion_output":true,"text":"medications, infections, etc; these other causative agents should be","text_display":" medications, infections, etc; these other causative agents should be","confidence":1,"confidence_rate":1},{"cnt":[[511,1296],[1738,1296],[1738,1343],[511,1343]],"region":{"top_left_x":511,"top_left_y":1295,"width":1228,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b0bfbe9ac494bd5ae85cce437ed4fdf","type":"text","conversion_output":true,"text":"discontinued and alterative agents considered if medically necessary.","text_display":" discontinued and alterative agents considered if medically necessary.","confidence":1,"confidence_rate":1},{"cnt":[[511,1435],[1820,1435],[1820,1480],[511,1480]],"region":{"top_left_x":511,"top_left_y":1435,"width":1309,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4566846423e4ecabcac99c3f8bd467a","type":"text","conversion_output":true,"text":"The rare risks of Stevens-Johnson syndrome, toxic epidermal necrolysis, drug","text_display":"\n\nThe rare risks of Stevens-Johnson syndrome, toxic epidermal necrolysis, drug","confidence":1,"confidence_rate":1},{"cnt":[[511,1482],[1785,1482],[1785,1528],[511,1528]],"region":{"top_left_x":511,"top_left_y":1482,"width":1275,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6db7f0757ef472c86b8c9d6a973dbcf","type":"text","conversion_output":true,"text":"reaction with eosinophilia and systemic symptoms (DRESS syndrome), and","text_display":" reaction with eosinophilia and systemic symptoms (DRESS syndrome), and","confidence":0.99951171875,"confidence_rate":0.9999934880145616},{"cnt":[[511,1530],[1858,1530],[1858,1577],[511,1577]],"region":{"top_left_x":511,"top_left_y":1529,"width":1348,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dacc797f4b5349349c7c16235d3afebd","type":"text","conversion_output":true,"text":"pemphigus vulgaris have been reported in oncology studies when MLN9708 (or","text_display":" pemphigus vulgaris have been reported in oncology studies when MLN9708 (or","confidence":0.998046875,"confidence_rate":0.9999752530298087},{"cnt":[[511,1577],[1841,1577],[1841,1626],[511,1626]],"region":{"top_left_x":511,"top_left_y":1576,"width":1331,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d20b184beab49738a4217d827f82b46","type":"text","conversion_output":true,"text":"placebo) was given with concomitant medications that are known to cause rash","text_display":" placebo) was given with concomitant medications that are known to cause rash","confidence":0.9824983484577388,"confidence_rate":0.9997820408405104},{"cnt":[[511,1626],[1734,1626],[1734,1674],[511,1674]],"region":{"top_left_x":511,"top_left_y":1626,"width":1223,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8d4d256c725476899ed4fd943d73833","type":"text","conversion_output":true,"text":"(eg, Bactrim, lenalidomide, aspirin), and/or in the setting of confounding","text_display":" (eg, Bactrim, lenalidomide, aspirin), and/or in the setting of confounding","confidence":1,"confidence_rate":1},{"cnt":[[511,1671],[1781,1671],[1781,1721],[511,1721]],"region":{"top_left_x":511,"top_left_y":1671,"width":1271,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e4dba0afeec46cabea658222e2ffc9e","type":"text","conversion_output":true,"text":"TEAEs. These severe, potentially life-threatening or deadly conditions may","text_display":" TEAEs. These severe, potentially life-threatening or deadly conditions may","confidence":1,"confidence_rate":1},{"cnt":[[511,1721],[1876,1721],[1876,1768],[511,1768]],"region":{"top_left_x":511,"top_left_y":1720,"width":1365,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e6559c732004ad3a833ef62a7989500","type":"text","conversion_output":true,"text":"involve rash with skin peeling and mouth sores and should be clinically managed","text_display":" involve rash with skin peeling and mouth sores and should be clinically managed","confidence":1,"confidence_rate":1},{"cnt":[[511,1766],[1792,1766],[1792,1815],[511,1815]],"region":{"top_left_x":511,"top_left_y":1766,"width":1281,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88535cfef0bf4d098877a8ce031bf986","type":"text","conversion_output":true,"text":"according to standard medical