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The Response-Evaluable population will be used for the analyses of response","text_display":" assessment. The Response-Evaluable population will be used for the analyses of response","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[318,1897],[1824,1897],[1824,1949],[318,1949]],"region":{"top_left_x":317,"top_left_y":1897,"width":1508,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f17732176284decaa1a3cb912126c45","type":"text","conversion_output":true,"text":"rates, time to response, and DOR (More specifically, TTR and DOR is defined in patients","text_display":" rates, time to response, and DOR (More specifically, TTR and DOR is defined in patients","confidence":1,"confidence_rate":1},{"cnt":[[320,1959],[1725,1959],[1725,2009],[320,2009]],"region":{"top_left_x":320,"top_left_y":1959,"width":1406,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ceeca4c6d1b4a7589b9d09f3249adbf","type":"text","conversion_output":true,"text":"with confirmed response and will be summarized descriptively). Patients must have","text_display":" with confirmed response and will be summarized descriptively). Patients must have","confidence":1,"confidence_rate":1},{"cnt":[[318,2024],[1566,2024],[1566,2073],[318,2073]],"region":{"top_left_x":317,"top_left_y":2023,"width":1250,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fbc9938ea114ebb9c25b5f39b1cf6b5","type":"text","conversion_output":true,"text":"measurable disease defined by at least 1 of the following 3 measurements:","text_display":" measurable disease defined by at least 1 of the following 3 measurements:","confidence":1,"confidence_rate":1},{"cnt":[[382,2127],[1068,2127],[1068,2176],[382,2176]],"region":{"top_left_x":382,"top_left_y":2126,"width":686,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"275419c3ef234c429eef6f73196279fc","type":"text","conversion_output":true,"text":"- Serum M-protein \\(\\geq 1 g / dL (\\geq 10 g / L )\\)","text_display":"\n- Serum M-protein \\(\\geq 1 g / dL (\\geq 10 g / L )\\)","confidence":0.94189453125,"confidence_rate":0.9987790730150266},{"cnt":[[382,2230],[1051,2230],[1051,2279],[382,2279]],"region":{"top_left_x":382,"top_left_y":2230,"width":669,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bc1c8a00b0f4209a15294f2b08d9394","type":"text","conversion_output":true,"text":"- Urine M-protein \\(\\geq 200 mg / 24\\) hours","text_display":"\n- Urine M-protein \\(\\geq 200 mg / 24\\) hours","confidence":1,"confidence_rate":1},{"cnt":[[382,2333],[1876,2333],[1876,2385],[382,2385]],"region":{"top_left_x":382,"top_left_y":2333,"width":1494,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5400983ad2774e609ae9e827ea039c8f","type":"text","conversion_output":true,"text":"- Serum free light chain assay: involved free light chain level \\(\\geq 10 mg / dL (\\geq 100 mg / L )\\)","text_display":"\n- Serum free light chain assay: involved free light chain level \\(\\geq 10 mg / dL (\\geq 100 mg / L )\\)","confidence":0.7781286239624023,"confidence_rate":0.9974692336404503},{"cnt":[[443,2398],[1332,2398],[1332,2447],[443,2447]],"region":{"top_left_x":442,"top_left_y":2397,"width":891,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"239eacfef1ba478faf8ea0fced1a3d6b","type":"text","conversion_output":true,"text":"provided the serum free light chain ratio is abnormal","text_display":" provided the serum free light chain ratio is abnormal","confidence":1,"confidence_rate":1},{"cnt":[[1074,2585],[1124,2585],[1124,2628],[1074,2628]],"region":{"top_left_x":1074,"top_left_y":2584,"width":50,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c129e8e6c5747df989104ed8f8c82c4","type":"page_info","conversion_output":false,"text":"11","text_display":"","confidence":0.9970703125,"confidence_rate":0.9985340817919036}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-13","page":13,"lines":[{"cnt":[[320,127],[681,127],[681,174],[320,174]],"region":{"top_left_x":320,"top_left_y":126,"width":362,"height":49},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1af1619a887d4b4d8214ee67dafe4e84","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,172],[969,172],[969,217],[320,217]],"region":{"top_left_x":320,"top_left_y":171,"width":649,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d655a786d9ca44089ec24fcafd071e1f","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[314,245],[917,245],[917,312],[314,312]],"region":{"top_left_x":313,"top_left_y":244,"width":605,"height":68},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2238042eb41b4d7ebfa8c654721da1d0","type":"section_header","conversion_output":false,"children_ids":["cd52eba3ff944b0fad571ea0be4ff0c9"],"text":"","text_display":""},{"cnt":[[318,249],[913,249],[913,305],[318,305]],"region":{"top_left_x":317,"top_left_y":249,"width":597,"height":57},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd52eba3ff944b0fad571ea0be4ff0c9","type":"text","conversion_output":true,"parent_id":"2238042eb41b4d7ebfa8c654721da1d0","text":"2.4 Per-Protocol Population","text_display":"\n\n\\subsection*{2.4 Per-Protocol 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the","text_display":" the protocol in a way that would affect the study outcome significantly as determined by the","confidence":0.9970703125,"confidence_rate":0.9999697531643026},{"cnt":[[318,464],[1790,464],[1790,518],[318,518]],"region":{"top_left_x":317,"top_left_y":464,"width":1473,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cda5b7c65d084bf6b0392327cdaa901f","type":"text","conversion_output":true,"text":"medical monitor, who is blinded to study drug assignment. The PP population includes","text_display":" medical monitor, who is blinded to study drug assignment. The PP population includes","confidence":1,"confidence_rate":1},{"cnt":[[318,529],[544,529],[544,580],[318,580]],"region":{"top_left_x":317,"top_left_y":528,"width":227,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"928112f7dfd142829789af9e90ef986f","type":"text","conversion_output":true,"text":"patients who","text_display":" patients who","confidence":1,"confidence_rate":1},{"cnt":[[382,632],[1863,632],[1863,685],[382,685]],"region":{"top_left_x":382,"top_left_y":631,"width":1481,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7576e1a56c0e4f7d905fdd8124d6a159","type":"text","conversion_output":true,"text":"- Do not have major inclusion/exclusion violation (inclusion criteria \\#3, \\#4; exclusion","text_display":"\n- Do not have major inclusion/exclusion violation (inclusion criteria \\#3, \\#4; exclusion","confidence":0.9931697845458984,"confidence_rate":0.9999255065993711},{"cnt":[[443,696],[784,696],[784,746],[443,746]],"region":{"top_left_x":442,"top_left_y":696,"width":343,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4c15d246a614766a85f8976b27933c8","type":"text","conversion_output":true,"text":"criteria \\#1, \\#8), and","text_display":" criteria \\#1, \\#8), and","confidence":1,"confidence_rate":1},{"cnt":[[382,804],[1876,804],[1876,857],[382,857]],"region":{"top_left_x":382,"top_left_y":803,"width":1494,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"923046cbbe7c42afa48147733f5c8119","type":"text","conversion_output":true,"text":"- Do not have low drug compliance ( compliance rate \\(\\leq 70 \\%\\) ) or overdose (compliance","text_display":"\n- Do not have low drug compliance ( compliance rate \\(\\leq 70 \\%\\) ) or overdose (compliance","confidence":1,"confidence_rate":1},{"cnt":[[443,864],[1068,864],[1068,917],[443,917]],"region":{"top_left_x":442,"top_left_y":863,"width":626,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f19471befa42463f916fdb20fec3f086","type":"text","conversion_output":true,"text":"rate \\(\\geq 120 \\%\\) ) or dispensing error, and","text_display":" rate \\(\\geq 120 \\%\\) ) or dispensing error, and","confidence":0.998046875,"confidence_rate":0.9999565557251564},{"cnt":[[382,971],[1869,971],[1869,1025],[382,1025]],"region":{"top_left_x":382,"top_left_y":971,"width":1488,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffae68bd31ec4c6596b7f5d3ba4b47b3","type":"text","conversion_output":true,"text":"- Have not taken excluded concomitant medication (ie, systemic treatment with strong","text_display":"\n- Have not taken excluded concomitant medication (ie, systemic treatment with 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voriconazole, ketoconazole,","confidence":1,"confidence_rate":1},{"cnt":[[443,1158],[1740,1158],[1740,1214],[443,1214]],"region":{"top_left_x":442,"top_left_y":1158,"width":1299,"height":56},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87ba4eae55974a9bb514a0d5fed64b0a","type":"text","conversion_output":true,"text":"nefazodone, posaconazole] or strong CYP3A inducers [rifampin, rifapentine,","text_display":" nefazodone, posaconazole] or strong CYP3A inducers [rifampin, rifapentine,","confidence":1,"confidence_rate":1},{"cnt":[[443,1220],[1837,1220],[1837,1274],[443,1274]],"region":{"top_left_x":442,"top_left_y":1220,"width":1395,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"001aac538a264f4abfab0af8f0c5fbb1","type":"text","conversion_output":true,"text":"rifabutin, carbamazepine, phenytoin, phenobarbital], or use of Ginkgo biloba or St.","text_display":" rifabutin, carbamazepine, phenytoin, phenobarbital], or use of Ginkgo biloba or St.","confidence":1,"confidence_rate":1},{"cnt":[[443,1285],[675,1285],[675,1334],[443,1334]],"region":{"top_left_x":442,"top_left_y":1284,"width":233,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b678a7ccb6104d1d8731cd947a5a86f6","type":"text","conversion_output":true,"text":"John's wort).","text_display":" John's wort).","confidence":1,"confidence_rate":1},{"cnt":[[318,1388],[1745,1388],[1745,1439],[318,1439]],"region":{"top_left_x":317,"top_left_y":1387,"width":1428,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc7432f0007045fea09512973eb80c13","type":"text","conversion_output":true,"text":"The PP population will be used as a sensitivity analysis of the ITT population for the","text_display":"\n\nThe PP population will be used as a sensitivity analysis of the ITT population for the","confidence":0.99853515625,"confidence_rate":0.999983891144227},{"cnt":[[318,1448],[853,1448],[853,1502],[318,1502]],"region":{"top_left_x":317,"top_left_y":1448,"width":536,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a2ce25e8a2b497db960dbbe8fb8af07","type":"text","conversion_output":true,"text":"primary efficacy endpoint PFS.","text_display":" primary efficacy endpoint PFS.","confidence":0.94189453125,"confidence_rate":0.9982911197085632},{"cnt":[[318,1551],[1876,1551],[1876,1605],[318,1605]],"region":{"top_left_x":317,"top_left_y":1551,"width":1559,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebd9d1963d3e4450ad526367d82fecdf","type":"text","conversion_output":true,"text":"All patients in the PP population will be analyzed according to the actual treatment received.","text_display":"\n\nAll patients in the PP population will be analyzed according to the actual treatment received.","confidence":1,"confidence_rate":1},{"cnt":[[312,1757],[1210,1757],[1210,1815],[312,1815]],"region":{"top_left_x":311,"top_left_y":1757,"width":899,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f156528fe8184c4599c35cbc2c932754","type":"section_header","conversion_output":false,"children_ids":["9ad127ca50d844f69457f54cb5f579a4"],"text":"","text_display":""},{"cnt":[[318,1762],[1201,1762],[1201,1811],[318,1811]],"region":{"top_left_x":317,"top_left_y":1761,"width":884,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ad127ca50d844f69457f54cb5f579a4","type":"text","conversion_output":true,"parent_id":"f156528fe8184c4599c35cbc2c932754","text":"3. HYPOTHESES AND DECISION RULES","text_display":"\n\n\\section*{3. 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hypotheses for PFS are:","confidence":0.99951171875,"confidence_rate":0.9999907849387211},{"cnt":[[434,2140],[1474,2140],[1474,2307],[434,2307]],"region":{"top_left_x":433,"top_left_y":2139,"width":1041,"height":169},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17ec84afdbea4d4f8cd99615313f9289","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& H_{0}: PFS \\text { in Arm Ixazomib }+ \\text { LenDex }=PFS \\text { in Arm LenDex } \\\\\n& H_{a}: PFS \\text { in Arm Ixazomib }+ \\text { LenDex }>PFS \\text { in Arm LenDex }\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: PFS \\text { in Arm Ixazomib }+ \\text { LenDex }=PFS \\text { in Arm LenDex } \\\\\n& H_{a}: PFS \\text { in Arm Ixazomib }+ \\text { LenDex }>PFS \\text { in Arm LenDex }\n\\end{aligned}\n\\]","confidence":0.562056400656802,"confidence_rate":0.9965142525416583},{"cnt":[[318,2357],[1854,2357],[1854,2411],[318,2411]],"region":{"top_left_x":317,"top_left_y":2356,"width":1538,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13e51f98aea74fc88e850ae12dc04aa5","type":"text","conversion_output":true,"text":"There are 2 key secondary efficacy endpoints in this study, OS and OS in high-risk patients","text_display":"\n\nThere are 2 key secondary efficacy endpoints in this study, OS and OS in high-risk patients","confidence":0.9150390625,"confidence_rate":0.9991035482818168},{"cnt":[[318,2419],[763,2419],[763,2471],[318,2471]],"region":{"top_left_x":317,"top_left_y":2419,"width":446,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d0cc26d764a485dad2e736a1bb16547","type":"text","conversion_output":true,"text":"carrying deletion del (17).","text_display":" carrying deletion del (17).","confidence":1,"confidence_rate":1},{"cnt":[[1076,2582],[1126,2582],[1126,2625],[1076,2625]],"region":{"top_left_x":1076,"top_left_y":2582,"width":50,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31b037cc061e42808808bf1387ff71a3","type":"page_info","conversion_output":false,"text":"12","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-14","page":14,"lines":[{"cnt":[[318,125],[683,125],[683,174],[318,174]],"region":{"top_left_x":317,"top_left_y":124,"width":367,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b08e14268064948ae2f1bf81d4a9f46","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,172],[969,172],[969,217],[320,217]],"region":{"top_left_x":320,"top_left_y":171,"width":649,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93ac4eb745714916a4b91d7052324d61","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1119,249],[1119,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":803,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"186f10bc024646faab5a5029732964ea","type":"text","conversion_output":true,"text":"The null and alternative hypotheses for OS are:","text_display":"\n\nThe null and alternative hypotheses for OS are:","confidence":0.99365234375,"confidence_rate":0.9998775481077931},{"cnt":[[443,352],[1433,352],[1433,404],[443,404]],"region":{"top_left_x":442,"top_left_y":352,"width":992,"height":52},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3c1a3037cf94af89bee3cb7548ee209","type":"text","conversion_output":true,"text":"\\(H _{0}\\) : OS in Arm Ixazomib + LenDex \\(= OS\\) in Arm LenDex","text_display":"\n\\(H _{0}\\) : OS in Arm Ixazomib + LenDex \\(= OS\\) in Arm LenDex","confidence":0.7603165602053319,"confidence_rate":0.9962533321511301},{"cnt":[[443,455],[1433,455],[1433,509],[443,509]],"region":{"top_left_x":442,"top_left_y":455,"width":992,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f4fde26e9804bd3a508a659337f279b","type":"text","conversion_output":true,"text":"\\(H _{ a }\\) : OS in Arm Ixazomib + LenDex \\(>\\) OS in Arm LenDex","text_display":"\n\\(H _{ a }\\) : OS in Arm Ixazomib + LenDex \\(>\\) OS in Arm LenDex","confidence":0.6376963249923874,"confidence_rate":0.9939388072609959},{"cnt":[[318,563],[1811,563],[1811,614],[318,614]],"region":{"top_left_x":317,"top_left_y":562,"width":1495,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2113e267f1c94ac6921fcf576d50e857","type":"text","conversion_output":true,"text":"The null and alternative hypotheses for OS in high-risk patients carrying deletion del(17)","text_display":"\nThe null and alternative hypotheses for OS in high-risk patients carrying deletion del(17)","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[312,623],[389,623],[389,672],[312,672]],"region":{"top_left_x":311,"top_left_y":623,"width":78,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1246755ad173450dad26610994301b8b","type":"text","conversion_output":true,"text":"are:","text_display":" are:","confidence":1,"confidence_rate":1},{"cnt":[[443,726],[1865,726],[1865,780],[443,780]],"region":{"top_left_x":442,"top_left_y":726,"width":1423,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"047220ce0001470e8a6825786bd4fb1d","type":"text","conversion_output":true,"text":"\\(H _{0}\\) : OS in high-risk patients carrying deletion del(17) in Arm Ixazomib ± LenDex \\(=\\)","text_display":"\n\\(H _{0}\\) : OS in high-risk patients carrying deletion del(17) in Arm Ixazomib ± LenDex \\(=\\)","confidence":0.7025382153214716,"confidence_rate":0.9964401344274301},{"cnt":[[443,786],[1553,786],[1553,844],[443,844]],"region":{"top_left_x":442,"top_left_y":786,"width":1112,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84cde20f9581453ba9faba85d1a34d80","type":"text","conversion_output":true,"text":"OS in high-risk patients carrying deletion del(17) in Arm LenDex","text_display":" OS in high-risk patients carrying deletion del(17) in Arm LenDex","confidence":0.98046875,"confidence_rate":0.9997141784584171},{"cnt":[[443,894],[1863,894],[1863,947],[443,947]],"region":{"top_left_x":442,"top_left_y":893,"width":1421,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9690481298ad49a5a0e8c84556b39fad","type":"text","conversion_output":true,"text":"\\(H _{ a }\\) : OS in high-risk patients carrying deletion del(17) in Arm Ixazomib + LenDex \\(>\\)","text_display":"\n\\(H _{ a }\\) : OS in high-risk patients carrying deletion del(17) in Arm Ixazomib + LenDex \\(>\\)","confidence":0.6174285716288402,"confidence_rate":0.9952372011340548},{"cnt":[[443,954],[1553,954],[1553,1010],[443,1010]],"region":{"top_left_x":442,"top_left_y":953,"width":1112,"height":57},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0ccd3cf42734096ae8e0de3059ca82e","type":"text","conversion_output":true,"text":"OS in high-risk patients carrying deletion del(17) in Arm LenDex","text_display":" OS in high-risk patients carrying deletion del(17) in Arm LenDex","confidence":0.9033203125,"confidence_rate":0.9985274900186064},{"cnt":[[314,1057],[930,1057],[930,1115],[314,1115]],"region":{"top_left_x":313,"top_left_y":1057,"width":618,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c58fccc5dd4e4458a617cf305556c3d1","type":"section_header","conversion_output":false,"children_ids":["9f8b6fbe66554f2cb745c146a92c6e1e"],"text":"","text_display":""},{"cnt":[[318,1061],[926,1061],[926,1109],[318,1109]],"region":{"top_left_x":317,"top_left_y":1061,"width":609,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f8b6fbe66554f2cb745c146a92c6e1e","type":"text","conversion_output":true,"parent_id":"c58fccc5dd4e4458a617cf305556c3d1","text":"3.2 Statistical Decision Rules","text_display":"\n\n\\subsection*{3.2 Statistical Decision Rules}","confidence":1,"confidence_rate":1},{"cnt":[[318,1152],[1811,1152],[1811,1205],[318,1205]],"region":{"top_left_x":317,"top_left_y":1151,"width":1495,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13eb4c9a349b4e759b4c564befb9667c","type":"text","conversion_output":true,"text":"A closed sequential testing procedure will be used to control type I error rate at a 2 -sided","text_display":"\n\nA closed sequential testing procedure will be used to control type I error rate at a 2 -sided","confidence":0.97607421875,"confidence_rate":0.9997602599139414},{"cnt":[[318,1212],[1854,1212],[1854,1265],[318,1265]],"region":{"top_left_x":317,"top_left_y":1211,"width":1538,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9035aa655d484d7db8724a25bc84f7e4","type":"text","conversion_output":true,"text":"alpha level of 0.05 for the primary endpoint (PFS) and key secondary endpoints (OS, OS in","text_display":" alpha level of 0.05 for the primary endpoint (PFS) and key secondary endpoints (OS, OS in","confidence":0.9985356330871582,"confidence_rate":0.9999848924837492},{"cnt":[[318,1274],[1876,1274],[1876,1328],[318,1328]],"region":{"top_left_x":317,"top_left_y":1274,"width":1559,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"336582edf2de43f8b799587375408b6f","type":"text","conversion_output":true,"text":"high-risk patients carrying del(17)). That is, only if PFS is significant based on the O'Brien-","text_display":" high-risk patients carrying del(17)). That is, only if PFS is significant based on the O'Brien","confidence":1,"confidence_rate":1},{"cnt":[[318,1336],[1863,1336],[1863,1390],[318,1390]],"region":{"top_left_x":317,"top_left_y":1336,"width":1546,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23014960ca694467b50ea44139f2a408","type":"text","conversion_output":true,"text":"Fleming alpha spending function (the Lan-DeMets method) at the first interim analysis (IA)","text_display":"Fleming alpha spending function (the Lan-DeMets method) at the first interim analysis (IA)","confidence":1,"confidence_rate":1},{"cnt":[[318,1399],[1841,1399],[1841,1450],[318,1450]],"region":{"top_left_x":317,"top_left_y":1398,"width":1525,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3ad47491db343f3b262a43c6c3c8669","type":"text","conversion_output":true,"text":"or the second IA (whichever occur first), the test of OS will be conducted on its own alpha","text_display":" or the second IA (whichever occur first), the test of OS will be conducted on its own alpha","confidence":1,"confidence_rate":1},{"cnt":[[318,1463],[655,1463],[655,1515],[318,1515]],"region":{"top_left_x":317,"top_left_y":1463,"width":339,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86956274e8d1471289dc24d3a73b5946","type":"text","conversion_output":true,"text":"spending functions.","text_display":" spending functions.","confidence":1,"confidence_rate":1},{"cnt":[[318,1566],[1861,1566],[1861,1618],[318,1618]],"region":{"top_left_x":317,"top_left_y":1566,"width":1544,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2969ddf7b3e4682aaa67658b8e927cd","type":"text","conversion_output":true,"text":"The first IA will be performed \\&hen approximately 262 PFS events have occurred based on","text_display":"\n\nThe first IA will be performed \\&hen approximately 262 PFS events have occurred based on","confidence":0.8770129680633545,"confidence_rate":0.998619548439218},{"cnt":[[318,1629],[1764,1629],[1764,1682],[318,1682]],"region":{"top_left_x":317,"top_left_y":1628,"width":1447,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4dd7505593e4482b3c3916c3bf25e7b","type":"text","conversion_output":true,"text":"IRC assessment. This will be the first analysis for PFS for statistical testing purposes.","text_display":" IRC assessment. This will be the first analysis for PFS for statistical testing purposes.","confidence":0.9551627328619361,"confidence_rate":0.9995121025488228},{"cnt":[[318,1691],[1861,1691],[1861,1742],[318,1742]],"region":{"top_left_x":317,"top_left_y":1690,"width":1544,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d09981dd9dc54292a44e4673382ba0e8","type":"text","conversion_output":true,"text":"Based on the O'Brien-Fleming stopping boundary, the alpha level at the first IA and second","text_display":" Based on the O'Brien-Fleming stopping boundary, the alpha level at the first IA and second","confidence":1,"confidence_rate":1},{"cnt":[[318,1753],[1882,1753],[1882,1807],[318,1807]],"region":{"top_left_x":317,"top_left_y":1753,"width":1566,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0229cd9b306845ec98d89f60bfb3253a","type":"text","conversion_output":true,"text":"IA on PFS would be 0.0163 and 0.0337 , respectively, if the number of PFS events at the first","text_display":" IA on PFS would be 0.0163 and 0.0337 , respectively, if the number of PFS events at the first","confidence":0.99951171875,"confidence_rate":0.9999953038523913},{"cnt":[[318,1809],[1871,1809],[1871,1867],[318,1867]],"region":{"top_left_x":317,"top_left_y":1808,"width":1555,"height":59},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b70193bd7c8344bc9294bd5274da29d4","type":"text","conversion_output":true,"text":"IA is exactly \\(262 .^{\\text {(I) }}\\) Correspondingly, if the observed p value is less than 0.0163 and 0.0451","text_display":" IA is exactly \\(262 .