practice. Punch biopsies for histopathological","text_display":" according to standard medical practice. Punch biopsies for histopathological","confidence":1,"confidence_rate":1},{"cnt":[[511,1818],[1858,1818],[1858,1867],[511,1867]],"region":{"top_left_x":511,"top_left_y":1817,"width":1348,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03b6f8c1b417435589de2624dfc2e9b5","type":"text","conversion_output":true,"text":"analysis are encouraged at the discretion of the investigator. Study medications","text_display":" analysis are encouraged at the discretion of the investigator. Study medications","confidence":1,"confidence_rate":1},{"cnt":[[511,1865],[1809,1865],[1809,1914],[511,1914]],"region":{"top_left_x":511,"top_left_y":1864,"width":1298,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b99ef60f3bb54ccdbf8c44c1371dc23a","type":"text","conversion_output":true,"text":"should be discontinued in the event of severe, potentially life-threatening","text_display":" should be discontinued in the event of severe, potentially life-threatening","confidence":0.9980475902557373,"confidence_rate":0.9999755713211275},{"cnt":[[511,1912],[1824,1912],[1824,1962],[511,1962]],"region":{"top_left_x":511,"top_left_y":1912,"width":1314,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57becbbf69d14945a9f568cadb47a5b1","type":"text","conversion_output":true,"text":"rash. Additional information regarding these reactions can be found in the IB.","text_display":" rash. Additional information regarding these reactions can be found in the IB.","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[507,1979],[866,1979],[866,2035],[507,2035]],"region":{"top_left_x":507,"top_left_y":1978,"width":359,"height":57},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88b41f3374e048f69c6ae748ff419d8a","type":"section_header","conversion_output":false,"children_ids":["b04f1c4b357241a09d9089ec831af868"],"text":"","text_display":""},{"cnt":[[511,1983],[862,1983],[862,2030],[511,2030]],"region":{"top_left_x":511,"top_left_y":1983,"width":351,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b04f1c4b357241a09d9089ec831af868","type":"text","conversion_output":true,"parent_id":"88b41f3374e048f69c6ae748ff419d8a","text":"Thrombocytopenia","text_display":"\n\n\\section*{Thrombocytopenia}","confidence":1,"confidence_rate":1},{"cnt":[[511,2071],[1796,2071],[1796,2121],[511,2121]],"region":{"top_left_x":511,"top_left_y":2071,"width":1286,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74c4d3f6304747fc99e52790444a76e8","type":"text","conversion_output":true,"text":"Blood counts should be monitored regularly as outlined in the protocol, with","text_display":"\n\nBlood counts should be monitored regularly as outlined in the protocol, with","confidence":1,"confidence_rate":1},{"cnt":[[511,2118],[1618,2118],[1618,2168],[511,2168]],"region":{"top_left_x":511,"top_left_y":2118,"width":1107,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87034aa174e54987a286e8abefd3451e","type":"text","conversion_output":true,"text":"additional testing obtained according to standard clinical practice.","text_display":" additional testing obtained according to standard clinical practice.","confidence":1,"confidence_rate":1},{"cnt":[[511,2166],[1734,2166],[1734,2215],[511,2215]],"region":{"top_left_x":511,"top_left_y":2165,"width":1223,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8952e3cf8574f4ea2d8df9b48c90278","type":"text","conversion_output":true,"text":"Thrombocytopenia may be severe but has been manageable with platelet","text_display":" Thrombocytopenia may be severe but has been manageable with platelet","confidence":1,"confidence_rate":1},{"cnt":[[511,2213],[1854,2213],[1854,2262],[511,2262]],"region":{"top_left_x":511,"top_left_y":2212,"width":1344,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3fdc8e489b54887a026561885476330","type":"text","conversion_output":true,"text":"transfusions according to standard clinical practice. Lenalidomide or study drug","text_display":" transfusions according to standard clinical practice. Lenalidomide or study drug","confidence":1,"confidence_rate":1},{"cnt":[[511,2260],[1863,2260],[1863,2310],[511,2310]],"region":{"top_left_x":511,"top_left_y":2260,"width":1352,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7b5faf5364e467cbb64e9411ef9d5e5","type":"text","conversion_output":true,"text":"administration should be modified as per dose modification recommendations in","text_display":" administration should be modified as per dose modification recommendations in","confidence":1,"confidence_rate":1},{"cnt":[[511,2312],[1794,2312],[1794,2359],[511,2359]],"region":{"top_left_x":511,"top_left_y":2311,"width":1283,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"507305bd46e74aa6b65c618c9315ffa8","type":"text","conversion_output":true,"text":"the protocol when thrombocytopenia occurs (see Table 6-1). Therapy can be","text_display":" the protocol when thrombocytopenia occurs (see Table 6-1). Therapy can be","confidence":1,"confidence_rate":1},{"cnt":[[511,2359],[1742,2359],[1742,2408],[511,2408]],"region":{"top_left_x":511,"top_left_y":2358,"width":1232,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84fc54abfc0747cc9c62ac6e6607780c","type":"text","conversion_output":true,"text":"reinitiated at a reduced level upon recovery of platelet counts. A rare risk","text_display":" reinitiated at a reduced level upon recovery of platelet counts. A rare risk","confidence":1,"confidence_rate":1},{"cnt":[[511,2406],[1592,2406],[1592,2456],[511,2456]],"region":{"top_left_x":511,"top_left_y":2406,"width":1081,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85bbad8cf75642848b85fb197aca4362","type":"text","conversion_output":true,"text":"isThrombotic microangiopathy (TMA), including thrombotic","text_display":" isThrombotic microangiopathy (TMA), including thrombotic","confidence":1,"confidence_rate":1},{"cnt":[[1070,2587],[1134,2587],[1134,2628],[1070,2628]],"region":{"top_left_x":1069,"top_left_y":2586,"width":66,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dcafdccb7424204a1ea8a755514b166","type":"page_info","conversion_output":false,"text":"180","text_display":"","confidence":0.9990234375,"confidence_rate":0.9996743731453273}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"d6e5225d-d7a1-4e2c-b412-132ff953cb04-182","page":182,"lines":[{"cnt":[[322,129],[492,129],[492,165],[322,165]],"region":{"top_left_x":322,"top_left_y":128,"width":170,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"639dd869a00a4735b16c455272e42fac","type":"page_info","conversion_output":false,"text":"MLN9708","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[1369,172],[1369,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":1047,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"059f778cff734ed5b137a16b3dd24812","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol C16010 Amendment 8, 08 January 2021","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[511,260],[1772,260],[1772,307],[511,307]],"region":{"top_left_x":511,"top_left_y":259,"width":1262,"height":49},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a164382f707344098d7f2db6c0f1d8d6","type":"text","conversion_output":true,"text":"thrombocytopeniea purpura, a and hemolytic uremic syndrome, are rare,","text_display":"\nthrombocytopeniea purpura, a and hemolytic uremic syndrome, are rare,","confidence":0.9892885559238493,"confidence_rate":0.9998544805272015},{"cnt":[[511,309],[1848,309],[1848,357],[511,357]],"region":{"top_left_x":511,"top_left_y":309,"width":1337,"height":48},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c757f9271cb497bb805153d6c702a9a","type":"text","conversion_output":true,"text":"serious blood disorders wherethat cause low levels of platelets and red blood","text_display":" serious blood disorders wherethat cause low levels of platelets and red blood","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[511,357],[1846,357],[1846,402],[511,402]],"region":{"top_left_x":511,"top_left_y":356,"width":1335,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3e7049b57a84e20980a3d16948a05ea","type":"text","conversion_output":true,"text":"cells and result in blood clots form-in small blood vessels throughout the body","text_display":" cells and result in blood clots form-in small blood vessels throughout the