^{\\text {(I) }}\\) Correspondingly, if the observed p value is less than 0.0163 and 0.0451","confidence":0.5395293636848912,"confidence_rate":0.9949133277008531},{"cnt":[[318,1878],[1729,1878],[1729,1929],[318,1929]],"region":{"top_left_x":317,"top_left_y":1877,"width":1413,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"582e11ef6bd04c049ac93e4792ac0b6e","type":"text","conversion_output":true,"text":"at the first IA and the second IA, respectively, the test for PFS will be claimed to be","text_display":" at the first IA and the second IA, respectively, the test for PFS will be claimed to be","confidence":1,"confidence_rate":1},{"cnt":[[318,1938],[1734,1938],[1734,1992],[318,1992]],"region":{"top_left_x":317,"top_left_y":1937,"width":1417,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaee353132d74b3f88ecbe8f7828a246","type":"text","conversion_output":true,"text":"statistically significant. If the test for PFS is statistically significant at the first IA, a","text_display":" statistically significant. If the test for PFS is statistically significant at the first IA, a","confidence":0.9990236759185791,"confidence_rate":0.999990133371946},{"cnt":[[318,2002],[1811,2002],[1811,2056],[318,2056]],"region":{"top_left_x":317,"top_left_y":2002,"width":1495,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"433322a9bef74399a2cf94fe71964403","type":"text","conversion_output":true,"text":"non-inferential analysis of PFS will be performed at the second IA where the PFS data is","text_display":" non-inferential analysis of PFS will be performed at the second IA where the PFS data is","confidence":1,"confidence_rate":1},{"cnt":[[318,2067],[647,2067],[647,2112],[318,2112]],"region":{"top_left_x":317,"top_left_y":2066,"width":330,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"980f3f456c0e459fad1c41313c0e464b","type":"text","conversion_output":true,"text":"considered mature.","text_display":" considered mature.","confidence":1,"confidence_rate":1},{"cnt":[[320,2170],[1820,2170],[1820,2219],[320,2219]],"region":{"top_left_x":320,"top_left_y":2169,"width":1500,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c76ac54e9e604a81b58540d78bd8af17","type":"text","conversion_output":true,"text":"If the test for PFS is not statistically significant at the first IA, the study will continue and","text_display":"\n\nIf the test for PFS is not statistically significant at the first IA, the study will continue and","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[318,2230],[1820,2230],[1820,2284],[318,2284]],"region":{"top_left_x":317,"top_left_y":2230,"width":1503,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f0a2503b21843748949e798d2fd0e6b","type":"text","conversion_output":true,"text":"PFS testing will be conducted at the second IA when approximately 365 PFS events have","text_display":" PFS testing will be conducted at the second IA when approximately 365 PFS events have","confidence":1,"confidence_rate":1},{"cnt":[[318,2295],[1828,2295],[1828,2346],[318,2346]],"region":{"top_left_x":317,"top_left_y":2294,"width":1512,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d35e93dcdf584c98ad618df8de4e95b0","type":"text","conversion_output":true,"text":"occurred, which will also be the final analysis of PFS for statistical testing purpose. If the","text_display":" occurred, which will also be the final analysis of PFS for statistical testing purpose. If the","confidence":1,"confidence_rate":1},{"cnt":[[318,2355],[1721,2355],[1721,2408],[318,2408]],"region":{"top_left_x":317,"top_left_y":2354,"width":1404,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0449d06ff8864f56a1fcef061809f5b7","type":"text","conversion_output":true,"text":"test for PFS is not statistically significant at second IA, the study will be claimed as","text_display":" test for PFS is not statistically significant at second IA, the study will be claimed as","confidence":1,"confidence_rate":1},{"cnt":[[318,2419],[1227,2419],[1227,2469],[318,2469]],"region":{"top_left_x":317,"top_left_y":2419,"width":910,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e4e6c71c34f43c6a21736ac9dcd5515","type":"text","conversion_output":true,"text":"unsuccessful and no further testing will be conducted.","text_display":" unsuccessful and no further testing will be conducted.","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":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"144fb9d987c04cc1a4b59d2762c04599","type":"page_info","conversion_output":false,"text":"13","text_display":"","confidence":0.99658203125,"confidence_rate":0.9982895528102055}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-15","page":15,"lines":[{"cnt":[[318,125],[973,125],[973,221],[318,221]],"region":{"top_left_x":317,"top_left_y":124,"width":657,"height":98},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35632bee17484957bed34dc7f8ebe0e9","type":"section_header","conversion_output":false,"children_ids":["a942c845513148bd904817e84ea0f473","9726da9d56c1463cac512bec0bd9419b"],"text":"","text_display":""},{"cnt":[[322,129],[681,129],[681,170],[322,170]],"region":{"top_left_x":322,"top_left_y":128,"width":360,"height":42},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a942c845513148bd904817e84ea0f473","type":"text","conversion_output":true,"parent_id":"35632bee17484957bed34dc7f8ebe0e9","text":"MLN9708 (Ixazomib)","text_display":"\n\n\\section*{MLN9708 (Ixazomib)","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[969,172],[969,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":647,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9726da9d56c1463cac512bec0bd9419b","type":"text","conversion_output":true,"parent_id":"35632bee17484957bed34dc7f8ebe0e9","text":"Statistical Analysis Plan, Study C16010","text_display":" \\\\ Statistical Analysis Plan, Study C16010}","confidence":1,"confidence_rate":1},{"cnt":[[320,254],[1798,254],[1798,303],[320,303]],"region":{"top_left_x":320,"top_left_y":253,"width":1479,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"676a141156164e5bb8b6c37f111efa00","type":"text","conversion_output":true,"text":"The key secondary endpoint, OS, will be tested at the 3 planned IAs with approximately","text_display":"\n\nThe key secondary endpoint, OS, will be tested at the 3 planned IAs with approximately","confidence":1,"confidence_rate":1},{"cnt":[[322,314],[1850,314],[1850,363],[322,363]],"region":{"top_left_x":322,"top_left_y":313,"width":1528,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5474dbb5e2044ea6bd4f899c5ae46199","type":"text","conversion_output":true,"text":"154, 222, and 322 death events and again at the final analysis (FA) with approximately 486","text_display":" 154, 222, and 322 death events and again at the final analysis (FA) with approximately 486","confidence":0.9682769775390625,"confidence_rate":0.9996677139943544},{"cnt":[[320,374],[1762,374],[1762,425],[320,425]],"region":{"top_left_x":320,"top_left_y":373,"width":1442,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90fad7208b53406db48b1f0b8d1d6870","type":"text","conversion_output":true,"text":"events if necessary. The O'Brien-Fleming boundary will be calculated using the Lan-","text_display":" events if necessary. The O'Brien-Fleming boundary will be calculated using the Lan","confidence":1,"confidence_rate":1},{"cnt":[[320,438],[1858,438],[1858,488],[320,488]],"region":{"top_left_x":320,"top_left_y":438,"width":1539,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5ad7838022d4cd29e409a792e49565e","type":"text","conversion_output":true,"text":"DeMets method. The information fraction for the IA is equal to the number of death events","text_display":"DeMets method. The information fraction for the IA is equal to the number of death events","confidence":1,"confidence_rate":1},{"cnt":[[320,501],[1755,501],[1755,552],[320,552]],"region":{"top_left_x":320,"top_left_y":500,"width":1436,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7da3e88da634ab4b00ffe2763040bfb","type":"text","conversion_output":true,"text":"observed divided by 486 . If there are exactly 154 death events at the first IA, the null","text_display":" observed divided by 486 . If there are exactly 154 death events at the first IA, the null","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[318,563],[1811,563],[1811,614],[318,614]],"region":{"top_left_x":317,"top_left_y":562,"width":1495,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f77c0464030a4713b134178bf0c36fec","type":"text","conversion_output":true,"text":"hypothesis for OS will be rejected if the observed p value of the stratified log-rank test is","text_display":" hypothesis for OS will be rejected if the observed p value of the stratified log-rank test is","confidence":0.9873458943329751,"confidence_rate":0.9998775570087108},{"cnt":[[318,623],[1850,623],[1850,672],[318,672]],"region":{"top_left_x":317,"top_left_y":623,"width":1533,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16b98837871a4fe487512297a2fcaa09","type":"text","conversion_output":true,"text":"less than 0.0001 . If there are exactly 222 death events at the second IA, the null hypothesis","text_display":" less than 0.0001 . If there are exactly 222 death events at the second IA, the null hypothesis","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[320,688],[1777,688],[1777,737],[320,737]],"region":{"top_left_x":320,"top_left_y":687,"width":1457,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebf7d5cdddd74d97bbc1cf88c503d9b6","type":"text","conversion_output":true,"text":"for OS will be rejected if the observed p value of the stratified log-rank test is less than","text_display":" for OS will be rejected if the observed p value of the stratified log-rank test is less than","confidence":0.979560554260388,"confidence_rate":0.9997995227981903},{"cnt":[[318,748],[1820,748],[1820,799],[318,799]],"region":{"top_left_x":317,"top_left_y":747,"width":1503,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd3c5ba736044df090d5d767ef92f6d7","type":"text","conversion_output":true,"text":"0.0018 . If there are exactly 322 death events at the second IA, the null hypothesis for OS","text_display":" 0.0018 . If there are exactly 322 death events at the second IA, the null hypothesis for OS","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[318,812],[1876,812],[1876,862],[318,862]],"region":{"top_left_x":317,"top_left_y":812,"width":1559,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf5e025172de469b935b50b9c4081da6","type":"text","conversion_output":true,"text":"will be rejected if the observed p value of the stratified log-rank test is less than 0.0112 . The","text_display":" will be rejected if the observed p value of the stratified log-rank test is less than 0.0112 . The","confidence":0.8843886852264404,"confidence_rate":0.9989036494336121},{"cnt":[[320,872],[1841,872],[1841,924],[320,924]],"region":{"top_left_x":320,"top_left_y":872,"width":1522,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab36935a69304ee3b5b61d23a684c35e","type":"text","conversion_output":true,"text":"trial will be stopped for futility if the observed p value is greater than 0.366 at the third IA;","text_display":" trial will be stopped for futility if the observed p value is greater than 0.366 at the third IA;","confidence":0.9990236759185791,"confidence_rate":0.9999912000297451},{"cnt":[[318,937],[1835,937],[1835,986],[318,986]],"region":{"top_left_x":317,"top_left_y":936,"width":1518,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ce1abca017b497ca52c3ae0f9b0edad","type":"text","conversion_output":true,"text":"otherwise, the OS hypothesis will be tested again at the FA. If the observed p value of the","text_display":" otherwise, the OS hypothesis will be tested again at the FA. If the observed p value of the","confidence":0.9542715079151094,"confidence_rate":0.999541212642445},{"cnt":[[320,999],[1813,999],[1813,1051],[320,1051]],"region":{"top_left_x":320,"top_left_y":999,"width":1494,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab6a417ccaaf4369a021d3cc2a4e341b","type":"text","conversion_output":true,"text":"stratified log-rank test is less than 0.0462 at the FA (corresponding to a nominal alpha of","text_display":" stratified log-rank test is less than 0.0462 at the FA (corresponding to a nominal alpha of","confidence":1,"confidence_rate":1},{"cnt":[[320,1061],[1869,1061],[1869,1113],[320,1113]],"region":{"top_left_x":320,"top_left_y":1061,"width":1550,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69eaf7263066451dbd8b2a0fec1fdea3","type":"text","conversion_output":true,"text":"0.0382 ), the null hypothesis for OS will be rejected. However, the study will not be stopped","text_display":" 0.0382 ), the null hypothesis for OS will be rejected. However, the study will not be stopped","confidence":0.9786254481878132,"confidence_rate":0.9997772794886067},{"cnt":[[320,1124],[1016,1124],[1016,1167],[320,1167]],"region":{"top_left_x":320,"top_left_y":1123,"width":697,"height":44},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b53d192b188b497a8fcbd7c63eae64f1","type":"text","conversion_output":true,"text":"after the first IA based on the test for OS.","text_display":" after the first IA based on the test for OS.","confidence":1,"confidence_rate":1},{"cnt":[[320,1227],[1852,1227],[1852,1278],[320,1278]],"region":{"top_left_x":320,"top_left_y":1226,"width":1532,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6259268bb29049d4b7b77cc4839fc573","type":"text","conversion_output":true,"text":"The hypothesis for the additional key secondary endpoint, OS in high-risk patients carrying","text_display":"\n\nThe hypothesis for the additional key secondary endpoint, OS in high-risk patients carrying","confidence":1,"confidence_rate":1},{"cnt":[[320,1289],[1852,1289],[1852,1338],[320,1338]],"region":{"top_left_x":320,"top_left_y":1289,"width":1532,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d84ed4cf38fb41299d36a08270b7bd2f","type":"text","conversion_output":true,"text":"del(17), will be tested sequentially when the OS null hypothesis is rejected either at the IAs","text_display":" del(17), will be tested sequentially when the OS null hypothesis is rejected either at the IAs","confidence":1,"confidence_rate":1},{"cnt":[[320,1351],[1837,1351],[1837,1403],[320,1403]],"region":{"top_left_x":320,"top_left_y":1351,"width":1517,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e0c9d9d20944360b644d6d72a1eb34d","type":"text","conversion_output":true,"text":"or at the FA. The testing levels of significance will be the same as those used for OS. For","text_display":" or at the FA. The testing levels of significance will be the same as those used for OS. For","confidence":0.9985356330871582,"confidence_rate":0.9999847351149894},{"cnt":[[320,1409],[1790,1409],[1790,1465],[320,1465]],"region":{"top_left_x":320,"top_left_y":1409,"width":1470,"height":57},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c136c8e01c2463d8ee6aa5ccaf1e900","type":"text","conversion_output":true,"text":"instance, if OS is significant at the 0.0382 level at FA, OS in high-risk patients carrying","text_display":" instance, if OS is significant at the 0.0382 level at FA, OS in high-risk patients carrying","confidence":0.998046875,"confidence_rate":0.9999802523683627},{"cnt":[[320,1474],[1470,1474],[1470,1525],[320,1525]],"region":{"top_left_x":320,"top_left_y":1473,"width":1150,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab786b5496ec4959af203cbc66ba4c3b","type":"text","conversion_output":true,"text":"del(17) will also be tested at 2-sided alpha level of 0.0382 at the FA.","text_display":" del(17) will also be tested at 2-sided alpha level of 0.0382 at the FA.","confidence":0.84814453125,"confidence_rate":0.9979173082751502},{"cnt":[[322,1581],[1755,1581],[1755,1631],[322,1631]],"region":{"top_left_x":322,"top_left_y":1581,"width":1434,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b36ac15a8814ec899a917ceff4fa991","type":"text","conversion_output":true,"text":"The rejection boundary for OS in high-risk patients carrying del(17) at the FA will be","text_display":"\n\nThe rejection boundary for OS in high-risk patients carrying del(17) at the FA will be","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[320,1644],[1828,1644],[1828,1691],[320,1691]],"region":{"top_left_x":320,"top_left_y":1643,"width":1509,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc8f7dc2cea24ed2872ba679d75502b6","type":"text","conversion_output":true,"text":"calculated on the basis of the actual correlation between the test statistics at the second IA","text_display":" calculated on the basis of the actual correlation between the test statistics at the second IA","confidence":1,"confidence_rate":1},{"cnt":[[320,1706],[1830,1706],[1830,1755],[320,1755]],"region":{"top_left_x":320,"top_left_y":1705,"width":1511,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce6417fc976e4600bdf2fe0ddec6a0a9","type":"text","conversion_output":true,"text":"and the FA. Examples of critical values at the FA based on different correlations between","text_display":" and the FA. Examples of critical values at the FA based on different correlations between","confidence":1,"confidence_rate":1},{"cnt":[[320,1766],[1841,1766],[1841,1818],[320,1818]],"region":{"top_left_x":320,"top_left_y":1766,"width":1522,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23371a8d49914dfa846c55d92bc84d40","type":"text","conversion_output":true,"text":"the test statistics at the IA and the FA using a 2 -sided alpha of 0.0379 are presented below.","text_display":" the test statistics at the IA and the FA using a 2 -sided alpha of 0.0379 are presented below.","confidence":0.89013671875,"confidence_rate":0.998892231063036},{"cnt":[[320,1828],[1820,1828],[1820,1880],[320,1880]],"region":{"top_left_x":320,"top_left_y":1828,"width":1500,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4f01fcd2323467d9fae540a0d7153e8","type":"text","conversion_output":true,"text":"The formula to calculate the critical values is also shown in the proof of strong control of","text_display":" The formula to calculate the critical values is also shown in the proof of strong control of","confidence":1,"confidence_rate":1},{"cnt":[[322,1895],[754,1895],[754,1936],[322,1936]],"region":{"top_left_x":322,"top_left_y":1894,"width":433,"height":42},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0ced5fa58614bd9b3733811092efb54","type":"text","conversion_output":true,"text":"error rate in Section 10.1.","text_display":" error rate in Section 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Information fraction ( \\(n _{ 1 } / n _{ 2 }\\) ) & Correlation \\(\\left(\\sqrt{n_{1} / n_{2}}\\right)\\) & Critical value \\\\\n\\hline 8 & 0.71 & 2.02 \\\\\n\\hline 2/3 & 0.82 & 1.99 \\\\\n\\hline 5/6 & 0.91 & 1.97 \\\\\n\\hline 1 & 1 & 1.96 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Information fraction ( \\(n _{ 1 } / n _{ 2 }\\) ) & Correlation \\(\\left(\\sqrt{n_{1} / n_{2}}\\right)\\) & Critical value \\\\\n\\hline 8 & 0.71 & 2.02 \\\\\n\\hline 2/3 & 0.82 & 1.99 \\\\\n\\hline 5/6 & 0.91 & 1.97 \\\\\n\\hline 1 & 1 & 1.96 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However, the study will not be stopped","confidence":1,"confidence_rate":1},{"cnt":[[318,1676],[1833,1676],[1833,1727],[318,1727]],"region":{"top_left_x":317,"top_left_y":1675,"width":1516,"height":53},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4ff932791a8453fb049c6b111a4a97f","type":"text","conversion_output":true,"text":"after the first IA based on the test for OS. Based on the projected number of death events,","text_display":" after the first IA based on the test for OS. 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All","text_display":" efficacy data at regularly scheduled meetings prespecified in the IDMC charter. All","confidence":1,"confidence_rate":1},{"cnt":[[320,2243],[1749,2243],[1749,2297],[320,2297]],"region":{"top_left_x":320,"top_left_y":2242,"width":1429,"height":55},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb1723db89744dec99ec29ac122c5da0","type":"text","conversion_output":true,"text":"activities of the IDMC (eg, type of data reviewed, frequency of meetings, location of","text_display":" activities of the IDMC (eg, type of data reviewed, frequency of meetings, location of","confidence":1,"confidence_rate":1},{"cnt":[[318,2305],[1828,2305],[1828,2357],[318,2357]],"region":{"top_left_x":317,"top_left_y":2305,"width":1512,"height":52},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c135dfbf145a4449973103d327b24e95","type":"text","conversion_output":true,"text":"meetings) have been summarized in the charter. At the time of the IAs, the IDMC will be","text_display":" meetings) have been summarized in the charter. 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The study","text_display":"\n\nThe total sample size was calculated to provide \\(80 \\%\\) power for the OS endpoint. The study","confidence":1,"confidence_rate":1},{"cnt":[[320,1308],[1579,1308],[1579,1360],[320,1360]],"region":{"top_left_x":320,"top_left_y":1308,"width":1260,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f20930ef8a3f425aa05a5cacb84d35a3","type":"text","conversion_output":true,"text":"is also adequately powered to test PFS. There are 3 planned IAs and 1 FA.","text_display":" is also adequately powered to test PFS. There are 3 planned IAs and 1 FA.","confidence":1,"confidence_rate":1},{"cnt":[[318,1414],[1852,1414],[1852,1465],[318,1465]],"region":{"top_left_x":317,"top_left_y":1413,"width":1535,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9abe351d1734c188510a85a8c8e1900","type":"text","conversion_output":true,"text":"The parameters used for sample size calculation on OS are a 2 -sided test at the significance","text_display":"\n\nThe parameters used for sample size calculation on OS are a 2 -sided test at the significance","confidence":0.9556090728146955,"confidence_rate":0.9995505330285658},{"cnt":[[320,1474],[1811,1474],[1811,1525],[320,1525]],"region":{"top_left_x":320,"top_left_y":1473,"width":1492,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a00cb6eb02f84d088065b8f17771a009","type":"text","conversion_output":true,"text":"level of \\(\\alpha=0.05\\), power of \\(80 \\%\\), a control arm median OS of 30 months, and testing arm","text_display":" level of \\(\\alpha=0.05\\), power of \\(80 \\%\\), a control arm median OS of 30 months, and testing arm","confidence":1,"confidence_rate":1},{"cnt":[[318,1538],[1848,1538],[1848,1588],[318,1588]],"region":{"top_left_x":317,"top_left_y":1538,"width":1531,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42baa8ef92244b1ea4ee80f9c0a38773","type":"text","conversion_output":true,"text":"median OS of 39 months (assuming exponential distribution, hazard ratio 0.77). A total of","text_display":" median OS of 39 months (assuming exponential distribution, hazard ratio 0.77). A total of","confidence":0.93896484375,"confidence_rate":0.9993509608143231},{"cnt":[[318,1601],[1777,1601],[1777,1652],[318,1652]],"region":{"top_left_x":317,"top_left_y":1600,"width":1460,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af4b1fcd161141b88c97f1187682c849","type":"text","conversion_output":true,"text":"approximately 703 patients will need to be randomized in a \\(1: 1\\) ratio into those 2 arms,","text_display":" approximately 703 patients will need to be randomized in a \\(1: 1\\) ratio into those 2 arms,","confidence":0.9921941757202148,"confidence_rate":0.9999224144039901},{"cnt":[[318,1663],[1747,1663],[1747,1712],[318,1712]],"region":{"top_left_x":317,"top_left_y":1662,"width":1430,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4eb2a389dd141fe95152ec18eaedd81","type":"text","conversion_output":true,"text":"assuming an average enrollment rate of approximately 13 patients/month for the first","text_display":" assuming an average enrollment rate of approximately 13 patients/month for the first","confidence":1,"confidence_rate":1},{"cnt":[[318,1723],[1835,1723],[1835,1777],[318,1777]],"region":{"top_left_x":317,"top_left_y":1723,"width":1518,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd6b0290f5964af28e14d914cc68fe6d","type":"text","conversion_output":true,"text":"6 months, approximately 45 patients/month thereafter, and an approximately \\(10 \\%\\) dropout","text_display":" 6 months, approximately 45 patients/month thereafter, and an approximately \\(10 \\%\\) dropout","confidence":1,"confidence_rate":1},{"cnt":[[318,1788],[1815,1788],[1815,1841],[318,1841]],"region":{"top_left_x":317,"top_left_y":1787,"width":1499,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d34972197392487c87eb4b2ead7f8781","type":"text","conversion_output":true,"text":"rate at month 35 . The FA of OS is estimated to occur approximately 80 months from the","text_display":" rate at month 35 . The FA of OS is estimated to occur approximately 80 months from the","confidence":0.6377910482697189,"confidence_rate":0.9953741903131468},{"cnt":[[318,1848],[1863,1848],[1863,1901],[318,1901]],"region":{"top_left_x":317,"top_left_y":1847,"width":1546,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfb856f827024dfab2bd667c935607e8","type":"text","conversion_output":true,"text":"enrollment of the first patient, including a 20 -month randomization period and an additional","text_display":" enrollment of the first patient, including a 20 -month randomization period and an additional","confidence":0.9892628192901611,"confidence_rate":0.9998931221454537},{"cnt":[[318,1912],[1841,1912],[1841,1964],[318,1964]],"region":{"top_left_x":317,"top_left_y":1912,"width":1525,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b94b90e5fd04a19a69bb0d7718c5d18","type":"text","conversion_output":true,"text":"60-monthfollow-up from the last patient enrolled. With an observed hazard ratio of 0.833","text_display":" 60-monthfollow-up from the last patient enrolled. With an observed hazard ratio of 0.833","confidence":0.7828257083892822,"confidence_rate":0.9973421773854741},{"cnt":[[318,1972],[1824,1972],[1824,2026],[318,2026]],"region":{"top_left_x":317,"top_left_y":1972,"width":1508,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cadbf59e1fe4ab5aca944d04f89e5c2","type":"text","conversion_output":true,"text":"(eg, median OS of 30 months for control vs 36 months for treatment, 20\\% improvement),","text_display":" (eg, median OS of 30 months for control vs 36 months for treatment, 20\\% improvement),","confidence":0.6259765625,"confidence_rate":0.9951322781466213},{"cnt":[[318,2037],[1510,2037],[1510,2086],[318,2086]],"region":{"top_left_x":317,"top_left_y":2036,"width":1194,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f69576f094a9423ea52602638784f40b","type":"text","conversion_output":true,"text":"statistical significance can be claimed at the FA with 486 death events.","text_display":" statistical significance can be claimed at the FA with 486 death events.","confidence":1,"confidence_rate":1},{"cnt":[[318,2140],[1766,2140],[1766,2191],[318,2191]],"region":{"top_left_x":317,"top_left_y":2139,"width":1450,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adee830247834e6bafa27ae194f2362f","type":"text","conversion_output":true,"text":"Assuming a hazard ratio of 0.728 (median PFS of 15 months in the control arm versus","text_display":"\n\nAssuming a hazard ratio of 0.728 (median PFS of 15 months in the control arm versus","confidence":1,"confidence_rate":1},{"cnt":[[318,2202],[1850,2202],[1850,2254],[318,2254]],"region":{"top_left_x":317,"top_left_y":2202,"width":1533,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db9265adf23a41b3bcd36c387c1901b8","type":"text","conversion_output":true,"text":"20.6 months in the treatment arm), 365 PFS events will be needed ( \\(85 \\%\\) power and 2 -sided","text_display":" 20.6 months in the treatment arm), 365 PFS events will be needed ( \\(85 \\%\\) power and 2 -sided","confidence":0.9980478286743164,"confidence_rate":0.999980842543353},{"cnt":[[318,2264],[1850,2264],[1850,2314],[318,2314]],"region":{"top_left_x":317,"top_left_y":2264,"width":1533,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2752df3f69bf4f2aa2b3d5316bc2ca49","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":0.996584415435791,"confidence_rate":0.9999667827751061},{"cnt":[[318,2325],[1861,2325],[1861,2378],[318,2378]],"region":{"top_left_x":317,"top_left_y":2324,"width":1544,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dac8749c6a2f4d1a8b5ad8be9219f522","type":"text","conversion_output":true,"text":"will be performed when approximately 262 PFS events have occurred. With an assumption","text_display":" will be performed when approximately 262 PFS events have occurred. With an assumption","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[318,2389],[1861,2389],[1861,2441],[318,2441]],"region":{"top_left_x":317,"top_left_y":2389,"width":1544,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8368163207e499185f62b94c4d3f65c","type":"text","conversion_output":true,"text":"of approximately 13 patients/month for the first 6 months, 45 patients/month thereafter, and","text_display":" of approximately 13 patients/month for the first 6 months, 45 patients/month thereafter, and","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[318,2454],[1747,2454],[1747,2503],[318,2503]],"region":{"top_left_x":317,"top_left_y":2453,"width":1430,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77286c76fad54d119a121363075ccd2e","type":"text","conversion_output":true,"text":"approximately \\(10 \\%\\) dropout rate at month 30,262 PFS events is expected to occur at","text_display":" approximately \\(10 \\%\\) dropout rate at month 30,262 PFS events is expected to occur at","confidence":0.8870118215075248,"confidence_rate":0.9986976209061635},{"cnt":[[1079,2582],[1126,2582],[1126,2625],[1079,2625]],"region":{"top_left_x":1078,"top_left_y":2582,"width":48,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9460935273f74a629d769cdebeb2557d","type":"page_info","conversion_output":false,"text":"16","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-18","page":18,"lines":[{"cnt":[[318,125],[685,125],[685,174],[318,174]],"region":{"top_left_x":317,"top_left_y":124,"width":369,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d094c34b76e4c4a873a34fcb685cbcf","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[316,168],[973,168],[973,221],[316,221]],"region":{"top_left_x":315,"top_left_y":167,"width":659,"height":55},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"841dd06dfaa24978b2cd9a1e7844d500","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1854,249],[1854,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1538,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c74e164efe814e88b101ed6dafc1e6e0","type":"text","conversion_output":true,"text":"approximately 24.5 months after the first patient is enrolled and approximately 703 patients","text_display":"\napproximately 24.5 months after the first patient is enrolled and approximately 703 patients","confidence":0.9931640625,"confidence_rate":0.9999334060082463},{"cnt":[[318,314],[1764,314],[1764,365],[318,365]],"region":{"top_left_x":317,"top_left_y":313,"width":1447,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f277ac2ca9c148b7b451903a05ef7373","type":"text","conversion_output":true,"text":"have been enrolled. This is the first IA of the study with the opportunity to claim PFS","text_display":" have been enrolled. This is the first IA of the study with the opportunity to claim PFS","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1880,374],[1880,425],[318,425]],"region":{"top_left_x":317,"top_left_y":373,"width":1563,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a914dfdba44f4718abd3422b5c0b6362","type":"text","conversion_output":true,"text":"benefit. With an observed hazard ratio of 0.743 (eg, median PFS of 15 months in the control","text_display":" benefit. With an observed hazard ratio of 0.743 (eg, median PFS of 15 months in the control","confidence":1,"confidence_rate":1},{"cnt":[[318,438],[1841,438],[1841,488],[318,488]],"region":{"top_left_x":317,"top_left_y":438,"width":1525,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08bec7c50963422e9999a2888fab29bb","type":"text","conversion_output":true,"text":"arm versus 20.2 months in the treatment arm), statistical significance can be claimed at the","text_display":" arm versus 20.2 months in the treatment arm), statistical significance can be claimed at the","confidence":1,"confidence_rate":1},{"cnt":[[318,498],[1846,498],[1846,552],[318,552]],"region":{"top_left_x":317,"top_left_y":498,"width":1529,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68df1cbb7a34419ea04ddf3dc410d321","type":"text","conversion_output":true,"text":"analysis for PFS with 262 progression/death events. If the test for the PFS at the first IA is","text_display":" analysis for PFS with 262 progression/death events. If the test for the PFS at the first IA is","confidence":1,"confidence_rate":1},{"cnt":[[318,563],[1609,563],[1609,612],[318,612]],"region":{"top_left_x":317,"top_left_y":562,"width":1293,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2657c0dfce5847f0959e1607517eab31","type":"text","conversion_output":true,"text":"statistically significant, the PFS test at the second IA will be non-inferential .","text_display":" statistically significant, the PFS test at the second IA will be non-inferential .","confidence":0.9609375,"confidence_rate":0.9995421059166901},{"cnt":[[318,666],[1820,666],[1820,715],[318,715]],"region":{"top_left_x":317,"top_left_y":666,"width":1503,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37117234c6744b3aad14bce50cc28920","type":"text","conversion_output":true,"text":"If the test for PFS is not statistically significant at the first IA, the study will continue and","text_display":"\n\nIf the test for PFS is not statistically significant at the first IA, the study will continue and","confidence":0.9980475902557373,"confidence_rate":0.9999808402013884},{"cnt":[[318,726],[1820,726],[1820,780],[318,780]],"region":{"top_left_x":317,"top_left_y":726,"width":1503,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fc422a47ff24023adcda5d5bb05bf0b","type":"text","conversion_output":true,"text":"PFS testing will be conducted at the second IA when approximately 365 PFS events have","text_display":" PFS testing will be conducted at the second IA when approximately 365 PFS events have","confidence":1,"confidence_rate":1},{"cnt":[[318,791],[1809,791],[1809,844],[318,844]],"region":{"top_left_x":317,"top_left_y":790,"width":1492,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2878e4be2454f9a88d954886e0e79fb","type":"text","conversion_output":true,"text":"occurred, which will also be the final analysis of PFS for statistical testing purposes. An","text_display":" occurred, which will also be the final analysis of PFS for statistical testing purposes. 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Before dosing, a randomization number will be assigned to","text_display":" who is not on the study team. Before dosing, a randomization number will be assigned to","confidence":1,"confidence_rate":1},{"cnt":[[318,1293],[1818,1293],[1818,1347],[318,1347]],"region":{"top_left_x":317,"top_left_y":1293,"width":1501,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"721313e2f7c14df0ade918f81ed410cd","type":"text","conversion_output":true,"text":"each patient. The randomization assignment will be implemented by an interactive voice","text_display":" each patient. 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Rules for censoring are detailed","text_display":" follow-up before documentation of the events (PD/death). Rules for censoring are detailed","confidence":0.9985356330871582,"confidence_rate":0.9999844103327336},{"cnt":[[320,1040],[569,1040],[569,1085],[320,1085]],"region":{"top_left_x":320,"top_left_y":1039,"width":250,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03682733b965419791f88a88c8b3b25d","type":"text","conversion_output":true,"text":"in Section 5.8.","text_display":" in Section 5.8.","confidence":1,"confidence_rate":1},{"cnt":[[316,1139],[823,1139],[823,1199],[316,1199]],"region":{"top_left_x":315,"top_left_y":1138,"width":508,"height":61},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8341819e5968492da08deb673217767a","type":"section_header","conversion_output":false,"children_ids":["dfa6706f85f741f8a3e1904cb919e202"],"text":"","text_display":""},{"cnt":[[322,1143],[816,1143],[816,1192],[322,1192]],"region":{"top_left_x":322,"top_left_y":1142,"width":495,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfa6706f85f741f8a3e1904cb919e202","type":"text","conversion_output":true,"parent_id":"8341819e5968492da08deb673217767a","text":"5.5 Patient Disposition","text_display":"\n\n\\subsection*{5.5 Patient Disposition}","confidence":1,"confidence_rate":1},{"cnt":[[320,1233],[1727,1233],[1727,1285],[320,1285]],"region":{"top_left_x":320,"top_left_y":1233,"width":1408,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2798eb57bcb84c3d8b80c21daa14dedc","type":"text","conversion_output":true,"text":"Patient disposition includes the number and percentage of patients for the following","text_display":"\n\nPatient disposition includes the number and percentage of patients for the following","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[322,1298],[1846,1298],[1846,1347],[322,1347]],"region":{"top_left_x":322,"top_left_y":1297,"width":1524,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53664bbad189430daa3794682c80127f","type":"text","conversion_output":true,"text":"categories: patients in each of the study populations, patients discontinued from treatment,","text_display":" categories: patients in each of the study populations, patients discontinued from treatment,","confidence":1,"confidence_rate":1},{"cnt":[[320,1358],[1876,1358],[1876,1407],[320,1407]],"region":{"top_left_x":320,"top_left_y":1357,"width":1556,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2b04697375a4c01a834d79934a192fb","type":"text","conversion_output":true,"text":"primary reason for discontinuation from treatment, patients discontinued from the study, and","text_display":" primary reason for discontinuation from treatment, patients discontinued from the study, and","confidence":1,"confidence_rate":1},{"cnt":[[318,1418],[1798,1418],[1798,1472],[318,1472]],"region":{"top_left_x":317,"top_left_y":1417,"width":1482,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e314f7f00c6499e95ba0531ae818884","type":"text","conversion_output":true,"text":"primary reason for discontinuation from the study. All percentages will be based on the","text_display":" primary reason for discontinuation from the study. All percentages will be based on the","confidence":0.99658203125,"confidence_rate":0.9999627852212962},{"cnt":[[318,1482],[1021,1482],[1021,1532],[318,1532]],"region":{"top_left_x":317,"top_left_y":1482,"width":704,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b07b4bc665574584b4b8e41935b1de09","type":"text","conversion_output":true,"text":"number of patients in the ITT population.","text_display":" number of patients in the ITT population.","confidence":1,"confidence_rate":1},{"cnt":[[318,1586],[1280,1586],[1280,1637],[318,1637]],"region":{"top_left_x":317,"top_left_y":1585,"width":964,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc9207c372d54442a05909bc70b4b8f0","type":"text","conversion_output":true,"text":"A listing will present data concerning patient disposition.","text_display":"\n\nA listing will present data concerning patient disposition.","confidence":1,"confidence_rate":1},{"cnt":[[316,1687],[1401,1687],[1401,1745],[316,1745]],"region":{"top_left_x":315,"top_left_y":1686,"width":1086,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14bf7b797ba649f7b2eb3f9af4de1a4a","type":"section_header","conversion_output":false,"children_ids":["6723fc3bbde84f9fa33fab7cd7871eee"],"text":"","text_display":""},{"cnt":[[322,1691],[1394,1691],[1394,1738],[322,1738]],"region":{"top_left_x":322,"top_left_y":1690,"width":1073,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6723fc3bbde84f9fa33fab7cd7871eee","type":"text","conversion_output":true,"parent_id":"14bf7b797ba649f7b2eb3f9af4de1a4a","text":"5.6 Demographics and Baseline Disease Characteristics","text_display":"\n\n\\subsection*{5.6 Demographics and Baseline Disease Characteristics}","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[318,1779],[765,1779],[765,1835],[318,1835]],"region":{"top_left_x":317,"top_left_y":1778,"width":448,"height":57},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6b8937c7d674e519f0ead57226310f9","type":"section_header","conversion_output":false,"children_ids":["0ffcb111443646ecbf8201333b70b7f7"],"text":"","text_display":""},{"cnt":[[322,1779],[761,1779],[761,1833],[322,1833]],"region":{"top_left_x":322,"top_left_y":1778,"width":439,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ffcb111443646ecbf8201333b70b7f7","type":"text","conversion_output":true,"parent_id":"b6b8937c7d674e519f0ead57226310f9","text":"5.6.1 Demographics","text_display":"\n\n\\subsection*{5.6.1 Demographics}","confidence":1,"confidence_rate":1},{"cnt":[[320,1869],[1833,1869],[1833,1921],[320,1921]],"region":{"top_left_x":320,"top_left_y":1869,"width":1513,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1af0b2cd1ad4c1a8670517fabe0e2c4","type":"text","conversion_output":true,"text":"Demographies will be summarized by treatment group in a descriptive fashion for the ITT","text_display":"\n\nDemographies will be summarized by treatment group in a descriptive fashion for the ITT","confidence":0.83837890625,"confidence_rate":0.9980856919634766},{"cnt":[[320,1931],[1871,1931],[1871,1983],[320,1983]],"region":{"top_left_x":320,"top_left_y":1931,"width":1552,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45ac34613c944eeb8eb0491b89e9216f","type":"text","conversion_output":true,"text":"population. Baseline demographic data to be evaluated will include age, sex, race, ethnicity,","text_display":" population. Baseline demographic data to be evaluated will include age, sex, race, ethnicity,","confidence":1,"confidence_rate":1},{"cnt":[[318,1994],[1760,1994],[1760,2043],[318,2043]],"region":{"top_left_x":317,"top_left_y":1993,"width":1443,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea37190194704991a1c64e855dd1ac05","type":"text","conversion_output":true,"text":"height, weight, and other parameters as appropriate. Patient enrollment by region and","text_display":" height, weight, and other parameters as appropriate. Patient enrollment by region and","confidence":1,"confidence_rate":1},{"cnt":[[318,2058],[1225,2058],[1225,2108],[318,2108]],"region":{"top_left_x":317,"top_left_y":2058,"width":908,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5bebdf85bc847259ae7f9dddc5e1209","type":"text","conversion_output":true,"text":"country will also be summarized by treatment groups.","text_display":" country will also be summarized by treatment groups.","confidence":1,"confidence_rate":1},{"cnt":[[318,2157],[797,2157],[797,2215],[318,2215]],"region":{"top_left_x":317,"top_left_y":2157,"width":481,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79966395d7e446a5bacef95fc7c486ed","type":"section_header","conversion_output":false,"children_ids":["cbe95e7b032d4938b751a37f9b26a105"],"text":"","text_display":""},{"cnt":[[322,2161],[793,2161],[793,2211],[322,2211]],"region":{"top_left_x":322,"top_left_y":2161,"width":471,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbe95e7b032d4938b751a37f9b26a105","type":"text","conversion_output":true,"parent_id":"79966395d7e446a5bacef95fc7c486ed","text":"5.6.2 Medical History","text_display":"\n\n\\subsection*{5.6.2 Medical History}","confidence":1,"confidence_rate":1},{"cnt":[[320,2247],[1588,2247],[1588,2301],[320,2301]],"region":{"top_left_x":320,"top_left_y":2247,"width":1268,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae4b34f613044795a2d7b1505e3ecd71","type":"text","conversion_output":true,"text":"General medical history and prior medications will be listed for all patients.","text_display":"\n\nGeneral medical history and prior medications will be listed for all patients.","confidence":1,"confidence_rate":1},{"cnt":[[1074,2585],[1121,2585],[1121,2625],[1074,2625]],"region":{"top_left_x":1074,"top_left_y":2584,"width":48,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f85f790890a4794a20314c89f5c7d3a","type":"page_info","conversion_output":false,"text":"21","text_display":"","confidence":0.966796875,"confidence_rate":0.9832582951595171}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-23","page":23,"lines":[{"cnt":[[320,127],[681,127],[681,174],[320,174]],"region":{"top_left_x":320,"top_left_y":126,"width":362,"height":49},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d27b294c56a349efb96d682a4b1728c3","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,172],[969,172],[969,217],[320,217]],"region":{"top_left_x":320,"top_left_y":171,"width":649,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9ab605a7fcf4cc68a3758e2847e642c","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[314,247],[922,247],[922,303],[314,303]],"region":{"top_left_x":313,"top_left_y":247,"width":609,"height":56},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6953740a8ba437eaceb2be7b4874fac","type":"section_header","conversion_output":false,"children_ids":["9f876cec022c47a3abd28302b2f9c083"],"text":"","text_display":""},{"cnt":[[320,254],[917,254],[917,296],[320,296]],"region":{"top_left_x":320,"top_left_y":253,"width":598,"height":44},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f876cec022c47a3abd28302b2f9c083","type":"text","conversion_output":true,"parent_id":"d6953740a8ba437eaceb2be7b4874fac","text":"5.6.3 Baseline Disease Status","text_display":"\n\n\\subsection*{5.6.3 Baseline Disease Status}","confidence":1,"confidence_rate":1},{"cnt":[[320,339],[1813,339],[1813,391],[320,391]],"region":{"top_left_x":320,"top_left_y":339,"width":1494,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9a040307aba4473b39aa772b403820e","type":"text","conversion_output":true,"text":"Baseline disease characteristics including Eastern Cooperative Oncology Group (ECOG)","text_display":"\n\nBaseline disease characteristics including Eastern Cooperative Oncology Group (ECOG)","confidence":1,"confidence_rate":1},{"cnt":[[318,404],[1841,404],[1841,453],[318,453]],"region":{"top_left_x":317,"top_left_y":403,"width":1525,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e86e4181af349b3b33c446c15e39fbc","type":"text","conversion_output":true,"text":"performance status; type of myeloma; ISS stage; serum M-protein; urine M-protein; serum","text_display":" performance status; type of myeloma; ISS stage; serum M-protein; urine M-protein; serum","confidence":1,"confidence_rate":1},{"cnt":[[318,468],[1858,468],[1858,520],[318,520]],"region":{"top_left_x":317,"top_left_y":468,"width":1542,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51cc7a688f404fe18bb73c0e1627567f","type":"text","conversion_output":true,"text":"FLC; \\(\\beta_{2}\\)-microglobulin by category (ie, \\(<3.5,3.5-5.5, \\geq 5.5 mg / L\\) ); serum creatinine and its","text_display":" FLC; \\(\\beta_{2}\\)-microglobulin by category (ie, \\(<3.5,3.5-5.5, \\geq 5.5 mg / L\\) ); serum creatinine and its","confidence":0.99072265625,"confidence_rate":0.9999175198058058},{"cnt":[[320,533],[1876,533],[1876,582],[320,582]],"region":{"top_left_x":320,"top_left_y":532,"width":1556,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d3988dec10c42f181010f091f5c2b2f","type":"text","conversion_output":true,"text":"category ( \\(\\leq 2,>2 mg / dL\\) ); creatinine clearance by category (ie, \\(30-60, \\geq 60 mL / min\\) ); serum","text_display":" category ( \\(\\leq 2,>2 mg / dL\\) ); creatinine clearance by category (ie, \\(30-60, \\geq 60 mL / min\\) ); serum","confidence":0.9839468002319336,"confidence_rate":0.9998528885656176},{"cnt":[[318,593],[1846,593],[1846,645],[318,645]],"region":{"top_left_x":317,"top_left_y":592,"width":1529,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ed4f8e659864a5a8793273523872e80","type":"text","conversion_output":true,"text":"albumin by category (ie, \\(<3.5, \\geq 3.5 g / dL\\) ); corrected calcium; hemoglobin; Durle-Salmon","text_display":" albumin by category (ie, \\(<3.5, \\geq 3.5 g / dL\\) ); corrected calcium; hemoglobin; Durle-Salmon","confidence":0.9766151604708284,"confidence_rate":0.9997610123626108},{"cnt":[[318,657],[1818,657],[1818,711],[318,711]],"region":{"top_left_x":317,"top_left_y":657,"width":1501,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b94c0aa758e84918a03478f7f83fa1c0","type":"text","conversion_output":true,"text":"stage; Lytic bone lesions; and extramedullary disease will be summarized for all patients.","text_display":" stage; Lytic bone lesions; and extramedullary disease will be summarized for all patients.","confidence":1,"confidence_rate":1},{"cnt":[[318,761],[1811,761],[1811,810],[318,810]],"region":{"top_left_x":317,"top_left_y":760,"width":1495,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82859aefe5aa4b3d92da9279bd366dcd","type":"text","conversion_output":true,"text":"A patient's type of myeloma is determined by the combination of heavy chain type (IgG,","text_display":"\n\nA patient's type of myeloma is determined by the combination of heavy chain type (IgG,","confidence":0.961462727165781,"confidence_rate":0.999568230821537},{"cnt":[[318,821],[1869,821],[1869,874],[318,874]],"region":{"top_left_x":317,"top_left_y":820,"width":1553,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9307f98dfd84477db8a7c4cd9334cfc5","type":"text","conversion_output":true,"text":"IgA, IgM, IgD, and other) and light chain type (kappa, lambda, and biclonal). In descriptive","text_display":" IgA, IgM, IgD, and other) and light chain type (kappa, lambda, and biclonal). In descriptive","confidence":0.8353579044342041,"confidence_rate":0.9981471308719166},{"cnt":[[318,883],[1869,883],[1869,939],[318,939]],"region":{"top_left_x":317,"top_left_y":883,"width":1553,"height":56},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eda0593102043688f43d3d06a64441a","type":"text","conversion_output":true,"text":"summaries, the disease will be categorized by the heavy chain type first, then within each of","text_display":" summaries, the disease will be categorized by the heavy chain type first, then within each of","confidence":0.9936618804931641,"confidence_rate":0.9999351215877267},{"cnt":[[318,945],[1747,945],[1747,999],[318,999]],"region":{"top_left_x":317,"top_left_y":945,"width":1430,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ef1a9007efe4b88aba2def37dbba92f","type":"text","conversion_output":true,"text":"these categories, patients will be further classified according to their light chain type.","text_display":" these categories, patients will be further classified according to their light chain type.","confidence":0.86328125,"confidence_rate":0.9984536731871007},{"cnt":[[318,1051],[1858,1051],[1858,1102],[318,1102]],"region":{"top_left_x":317,"top_left_y":1050,"width":1542,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70fa6b9c52894a14a28248f09bfe22f2","type":"text","conversion_output":true,"text":"Patients are to be classified into 3 stages on the basis of the ISS. The derivation is based on","text_display":"\n\nPatients are to be classified into 3 stages on the basis of the ISS. The derivation is based on","confidence":0.995611902908422,"confidence_rate":0.9999573042799592},{"cnt":[[318,1117],[1538,1117],[1538,1167],[318,1167]],"region":{"top_left_x":317,"top_left_y":1117,"width":1222,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e230987c98d4c1d98aed92581e72a08","type":"text","conversion_output":true,"text":"the