body","confidence":0.8419561693444848,"confidence_rate":0.9979541513034971},{"cnt":[[511,404],[1824,404],[1824,453],[511,453]],"region":{"top_left_x":511,"top_left_y":403,"width":1314,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"699117c68340466b886605ea3f5226e6","type":"text","conversion_output":true,"text":"eharacterized by thrombocytopenia, petechiae, fever, or possibly more serious","text_display":" eharacterized by thrombocytopenia, petechiae, fever, or possibly more serious","confidence":0.9873530266531816,"confidence_rate":0.9998447970811628},{"cnt":[[511,451],[1863,451],[1863,501],[511,501]],"region":{"top_left_x":511,"top_left_y":451,"width":1352,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ef108971c3f34f7c847e3df7c0f1b74b","type":"text","conversion_output":true,"text":"signs and symptoms. Thrombotic thrombocytopenic purpura should be managed","text_display":" signs and symptoms. Thrombotic thrombocytopenic purpura should be managed","confidence":1,"confidence_rate":1},{"cnt":[[511,503],[1747,503],[1747,552],[511,552]],"region":{"top_left_x":511,"top_left_y":502,"width":1236,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf9da3e9019d47179f92748330500245","type":"text","conversion_output":true,"text":"symptomatically. Symptoms may include fatigue, fever, bruising, nose","text_display":" symptomatically. Symptoms may include fatigue, fever, bruising, nose","confidence":0.9990234375,"confidence_rate":0.999986615984802},{"cnt":[[511,550],[1869,550],[1869,597],[511,597]],"region":{"top_left_x":511,"top_left_y":550,"width":1359,"height":48},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"821bc3d527ff468786cb70c70b9c3207","type":"text","conversion_output":true,"text":"bleeds, and decreased urination. These disorders, including fatal cases, have","text_display":" bleeds, and decreased urination. These disorders, including fatal cases, have","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[511,597],[1721,597],[1721,647],[511,647]],"region":{"top_left_x":511,"top_left_y":597,"width":1210,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e1ecad56a3f47fca58108ab8a92c5a4","type":"text","conversion_output":true,"text":"been reported in patients receiving MLN9708. If TMA is suspected,","text_display":" been reported in patients receiving MLN9708. If TMA is suspected,","confidence":1,"confidence_rate":1},{"cnt":[[511,645],[1863,645],[1863,694],[511,694]],"region":{"top_left_x":511,"top_left_y":644,"width":1352,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6ddb7d8eb04471abe9609b7106d3f92","type":"text","conversion_output":true,"text":"consider withdrawal of the suspected causative agent and manage according","text_display":" consider withdrawal of the suspected causative agent and manage according","confidence":1,"confidence_rate":1},{"cnt":[[511,692],[999,692],[999,741],[511,741]],"region":{"top_left_x":511,"top_left_y":691,"width":489,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30794c8e9aac43bd847f365234c17975","type":"text","conversion_output":true,"text":"to standard medical practice.","text_display":" to standard medical practice.","confidence":1,"confidence_rate":1},{"cnt":[[511,756],[750,756],[750,810],[511,810]],"region":{"top_left_x":511,"top_left_y":756,"width":239,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9420c0005fd64fdeb1c21638c215b4f1","type":"section_header","conversion_output":false,"children_ids":["f505a62dc1414bb996bdb017821372f5"],"text":"","text_display":""},{"cnt":[[511,761],[746,761],[746,806],[511,806]],"region":{"top_left_x":511,"top_left_y":760,"width":235,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f505a62dc1414bb996bdb017821372f5","type":"text","conversion_output":true,"parent_id":"9420c0005fd64fdeb1c21638c215b4f1","text":"Fluid Deficit","text_display":"\n\n\\section*{Fluid Deficit}","confidence":1,"confidence_rate":1},{"cnt":[[511,851],[1833,851],[1833,900],[511,900]],"region":{"top_left_x":511,"top_left_y":850,"width":1322,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5b1b8271a98413c85a26e544154d65f","type":"text","conversion_output":true,"text":"Dehydration should be avoided since lenalidomide is substantially excreted by","text_display":"\n\nDehydration should be avoided