baseline \\(\\beta_{2}\\)-microglobulin and baseline albumin level measurements.","text_display":" the baseline \\(\\beta_{2}\\)-microglobulin and baseline albumin level measurements.","confidence":1,"confidence_rate":1},{"cnt":[[299,1205],[1865,1205],[1865,1493],[299,1493]],"region":{"top_left_x":298,"top_left_y":1205,"width":1567,"height":289},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b495adb69aae4b219652ab5e4afb0b03","type":"table","conversion_output":true,"children_ids":["162cc121bb8f4a3ea8254ca9bd345384","86ba8eabbda547f8a9a0e2bf0d96b50f","e6fe0839557e45ad979720dc0ba2d096","89572a755ddb4d3eaaf7cddb0bd9fc3c","e547e08016484190b758792fed25e169","ecb197fcd388478da8a9d2981fe3f006","67d6cf15834d4be082d9132094741c96","dad578768edf4d089606874c52abb8cb","11b86b97ed494373b12587fa6663d801","fd2b9bafa5b54ca6b377f98261a5729e","5734ecb1aa9c422abe603de40205eed8","9a694eab1066448ca973c6d725f3e64a","865bd0fc909d4ea1879ac80eb877c4ec","1299a96e9b30449482d977717da57427"],"text":"\\begin{tabular}{|l|l|}\n\\hline Stage & Criteria \\\\\n\\hline Stage I & \\begin{tabular}{l}\nSerum \\(\\beta_{2}\\)-microglobulin \\(<3.5 mg / L\\) \\\\\nSerum albumin \\(\\geq 3.5 g / dL\\)\n\\end{tabular} \\\\\n\\hline Stage II & Neither Stage I nor Stage III \\\\\n\\hline Stage III & Serum \\(\\beta_{2}\\)-microglobulin \\(\\geq 5.5 mg / L\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Stage & Criteria \\\\\n\\hline Stage I & \\begin{tabular}{l}\nSerum \\(\\beta_{2}\\)-microglobulin \\(<3.5 mg / L\\) \\\\\nSerum albumin \\(\\geq 3.5 g / dL\\)\n\\end{tabular} \\\\\n\\hline Stage II & Neither Stage I nor Stage III \\\\\n\\hline Stage III & Serum \\(\\beta_{2}\\)-microglobulin \\(\\geq 5.5 mg / L\\) \\\\\n\\hline\n\\end{tabular}","confidence":1,"confidence_rate":1},{"cnt":[[317,1205],[456,1205],[456,1493],[317,1493]],"region":{"top_left_x":317,"top_left_y":1205,"width":140,"height":289},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"162cc121bb8f4a3ea8254ca9bd345384","type":"table_column","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"","text_display":""},{"cnt":[[664,1205],[1188,1205],[1188,1493],[664,1493]],"region":{"top_left_x":663,"top_left_y":1205,"width":526,"height":289},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86ba8eabbda547f8a9a0e2bf0d96b50f","type":"table_column","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"","text_display":""},{"cnt":[[298,1227],[1866,1227],[1866,1272],[298,1272]],"region":{"top_left_x":298,"top_left_y":1226,"width":1568,"height":47},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6fe0839557e45ad979720dc0ba2d096","type":"table_row","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"","text_display":""},{"cnt":[[298,1281],[1866,1281],[1866,1374],[298,1374]],"region":{"top_left_x":298,"top_left_y":1280,"width":1568,"height":94},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89572a755ddb4d3eaaf7cddb0bd9fc3c","type":"table_row","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"","text_display":""},{"cnt":[[298,1380],[1866,1380],[1866,1428],[298,1428]],"region":{"top_left_x":298,"top_left_y":1380,"width":1568,"height":49},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e547e08016484190b758792fed25e169","type":"table_row","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"","text_display":""},{"cnt":[[298,1437],[1866,1437],[1866,1489],[298,1489]],"region":{"top_left_x":298,"top_left_y":1436,"width":1568,"height":53},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ecb197fcd388478da8a9d2981fe3f006","type":"table_row","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"","text_display":""},{"cnt":[[324,1231],[408,1231],[408,1272],[324,1272]],"region":{"top_left_x":323,"top_left_y":1230,"width":86,"height":43},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"67d6cf15834d4be082d9132094741c96","type":"simple_cell","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"Stage","text_display":"Stage","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[666,1231],[794,1231],[794,1263],[666,1263]],"region":{"top_left_x":666,"top_left_y":1230,"width":128,"height":34},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dad578768edf4d089606874c52abb8cb","type":"simple_cell","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"Criteria","text_display":"Criteria","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,1287],[426,1287],[426,1328],[324,1328]],"region":{"top_left_x":323,"top_left_y":1287,"width":103,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11b86b97ed494373b12587fa6663d801","type":"simple_cell","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"Stage 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dL\\)\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[668,1287],[1177,1287],[1177,1328],[668,1328]],"region":{"top_left_x":668,"top_left_y":1287,"width":510,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb805ceec5e34fb4829ed76be8e42f0d","type":"text","conversion_output":false,"parent_id":"fd2b9bafa5b54ca6b377f98261a5729e","text":"Serum \\(\\beta_{2}\\)-microglobulin \\(<3.5 mg / L\\)","text_display":"Serum \\(\\beta_{2}\\)-microglobulin \\(<3.5 mg / L\\)","confidence":1,"confidence_rate":1},{"cnt":[[668,1331],[1036,1331],[1036,1372],[668,1372]],"region":{"top_left_x":668,"top_left_y":1330,"width":369,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1af70102ed664194b6306c94e1669efe","type":"text","conversion_output":false,"parent_id":"fd2b9bafa5b54ca6b377f98261a5729e","text":"Serum albumin \\(\\geq 3.5 g / dL\\)","text_display":"\nSerum albumin \\(\\geq 3.5 g / dL\\)","confidence":1,"confidence_rate":1},{"cnt":[[324,1387],[439,1387],[439,1424],[324,1424]],"region":{"top_left_x":323,"top_left_y":1386,"width":116,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5734ecb1aa9c422abe603de40205eed8","type":"simple_cell","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"Stage II","text_display":"Stage II","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[668,1387],[1069,1387],[1069,1424],[668,1424]],"region":{"top_left_x":668,"top_left_y":1386,"width":401,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a694eab1066448ca973c6d725f3e64a","type":"simple_cell","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"Neither Stage I nor Stage III","text_display":"Neither Stage I nor Stage III","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[324,1439],[450,1439],[450,1478],[324,1478]],"region":{"top_left_x":323,"top_left_y":1438,"width":127,"height":40},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"865bd0fc909d4ea1879ac80eb877c4ec","type":"simple_cell","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"Stage III","text_display":"Stage III","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[668,1439],[1175,1439],[1175,1480],[668,1480]],"region":{"top_left_x":668,"top_left_y":1438,"width":508,"height":43},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1299a96e9b30449482d977717da57427","type":"simple_cell","conversion_output":false,"parent_id":"b495adb69aae4b219652ab5e4afb0b03","text":"Serum \\(\\beta_{2}\\)-microglobulin \\(\\geq 5.5 mg / L\\)","text_display":"Serum \\(\\beta_{2}\\)-microglobulin \\(\\geq 5.5 mg / L\\)","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[318,1538],[1708,1538],[1708,1588],[318,1588]],"region":{"top_left_x":317,"top_left_y":1538,"width":1392,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c20eebf4c02e4f208c3d38f3add6100d","type":"text","conversion_output":true,"text":"If corrected calcium is not reported directly, it can be calculated using either of the","text_display":"\n\nIf corrected calcium is not reported directly, it can be calculated using either of the","confidence":1,"confidence_rate":1},{"cnt":[[320,1598],[1467,1598],[1467,1648],[320,1648]],"region":{"top_left_x":320,"top_left_y":1598,"width":1148,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9baefcf8dc5041a89cafba4627e671d0","type":"text","conversion_output":true,"text":"following 2 formulas according to the units of calcium and albumin:","text_display":" following 2 formulas according to the units of calcium and albumin:","confidence":1,"confidence_rate":1},{"cnt":[[322,1702],[1876,1702],[1876,1820],[322,1820]],"region":{"top_left_x":322,"top_left_y":1701,"width":1554,"height":119},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c66df772fb5c4071a57b29e0f55134cb","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& \\text { corrected calcium }(mg / dL)=\\text { serum calcium }(mg / dL)+0.98 \\times(4-\\text { serum albumin }[g / dL]) \\\\\n& \\text { corrected calcium }(mmol / L)=\\text { serum calcium }(mmol / L)+0.0246 \\times(40-\\text { serum albumin }[g / L])\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& \\text { corrected calcium }(mg / dL)=\\text { serum calcium }(mg / dL)+0.98 \\times(4-\\text { serum albumin }[g / dL]) \\\\\n& \\text { corrected calcium }(mmol / L)=\\text { serum calcium }(mmol / L)+0.0246 \\times(40-\\text { serum albumin }[g / L])\n\\end{aligned}\n\\]","confidence":0.9241175763488423,"confidence_rate":0.9996539372255363},{"cnt":[[322,1878],[1775,1878],[1775,1927],[322,1927]],"region":{"top_left_x":322,"top_left_y":1877,"width":1453,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e0308641c224fc6939a1d02f8b57051","type":"text","conversion_output":true,"text":"Creatinine clearance is to be calculated using the Cockcroft-Gault formulas as follows:","text_display":"\n\nCreatinine clearance is to be calculated using the Cockcroft-Gault formulas as follows:","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[322,1981],[629,1981],[629,2030],[322,2030]],"region":{"top_left_x":322,"top_left_y":1980,"width":308,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"022325fa8c164c8ca0b095f53fd80555","type":"text","conversion_output":true,"text":"For male patients:","text_display":"\nFor male patients:","confidence":1,"confidence_rate":1},{"cnt":[[451,2084],[1364,2084],[1364,2196],[451,2196]],"region":{"top_left_x":451,"top_left_y":2083,"width":914,"height":113},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61ace478f78a48fa80b5ed544243ddf1","type":"math","conversion_output":true,"text":"\\[\n\\text { creatinine clearance }=\\frac{(140-\\text { Age }[yrs]) \\times \\text { weight }[kg]}{72 \\times(\\text { serum creatinine }[mg / dL])}\n\\]","text_display":"\n\\[\n\\text { creatinine clearance }=\\frac{(140-\\text { Age }[yrs]) \\times \\text { weight }[kg]}{72 \\times(\\text { serum creatinine }[mg / dL])}\n\\]","confidence":0.9990236759185791,"confidence_rate":0.9999912000297451},{"cnt":[[320,2260],[660,2260],[660,2310],[320,2310]],"region":{"top_left_x":320,"top_left_y":2260,"width":340,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67937c93cff14f69819318cbd13865c6","type":"text","conversion_output":true,"text":"For female patients:","text_display":"\n\nFor female patients:","confidence":1,"confidence_rate":1},{"cnt":[[589,2363],[1607,2363],[1607,2473],[589,2473]],"region":{"top_left_x":588,"top_left_y":2363,"width":1020,"height":110},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ecf23cb88874438b5caf3bd6751d890","type":"math","conversion_output":true,"text":"\\[\n\\text { creatinine clearance }=0.85 \\times \\frac{(140-\\text { Age }[yrs]) \\times \\text { weight }[kg]}{72 \\times(\\text { serum creatinine }[mg / dL])}\n\\]","text_display":"\n\\[\n\\text { creatinine clearance }=0.85 \\times \\frac{(140-\\text { Age }[yrs]) \\times \\text { weight }[kg]}{72 \\times(\\text { serum creatinine }[mg / 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(Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,172],[969,172],[969,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":647,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0151014f12234498a5e80cca6677fa99","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,251],[784,251],[784,303],[320,303]],"region":{"top_left_x":320,"top_left_y":251,"width":465,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"916dae729643443a93013999402edbcb","type":"text","conversion_output":true,"text":"Integer values will be used.","text_display":"\n\nInteger values will be used.","confidence":0.9990234375,"confidence_rate":0.9999703931762353},{"cnt":[[318,354],[1792,354],[1792,406],[318,406]],"region":{"top_left_x":317,"top_left_y":354,"width":1475,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d34cb33a53114d02ba26497169703c30","type":"text","conversion_output":true,"text":"A separate table will summarize the numbers and percentages of patients who had prior","text_display":"\nA separate table will summarize the numbers and percentages of patients who had prior","confidence":1,"confidence_rate":1},{"cnt":[[320,417],[1863,417],[1863,468],[320,468]],"region":{"top_left_x":320,"top_left_y":416,"width":1543,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53d68c1501a84604abdef11b3422dffd","type":"text","conversion_output":true,"text":"systemic therapy, prior transplant, prior surgery, and prior radiation therapy. This table will","text_display":" systemic therapy, prior transplant, prior surgery, and prior radiation therapy. This table will","confidence":1,"confidence_rate":1},{"cnt":[[320,477],[1854,477],[1854,531],[320,531]],"region":{"top_left_x":320,"top_left_y":476,"width":1535,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31f938d2fd0545bb99dc9fdae22a6d10","type":"text","conversion_output":true,"text":"also include regimens and the number of lines of prior systemic therapies, best hematologic","text_display":" also include regimens and the number of lines of prior systemic therapies, best hematologic","confidence":1,"confidence_rate":1},{"cnt":[[318,541],[1764,541],[1764,593],[318,593]],"region":{"top_left_x":317,"top_left_y":541,"width":1447,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddca4336ee7b4ad897f35b860ab45c68","type":"text","conversion_output":true,"text":"responses to prior systemic therapy, relapsed and/or refractory status to prior systemic","text_display":" responses to prior systemic therapy, relapsed and/or refractory status to prior systemic","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":"2cd65d49f54d41e7a4d5803d1aaa6a61","type":"text","conversion_output":true,"text":"therapy, and months since progression from last prior systemic therapy and months since","text_display":" therapy, and months since progression from last prior systemic therapy and months since","confidence":1,"confidence_rate":1},{"cnt":[[318,666],[1833,666],[1833,715],[318,715]],"region":{"top_left_x":317,"top_left_y":666,"width":1516,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3f5fee7951f49b18f092f0999f6662b","type":"text","conversion_output":true,"text":"diagnosis for each treatment group in the ITT population. A by-patient listing will also be","text_display":" diagnosis for each treatment group in the ITT population. A by-patient listing will also be","confidence":1,"confidence_rate":1},{"cnt":[[318,726],[939,726],[939,780],[318,780]],"region":{"top_left_x":317,"top_left_y":726,"width":622,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eba24ed28f24f5f814888df06fee370","type":"text","conversion_output":true,"text":"presented for prior systemic therapy.","text_display":" presented for prior systemic therapy.","confidence":1,"confidence_rate":1},{"cnt":[[318,834],[1742,834],[1742,883],[318,883]],"region":{"top_left_x":317,"top_left_y":833,"width":1426,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98e0683f13414fbb9a2a7da6223ef20e","type":"text","conversion_output":true,"text":"Months from diagnosis to the randomization date for each treatment is calculated by:","text_display":"\n\nMonths from diagnosis to the randomization date for each treatment is calculated by:","confidence":1,"confidence_rate":1},{"cnt":[[804,928],[1521,928],[1521,1046],[804,1046]],"region":{"top_left_x":803,"top_left_y":928,"width":719,"height":119},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"204e0a008cab4a76ab2be8e93641e7eb","type":"math","conversion_output":true,"text":"\\[\n\\frac{\\text { randomization date - date of diagnosiß }}{365.25 / 12}\n\\]","text_display":"\n\\[\n\\frac{\\text { randomization date - date of diagnosiß }}{365.25 / 12}\n\\]","confidence":0.61376953125,"confidence_rate":0.9914727791882344},{"cnt":[[320,1087],[1351,1087],[1351,1137],[320,1137]],"region":{"top_left_x":320,"top_left_y":1087,"width":1032,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9abf4f2d20a34909939754d7cb9785dd","type":"text","conversion_output":true,"text":"Distribution of stratification factors will also be summarized.","text_display":"\n\nDistribution of stratification factors will also be summarized.","confidence":0.9980475902557373,"confidence_rate":0.9999712604397449},{"cnt":[[316,1190],[995,1190],[995,1244],[316,1244]],"region":{"top_left_x":315,"top_left_y":1190,"width":680,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71b1a0f059924ae2b3b7c3e66a14e2ea","type":"section_header","conversion_output":false,"children_ids":["bea60932b41c4a6d8434d41cdd2ceb97"],"text":"","text_display":""},{"cnt":[[322,1195],[990,1195],[990,1240],[322,1240]],"region":{"top_left_x":322,"top_left_y":1194,"width":669,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bea60932b41c4a6d8434d41cdd2ceb97","type":"text","conversion_output":true,"parent_id":"71b1a0f059924ae2b3b7c3e66a14e2ea","text":"5.7 Treatments and Medications","text_display":"\n\n\\subsection*{5.7 Treatments and Medications}","confidence":0.9990234375,"confidence_rate":0.9999720849711223},{"cnt":[[314,1280],[969,1280],[969,1334],[314,1334]],"region":{"top_left_x":313,"top_left_y":1280,"width":656,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef361bec2ddd45578e7dc0afaab8d6e7","type":"section_header","conversion_output":false,"children_ids":["2287d1cd8ac1415a832d643f13ef6173"],"text":"","text_display":""},{"cnt":[[320,1285],[965,1285],[965,1330],[320,1330]],"region":{"top_left_x":320,"top_left_y":1284,"width":645,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2287d1cd8ac1415a832d643f13ef6173","type":"text","conversion_output":true,"parent_id":"ef361bec2ddd45578e7dc0afaab8d6e7","text":"5.7.1 Concomitant Medications","text_display":"\n\n\\subsection*{5.7.1 Concomitant Medications}","confidence":0.99853515625,"confidence_rate":0.9999568857034922},{"cnt":[[322,1371],[1710,1371],[1710,1424],[322,1424]],"region":{"top_left_x":322,"top_left_y":1370,"width":1389,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edf15d6ea80a4c0ab75e56b4286b24cc","type":"text","conversion_output":true,"text":"Concomitant medications will be coded by Preferred Term using the World Health","text_display":"\n\nConcomitant medications will be coded by Preferred Term using the World Health","confidence":1,"confidence_rate":1},{"cnt":[[322,1433],[1764,1433],[1764,1489],[322,1489]],"region":{"top_left_x":322,"top_left_y":1433,"width":1442,"height":56},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09e3c882283541e5867e0be6e0af95dc","type":"text","conversion_output":true,"text":"Organization (WHO) Drug Dictionary. The number and percentage of patients taking","text_display":" Organization (WHO) Drug Dictionary. The number and percentage of patients taking","confidence":0.99853515625,"confidence_rate":0.9999827540583307},{"cnt":[[320,1495],[1858,1495],[1858,1549],[320,1549]],"region":{"top_left_x":320,"top_left_y":1495,"width":1539,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecb8e608806347f1933327dc9642ba7a","type":"text","conversion_output":true,"text":"concomitant medications from the first dose through the end of the on-treatment period will","text_display":" concomitant medications from the first dose through the end of the on-treatment period will","confidence":1,"confidence_rate":1},{"cnt":[[318,1558],[1809,1558],[1809,1609],[318,1609]],"region":{"top_left_x":317,"top_left_y":1557,"width":1492,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c27caae695f849bfbf3f2068945f4b91","type":"text","conversion_output":true,"text":"be tabulated by Anatomical Therapeutic Chemical (ATC) classification pharmacological","text_display":" be tabulated by Anatomical Therapeutic Chemical (ATC) classification pharmacological","confidence":1,"confidence_rate":1},{"cnt":[[320,1620],[1867,1620],[1867,1674],[320,1674]],"region":{"top_left_x":320,"top_left_y":1619,"width":1547,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a6f9544419c4c828b1a906b590bb3c1","type":"text","conversion_output":true,"text":"subgroup and WHO drug generic term for each treatment group in the Safety population. A","text_display":" subgroup and WHO drug generic term for each treatment group in the Safety population. A","confidence":1,"confidence_rate":1},{"cnt":[[318,1680],[1480,1680],[1480,1738],[318,1738]],"region":{"top_left_x":317,"top_left_y":1680,"width":1164,"height":59},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f687a540fd0741e3b27d55517eda8bb0","type":"text","conversion_output":true,"text":"by-patient listing will also be presented for concomitant medications.","text_display":" by-patient listing will also be presented for concomitant medications.","confidence":1,"confidence_rate":1},{"cnt":[[320,1788],[1781,1788],[1781,1841],[320,1841]],"region":{"top_left_x":320,"top_left_y":1787,"width":1462,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4dddfb7356f4cea9edd6a98893c25c7","type":"text","conversion_output":true,"text":"Concomitant procedures will not be coded but will be presented in a data listing for the","text_display":"\n\nConcomitant procedures will not be coded but will be presented in a data listing for the","confidence":0.60791015625,"confidence_rate":0.994662380102285},{"cnt":[[320,1850],[634,1850],[634,1901],[320,1901]],"region":{"top_left_x":320,"top_left_y":1849,"width":314,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f089e60e68dc4a9489e04ff704fe4bed","type":"text","conversion_output":true,"text":"Safety population.","text_display":" Safety population.","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[314,1951],[831,1951],[831,2011],[314,2011]],"region":{"top_left_x":313,"top_left_y":1950,"width":519,"height":61},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1364c5b40304b9492ab8a1dbef677f6","type":"section_header","conversion_output":false,"children_ids":["22f4c0934c834b2bbaad0595388f899d"],"text":"","text_display":""},{"cnt":[[320,1953],[827,1953],[827,2004],[320,2004]],"region":{"top_left_x":320,"top_left_y":1952,"width":508,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22f4c0934c834b2bbaad0595388f899d","type":"text","conversion_output":true,"parent_id":"e1364c5b40304b9492ab8a1dbef677f6","text":"5.7.2 Study Treatments","text_display":"\n\n\\subsection*{5.7.2 Study Treatments}","confidence":1,"confidence_rate":1},{"cnt":[[318,2041],[1867,2041],[1867,2095],[318,2095]],"region":{"top_left_x":317,"top_left_y":2041,"width":1550,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d939943172254f81854057cf5159260b","type":"text","conversion_output":true,"text":"Following the Screening period, patients who will be enrolled and treated with lenalidomide","text_display":"\n\nFollowing the Screening period, patients who will be enrolled and treated with lenalidomide","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[314,2105],[1826,2105],[1826,2159],[314,2159]],"region":{"top_left_x":313,"top_left_y":2105,"width":1514,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"949e00ebe5af467db655a8466892415e","type":"text","conversion_output":true,"text":"plus dexamethasone will be randomized to receive a study drug in a double-blind fashion,","text_display":" plus dexamethasone will be randomized to receive a study drug in a double-blind fashion,","confidence":1,"confidence_rate":1},{"cnt":[[320,2166],[1807,2166],[1807,2219],[320,2219]],"region":{"top_left_x":320,"top_left_y":2165,"width":1487,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bcbaf32197e4877bc266db8dda60538","type":"text","conversion_output":true,"text":"either ixazomib or placebo. Eligible patients will be randomized in a \\(1: 1\\) ratio into those","text_display":" either ixazomib or placebo. Eligible patients will be randomized in a \\(1: 1\\) ratio into those","confidence":0.98828125,"confidence_rate":0.9998797219712062},{"cnt":[[318,2230],[621,2230],[621,2277],[318,2277]],"region":{"top_left_x":317,"top_left_y":2230,"width":304,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70f2709932d64373ba440059257adb54","type":"text","conversion_output":true,"text":"2 treatment arms.","text_display":" 2 treatment arms.","confidence":1,"confidence_rate":1},{"cnt":[[318,2333],[1854,2333],[1854,2387],[318,2387]],"region":{"top_left_x":317,"top_left_y":2333,"width":1538,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f1111287db94801929c623bc08482e4","type":"text","conversion_output":true,"text":"Arm Ixazomib + LenDex: Patients will receive ixazomib ( 4.0 mg ) orally ( PO ) on Days 1,","text_display":"\n\nArm Ixazomib + LenDex: Patients will receive ixazomib ( 4.0 mg ) orally ( PO ) on Days 1,","confidence":0.9670453146100044,"confidence_rate":0.99968090879088},{"cnt":[[320,2398],[1841,2398],[1841,2451],[320,2451]],"region":{"top_left_x":320,"top_left_y":2397,"width":1522,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b61cee3111a46d49071e4ee1cf91e3f","type":"text","conversion_output":true,"text":"8, and 15 plus lenalidomide ( 25 mg ) on Days 1 through 21 and dexamethasone ( 40 mg ) on","text_display":" 8, and 15 plus lenalidomide ( 25 mg ) on Days 1 through 21 and dexamethasone ( 40 mg ) on","confidence":0.9692675996338949,"confidence_rate":0.9997238032413511},{"cnt":[[1074,2582],[1126,2582],[1126,2625],[1074,2625]],"region":{"top_left_x":1074,"top_left_y":2582,"width":52,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e96b915e93ff4bc0840306328edf67c1","type":"page_info","conversion_output":false,"text":"23","text_display":"","confidence":0.998046875,"confidence_rate":0.9990229601966113}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-25","page":25,"lines":[{"cnt":[[318,125],[685,125],[685,174],[318,174]],"region":{"top_left_x":317,"top_left_y":124,"width":369,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d825cc4343244b83a1d74c4a2d434718","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[314,168],[973,168],[973,221],[314,221]],"region":{"top_left_x":313,"top_left_y":167,"width":661,"height":55},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf26de0734444840a53ce41f0dcfeb40","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1876,249],[1876,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1559,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"430864ba222f4d8abc928483e89143ba","type":"text","conversion_output":true,"text":"Days \\(1,8,15\\), and 22 of a 28 -day cycle. Patients may continue to receive treatment until PD","text_display":"\n\nDays \\(1,8,15\\), and 22 of a 28 -day cycle. Patients may continue to receive treatment until PD","confidence":0.9892628192901611,"confidence_rate":0.9998981632969779},{"cnt":[[318,314],[1824,314],[1824,365],[318,365]],"region":{"top_left_x":317,"top_left_y":313,"width":1508,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a53309fc2e1e4a7493a2c03c191fefe2","type":"text","conversion_output":true,"text":"or unacceptable toxicity, whichever comes first. Dose modifications may be made on the","text_display":" or unacceptable toxicity, whichever comes first. Dose modifications may be made on the","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1837,374],[1837,425],[318,425]],"region":{"top_left_x":317,"top_left_y":373,"width":1520,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52b9d333398a4e189f269e0f5f032662","type":"text","conversion_output":true,"text":"basis of toxicities. Patients with creatinine clearance \\(\\leq 60 mL / \\min\\) (or \\(\\leq 50 mL / min\\) based","text_display":" basis of toxicities. Patients with creatinine clearance \\(\\leq 60 mL / \\min\\) (or \\(\\leq 50 mL / min\\) based","confidence":0.5444876737892628,"confidence_rate":0.9943870159306407},{"cnt":[[318,436],[1837,436],[1837,492],[318,492]],"region":{"top_left_x":317,"top_left_y":436,"width":1520,"height":56},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17dfde300ff54103b0e1cdd1365dc309","type":"text","conversion_output":true,"text":"on regional label) will receive a reduced lenalidomide dose of 10 mg once daily on Days 1","text_display":" on regional label) will receive a reduced lenalidomide dose of 10 mg once daily on Days 1","confidence":0.9541015625,"confidence_rate":0.9995206745707406},{"cnt":[[318,498],[1858,498],[1858,552],[318,552]],"region":{"top_left_x":317,"top_left_y":498,"width":1542,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8652d9215834f7081ff91c9b0d277b8","type":"text","conversion_output":true,"text":"through 21 of a 28-day cycle. The lenalidomide dose may be escalated to 15 mg once daily","text_display":" through 21 of a 28-day cycle. 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Patients may continue to receive treatment until PD or","text_display":" and 22 of a 28-day cycle. Patients may continue to receive treatment until PD or","confidence":0.7869672775268555,"confidence_rate":0.9972813317201571},{"cnt":[[318,851],[1871,851],[1871,907],[318,907]],"region":{"top_left_x":317,"top_left_y":850,"width":1555,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95c17527b0a146979f62275002fc8899","type":"text","conversion_output":true,"text":"unacceptable toxicity, whichever comes first. Dose modifications may be made on the basis","text_display":" unacceptable toxicity, whichever comes first. Dose modifications may be made on the basis","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[318,913],[1798,913],[1798,967],[318,967]],"region":{"top_left_x":317,"top_left_y":913,"width":1482,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36bd73cadb0c454f95155b675ca0bb73","type":"text","conversion_output":true,"text":"of toxicities. Patients with creatinine clearance \\(\\leq 60 mL / min\\) (or \\(\\leq 50 mL / min\\) based on","text_display":" of toxicities. Patients with creatinine clearance \\(\\leq 60 mL / min\\) (or \\(\\leq 50 mL / min\\) based on","confidence":0.9970731723589665,"confidence_rate":0.9999720849689001},{"cnt":[[316,975],[1785,975],[1785,1033],[316,1033]],"region":{"top_left_x":315,"top_left_y":975,"width":1471,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a3f9a07d08f48be854e68aa86fc5467","type":"text","conversion_output":true,"text":"regional label) will receive a reduced lenalidomide dose of 10 mg once daily on Days 1","text_display":" regional label) will receive a reduced lenalidomide dose of 10 mg once daily on Days 1","confidence":0.96728515625,"confidence_rate":0.9996499356083073},{"cnt":[[318,1036],[1858,1036],[1858,1094],[318,1094]],"region":{"top_left_x":317,"top_left_y":1035,"width":1542,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"415b6f6099434523a00ca9de9d592e84","type":"text","conversion_output":true,"text":"through 21 of a 28-day cycle. The lenalidomide dose may be escalated to 15 mg once daily","text_display":" through 21 of a 28-day cycle. The lenalidomide dose may be escalated to 15 mg once daily","confidence":0.9814541339874268,"confidence_rate":0.9998146706717916},{"cnt":[[318,1100],[1800,1100],[1800,1156],[318,1156]],"region":{"top_left_x":317,"top_left_y":1100,"width":1484,"height":56},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca976a33e7a7475d8348dff174e88cf0","type":"text","conversion_output":true,"text":"after 2 cycles if the patient is not responding to treatment and is tolerating the treatment.","text_display":" after 2 cycles if the patient is not responding to treatment and is tolerating the treatment.","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[312,1199],[937,1199],[937,1268],[312,1268]],"region":{"top_left_x":311,"top_left_y":1198,"width":626,"height":70},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8a1c961acbd4837a1764beac13400bc","type":"section_header","conversion_output":false,"children_ids":["8982f1a3548742fdb5aaf6e6aaef83c7"],"text":"","text_display":""},{"cnt":[[318,1207],[930,1207],[930,1261],[318,1261]],"region":{"top_left_x":317,"top_left_y":1207,"width":614,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8982f1a3548742fdb5aaf6e6aaef83c7","type":"text","conversion_output":true,"parent_id":"e8a1c961acbd4837a1764beac13400bc","text":"5.7.2.1 Duration of Follow-up","text_display":"\n\n\\subsection*{5.7.2.1 Duration of Follow-up}","confidence":0.99951171875,"confidence_rate":0.9999856353826395},{"cnt":[[318,1293],[1858,1293],[1858,1349],[318,1349]],"region":{"top_left_x":317,"top_left_y":1293,"width":1542,"height":57},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fb7e638188f4724826bb9b82b38fd82","type":"text","conversion_output":true,"text":"The duration of follow-up is defined as time from randomization to the date of death or last","text_display":"\n\nThe duration of follow-up is defined as time from randomization to the date of death or last","confidence":1,"confidence_rate":1},{"cnt":[[318,1354],[1807,1354],[1807,1412],[318,1412]],"region":{"top_left_x":317,"top_left_y":1353,"width":1490,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71e0b167860143afacfd6213f6cff47c","type":"text","conversion_output":true,"text":"known visit. If a subject dies, the duration will equal the date of death minus the date of","text_display":" known visit. If a subject dies, the duration will equal the date of death minus the date of","confidence":1,"confidence_rate":1},{"cnt":[[318,1405],[1861,1405],[1861,1474],[318,1474]],"region":{"top_left_x":317,"top_left_y":1405,"width":1544,"height":69},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa36378b9c2640038b82409de861b994","type":"text","conversion_output":true,"text":"study start +1 , with a censor variable \\(=\\operatorname{col}\\) (censored for follow-up). If a subject is alive, the","text_display":" study start +1 , with a censor variable \\(=\\operatorname{col}\\) (censored for follow-up). If a subject is alive, the","confidence":0.2759748296792878,"confidence_rate":0.9884683954262399},{"cnt":[[318,1480],[1833,1480],[1833,1536],[318,1536]],"region":{"top_left_x":317,"top_left_y":1480,"width":1516,"height":57},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"716f3d2c4d534a129d43c04760d58a07","type":"text","conversion_output":true,"text":"duration will equal the date when the subject was last known to be alive minus the date of","text_display":" duration will equal the date when the subject was last known to be alive minus the date of","confidence":1,"confidence_rate":1},{"cnt":[[318,1543],[1394,1543],[1394,1601],[318,1601]],"region":{"top_left_x":317,"top_left_y":1542,"width":1078,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4555e610034469e866489bb82914839","type":"text","conversion_output":true,"text":"study start +1 , with a censor variable \\(=0\\) (event for follow-up).","text_display":" study start +1 , with a censor variable \\(=0\\) (event for follow-up).","confidence":0.9873478231020272,"confidence_rate":0.9998324759117564},{"cnt":[[312,1641],[883,1641],[883,1712],[312,1712]],"region":{"top_left_x":311,"top_left_y":1641,"width":573,"height":72},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f4d7c93311047069a5f66b4b9e50494","type":"section_header","conversion_output":false,"children_ids":["3d3cd20882c944f190b2448848900def"],"text":"","text_display":""},{"cnt":[[320,1650],[874,1650],[874,1706],[320,1706]],"region":{"top_left_x":320,"top_left_y":1650,"width":555,"height":56},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d3cd20882c944f190b2448848900def","type":"text","conversion_output":true,"parent_id":"1f4d7c93311047069a5f66b4b9e50494","text":"5.7.2.2 Extent of Exposure","text_display":"\n\n\\subsection*{5.7.2.2 Extent of Exposure}","confidence":1,"confidence_rate":1},{"cnt":[[318,1738],[1869,1738],[1869,1790],[318,1790]],"region":{"top_left_x":317,"top_left_y":1738,"width":1553,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d0a606485e94d9ab551dcee81385cd1","type":"text","conversion_output":true,"text":"An overall summary of drug exposure will be presented, including number of treated cycles,","text_display":"\n\nAn overall summary of drug exposure will be presented, including number of treated cycles,","confidence":1,"confidence_rate":1},{"cnt":[[318,1800],[1841,1800],[1841,1854],[318,1854]],"region":{"top_left_x":317,"top_left_y":1800,"width":1525,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f38c7c1394f849639a91a3b88a0fb72e","type":"text","conversion_output":true,"text":"and numbers and percentages of patients who had \\(\\geq 1, \\geq 2, \\ldots\\), and \\(\\geq 18\\) treated cycles, for","text_display":" and numbers and percentages of patients who had \\(\\geq 1, \\geq 2, \\ldots\\), and \\(\\geq 18\\) treated cycles, for","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[318,1861],[1783,1861],[1783,1916],[318,1916]],"region":{"top_left_x":317,"top_left_y":1860,"width":1467,"height":57},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8aac0d8511f24626bb3f7f209e3de29a","type":"text","conversion_output":true,"text":"each treatment group in the Safety population. An aggregate summary of numbers and","text_display":" each treatment group in the Safety population. An aggregate summary of numbers and","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[318,1921],[1876,1921],[1876,1979],[318,1979]],"region":{"top_left_x":317,"top_left_y":1920,"width":1559,"height":59},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bff475c583bd4cb4ac90fa627e86c17a","type":"text","conversion_output":true,"text":"percentages of patients who had 1 to 6,7 to 12,13 to 18 , and \\(\\geq 19\\) treated cycles will also be","text_display":" percentages of patients who had 1 to 6,7 to 12,13 to 18 , and \\(\\geq 19\\) treated cycles will also be","confidence":0.9980480668600649,"confidence_rate":0.9999827095243135},{"cnt":[[318,1987],[793,1987],[793,2039],[318,2039]],"region":{"top_left_x":317,"top_left_y":1987,"width":476,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffdb4f9141274a15877e366942f09038","type":"text","conversion_output":true,"text":"presented in the same table.","text_display":" presented in the same table.","confidence":1,"confidence_rate":1},{"cnt":[[312,2090],[1785,2090],[1785,2144],[312,2144]],"region":{"top_left_x":311,"top_left_y":2090,"width":1475,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b38d45b3b1d483086a496d5963aeb76","type":"text","conversion_output":true,"text":"Additionally, exposure to dexamethasone will be characterized by total amount of dose","text_display":"\n\nAdditionally, exposure to dexamethasone will be characterized by total amount of dose","confidence":1,"confidence_rate":1},{"cnt":[[318,2153],[1867,2153],[1867,2206],[318,2206]],"region":{"top_left_x":317,"top_left_y":2152,"width":1550,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1583020f5f04893b968353aef01f332","type":"text","conversion_output":true,"text":"taken in mg, total number of dose taken, number of treated cycles, numbers and percentages","text_display":" taken in mg, total number of dose taken, number of treated cycles, numbers and percentages","confidence":0.85595703125,"confidence_rate":0.9983641279078032},{"cnt":[[318,2213],[1863,2213],[1863,2271],[318,2271]],"region":{"top_left_x":317,"top_left_y":2212,"width":1546,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b29c3ea43c0542dca3671bfeea964569","type":"text","conversion_output":true,"text":"of patients who had \\(\\geq 1, \\geq 2, \\ldots\\), and \\(\\geq 18\\) treated cycles, and relative dose intensity (\\%) for","text_display":" of patients who had \\(\\geq 1, \\geq 2, \\ldots\\), and \\(\\geq 18\\) treated cycles, and relative dose intensity (\\%) for","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[318,2277],[1785,2277],[1785,2331],[318,2331]],"region":{"top_left_x":317,"top_left_y":2277,"width":1469,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceed74ba17494df19a7af2a8690f44d9","type":"text","conversion_output":true,"text":"each treatment group in the Safety population. An aggregate summary of numbers and","text_display":" each treatment group in the Safety population. An aggregate summary of numbers and","confidence":1,"confidence_rate":1},{"cnt":[[318,2340],[1876,2340],[1876,2396],[318,2396]],"region":{"top_left_x":317,"top_left_y":2339,"width":1559,"height":57},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45021da07109496e9466ddd1951fb3b7","type":"text","conversion_output":true,"text":"percentages of patients who had 1 to 6,7 to 12,13 to 18 , and \\(\\geq 19\\) treated cycles will also be","text_display":" percentages of patients who had 1 to 6,7 to 12,13 to 18 , and \\(\\geq 19\\) treated cycles will also be","confidence":0.9990236759185791,"confidence_rate":0.9999913557807578},{"cnt":[[318,2402],[793,2402],[793,2456],[318,2456]],"region":{"top_left_x":317,"top_left_y":2401,"width":476,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b4a9875e5dd465d8a15abd7dd94a242","type":"text","conversion_output":true,"text":"presented in the same table.","text_display":" presented in the same table.","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":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24929a6c1b9f4b1a9692a2f0827d94de","type":"page_info","conversion_output":false,"text":"24","text_display":"","confidence":0.9990234375,"confidence_rate":0.9995115994824673}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-26","page":26,"lines":[{"cnt":[[318,125],[685,125],[685,174],[318,174]],"region":{"top_left_x":317,"top_left_y":124,"width":369,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42a8aa2ba4b441b592c48349240fc74c","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[316,168],[973,168],[973,221],[316,221]],"region":{"top_left_x":315,"top_left_y":167,"width":659,"height":55},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"46b9f84b9a4f4418927bab0d9b314546","type":"section_header","conversion_output":false,"children_ids":["83d67ab2b5624cba946a72a7f785124b"],"text":"","text_display":""},{"cnt":[[322,172],[969,172],[969,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":647,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83d67ab2b5624cba946a72a7f785124b","type":"text","conversion_output":true,"parent_id":"46b9f84b9a4f4418927bab0d9b314546","text":"Statistical Analysis Plan, Study C16010","text_display":"\n\n\\section*{Statistical Analysis Plan, Study C16010}","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1706,249],[1706,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1389,"height":54},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"825385aeef514838b04e289d31d39316","type":"text","conversion_output":true,"text":"Ixazomib/placebo and lenalidomide exposure will be summarized similarly for the","text_display":"\n\nIxazomib/placebo and lenalidomide exposure will be summarized similarly for the","confidence":1,"confidence_rate":1},{"cnt":[[318,314],[904,314],[904,365],[318,365]],"region":{"top_left_x":317,"top_left_y":313,"width":588,"height":53},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"615f26a0948f462b9fdd8b6f928ea514","type":"text","conversion_output":true,"text":"applicable treatment group/option.","text_display":" applicable treatment group/option.","confidence":1,"confidence_rate":1},{"cnt":[[318,417],[1843,417],[1843,468],[318,468]],"region":{"top_left_x":317,"top_left_y":416,"width":1527,"height":53},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38d7b395f4a448fbbef3f38f8f75e997","type":"text","conversion_output":true,"text":"A treated cycle is defined as a cycle in which the patient received any amount of any study","text_display":"\n\nA treated cycle is defined as a cycle in which the patient received any amount of any study","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[318,477],[415,477],[415,531],[318,531]],"region":{"top_left_x":317,"top_left_y":476,"width":98,"height":55},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6cde61bdc23486681add2b20ea9b8a9","type":"text","conversion_output":true,"text":"drug.","text_display":" drug.","confidence":1,"confidence_rate":1},{"cnt":[[318,580],[1807,580],[1807,634],[318,634]],"region":{"top_left_x":317,"top_left_y":580,"width":1490,"height":54},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f88746872cb4ca8bcc73ac6ba59a3e9","type":"text","conversion_output":true,"text":"A treated cycle for a specific drug is defined as a cycle in which the patient received any","text_display":"\n\nA treated cycle for a specific drug is defined as a cycle in which the patient received any","confidence":1,"confidence_rate":1},{"cnt":[[318,645],[797,645],[797,698],[318,698]],"region":{"top_left_x":317,"top_left_y":644,"width":481,"height":55},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d2b60822613496ea49a2292a50be7b3","type":"text","conversion_output":true,"text":"amount of the specific drug.","text_display":" amount of the specific drug.","confidence":1,"confidence_rate":1},{"cnt":[[449,733],[1878,733],[1878,862],[449,862]],"region":{"top_left_x":449,"top_left_y":732,"width":1429,"height":130},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b0c0d544eeb4fe980756003f343cf1e","type":"math","conversion_output":true,"text":"\\[\n\\text { relative dose intensity }(\\%)=100 \\times \\frac{\\text { total dose received }}{\\text { sum of prescrbed dose over treated cycles }}\n\\]","text_display":"\n\\[\n\\text { relative dose intensity }(\\%)=100 \\times \\frac{\\text { total dose received }}{\\text { sum of prescrbed dose over treated cycles }}\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[318,907],[1837,907],[1837,960],[318,960]],"region":{"top_left_x":317,"top_left_y":906,"width":1520,"height":55},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b1585727b7547feb96061dc7bbacf65","type":"text","conversion_output":true,"text":"The number of patients with \\(100 \\%\\) relative dose intensity, \\(80 \\%\\) to \\(<100 \\%, 50 \\%\\) to \\(<80 \\%\\),","text_display":"\n\nThe number of patients with \\(100 \\%\\) relative dose intensity, \\(80 \\%\\) to \\(<100 \\%, 50 \\%\\) to \\(<80 \\%\\),","confidence":0.9416462341323495,"confidence_rate":0.9994048739640117},{"cnt":[[318,971],[1508,971],[1508,1023],[318,1023]],"region":{"top_left_x":317,"top_left_y":971,"width":1192,"height":52},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b63cd6c263f448085b17e35567c857a","type":"text","conversion_output":true,"text":"and \\(<50 \\%\\) will be summarized by treatment group and for all patients.","text_display":" and \\(<50 \\%\\) will be summarized by treatment group and for all patients.","confidence":1,"confidence_rate":1},{"cnt":[[318,1074],[1863,1074],[1863,1128],[318,1128]],"region":{"top_left_x":317,"top_left_y":1074,"width":1546,"height":54},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a178093c51c405795e494a44eb411a3","type":"text","conversion_output":true,"text":"Percent compliance is calculated as \\(100 \\%\\) * (study drug taken in mg ) / (study drug expected","text_display":"\n\nPercent compliance is calculated as \\(100 \\%\\) * (study drug taken in mg ) / (study drug expected","confidence":0.6907468394408625,"confidence_rate":0.9964825636692449},{"cnt":[[318,1139],[1725,1139],[1725,1188],[318,1188]],"region":{"top_left_x":317,"top_left_y":1138,"width":1409,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d7aee8378fd43e79d7d3fbe4827c669","type":"text","conversion_output":true,"text":"to be taken in mg ). Only reduced prescribed or increased prescribed or dose hold or","text_display":" to be taken in mg ). Only reduced prescribed or increased prescribed or dose hold or","confidence":0.990234375,"confidence_rate":0.9998967040569899},{"cnt":[[318,1199],[1463,1199],[1463,1250],[318,1250]],"region":{"top_left_x":317,"top_left_y":1198,"width":1147,"height":53},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44dffe6e42cc4bf4b65e270fef3a792b","type":"text","conversion_output":true,"text":"discontinued permanently will change the expected prescribed dose.","text_display":" discontinued permanently will change the expected prescribed dose.","confidence":1,"confidence_rate":1},{"cnt":[[318,1302],[1276,1302],[1276,1356],[318,1356]],"region":{"top_left_x":317,"top_left_y":1301,"width":960,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"693307bc7f5543ebb211fc8fad407923","type":"text","conversion_output":true,"text":"Dosing data will also be presented in a by-patient listing.","text_display":"\n\nDosing data will also be presented in a by-patient listing.","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[314,1405],[984,1405],[984,1459],[314,1459]],"region":{"top_left_x":313,"top_left_y":1405,"width":671,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56429214bb054966be792f297b19dcc1","type":"section_header","conversion_output":false,"children_ids":["918f0a8748424a68949bbead1cb6a30a"],"text":"","text_display":""},{"cnt":[[318,1409],[978,1409],[978,1454],[318,1454]],"region":{"top_left_x":317,"top_left_y":1409,"width":661,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"918f0a8748424a68949bbead1cb6a30a","type":"text","conversion_output":true,"parent_id":"56429214bb054966be792f297b19dcc1","text":"5.7.2.3 Treatment Modifications","text_display":"\n\n\\subsection*{5.7.2.3 Treatment 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cycles","text_display":" remainder cycles, Cycles 1 through 6, Cycles 7 through 12, 13 through 18, and \\(\\geq 19\\) cycles","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[318,1626],[1313,1626],[1313,1678],[318,1678]],"region":{"top_left_x":317,"top_left_y":1626,"width":996,"height":52},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a213f85e146044d4aa69438d40002ed0","type":"text","conversion_output":true,"text":"and total for each treatment group in the Safety population.","text_display":" and total for each treatment group in the Safety 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IMWG criteria as","text_display":" date of first documentation of PD based on central laboratory results and IMWG criteria as","confidence":1,"confidence_rate":1},{"cnt":[[318,2200],[1852,2200],[1852,2249],[318,2249]],"region":{"top_left_x":317,"top_left_y":2200,"width":1535,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bcfc4e2aa67c44059d65161bfe428b02","type":"text","conversion_output":true,"text":"evaluated by an IRC, or death due to any cause, whichever occurs first. 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The details regarding the handling of","text_display":"\nassessment that is stable disease (SD) or better. 