since lenalidomide is substantially excreted by","confidence":1,"confidence_rate":1},{"cnt":[[511,898],[1818,898],[1818,947],[511,947]],"region":{"top_left_x":511,"top_left_y":898,"width":1307,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42a423d24f184be1b31e1670f0ecc00e","type":"text","conversion_output":true,"text":"kidney, and MLN9708 may cause vomiting, diarrhea, and dehydration. Acute","text_display":" kidney, and MLN9708 may cause vomiting, diarrhea, and dehydration. Acute","confidence":1,"confidence_rate":1},{"cnt":[[511,937],[1848,937],[1848,995],[511,995]],"region":{"top_left_x":511,"top_left_y":936,"width":1337,"height":59},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56f913704c954be78725f91e5112d9dc","type":"text","conversion_output":true,"text":"renal failure has been reported in patients treated with MLN9708, commonly in","text_display":" renal failure has been reported in patients treated with MLN9708, commonly in","confidence":1,"confidence_rate":1},{"cnt":[[511,993],[1807,993],[1807,1042],[511,1042]],"region":{"top_left_x":511,"top_left_y":992,"width":1296,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04eca4c804024588a3b7ffad86ba7673","type":"text","conversion_output":true,"text":"the setting of the previously noted gastrointestinal toxicities and dehydration.","text_display":" the setting of the previously noted gastrointestinal toxicities and dehydration.","confidence":1,"confidence_rate":1},{"cnt":[[511,1040],[1876,1040],[1876,1089],[511,1089]],"region":{"top_left_x":511,"top_left_y":1039,"width":1365,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f923ae29e22447192953be5de1c10bc","type":"text","conversion_output":true,"text":"Fluid deficit should be promptly corrected before initiation of study drug and as","text_display":" Fluid deficit should be promptly corrected before initiation of study drug and as","confidence":0.9990234375,"confidence_rate":0.9999886391383975},{"cnt":[[511,1087],[1583,1087],[1583,1137],[511,1137]],"region":{"top_left_x":511,"top_left_y":1087,"width":1073,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"568d0a8f735145b3bed23414c2e4c6b9","type":"text","conversion_output":true,"text":"needed during treatment to avoid dehydration (see Section 6.8).","text_display":" needed during treatment to avoid dehydration (see Section 6.8).","confidence":1,"confidence_rate":1},{"cnt":[[507,1156],[750,1156],[750,1212],[507,1212]],"region":{"top_left_x":507,"top_left_y":1155,"width":243,"height":57},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fba644a1916441381e6cde489293e08","type":"section_header","conversion_output":false,"children_ids":["613ab86e100d43d88120f04f5d3198ca"],"text":"","text_display":""},{"cnt":[[511,1160],[746,1160],[746,1210],[511,1210]],"region":{"top_left_x":511,"top_left_y":1160,"width":235,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"613ab86e100d43d88120f04f5d3198ca","type":"text","conversion_output":true,"parent_id":"3fba644a1916441381e6cde489293e08","text":"Hypotension","text_display":"\n\n\\section*{Hypotension}","confidence":1,"confidence_rate":1},{"cnt":[[511,1246],[1843,1246],[1843,1296],[511,1296]],"region":{"top_left_x":511,"top_left_y":1246,"width":1333,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f7dcfc0cf794efe8b9468b796375616","type":"text","conversion_output":true,"text":"Symptomatic hypotension and orthostatic hypotension with or without syncope","text_display":"\n\nSymptomatic hypotension and orthostatic hypotension with or without syncope","confidence":1,"confidence_rate":1},{"cnt":[[511,1293],[1863,1293],[1863,1343],[511,1343]],"region":{"top_left_x":511,"top_left_y":1293,"width":1352,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"878e1762ce924681987d720e1348f4f5","type":"text","conversion_output":true,"text":"have been reported with MLN9708. Blood pressure should be closely monitored","text_display":" have been reported with MLN9708. 