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Suryival}","confidence":0.982421875,"confidence_rate":0.9991558586336801},{"cnt":[[320,1942],[1833,1942],[1833,1989],[320,1989]],"region":{"top_left_x":320,"top_left_y":1942,"width":1513,"height":48},"line":75,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21e87459389d475eb2d44d893c87cea6","type":"text","conversion_output":true,"text":"Overall survival is defined as the time from the date of randomization to the date of death.","text_display":"\n\nOverall survival is defined as the time from the date of randomization to the date of death.","confidence":1,"confidence_rate":1},{"cnt":[[318,2004],[1828,2004],[1828,2056],[318,2056]],"region":{"top_left_x":317,"top_left_y":2004,"width":1512,"height":53},"line":76,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"798d239157a5412d9b97c69da4eaff6c","type":"text","conversion_output":true,"text":"Patients without documentation of death at the time of the analysis will be censored at the","text_display":" Patients without documentation of death at the time of the analysis will be censored at the","confidence":1,"confidence_rate":1},{"cnt":[[318,2067],[1871,2067],[1871,2116],[318,2116]],"region":{"top_left_x":317,"top_left_y":2066,"width":1555,"height":51},"line":77,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32764e0e4955494ab44ed518d8573345","type":"text","conversion_output":true,"text":"date when they were last known to be alive. Overall survival will be analyzed using the ITT","text_display":" date when they were last known to be alive. Overall survival will be analyzed using the ITT","confidence":1,"confidence_rate":1},{"cnt":[[318,2127],[518,2127],[518,2181],[318,2181]],"region":{"top_left_x":317,"top_left_y":2126,"width":201,"height":55},"line":78,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f766714ce5d04cdaadfc2c3dca4cb317","type":"text","conversion_output":true,"text":"population.","text_display":" population.","confidence":1,"confidence_rate":1},{"cnt":[[314,2230],[1257,2230],[1257,2288],[314,2288]],"region":{"top_left_x":313,"top_left_y":2230,"width":944,"height":59},"line":79,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bb889ed98c64747a8cac2052a0ca627","type":"section_header","conversion_output":false,"children_ids":["07555c42c50f4750827091d805b9b599"],"text":"","text_display":""},{"cnt":[[320,2234],[1250,2234],[1250,2284],[320,2284]],"region":{"top_left_x":320,"top_left_y":2234,"width":931,"height":50},"line":80,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07555c42c50f4750827091d805b9b599","type":"text","conversion_output":true,"parent_id":"3bb889ed98c64747a8cac2052a0ca627","text":"Overall Survival in High-Risk Patients With del(17)","text_display":"\n\n\\section*{Overall Survival in High-Risk Patients With del(17)}","confidence":1,"confidence_rate":1},{"cnt":[[318,2368],[1852,2368],[1852,2421],[318,2421]],"region":{"top_left_x":317,"top_left_y":2367,"width":1535,"height":55},"line":81,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb2dbbf474234ecaaf0743f45966e22e","type":"text","conversion_output":true,"text":"The high-risk patients with del(17) subgroup is defined as the cases reported as positive for","text_display":"\n\nThe high-risk patients with del(17) subgroup is defined as the cases reported as positive for","confidence":1,"confidence_rate":1},{"cnt":[[318,2432],[1813,2432],[1813,2484],[318,2484]],"region":{"top_left_x":317,"top_left_y":2432,"width":1497,"height":52},"line":82,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dbf0dcde9164d539f083fd6a814a585","type":"text","conversion_output":true,"text":"del(17) by the central laboratory combined with those cases that lack a central laboratory","text_display":" del(17) by the central laboratory combined with those cases that lack a central laboratory","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[1072,2582],[1126,2582],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2582,"width":54,"height":46},"line":83,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36d9b6a41ad7444d8f6cb42d3d7f47bb","type":"page_info","conversion_output":false,"text":"28","text_display":"","confidence":0.94580078125,"confidence_rate":0.9725228949747147}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-30","page":30,"lines":[{"cnt":[[318,125],[685,125],[685,174],[318,174]],"region":{"top_left_x":317,"top_left_y":124,"width":369,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9813407401f3401a8541b2a1a2df466a","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,168],[973,168],[973,221],[318,221]],"region":{"top_left_x":317,"top_left_y":167,"width":657,"height":55},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b87998b6e71f4276927b573074e162c0","type":"section_header","conversion_output":false,"children_ids":["3d43b89b0c0f41098abb247d89d7d15c"],"text":"","text_display":""},{"cnt":[[322,172],[969,172],[969,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":647,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d43b89b0c0f41098abb247d89d7d15c","type":"text","conversion_output":true,"parent_id":"b87998b6e71f4276927b573074e162c0","text":"Statistical Analysis Plan, Study C16010","text_display":"\n\n\\section*{Statistical Analysis Plan, Study C16010}","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1738,249],[1738,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1422,"height":54},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2014ef957bed495cacc3b0a3aa7fcf23","type":"text","conversion_output":true,"text":"result for \\(\\operatorname{del}(17)\\) and were reported positive for \\(\\operatorname{del}(17)\\) by local laboratory. Overall","text_display":"\nresult for \\(\\operatorname{del}(17)\\) and were reported positive for \\(\\operatorname{del}(17)\\) by local laboratory. 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The second key secondary endpoint will be","text_display":" 2) OS in high-risk patients carrying del(17). The second key secondary endpoint will be","confidence":0.945950984954834,"confidence_rate":0.9993962201287219},{"cnt":[[318,692],[1708,692],[1708,746],[318,746]],"region":{"top_left_x":317,"top_left_y":691,"width":1392,"height":55},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a860f4ea8914b9db30863c3ed5761f8","type":"text","conversion_output":true,"text":"tested only if the test for OS is statistically significant at the IAs or FA at the same","text_display":" tested only if the test for OS is statistically significant at the IAs or FA at the same","confidence":1,"confidence_rate":1},{"cnt":[[318,756],[1729,756],[1729,810],[318,810]],"region":{"top_left_x":317,"top_left_y":756,"width":1413,"height":54},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"449c8f138de54dc5b2e26816327aca80","type":"text","conversion_output":true,"text":"significance level as OS to ensure strong type I error control for both key secondary","text_display":" significance level as OS to ensure strong type I error control for both key secondary","confidence":1,"confidence_rate":1},{"cnt":[[320,819],[501,819],[501,870],[320,870]],"region":{"top_left_x":320,"top_left_y":818,"width":181,"height":53},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f1126aa44a64dd6aeb2c52d1e2be3c5","type":"text","conversion_output":true,"text":"endpoints.","text_display":" endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[316,920],[629,920],[629,973],[316,973]],"region":{"top_left_x":315,"top_left_y":919,"width":315,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de5288f621c6497ba621df77c5dd6f01","type":"section_header","conversion_output":false,"children_ids":["8db4573ad8c74ee8aeaee42592fab417"],"text":"","text_display":""},{"cnt":[[322,924],[625,924],[625,969],[322,969]],"region":{"top_left_x":322,"top_left_y":923,"width":304,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8db4573ad8c74ee8aeaee42592fab417","type":"text","conversion_output":true,"parent_id":"de5288f621c6497ba621df77c5dd6f01","text":"Overall Survival","text_display":"\n\n\\section*{Overall Survival}","confidence":1,"confidence_rate":1},{"cnt":[[318,1010],[1781,1010],[1781,1063],[318,1063]],"region":{"top_left_x":317,"top_left_y":1009,"width":1465,"height":55},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7108e792d3354fd8ab6e41c7e7aa52d6","type":"text","conversion_output":true,"text":"Overall survival will be tested only after statistical significance is achieved for PFS. A","text_display":"\n\nOverall survival will be tested only after statistical significance is achieved for PFS. A","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[318,1074],[1858,1074],[1858,1124],[318,1124]],"region":{"top_left_x":317,"top_left_y":1074,"width":1542,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd0dbfc37e9945b7929c037d18a39aa2","type":"text","conversion_output":true,"text":"2-sided, stratified log-rank test will be used to compare the treatment groups with respect to","text_display":" 2-sided, stratified log-rank test will be used to compare the treatment groups with respect to","confidence":0.970703125,"confidence_rate":0.9996996956161195},{"cnt":[[318,1134],[1850,1134],[1850,1188],[318,1188]],"region":{"top_left_x":317,"top_left_y":1134,"width":1533,"height":55},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"818658a03b2c4b36a8307be66df5fbc3","type":"text","conversion_output":true,"text":"OS. 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The K-M survival curves and K-M medians (if estimable), along","text_display":" the stratification factors. 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discontinue study treatment, the following 2 methods will be used:","confidence":1,"confidence_rate":1},{"cnt":[[382,2067],[1549,2067],[1549,2125],[382,2125]],"region":{"top_left_x":382,"top_left_y":2066,"width":1168,"height":59},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdab3ffc51304d2aa9c8d9606aab9fbb","type":"text","conversion_output":true,"text":"- Marginal Structural Models (MSMs) by Robins and Finkelstein \\({ }^{(2)}\\)","text_display":"\n- Marginal Structural Models (MSMs) by Robins and Finkelstein \\({ }^{(2)}\\)","confidence":1,"confidence_rate":1},{"cnt":[[382,2179],[1704,2179],[1704,2232],[382,2232]],"region":{"top_left_x":382,"top_left_y":2178,"width":1322,"height":55},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"912c52ba9a6d4d82ad98650488ddd331","type":"text","conversion_output":true,"text":"- Inverse Probability of Censoring Weighted (IPCW) method by Robins and","text_display":"\n- Inverse 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The estimated mean difference in the changes","confidence":1,"confidence_rate":1},{"cnt":[[320,1848],[1562,1848],[1562,1901],[320,1901]],"region":{"top_left_x":320,"top_left_y":1847,"width":1242,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db94ea946d364f3581e7601d67fff824","type":"text","conversion_output":true,"text":"from baseline between the 2 treatments and the \\(95 \\%\\) CIs will be provided.","text_display":" from baseline between the 2 treatments and the \\(95 \\%\\) CIs will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[318,1953],[1871,1953],[1871,2004],[318,2004]],"region":{"top_left_x":317,"top_left_y":1952,"width":1555,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ca9ed9b8529412e8509965e80379a93","type":"text","conversion_output":true,"text":"Details of scoring and initial handling of missing data are included in the EORTC QLQ-C30","text_display":"\n\nDetails of scoring and initial handling of missing data are included in the EORTC QLQ-C30","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[318,2015],[831,2015],[831,2067],[318,2067]],"region":{"top_left_x":317,"top_left_y":2015,"width":515,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65752f593cf44cefb79d4af07339d035","type":"text","conversion_output":true,"text":"and MY20 scoring guidelines.","text_display":" and MY20 scoring guidelines.","confidence":0.9417624436318874,"confidence_rate":0.9981834029470532},{"cnt":[[316,2118],[1764,2118],[1764,2172],[316,2172]],"region":{"top_left_x":315,"top_left_y":2118,"width":1449,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63c6fc14512a4b6b8663754ad6111458","type":"text","conversion_output":true,"text":"Missing data patterns will be examined. For sensitivity analyses, different imputation","text_display":"\n\nMissing data patterns will be examined. For sensitivity analyses, different imputation","confidence":1,"confidence_rate":1},{"cnt":[[318,2183],[1867,2183],[1867,2237],[318,2237]],"region":{"top_left_x":317,"top_left_y":2182,"width":1550,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f46ec3b44f4944bcb71d9bdda874714a","type":"text","conversion_output":true,"text":"methods for missing data including LOCF, the random slope model, and the pattern mixture","text_display":" methods for missing data including LOCF, the random slope model, and the pattern mixture","confidence":1,"confidence_rate":1},{"cnt":[[318,2243],[1631,2243],[1631,2297],[318,2297]],"region":{"top_left_x":317,"top_left_y":2242,"width":1314,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2f857387cae4614aad38a15fbd7d376","type":"text","conversion_output":true,"text":"model may be performed if appropriate after examining missing data patterns.","text_display":" model may be performed if appropriate after examining missing data patterns.","confidence":1,"confidence_rate":1},{"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":"6cb5da308d71452bb98753557738d4df","type":"page_info","conversion_output":false,"text":"35","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-37","page":37,"lines":[{"cnt":[[322,129],[681,129],[681,170],[322,170]],"region":{"top_left_x":322,"top_left_y":128,"width":360,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3f50fdac2d1418aa85da2f0e81d0a4d","type":"page_info","conversion_output":false,"text":"MLN9708 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C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[314,249],[1338,249],[1338,307],[314,307]],"region":{"top_left_x":313,"top_left_y":249,"width":1026,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80e267700be54135ba62de9c79204df5","type":"section_header","conversion_output":false,"children_ids":["fb2e133b75f04276b517d54bc5b376c9"],"text":"","text_display":""},{"cnt":[[320,254],[1334,254],[1334,303],[320,303]],"region":{"top_left_x":320,"top_left_y":253,"width":1015,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb2e133b75f04276b517d54bc5b376c9","type":"text","conversion_output":true,"parent_id":"80e267700be54135ba62de9c79204df5","text":"5.10.2 Health Economics (Health Care Resource Use)","text_display":"\n\n\\subsection*{5.10.2 Health Economics (Health Care Resource Use)}","confidence":1,"confidence_rate":1},{"cnt":[[320,339],[1783,339],[1783,389],[320,389]],"region":{"top_left_x":320,"top_left_y":339,"width":1464,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"753396db788644eb896f50f93369b81e","type":"text","conversion_output":true,"text":"EuroQol 5 Dimensional Health Questionnaire scores will be summarized in descriptive","text_display":"\n\nEuroQol 5 Dimensional Health Questionnaire scores will be summarized in descriptive","confidence":1,"confidence_rate":1},{"cnt":[[322,404],[969,404],[969,449],[322,449]],"region":{"top_left_x":322,"top_left_y":403,"width":647,"height":47},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fafb27fdb42456f9a359b3eaabfc87a","type":"text","conversion_output":true,"text":"statistics for treatment arms over time.","text_display":" statistics for treatment arms over time.","confidence":1,"confidence_rate":1},{"cnt":[[320,507],[1807,507],[1807,559],[320,559]],"region":{"top_left_x":320,"top_left_y":507,"width":1487,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d39ab19b27d543a7a087721db44b1b16","type":"text","conversion_output":true,"text":"Health utilization data will be summarized in descriptive statistics of medical encounters","text_display":"\n\nHealth utilization data will be summarized in descriptive statistics of medical encounters","confidence":1,"confidence_rate":1},{"cnt":[[322,569],[1803,569],[1803,621],[322,621]],"region":{"top_left_x":322,"top_left_y":569,"width":1481,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33ba24c9056f43e58f39cf378b470207","type":"text","conversion_output":true,"text":"(length of stay, inpatient, outpatient, and reason), number of missing days from work, or","text_display":" (length of stay, inpatient, outpatient, and reason), number of missing days from work, or","confidence":1,"confidence_rate":1},{"cnt":[[320,632],[1330,632],[1330,681],[320,681]],"region":{"top_left_x":320,"top_left_y":631,"width":1010,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc110dd1390e4d6d99692a6dac9fb0e6","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 arms.","confidence":1,"confidence_rate":1},{"cnt":[[318,735],[1459,735],[1459,786],[318,786]],"region":{"top_left_x":317,"top_left_y":734,"width":1142,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ac3bacb22084262a48df5534a96591e","type":"text","conversion_output":true,"text":"Further modeling will be performed separately at post hoc analyses.","text_display":"\n\nFurther modeling will be performed separately at post hoc analyses.","confidence":1,"confidence_rate":1},{"cnt":[[316,838],[591,838],[591,887],[316,887]],"region":{"top_left_x":315,"top_left_y":837,"width":276,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f9b189cd2f242c78626ddcece5a02dd","type":"section_header","conversion_output":false,"children_ids":["9fc4a42690dc409bbcf4031a5c29b378"],"text":"","text_display":""},{"cnt":[[322,842],[587,842],[587,883],[322,883]],"region":{"top_left_x":322,"top_left_y":842,"width":265,"height":42},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fc4a42690dc409bbcf4031a5c29b378","type":"text","conversion_output":true,"parent_id":"4f9b189cd2f242c78626ddcece5a02dd","text":"5.10.3 Pain","text_display":"\n\n\\subsection*{5.10.3 Pain}","confidence":1,"confidence_rate":1},{"cnt":[[318,928],[1785,928],[1785,982],[318,982]],"region":{"top_left_x":317,"top_left_y":928,"width":1469,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b69e317a570e4f83bd3e17b369b9818d","type":"text","conversion_output":true,"text":"Pain response rate will be analyzed in patients with a baseline pain score \\(\\geq 4\\) in the ITT","text_display":"\n\nPain response rate will be analyzed in patients with a baseline pain score \\(\\geq 4\\) in the ITT","confidence":1,"confidence_rate":1},{"cnt":[[318,993],[1824,993],[1824,1042],[318,1042]],"region":{"top_left_x":317,"top_left_y":992,"width":1508,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c57676cf87c406ba34669460935f382","type":"text","conversion_output":true,"text":"population. 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":1,"confidence_rate":1},{"cnt":[[318,1053],[1742,1053],[1742,1104],[318,1104]],"region":{"top_left_x":317,"top_left_y":1052,"width":1426,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b823d2585ea04d81b6098b4598688f87","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":0.9990234375,"confidence_rate":0.9999885054819704},{"cnt":[[318,1113],[1863,1113],[1863,1167],[318,1167]],"region":{"top_left_x":317,"top_left_y":1112,"width":1546,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c81cf6c1019f4b7a997d30b18286f6f7","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":[[318,1177],[1841,1177],[1841,1231],[318,1231]],"region":{"top_left_x":317,"top_left_y":1177,"width":1525,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"930f335f83f04dadaa29dfcf623c2bc3","type":"text","conversion_output":true,"text":"pain response rate will be provided, along with the \\(95 \\% CI\\). A CDF plot will be generated","text_display":" pain response rate will be provided, along with the \\(95 \\% CI\\). A CDF plot will be generated","confidence":0.9814453125,"confidence_rate":0.9998108362259831},{"cnt":[[318,1240],[625,1240],[625,1291],[318,1291]],"region":{"top_left_x":317,"top_left_y":1239,"width":309,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cf0de728cae4afcbef7e65c7ba63627","type":"text","conversion_output":true,"text":"for pain response.","text_display":" for pain response.","confidence":1,"confidence_rate":1},{"cnt":[[320,1345],[1779,1345],[1779,1399],[320,1399]],"region":{"top_left_x":320,"top_left_y":1344,"width":1459,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"510ea4f0d467485c915ec29eb60bdf92","type":"text","conversion_output":true,"text":"Pain response is defined as the occurrence of a \\(30 \\%\\) reduction from baseline in BPI-SF","text_display":"\n\nPain response is defined as the occurrence of a \\(30 \\%\\) reduction from baseline in BPI-SF","confidence":0.9892749786376953,"confidence_rate":0.9998840610337063},{"cnt":[[318,1405],[1858,1405],[1858,1459],[318,1459]],"region":{"top_left_x":317,"top_left_y":1405,"width":1542,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6e30fdb096443ebbdc29431a058f9e3","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 consecutive","confidence":1,"confidence_rate":1},{"cnt":[[318,1470],[529,1470],[529,1515],[318,1515]],"region":{"top_left_x":317,"top_left_y":1469,"width":212,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b20d637f8984f60a14e37370c67833e","type":"text","conversion_output":true,"text":"evaluations.","text_display":" 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to","confidence":0.99609375,"confidence_rate":0.9999550136633968},{"cnt":[[443,1740],[1145,1740],[1145,1794],[443,1794]],"region":{"top_left_x":442,"top_left_y":1740,"width":704,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"345f5e49b01e473fb609027eb587081d","type":"text","conversion_output":true,"text":"initial response/progression classification","text_display":" initial response/progression classification","confidence":1,"confidence_rate":1},{"cnt":[[382,1848],[1785,1848],[1785,1901],[382,1901]],"region":{"top_left_x":382,"top_left_y":1847,"width":1404,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d48bb0566254c0c9f6a3316c6b68753","type":"text","conversion_output":true,"text":"- Duration of pain response, measured as the time from the first documented pain","text_display":"\n- Duration of pain response, measured as the time from the first documented pain","confidence":1,"confidence_rate":1},{"cnt":[[443,1912],[1515,1912],[1515,1964],[443,1964]],"region":{"top_left_x":442,"top_left_y":1912,"width":1073,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0348f039791b43259a65e436d8f3010a","type":"text","conversion_output":true,"text":"response to the first documented pain progression classification","text_display":" response to the first documented pain progression classification","confidence":1,"confidence_rate":1},{"cnt":[[318,2015],[1871,2015],[1871,2067],[318,2067]],"region":{"top_left_x":317,"top_left_y":2015,"width":1555,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db2b2c00f8944fa2bcbd0a7a61fb58ac","type":"text","conversion_output":true,"text":"Time to pain progression and duration of pain response will be compared using the stratified","text_display":"\n\nTime to pain progression and duration of pain response will be compared using the stratified","confidence":1,"confidence_rate":1},{"cnt":[[318,2133],[318,2073],[1824,2075],[1824,2136]],"region":{"top_left_x":317,"top_left_y":2073,"width":1508,"height":63},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79799e8e73d94a8fa50a0d3bdbfc8ef9","type":"text","conversion_output":true,"text":"fog-rank test between the 2 treatment groups. An unadjusted stratified Cox model will be","text_display":" fog-rank test between the 2 treatment groups. An unadjusted stratified Cox model will be","confidence":0.53759765625,"confidence_rate":0.9935558029603233},{"cnt":[[318,2140],[1699,2140],[1699,2191],[318,2191]],"region":{"top_left_x":317,"top_left_y":2139,"width":1383,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44409b89114f42fb95796ca67c33d811","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":0.9829459190368652,"confidence_rate":0.9998067470287096},{"cnt":[[318,2200],[1858,2200],[1858,2254],[318,2254]],"region":{"top_left_x":317,"top_left_y":2200,"width":1542,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e077489f52904072a0dcd3df48f31294","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":[[318,2264],[1854,2264],[1854,2316],[318,2316]],"region":{"top_left_x":317,"top_left_y":2264,"width":1538,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9029e57918d45eab3bebcebfa82c680","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":0.9728323617018759,"confidence_rate":0.9997300021248957},{"cnt":[[318,2327],[1480,2327],[1480,2378],[318,2378]],"region":{"top_left_x":317,"top_left_y":2326,"width":1164,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46e53edb06b64e4ab556d2e0f4b573f8","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":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":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d1640e2816f41329266937aad330dae","type":"page_info","conversion_output":false,"text":"36","text_display":"","confidence":0.998046875,"confidence_rate":0.9990229601966113}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-38","page":38,"lines":[{"cnt":[[320,125],[683,125],[683,174],[320,174]],"region":{"top_left_x":320,"top_left_y":124,"width":364,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d6b1f7d96c6423a9a280fc4c384fe9b","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,168],[973,168],[973,221],[318,221]],"region":{"top_left_x":317,"top_left_y":167,"width":657,"height":55},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d88943df50b745f39430ddcb4bc60286","type":"section_header","conversion_output":false,"children_ids":["b66989f0a5244252aa2af8f2c484a0e3"],"text":"","text_display":""},{"cnt":[[322,172],[969,172],[969,217],[322,217]],"region":{"top_left_x":322,"top_left_y":171,"width":647,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b66989f0a5244252aa2af8f2c484a0e3","type":"text","conversion_output":true,"parent_id":"d88943df50b745f39430ddcb4bc60286","text":"Statistical Analysis Plan, Study C16010","text_display":"\n\n\\section*{Statistical Analysis Plan, Study C16010}","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1742,249],[1742,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1426,"height":54},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab51bf6a249440c78b05679fa60274ff","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":1,"confidence_rate":1},{"cnt":[[320,314],[1858,314],[1858,363],[320,363]],"region":{"top_left_x":320,"top_left_y":313,"width":1539,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"abfab047227e4b9a9cfc59a427974b9a","type":"text","conversion_output":true,"text":"2 consecutive evaluations. 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To qualify as progression, the patient must have a worst BPI-SF","confidence":1,"confidence_rate":1},{"cnt":[[320,374],[814,374],[814,425],[320,425]],"region":{"top_left_x":320,"top_left_y":373,"width":495,"height":53},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22b13da79222427d88bd1fa00457d076","type":"text","conversion_output":true,"text":"score \\(\\geq 4\\) during progression.","text_display":" score \\(\\geq 4\\) during progression.","confidence":1,"confidence_rate":1},{"cnt":[[382,481],[1837,481],[1837,535],[382,535]],"region":{"top_left_x":382,"top_left_y":481,"width":1455,"height":54},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00098c5a92c945b2b7131e0df8dba109","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 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(SAEs)","confidence":1,"confidence_rate":1},{"cnt":[[318,1659],[1807,1659],[1807,1708],[318,1708]],"region":{"top_left_x":317,"top_left_y":1658,"width":1490,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"427a3d24203d4661a65fc78389c1bea9","type":"text","conversion_output":true,"text":"Patients with the same AE more than once will have that event counted only once within","text_display":"\n\nPatients with the same AE more than once will have that event counted only once within","confidence":0.99853515625,"confidence_rate":0.999983891144227},{"cnt":[[318,1721],[1876,1721],[1876,1772],[318,1772]],"region":{"top_left_x":317,"top_left_y":1720,"width":1559,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"719f3feaddd64cadb40b1ad23328ca8f","type":"text","conversion_output":true,"text":"each body system, once within each High Level Term, and once within each Preferred Term.","text_display":" each body system, once within each High Level Term, and once within each Preferred Term.","confidence":1,"confidence_rate":1},{"cnt":[[318,1824],[1775,1824],[1775,1876],[318,1876]],"region":{"top_left_x":317,"top_left_y":1824,"width":1458,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3c2b16c741f44bf817356dc3753e729","type":"text","conversion_output":true,"text":"Drug-related treatment-emergent AEs will also be summarized by the National Cancer","text_display":"\n\nDrug-related treatment-emergent AEs will also be summarized by the National Cancer","confidence":1,"confidence_rate":1},{"cnt":[[318,1886],[1867,1886],[1867,1936],[318,1936]],"region":{"top_left_x":317,"top_left_y":1886,"width":1550,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c48512b4f61c427b939752eb94bc8481","type":"text","conversion_output":true,"text":"Institute Common Toxicity Criteria (NCI CTCAE) version 4.03. Patients with the same AE","text_display":" Institute Common Toxicity Criteria (NCI CTCAE) version 4.03. Patients with the same AE","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[318,1949],[1807,1949],[1807,2000],[318,2000]],"region":{"top_left_x":317,"top_left_y":1948,"width":1490,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae9909b9c2c8457784d1d3ac5cb49ab5","type":"text","conversion_output":true,"text":"more than once will have the maximum intensity of that event counted within each body","text_display":" more than once will have the maximum intensity of that event counted within each body","confidence":1,"confidence_rate":1},{"cnt":[[318,2011],[1697,2011],[1697,2065],[318,2065]],"region":{"top_left_x":317,"top_left_y":2010,"width":1381,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd2d84c459f64f4bb0b020393aa2ef79","type":"text","conversion_output":true,"text":"system, once within each High Level Term, and once within each Preferred Term.","text_display":" system, once within each High Level Term, and once within each Preferred Term.","confidence":1,"confidence_rate":1},{"cnt":[[314,2118],[1846,2118],[1846,2168],[314,2168]],"region":{"top_left_x":313,"top_left_y":2118,"width":1533,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cc9a3d666204daea8fe4cfbc5e9b206","type":"text","conversion_output":true,"text":"The most commonly reported treatment-emergent AEs (ie, those events reported by \\(\\geq 10 \\%\\)","text_display":"\n\nThe most commonly reported treatment-emergent AEs (ie, those events reported by \\(\\geq 10 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[318,2183],[1867,2183],[1867,2232],[318,2232]],"region":{"top_left_x":317,"top_left_y":2182,"width":1550,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fefb5722619498e8e1e4fc6d8e82ed5","type":"text","conversion_output":true,"text":"of any treatment arm) will be tabulated by Preferred Term. Patients with the same AE more","text_display":" of any treatment arm) will be tabulated by Preferred Term. Patients with the same AE more","confidence":1,"confidence_rate":1},{"cnt":[[318,2243],[1622,2243],[1622,2297],[318,2297]],"region":{"top_left_x":317,"top_left_y":2242,"width":1306,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1a669202cac47bc90c841c332849449","type":"text","conversion_output":true,"text":"than once will have that event counted only once within each Preferred Term.","text_display":" than once will have that event counted only once within each Preferred Term.","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[318,2348],[1880,2348],[1880,2400],[318,2400]],"region":{"top_left_x":317,"top_left_y":2348,"width":1563,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7d2ba0c86744ce28d4009414371a8a4","type":"text","conversion_output":true,"text":"An overall summary AE table will include numbers and percentages of patients who had any","text_display":"\n\nAn overall summary AE table will include numbers and percentages of patients who had any","confidence":1,"confidence_rate":1},{"cnt":[[318,2411],[1792,2411],[1792,2460],[318,2460]],"region":{"top_left_x":317,"top_left_y":2410,"width":1475,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12ae7b5aad424e419ee342ce4fc499e9","type":"text","conversion_output":true,"text":"AE, drug-related AE, Grade 3 or higher AE (also Grade 3 and 4 AE), Grade 3 or higher","text_display":" AE, drug-related AE, Grade 3 or higher AE (also Grade 3 and 4 AE), Grade 3 or higher","confidence":1,"confidence_rate":1},{"cnt":[[1072,2587],[1126,2587],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2586,"width":54,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25710a5b5a49421eaa591b39a34c4116","type":"page_info","conversion_output":false,"text":"38","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-40","page":40,"lines":[{"cnt":[[318,125],[683,125],[683,174],[318,174]],"region":{"top_left_x":317,"top_left_y":124,"width":367,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"497daeaee0be40a48c0a598d7598a0c6","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[316,168],[973,168],[973,221],[316,221]],"region":{"top_left_x":315,"top_left_y":167,"width":659,"height":55},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e66d26ff148463d928cdafc37391a10","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,249],[1706,249],[1706,303],[318,303]],"region":{"top_left_x":317,"top_left_y":249,"width":1389,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a27856942224f25b3ec4e2eac63665c","type":"text","conversion_output":true,"text":"drug-related AE (also Grade 3 and 4 AE), SAE, drug-related SAE, AE resulting in","text_display":"\ndrug-related AE (also Grade 3 and 4 AE), SAE, drug-related SAE, AE resulting in","confidence":1,"confidence_rate":1},{"cnt":[[318,314],[1800,314],[1800,365],[318,365]],"region":{"top_left_x":317,"top_left_y":313,"width":1484,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6da2b763f4984d0aa2b4b529dfbfc2a7","type":"text","conversion_output":true,"text":"discontinuation, and on-study deaths. On-study death is defined as the death that occurs","text_display":" discontinuation, and on-study deaths. On-study death is defined as the death that occurs","confidence":1,"confidence_rate":1},{"cnt":[[318,374],[1803,374],[1803,425],[318,425]],"region":{"top_left_x":317,"top_left_y":373,"width":1486,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c58a4e81e53461db39dd2c6bceada0f","type":"text","conversion_output":true,"text":"between the first dose of any study drug and within 30 days of the last dose of any study","text_display":" between the first dose of any study drug and within 30 days of the last dose of any study","confidence":1,"confidence_rate":1},{"cnt":[[320,438],[415,438],[415,488],[320,488]],"region":{"top_left_x":320,"top_left_y":438,"width":95,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff4bed57e8744340a4bbb9701af5a765","type":"text","conversion_output":true,"text":"drug.","text_display":" drug.","confidence":1,"confidence_rate":1},{"cnt":[[318,541],[1727,541],[1727,593],[318,593]],"region":{"top_left_x":317,"top_left_y":541,"width":1411,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"803f30d642294f598020155a3cd35ab6","type":"text","conversion_output":true,"text":"Incidence rates will be calculated for the safety population based on AEs and SAEs.","text_display":"\n\nIncidence rates will be calculated for the safety population based on AEs and SAEs.","confidence":1,"confidence_rate":1},{"cnt":[[320,604],[1794,604],[1794,655],[320,655]],"region":{"top_left_x":320,"top_left_y":603,"width":1474,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdf6fdce583042b9adaf7522105ab111","type":"text","conversion_output":true,"text":"Incidence rate is defined as the number of events divided by the total number of person-","text_display":" Incidence rate is defined as the number of events divided by the total number of person","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[318,666],[1113,666],[1113,718],[318,718]],"region":{"top_left_x":317,"top_left_y":666,"width":796,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e31cf088540c431da0619241508090c6","type":"text","conversion_output":true,"text":"years at risk (per 100) in the Safety population.","text_display":"years at risk (per 100) in the Safety population.","confidence":0.99609375,"confidence_rate":0.9999275230095259},{"cnt":[[314,767],[952,767],[952,821],[314,821]],"region":{"top_left_x":313,"top_left_y":766,"width":639,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1305e76fb65340b6acfacdcaa3ecb265","type":"section_header","conversion_output":false,"children_ids":["a366b0db97a3469bb7746bd56b944b2e"],"text":"","text_display":""},{"cnt":[[318,769],[947,769],[947,816],[318,816]],"region":{"top_left_x":317,"top_left_y":769,"width":631,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a366b0db97a3469bb7746bd56b944b2e","type":"text","conversion_output":true,"parent_id":"1305e76fb65340b6acfacdcaa3ecb265","text":"5.11.1.2 Serious Adverse Events","text_display":"\n\n\\subsection*{5.11.1.2 Serious Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[320,859],[1863,859],[1863,909],[320,909]],"region":{"top_left_x":320,"top_left_y":859,"width":1543,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5c750122ed14b69986b2ed5ce50e0f5","type":"text","conversion_output":true,"text":"The number and percentage of patients experiencing at least 1 treatment-emergent SAE will","text_display":"\n\nThe number and percentage of patients experiencing at least 1 treatment-emergent SAE will","confidence":1,"confidence_rate":1},{"cnt":[[318,922],[1858,922],[1858,973],[318,973]],"region":{"top_left_x":317,"top_left_y":921,"width":1542,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a61ddef2a3414a8bb3ce7d153ab238e5","type":"text","conversion_output":true,"text":"be summarized by MedDRA primary System Organ Class, High Level, Term, and Preferred","text_display":" be summarized by MedDRA primary System Organ Class, High Level, Term, and Preferred","confidence":0.84765625,"confidence_rate":0.9981235798301124},{"cnt":[[318,984],[1274,984],[1274,1036],[318,1036]],"region":{"top_left_x":317,"top_left_y":983,"width":958,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8ed5f13a0f643589feb3bfda04344a7","type":"text","conversion_output":true,"text":"Term. Drug-related SAEs will be summarized similarly.","text_display":" Term. Drug-related SAEs will be summarized similarly.","confidence":1,"confidence_rate":1},{"cnt":[[318,1087],[1871,1087],[1871,1139],[318,1139]],"region":{"top_left_x":317,"top_left_y":1087,"width":1555,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8faf72182b6d4616bd1948182300c538","type":"text","conversion_output":true,"text":"In addition, a by-patient listing of the SAEs will be presented (the patient listing will contain","text_display":"\n\nIn addition, a by-patient listing of the SAEs will be presented (the patient listing will contain","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[320,1152],[1225,1152],[1225,1201],[320,1201]],"region":{"top_left_x":320,"top_left_y":1151,"width":905,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"272f966431d54f65b9159ee39f1299d0","type":"text","conversion_output":true,"text":"all SAEs regardless of treatment-emergent AE status)","text_display":" all SAEs regardless of treatment-emergent AE status)","confidence":1,"confidence_rate":1},{"cnt":[[314,1250],[655,1250],[655,1304],[314,1304]],"region":{"top_left_x":313,"top_left_y":1250,"width":343,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d7ec3a91e5e40b5a2d9c46c3b3e066b","type":"section_header","conversion_output":false,"children_ids":["b392dcd3d72d41dea5e4d5bcdddff372"],"text":"","text_display":""},{"cnt":[[320,1255],[651,1255],[651,1300],[320,1300]],"region":{"top_left_x":320,"top_left_y":1254,"width":331,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b392dcd3d72d41dea5e4d5bcdddff372","type":"text","conversion_output":true,"parent_id":"0d7ec3a91e5e40b5a2d9c46c3b3e066b","text":"5.11.1.3 Deaths","text_display":"\n\n\\subsection*{5.11.1.3 Deaths}","confidence":1,"confidence_rate":1},{"cnt":[[318,1345],[1768,1345],[1768,1394],[318,1394]],"region":{"top_left_x":317,"top_left_y":1344,"width":1452,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"079d308189ff4f0a9c9e6ca3d08ae08d","type":"text","conversion_output":true,"text":"A by-patient listing of the deaths will be presented. All deaths occurring on-study and","text_display":"\n\nA by-patient listing of the deaths will be presented. All deaths occurring on-study and","confidence":1,"confidence_rate":1},{"cnt":[[320,1405],[1678,1405],[1678,1459],[320,1459]],"region":{"top_left_x":320,"top_left_y":1405,"width":1358,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"823d956e77db476999fc1a30c087f4a9","type":"text","conversion_output":true,"text":"during follow-up will be displayed (regardless of treatment-emergent AE status).","text_display":" during follow-up will be displayed (regardless of treatment-emergent AE status).","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[314,1504],[1592,1504],[1592,1566],[314,1566]],"region":{"top_left_x":313,"top_left_y":1503,"width":1279,"height":64},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83df004ae00548949b2eba02690e6409","type":"section_header","conversion_output":false,"children_ids":["3baab69d67874e909f11804d436d5622"],"text":"","text_display":""},{"cnt":[[318,1512],[1588,1512],[1588,1562],[318,1562]],"region":{"top_left_x":317,"top_left_y":1512,"width":1271,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3baab69d67874e909f11804d436d5622","type":"text","conversion_output":true,"parent_id":"83df004ae00548949b2eba02690e6409","text":"5.11.1.4 Adverse Events Resulting in Discontinuation of Study Drug","text_display":"\n\n\\subsection*{5.11.1.4 Adverse Events Resulting in Discontinuation of Study Drug}","confidence":0.99951171875,"confidence_rate":0.9999931211434044},{"cnt":[[320,1601],[1815,1601],[1815,1652],[320,1652]],"region":{"top_left_x":320,"top_left_y":1600,"width":1496,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"835fd067478347619293bdfd9f8f9dc2","type":"text","conversion_output":true,"text":"A by-patient listing of treatment-emergent AEs resulting in discontinuation of study drug","text_display":"\n\nA by-patient listing of treatment-emergent AEs resulting in discontinuation of study drug","confidence":0.99951171875,"confidence_rate":0.9999948042635181},{"cnt":[[320,1663],[621,1663],[621,1712],[320,1712]],"region":{"top_left_x":320,"top_left_y":1662,"width":301,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01bc079112db4772b9e1732c630e3f09","type":"text","conversion_output":true,"text":"will be presented.","text_display":" will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[314,1762],[812,1762],[812,1824],[314,1824]],"region":{"top_left_x":313,"top_left_y":1761,"width":500,"height":64},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e52c3b33214453eaef01dfe635568ad","type":"section_header","conversion_output":false,"children_ids":["baba75126ce0465e85494c4cd5615310"],"text":"","text_display":""},{"cnt":[[318,1766],[806,1766],[806,1818],[318,1818]],"region":{"top_left_x":317,"top_left_y":1766,"width":489,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baba75126ce0465e85494c4cd5615310","type":"text","conversion_output":true,"parent_id":"6e52c3b33214453eaef01dfe635568ad","text":"5.11.2 Laboratory Data","text_display":"\n\n\\subsection*{5.11.2 Laboratory Data}","confidence":1,"confidence_rate":1},{"cnt":[[322,1856],[1846,1856],[1846,1906],[322,1906]],"region":{"top_left_x":322,"top_left_y":1856,"width":1524,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4958f716684845b9be5058b041e3f8cb","type":"text","conversion_output":true,"text":"For the purposes of summarization in both the tables and listings, all laboratory values will","text_display":"\n\nFor the purposes of summarization in both the tables and listings, all laboratory values will","confidence":1,"confidence_rate":1},{"cnt":[[320,1919],[1841,1919],[1841,1970],[320,1970]],"region":{"top_left_x":320,"top_left_y":1918,"width":1522,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37fd2f52c43a4504a88e5328799214f2","type":"text","conversion_output":true,"text":"be converted to standardized units. If a lab value is reported using a non-numeric qualifier","text_display":" be converted to standardized units. If a lab value is reported using a non-numeric qualifier","confidence":1,"confidence_rate":1},{"cnt":[[322,1981],[1876,1981],[1876,2030],[322,2030]],"region":{"top_left_x":322,"top_left_y":1980,"width":1554,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ace444c12324fd58e806331d10c2e4f","type":"text","conversion_output":true,"text":"(eg, less than (<) a certain value, or greater than (>) a certain value), the given numeric value","text_display":" (eg, less than (<) a certain value, or greater than (>) a certain value), the given numeric value","confidence":0.9814846515655518,"confidence_rate":0.999816792244195},{"cnt":[[318,2041],[1867,2041],[1867,2093],[318,2093]],"region":{"top_left_x":317,"top_left_y":2041,"width":1550,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c47d244ac16492ca25bc85e79a57923","type":"text","conversion_output":true,"text":"will be used in the summary statistics, ignoring the non-numeric qualifier. 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However, for the","confidence":1,"confidence_rate":1},{"cnt":[[314,2103],[1820,2103],[1820,2155],[314,2155]],"region":{"top_left_x":313,"top_left_y":2103,"width":1507,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32e11eb0cd0042dea8f46629f50f4598","type":"text","conversion_output":true,"text":"bone marrow plasma cell percentage, the convention of \\((x-1) \\%\\) (mainly for \\(<5 \\%\\) for CR)","text_display":" bone marrow plasma cell percentage, the convention of \\((x-1) \\%\\) (mainly for \\(<5 \\%\\) for CR)","confidence":0.7567447089604262,"confidence_rate":0.9970703070781077},{"cnt":[[320,2170],[539,2170],[539,2211],[320,2211]],"region":{"top_left_x":320,"top_left_y":2169,"width":220,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64a2e5ec0f3c46029cbfb67b3232a103","type":"text","conversion_output":true,"text":"will be used.","text_display":" will be 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Change from baseline will also be presented. Unscheduled laboratory test","text_display":" time point. Change from baseline will also be presented. Unscheduled laboratory test","confidence":1,"confidence_rate":1},{"cnt":[[318,539],[1848,539],[1848,595],[318,595]],"region":{"top_left_x":317,"top_left_y":539,"width":1531,"height":57},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55b31b0a5d684c1a9dcff67073945825","type":"text","conversion_output":true,"text":"results will be listed and included in laboratory shift tables. The parameters to be analyzed","text_display":" results will be listed and included in laboratory shift tables. The parameters to be analyzed","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[318,602],[569,602],[569,651],[318,651]],"region":{"top_left_x":317,"top_left_y":601,"width":253,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8625161540344034934e7993c3627423","type":"text","conversion_output":true,"text":"are as follows:","text_display":" are as follows:","confidence":1,"confidence_rate":1},{"cnt":[[382,709],[1824,709],[1824,763],[382,763]],"region":{"top_left_x":382,"top_left_y":708,"width":1443,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b042ddc14cb4e4ba42f5d87d359004f","type":"text","conversion_output":true,"text":"- Hematology: hemoglobin, hematocrit, absolute neutrophil count (ANC), absolute","text_display":"\n- Hematology: hemoglobin, hematocrit, absolute neutrophil count (ANC), absolute","confidence":0.994140625,"confidence_rate":0.9999300428222486},{"cnt":[[443,769],[1835,769],[1835,827],[443,827]],"region":{"top_left_x":442,"top_left_y":769,"width":1393,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9af4d534836346808b5391ce8b61588d","type":"text","conversion_output":true,"text":"lymphocyte count (ALC), monocytes, platelets, and white blood cell (WBC) count","text_display":" lymphocyte count (ALC), monocytes, platelets, and white blood cell (WBC) count","confidence":0.998046875,"confidence_rate":0.9999764456408323},{"cnt":[[382,879],[1828,879],[1828,935],[382,935]],"region":{"top_left_x":382,"top_left_y":878,"width":1447,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da9f7a6e063a47b9ab95c65a941cb612","type":"text","conversion_output":true,"text":"- Serum chemistry: blood urea nitrogen, creatinine, total bilirubin, uric acid, lactate","text_display":"\n- Serum chemistry: blood urea nitrogen, creatinine, total bilirubin, uric acid, lactate","confidence":1,"confidence_rate":1},{"cnt":[[443,941],[1820,941],[1820,995],[443,995]],"region":{"top_left_x":442,"top_left_y":941,"width":1378,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa0ed703bc1d48439ce5960cfb3de153","type":"text","conversion_output":true,"text":"dehydrogenase, albumin, alkaline phosphatase, aspartate aminotransferase (AST),","text_display":" dehydrogenase, albumin, alkaline phosphatase, aspartate aminotransferase (AST),","confidence":1,"confidence_rate":1},{"cnt":[[443,1003],[1790,1003],[1790,1057],[443,1057]],"region":{"top_left_x":442,"top_left_y":1003,"width":1348,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fa0c85115204262953ab430c3559713","type":"text","conversion_output":true,"text":"alanine aminotransferase (ALT), glucose, calcium, sodium, potassium, chloride,","text_display":" alanine aminotransferase (ALT), glucose, calcium, sodium, potassium, chloride,","confidence":1,"confidence_rate":1},{"cnt":[[443,1066],[1188,1066],[1188,1119],[443,1119]],"region":{"top_left_x":442,"top_left_y":1065,"width":747,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44d7e74755e34b05b4540b5281b2367b","type":"text","conversion_output":true,"text":"carbon dioxide, magnesium, and phosphate.","text_display":" carbon dioxide, magnesium, and phosphate.","confidence":1,"confidence_rate":1},{"cnt":[[318,1169],[1734,1169],[1734,1222],[318,1222]],"region":{"top_left_x":317,"top_left_y":1168,"width":1417,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17f186ec544443f591b49b0e52525e10","type":"text","conversion_output":true,"text":"Shift tables will be constructed for laboratory parameters to tabulate changes in NCI","text_display":"\n\nShift tables will be constructed for laboratory parameters to tabulate changes in NCI","confidence":0.9990234375,"confidence_rate":0.9999891440628391},{"cnt":[[318,1233],[1712,1233],[1712,1287],[318,1287]],"region":{"top_left_x":317,"top_left_y":1233,"width":1396,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f66c5831a48a42f2b993c5cc646aa153","type":"text","conversion_output":true,"text":"CTCAE for toxicity (version 4.03) from baseline to worst postbaseline CTC grade.","text_display":" CTCAE for toxicity (version 4.03) from baseline to worst postbaseline CTC grade.","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[318,1293],[990,1293],[990,1343],[318,1343]],"region":{"top_left_x":317,"top_left_y":1293,"width":674,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1eb309ab0ae4cb4a5439d9d4a9b9919","type":"text","conversion_output":true,"text":"Parameters to be tabulated will include:","text_display":" Parameters to be tabulated will include:","confidence":1,"confidence_rate":1},{"cnt":[[382,1401],[1450,1401],[1450,1454],[382,1454]],"region":{"top_left_x":382,"top_left_y":1400,"width":1069,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8347611efe92475d8a18cef001f73d15","type":"text","conversion_output":true,"text":"- Hematology: ALC, ANC, hemoglobin, platelets, and WBC","text_display":"\n- Hematology: ALC, ANC, hemoglobin, platelets, and WBC","confidence":0.99755859375,"confidence_rate":0.9999585704965006},{"cnt":[[382,1508],[1762,1508],[1762,1562],[382,1562]],"region":{"top_left_x":382,"top_left_y":1508,"width":1380,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69b10fe7f5fd4aaf93e9f361fb8bc8fa","type":"text","conversion_output":true,"text":"- Serum chemistry: ALT, AST, alkaline phosphatase, creatinine, total bilirubin,","text_display":"\n- Serum chemistry: 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listings to be presented include hematology, serum chemistry, urinalysis, urine","confidence":1,"confidence_rate":1},{"cnt":[[318,2067],[892,2067],[892,2121],[318,2121]],"region":{"top_left_x":317,"top_left_y":2066,"width":575,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d28281e79a1b48f2a70e5fbe4db6ae1c","type":"text","conversion_output":true,"text":"total protein, and urine creatinine.","text_display":" total protein, and urine 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The formulas are:","text_display":" correction, if necessary. 