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Patients taking","text_display":" such as nausea, vomiting, diarrhea, or decreased appetite. Patients taking","confidence":1,"confidence_rate":1},{"cnt":[[511,1487],[1850,1487],[1850,1536],[511,1536]],"region":{"top_left_x":511,"top_left_y":1486,"width":1339,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0eb4f582a3648029dd8a528426134cf","type":"text","conversion_output":true,"text":"medications and/or diuretics to manage their blood pressure (for either hypo- or","text_display":" medications and/or diuretics to manage their blood pressure (for either hypo- or","confidence":1,"confidence_rate":1},{"cnt":[[511,1534],[1738,1534],[1738,1583],[511,1583]],"region":{"top_left_x":511,"top_left_y":1533,"width":1228,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f54fb8f40e914d2ab65eddfb5e1c7fe8","type":"text","conversion_output":true,"text":"hypertension) should be managed according to standard clinical practice,","text_display":" hypertension) should be managed according to standard clinical practice,","confidence":1,"confidence_rate":1},{"cnt":[[511,1581],[1846,1581],[1846,1631],[511,1631]],"region":{"top_left_x":511,"top_left_y":1581,"width":1335,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb8a25b218c54a7fb309db768bf4c744","type":"text","conversion_output":true,"text":"including considerations for dose adjustments of their concomitant medications","text_display":" including considerations for dose adjustments of their concomitant medications","confidence":1,"confidence_rate":1},{"cnt":[[511,1629],[1837,1629],[1837,1678],[511,1678]],"region":{"top_left_x":511,"top_left_y":1628,"width":1326,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1eb34e16e30c401db6ddca845305388c","type":"text","conversion_output":true,"text":"during the course of the trial. 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If the","text_display":" by magnetic resonance imaging (MRI) or computed tomography (CT). If the","confidence":1,"confidence_rate":1},{"cnt":[[511,2075],[1783,2075],[1783,2125],[511,2125]],"region":{"top_left_x":511,"top_left_y":2075,"width":1273,"height":50},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dac9bf203764c6aaf89aac728876044","type":"text","conversion_output":true,"text":"syndrome is diagnosed or suspected, symptom-directed treatment should be","text_display":" syndrome is diagnosed or suspected, symptom-directed treatment should be","confidence":1,"confidence_rate":1},{"cnt":[[511,2123],[1807,2123],[1807,2172],[511,2172]],"region":{"top_left_x":511,"top_left_y":2122,"width":1296,"height":51},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74d0e6271f8541aca24e864d82c1dc0f","type":"text","conversion_output":true,"text":"maintained until the condition is reversed by control of hypertension or other","text_display":" maintained until the condition is reversed by control of hypertension or other","confidence":0.9990234375,"confidence_rate":0.9999882285072625},{"cnt":[[511,2170],[831,2170],[831,2224],[511,2224]],"region":{"top_left_x":511,"top_left_y":2169,"width":321,"height":55},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"843037dbbf2a4752a2d5698fa37ae34f","type":"text","conversion_output":true,"text":"instigating factors.","text_display":" instigating factors.","confidence":1,"confidence_rate":1},{"cnt":[[507,2239],[881,2239],[881,2292],[507,2292]],"region":{"top_left_x":507,"top_left_y":2238,"width":374,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57507d72a1dc422a8bc832a067a4f81d","type":"section_header","conversion_output":false,"children_ids":["c33645f4d4bf448391d81d36fbd530e3"],"text":"","text_display":""},{"cnt":[[511,2243],[874,2243],[874,2288],[511,2288]],"region":{"top_left_x":511,"top_left_y":2242,"width":364,"height":47},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c33645f4d4bf448391d81d36fbd530e3","type":"text","conversion_output":true,"parent_id":"57507d72a1dc422a8bc832a067a4f81d","text":"Transverse Myelitis","text_display":"\n\n\\section*{Transverse Myelitis}","confidence":1,"confidence_rate":1},{"cnt":[[511,2329],[1796,2329],[1796,2378],[511,2378]],"region":{"top_left_x":511,"top_left_y":2328,"width":1286,"height":51},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23c8d6a835ff41d89be4c1b7acef18e7","type":"text","conversion_output":true,"text":"One case of €Transverse myelitis has been reported with MLN9708. 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