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APPENDIX}","confidence":1,"confidence_rate":1},{"cnt":[[314,335],[1828,335],[1828,397],[314,397]],"region":{"top_left_x":313,"top_left_y":335,"width":1516,"height":63},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a94d969e16f249b3a6abd9f3767663db","type":"section_header","conversion_output":false,"children_ids":["1ccdfee0275d40cf8049f9aec7f29eeb"],"text":"","text_display":""},{"cnt":[[322,339],[1824,339],[1824,393],[322,393]],"region":{"top_left_x":322,"top_left_y":339,"width":1503,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ccdfee0275d40cf8049f9aec7f29eeb","type":"text","conversion_output":true,"parent_id":"a94d969e16f249b3a6abd9f3767663db","text":"10.1 Proof of Strong Control of Type I Error Rate for Key Secondary Endpoints","text_display":"\n\n\\subsection*{10.1 Proof of Strong Control of Type I Error Rate for Key Secondary Endpoints}","confidence":0.716796875,"confidence_rate":0.9959477111006856},{"cnt":[[318,430],[1865,430],[1865,479],[318,479]],"region":{"top_left_x":317,"top_left_y":429,"width":1548,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf122ace08d9465ba28d3f2c79a94043","type":"text","conversion_output":true,"text":"Proof of strong control of Type I error rate for both key secondary endpoints (OS and OS in","text_display":"\n\nProof of strong control of Type I error rate for both key secondary endpoints (OS and OS in","confidence":1,"confidence_rate":1},{"cnt":[[318,477],[932,477],[932,529],[318,529]],"region":{"top_left_x":317,"top_left_y":476,"width":616,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbd4912f0d274f80ba59fdc7b4d76d83","type":"text","conversion_output":true,"text":"high-risk patients carrying del(17)):","text_display":" high-risk patients carrying del(17)):","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[320,546],[1848,546],[1848,599],[320,599]],"region":{"top_left_x":320,"top_left_y":545,"width":1528,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"426c6db70fcf435e943a319789b8455e","type":"text","conversion_output":true,"text":"With the proposed testing procedure of the 2 key secondary endpoints (OS and OS in high-","text_display":"\nWith the proposed testing procedure of the 2 key secondary endpoints (OS and OS in high","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[318,610],[1852,610],[1852,660],[318,660]],"region":{"top_left_x":317,"top_left_y":610,"width":1535,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82042abc0c734e7c86f6b65c6499f543","type":"text","conversion_output":true,"text":"risk patients carrying del(17)), this is to prove the strong control of overall Type I error rate","text_display":"risk patients carrying del(17)), this is to prove the strong control of overall Type I error rate","confidence":1,"confidence_rate":1},{"cnt":[[318,670],[1061,670],[1061,724],[318,724]],"region":{"top_left_x":317,"top_left_y":670,"width":745,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"471886a245e74ae99b9cf45bb82f1346","type":"text","conversion_output":true,"text":"for both endpoints at one-sided 0.025 level.","text_display":" for both endpoints at one-sided 0.025 level.","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[318,776],[1790,776],[1790,827],[318,827]],"region":{"top_left_x":317,"top_left_y":775,"width":1473,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5c94ae0adfe4062938007f6b6b3b45e","type":"text","conversion_output":true,"text":"To facilitate the probability presentation, we introduce the following notations. Let P, S","text_display":"\n\nTo facilitate the probability presentation, we introduce the following notations. Let P, S","confidence":0.4943873882293701,"confidence_rate":0.9926123095840012},{"cnt":[[320,838],[1749,838],[1749,889],[320,889]],"region":{"top_left_x":320,"top_left_y":837,"width":1429,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e444aa75af8428a9939fdc321084a4f","type":"text","conversion_output":true,"text":"indicate the first and second key secondary, OS and OS in high-risk patients carrying","text_display":" indicate the first and second key secondary, OS and OS in high-risk patients carrying","confidence":1,"confidence_rate":1},{"cnt":[[318,902],[1727,902],[1727,982],[318,982]],"region":{"top_left_x":317,"top_left_y":902,"width":1411,"height":80},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a867b5b360843d79bbaa5acd8471672","type":"text","conversion_output":true,"text":"del(17). Denote the family of null hypotheses of interest as: \\(H _{0}^{ P }: \\theta^{ P } \\bar{\\oslash}{ }^{0}\\) (OS is not","text_display":" del(17). Denote the family of null hypotheses of interest as: \\(H _{0}^{ P }: \\theta^{ P } \\bar{\\oslash}{ }^{0}\\) (OS is not","confidence":0.18221118126693206,"confidence_rate":0.9861412816661275},{"cnt":[[318,993],[1815,993],[1815,1070],[318,1070]],"region":{"top_left_x":317,"top_left_y":992,"width":1499,"height":78},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a199efd8d87434eb9898852f15b23d4","type":"text","conversion_output":true,"text":"efficacious); \\(H _{0}^{ S }: \\theta^{S}=0\\) (OS in high-risk patients is not efficacious). Let \\(T _{1}^{ P }, T _{2}^{ P }\\) be the","text_display":" efficacious); \\(H _{0}^{ S }: \\theta^{S}=0\\) (OS in high-risk patients is not efficacious). Let \\(T _{1}^{ P }, T _{2}^{ P }\\) be the","confidence":0.9743299782070819,"confidence_rate":0.999820669557112},{"cnt":[[318,1079],[1826,1079],[1826,1158],[318,1158]],"region":{"top_left_x":317,"top_left_y":1078,"width":1510,"height":81},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03d87a9dea2541a895034d260d92a7ec","type":"text","conversion_output":true,"text":"log-rank test statistic for OS at the second interim and FA, and \\(T _{1}^{ S }, T _{2}^{ S }\\) be the log-rank test","text_display":" log-rank test statistic for OS at the second interim and FA, and \\(T _{1}^{ S }, T _{2}^{ S }\\) be the log-rank test","confidence":0.3267155485468616,"confidence_rate":0.9912302914721267},{"cnt":[[320,1164],[1846,1164],[1846,1216],[320,1216]],"region":{"top_left_x":320,"top_left_y":1164,"width":1526,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22cb6cf9970d466d9f7fb2235950547a","type":"text","conversion_output":true,"text":"statistic for OS in high risk patients at the second interim and FA. Denote z \\(\\alpha\\) as the upper \\(\\alpha\\)","text_display":" statistic for OS in high risk patients at the second interim and FA. Denote z \\(\\alpha\\) as the upper \\(\\alpha\\)","confidence":0.4947203020785075,"confidence_rate":0.9930562721142929},{"cnt":[[318,1229],[1106,1229],[1106,1278],[318,1278]],"region":{"top_left_x":317,"top_left_y":1228,"width":790,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2711486b2044be1b773b3aebaba5fa7","type":"text","conversion_output":true,"text":"quantile from the standard normal distribution.","text_display":" quantile from the standard normal distribution.","confidence":1,"confidence_rate":1},{"cnt":[[320,1332],[1760,1332],[1760,1386],[320,1386]],"region":{"top_left_x":320,"top_left_y":1332,"width":1440,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f845319d8d34445ca217740eb81874b0","type":"text","conversion_output":true,"text":"We use the fundamental multiple testing teehnique, partitioning principle to prove the","text_display":"\n\nWe use the fundamental multiple testing 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\\multicolumn{2}{|c|}{Table 10-1 Partition Hypotheses for Testing Both Key Secondary Endpoints} \\\\\n\\hline Index & Partition Hypothesis \\\\\n\\hline 1 & \\(\\theta^{P}=0, \\theta^{S}=0\\) \\\\\n\\hline 2 & \\(\\theta^{P}=0, \\theta^{S}>0\\) \\\\\n\\hline 3 & \\(\\theta^{P}>0, \\theta^{S}=0\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\multicolumn{2}{|c|}{Table 10-1 Partition Hypotheses for Testing Both Key Secondary Endpoints} \\\\\n\\hline Index & Partition Hypothesis \\\\\n\\hline 1 & \\(\\theta^{P}=0, \\theta^{S}=0\\) \\\\\n\\hline 2 & \\(\\theta^{P}=0, \\theta^{S}>0\\) \\\\\n\\hline 3 & \\(\\theta^{P}>0, \\theta^{S}=0\\) 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\\theta^{S}>0\\)","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[491,1931],[530,1931],[530,1983],[491,1983]],"region":{"top_left_x":491,"top_left_y":1931,"width":39,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"977576e9d1f04711bad3e82dffa879f1","type":"simple_cell","conversion_output":false,"parent_id":"00b6a492ed2d420c89db3ae5e5096056","text":"3","text_display":"3","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.94921875,"confidence_rate":0.94921875},{"cnt":[[1157,1934],[1411,1934],[1411,1986],[1157,1986]],"region":{"top_left_x":1157,"top_left_y":1933,"width":254,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4582ca08c64f440e8930841b2eb6279d","type":"simple_cell","conversion_output":false,"parent_id":"00b6a492ed2d420c89db3ae5e5096056","text":"\\(\\theta^{P}>0, \\theta^{S}=0\\)","text_display":"\\(\\theta^{P}>0, \\theta^{S}=0\\)","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[318,2058],[1861,2058],[1861,2112],[318,2112]],"region":{"top_left_x":317,"top_left_y":2058,"width":1544,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be85a87f60e2489e971e6b2b3c765213","type":"text","conversion_output":true,"text":"By partition principle, as long as each of the partition hypothesis is tested at level 0.025 , the","text_display":"\n\nBy partition principle, as long as each of the partition hypothesis is tested at level 0.025 , the","confidence":0.9931640625,"confidence_rate":0.9999352906828807},{"cnt":[[316,2123],[1321,2123],[1321,2172],[316,2172]],"region":{"top_left_x":315,"top_left_y":2122,"width":1007,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2642f5cee68440e29d2706e781a5659e","type":"text","conversion_output":true,"text":"overall Type I error rate is also controlled at the same level.","text_display":" overall Type I error rate is also controlled at the same level.","confidence":1,"confidence_rate":1},{"cnt":[[382,2226],[1854,2226],[1854,2301],[382,2301]],"region":{"top_left_x":382,"top_left_y":2225,"width":1473,"height":76},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5230ac5919244a328dc59902f450211a","type":"text","conversion_output":true,"text":"1. Under partition hypothesis \\(\\theta^{P}=0, \\theta^{S}=0\\), a false rejection is \\{reject P or reject S \\}.","text_display":"\n1. Under partition hypothesis \\(\\theta^{P}=0, \\theta^{S}=0\\), a false rejection is \\{reject P or reject S \\}.","confidence":0.99951171875,"confidence_rate":0.9999959636403931},{"cnt":[[443,2312],[1781,2312],[1781,2361],[443,2361]],"region":{"top_left_x":442,"top_left_y":2311,"width":1340,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"757f1708e1124494be3b72815dd29df3","type":"text","conversion_output":true,"text":"Due to the closed sequential testing between P and S at both second IA and FA,","text_display":" Due to the closed sequential testing between P and S at both second IA and FA,","confidence":0.97412109375,"confidence_rate":0.9997240416957579},{"cnt":[[443,2372],[1835,2372],[1835,2426],[443,2426]],"region":{"top_left_x":442,"top_left_y":2371,"width":1393,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e835c3d3f8cc4b0492c525341b5bedcd","type":"text","conversion_output":true,"text":"rejecting \\(S\\) implies rejecting \\(P\\), therefore probability of false rejection is simply the","text_display":" rejecting \\(S\\) implies rejecting \\(P\\), therefore probability of false rejection is simply the","confidence":0.8878268455155194,"confidence_rate":0.9987989183534834},{"cnt":[[443,2436],[943,2436],[943,2486],[443,2486]],"region":{"top_left_x":442,"top_left_y":2436,"width":502,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27c4e27eaa83453aa45d67e5eb8b0ff0","type":"text","conversion_output":true,"text":"probability of rejecting P , i.e.","text_display":" probability of rejecting P , i.e.","confidence":0.99853515625,"confidence_rate":0.9999666842440162},{"cnt":[[1072,2582],[1126,2582],[1126,2628],[1072,2628]],"region":{"top_left_x":1072,"top_left_y":2582,"width":54,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5998ef2fc89244d99a09027890daaaa9","type":"page_info","conversion_output":false,"text":"45","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7c31771c-e1a6-4d89-bd06-07621b105693-47","page":47,"lines":[{"cnt":[[318,125],[683,125],[683,174],[318,174]],"region":{"top_left_x":317,"top_left_y":124,"width":367,"height":51},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39eaa8df3d9c457a892e3ee62882bdcb","type":"page_info","conversion_output":false,"text":"MLN9708 (Ixazomib)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,168],[971,168],[971,219],[318,219]],"region":{"top_left_x":317,"top_left_y":167,"width":655,"height":53},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b51e98de69e4cfa809d9c72ac37a21c","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Study C16010","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[881,245],[1313,245],[1313,324],[881,324]],"region":{"top_left_x":880,"top_left_y":244,"width":433,"height":81},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66b36a8cc8184b21b96c3f9e56b9e2df","type":"math","conversion_output":true,"text":"\\[\nP\\left(T_{1}^{P}>z_{\\alpha_{1}} \\text { or } T_{2}^{P}>z_{\\alpha_{2}}\\right)\n\\]","text_display":"\n\\[\nP\\left(T_{1}^{P}>z_{\\alpha_{1}} \\text { or } T_{2}^{P}>z_{\\alpha_{2}}\\right)\n\\]","confidence":0.994140625,"confidence_rate":0.9999183837684389},{"cnt":[[442,333],[1854,331],[1854,385],[443,387]],"region":{"top_left_x":442,"top_left_y":330,"width":1413,"height":57},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cb83db11d4a4ce0bfeb61cbd923b65e","type":"text","conversion_output":true,"text":"where \\(\\alpha_{1}\\) and \\(\\alpha_{2}\\) are calculated based on the actual information fraction at second IA","text_display":"\nwhere \\(\\alpha_{1}\\) and \\(\\alpha_{2}\\) are calculated based on the actual information fraction at second IA","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[443,395],[1852,395],[1852,451],[443,451]],"region":{"top_left_x":442,"top_left_y":395,"width":1410,"height":57},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb411d6e81ce45dc8091a53901f03e3b","type":"text","conversion_output":true,"text":"from O'Brien-Fleming boundary (Lan-DeMets method). Base on this boundary, the","text_display":" from O'Brien-Fleming boundary (Lan-DeMets method). Base on this boundary, the","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[443,460],[1051,460],[1051,513],[443,513]],"region":{"top_left_x":442,"top_left_y":459,"width":609,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee27ec51f4da4c1590634ba71c6d865e","type":"text","conversion_output":true,"text":"probability is no greater than 0.025 .","text_display":" probability is no greater than 0.025 .","confidence":1,"confidence_rate":1},{"cnt":[[380,524],[1732,524],[1732,599],[380,599]],"region":{"top_left_x":380,"top_left_y":524,"width":1352,"height":76},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"145f836010c549a8bb77787cc1293b5d","type":"text","conversion_output":true,"text":"2. Under partition hypothesis \\(\\theta^{P}=0, \\theta^{S}>0\\), the probability of false rejection:","text_display":"\n2. Under partition hypothesis \\(\\theta^{P}=0, \\theta^{S}>0\\), the probability of false rejection:","confidence":1,"confidence_rate":1},{"cnt":[[443,606],[1682,606],[1682,664],[443,664]],"region":{"top_left_x":442,"top_left_y":605,"width":1241,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f86d2ac0630845e4adc8fbeb6805296e","type":"text","conversion_output":true,"text":"\\(\\operatorname{Pr}\\{\\) reject P \\(\\}\\) is again controlled at 0.025 by O 'Brien-Flemming boundary.","text_display":" \\(\\operatorname{Pr}\\{\\) reject P \\(\\}\\) is again controlled at 0.025 by O 'Brien-Flemming boundary.","confidence":0.8986320495605469,"confidence_rate":0.9988755630022238},{"cnt":[[380,670],[1850,670],[1850,750],[380,750]],"region":{"top_left_x":380,"top_left_y":670,"width":1470,"height":80},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f8d3ec6003b4fa5a3f782bdc5cc3ca4","type":"text","conversion_output":true,"text":"3. Under partition hypothesis \\(\\theta^{P}>0, \\theta^{S}=0\\), a false rejection is \\{reject S \\(\\}=\\{\\) reject P","text_display":"\n3. Under partition hypothesis \\(\\theta^{P}>0, \\theta^{S}=0\\), a false rejection is \\{reject S \\(\\}=\\{\\) reject P","confidence":0.9794921875,"confidence_rate":0.9998182532053403},{"cnt":[[443,752],[1858,752],[1858,810],[443,810]],"region":{"top_left_x":442,"top_left_y":751,"width":1417,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52cf331afab4498099698fa006f4d480","type":"text","conversion_output":true,"text":"at IA and reject \\(S\\) at IA) or (failed to reject \\(P\\) at IA and reject \\(P\\) at FA and reject \\(S\\) at","text_display":" at IA and reject \\(S\\) at IA) or (failed to reject \\(P\\) at IA and reject \\(P\\) at FA and reject \\(S\\) at","confidence":0.5770599842071533,"confidence_rate":0.994826550707524},{"cnt":[[443,814],[1697,814],[1697,870],[443,870]],"region":{"top_left_x":442,"top_left_y":814,"width":1256,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b962ddb7d50e4eb291494413f32eb192","type":"text","conversion_output":true,"text":"FA)\\} which is a subset of \\{reject S at IA or reject S at FA \\}. Therefore, the","text_display":" FA)\\} which is a subset of \\{reject S at IA or reject S at FA \\}. Therefore, the","confidence":0.6090546470840151,"confidence_rate":0.995053800104894},{"cnt":[[443,879],[1184,879],[1184,935],[443,935]],"region":{"top_left_x":442,"top_left_y":878,"width":742,"height":57},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2c56d565024425d864f0f50966dc7e2","type":"text","conversion_output":true,"text":"probability of false rejection is bounded by:","text_display":" probability of false rejection is bounded by:","confidence":1,"confidence_rate":1},{"cnt":[[563,932],[1609,932],[1609,1016],[563,1016]],"region":{"top_left_x":562,"top_left_y":932,"width":1048,"height":85},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"468c176b84994a86957c375b2290e001","type":"math","conversion_output":true,"text":"\\[\nP\\left(T_{1}^{S}>z_{\\alpha_{1}} \\text { or } T_{2}^{S}>c\\right)=P\\left(T_{1}^{S}>z_{\\alpha_{1}}\\right)+P\\left(T_{1}^{S} \\leq z_{\\alpha_{1}} \\text { and } T _{2}^{s}>c\\right)\n\\]","text_display":"\n\\[\nP\\left(T_{1}^{S}>z_{\\alpha_{1}} \\text { or } T_{2}^{S}>c\\right)=P\\left(T_{1}^{S}>z_{\\alpha_{1}}\\right)+P\\left(T_{1}^{S} \\leq z_{\\alpha_{1}} \\text { and } T _{2}^{s}>c\\right)\n\\]","confidence":0.45908291428759185,"confidence_rate":0.994891223074843},{"cnt":[[1702,950],[1766,950],[1766,1001],[1702,1001]],"region":{"top_left_x":1701,"top_left_y":949,"width":66,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5285da463dbb49b49b47bac682f849d9","type":"equation_number","conversion_output":false,"text":"(1)","text_display":"","confidence":0.71533203125,"confidence_rate":0.9589886320911307},{"cnt":[[443,1023],[1261,1023],[1261,1072],[443,1072]],"region":{"top_left_x":442,"top_left_y":1022,"width":820,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e66de39432da40158d36fba0a6e58624","type":"text","conversion_output":true,"text":"The critical value c will be calculated as follows","text_display":"\n\nThe critical value c will be calculated as follows","confidence":0.96533203125,"confidence_rate":0.9994217547402542},{"cnt":[[851,1083],[1470,1083],[1470,1158],[851,1158]],"region":{"top_left_x":850,"top_left_y":1082,"width":620,"height":77},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4127db11872e483485844968c94479d2","type":"math","conversion_output":true,"text":"\\[\nP\\left(T_{1}^{S} \\leq z_{\\alpha_{1}} \\text { and } T_{2}^{S}>c\\right)=0.025-\\alpha_{1}\n\\]","text_display":"\n\\[\nP\\left(T_{1}^{S} \\leq z_{\\alpha_{1}} \\text { and } T_{2}^{S}>c\\right)=0.025-\\alpha_{1}\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[443,1164],[1815,1164],[1815,1222],[443,1222]],"region":{"top_left_x":442,"top_left_y":1164,"width":1374,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e0a400d40d1451184bc04e4d5280153","type":"text","conversion_output":true,"text":"to maintain the probability equation (1) at 0.025 level using following asymptotic","text_display":"\nto maintain the probability equation (1) at 0.025 level using following asymptotic","confidence":0.947828745469451,"confidence_rate":0.9994048278376482},{"cnt":[[443,1229],[999,1229],[999,1283],[443,1283]],"region":{"top_left_x":442,"top_left_y":1228,"width":558,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e970c9ef13246829a6f12a7c2044f27","type":"text","conversion_output":true,"text":"multivariate normal distribution:","text_display":" multivariate normal distribution:","confidence":0.99951171875,"confidence_rate":0.9999871474379078},{"cnt":[[859,1289],[1467,1289],[1467,1571],[859,1571]],"region":{"top_left_x":859,"top_left_y":1289,"width":609,"height":282},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3af845fdf0dd4159b5813484dba8f9c7","type":"math","conversion_output":true,"text":"\\[\n\\binom{T_{1}^{S}}{T_{2}^{S}} \\sim M V N\\left(\\binom{0}{0},\\left(\\begin{array}{cc}\n1 & \\sqrt{\\frac{n_{1}}{n_{2}}} \\\\\n\\sqrt{\\frac{n_{1}}{n_{2}}} & 1\n\\end{array}\\right)\\right)\n\\]","text_display":"\n\\[\n\\binom{T_{1}^{S}}{T_{2}^{S}} \\sim M V N\\left(\\binom{0}{0},\\left(\\begin{array}{cc}\n1 & \\sqrt{\\frac{n_{1}}{n_{2}}} \\\\\n\\sqrt{\\frac{n_{1}}{n_{2}}} & 1\n\\end{array}\\right)\\right)\n\\]","confidence":0.10975159160542874,"confidence_rate":0.9835241851415155},{"cnt":[[443,1573],[1755,1573],[1755,1626],[443,1626]],"region":{"top_left_x":442,"top_left_y":1572,"width":1314,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14fec854321f4380aa089b85b68e6c88","type":"text","conversion_output":true,"text":"where \\(n_{1}\\) and \\(n_{2}\\) are the §ize of the patient population at the second IA and FA,","text_display":"\nwhere \\(n_{1}\\) and \\(n_{2}\\) are the §ize of the patient population at the second IA and FA,","confidence":0.48979754898297756,"confidence_rate":0.9931603902320382},{"cnt":[[443,1637],[668,1637],[668,1691],[443,1691]],"region":{"top_left_x":442,"top_left_y":1637,"width":227,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8eaa90483513401ca255f84f1650ae62","type":"text","conversion_output":true,"text":"respectively.","text_display":" respectively.","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":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af1dd84c04e84280b57a2a6e99b747fe","type":"page_info","conversion_output":false,"text":"46","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}
\ No newline at end of file