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Consideration will be given to reporting early at either time if (1)","text_display":" one year later. Consideration will be given to reporting early at either time if (1)","confidence":1,"confidence_rate":1},{"cnt":[[619,1280],[1878,1280],[1878,1321],[619,1321]],"region":{"top_left_x":618,"top_left_y":1280,"width":1260,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0b8618052074ab2a4dfaccb2d34d563","type":"text","conversion_output":true,"text":"TTR on the gemcitabine arm is superior at the one-sided 0.005 level or if (2) the","text_display":" TTR on the gemcitabine arm is superior at the one-sided 0.005 level or if (2) the","confidence":0.942947604926303,"confidence_rate":0.9993401665498696},{"cnt":[[621,1319],[1878,1319],[1878,1360],[621,1360]],"region":{"top_left_x":620,"top_left_y":1319,"width":1258,"height":41},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e93f1c776fe4579a159959dda75b817","type":"text","conversion_output":true,"text":"hypothesis \\(\\lambda=1.53\\) (where \\(\\lambda\\) is the sterile water/gemcitabine hazard ratio) is","text_display":" hypothesis \\(\\lambda=1.53\\) (where \\(\\lambda\\) is the sterile water/gemcitabine hazard ratio) is","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[621,1358],[1880,1358],[1880,1399],[621,1399]],"region":{"top_left_x":620,"top_left_y":1357,"width":1260,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c62340bb4c7e4f40ac11781a21022baf","type":"text","conversion_output":true,"text":"rejected in favor of \\(\\lambda<1.53\\) at the one-sided 0.005 level (testing using a","text_display":" rejected in favor of \\(\\lambda<1.53\\) at the one-sided 0.005 level (testing using a","confidence":1,"confidence_rate":1},{"cnt":[[621,1396],[1626,1396],[1626,1437],[621,1437]],"region":{"top_left_x":620,"top_left_y":1396,"width":1007,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"432f038a4723430fb832e168af07ecdc","type":"text","conversion_output":true,"text":"proportional hazards score test, an extension of the logrank test).","text_display":" proportional hazards score test, an extension of the logrank test).","confidence":1,"confidence_rate":1},{"cnt":[[619,1470],[1880,1470],[1880,1515],[619,1515]],"region":{"top_left_x":618,"top_left_y":1469,"width":1262,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"056b3489ea184dc9931e0cf93ba7aaa6","type":"text","conversion_output":true,"text":"Assuming the study does not terminate early, the final analysis will occur when","text_display":"\n\nAssuming the study does not terminate early, the final analysis will occur when","confidence":1,"confidence_rate":1},{"cnt":[[621,1508],[1880,1508],[1880,1551],[621,1551]],"region":{"top_left_x":620,"top_left_y":1508,"width":1260,"height":44},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94d2a5813a3242d5b9b2f4b1cfa5d0bd","type":"text","conversion_output":true,"text":"approximately 252 recurrences have been reported (estimated to be about two","text_display":" approximately 252 recurrences have been reported (estimated to be about two","confidence":0.994140625,"confidence_rate":0.9999291999945232},{"cnt":[[621,1547],[1880,1547],[1880,1590],[621,1590]],"region":{"top_left_x":620,"top_left_y":1546,"width":1260,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"912c22d42794410fbb7001e35d84e6a3","type":"text","conversion_output":true,"text":"years after completion of accrual). The final analysis will be based on the","text_display":" years after completion of accrual). The final analysis will be based on the","confidence":1,"confidence_rate":1},{"cnt":[[621,1586],[1880,1586],[1880,1626],[621,1626]],"region":{"top_left_x":620,"top_left_y":1585,"width":1260,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3091e1c564d41629481f26bf19b33eb","type":"text","conversion_output":true,"text":"stratified logrank test with stratification factors as specified in Section 6.0 with a","text_display":" stratified logrank test with stratification factors as specified in Section 6.0 with a","confidence":1,"confidence_rate":1},{"cnt":[[621,1624],[1880,1624],[1880,1665],[621,1665]],"region":{"top_left_x":620,"top_left_y":1624,"width":1260,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78f2e52080ab45eea9ffe660f72715b8","type":"text","conversion_output":true,"text":"one-sided 0.020 level to adjust for the two interim analyses, for an overall level of","text_display":" one-sided 0.020 level to adjust for the two interim analyses, for an overall level of","confidence":1,"confidence_rate":1},{"cnt":[[621,1663],[1880,1663],[1880,1704],[621,1704]],"region":{"top_left_x":620,"top_left_y":1662,"width":1260,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8883bdb54d774eeb88b29a62a56e2586","type":"text","conversion_output":true,"text":"0.025 (one-sided). In addition, the trial will be monitored for safety every six","text_display":" 0.025 (one-sided). In addition, the trial will be monitored for safety every six","confidence":1,"confidence_rate":1},{"cnt":[[621,1702],[763,1702],[763,1738],[621,1738]],"region":{"top_left_x":620,"top_left_y":1701,"width":143,"height":38},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aca38435d5e549f5b34efc2c9b8aedb8","type":"text","conversion_output":true,"text":"months.\"","text_display":" months.\"","confidence":1,"confidence_rate":1},{"cnt":[[619,1779],[698,1779],[698,1815],[619,1815]],"region":{"top_left_x":618,"top_left_y":1778,"width":81,"height":38},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e4c37d5a2284f6c82bf00eec6f70cf0","type":"text","conversion_output":true,"text":"New","text_display":"\n\nNew","confidence":1,"confidence_rate":1},{"cnt":[[621,1813],[1878,1813],[1878,1858],[621,1858]],"region":{"top_left_x":620,"top_left_y":1813,"width":1258,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed157afdee514b5baa9a3dc8c3877e11","type":"text","conversion_output":true,"text":"\"If one assumes roughly equal numbers of patients with newly diagnosed and","text_display":"\n\"If one assumes roughly equal numbers of patients with newly diagnosed and","confidence":1,"confidence_rate":1},{"cnt":[[621,1852],[1880,1852],[1880,1895],[621,1895]],"region":{"top_left_x":620,"top_left_y":1851,"width":1260,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d7b9139d2294d9b80b2b83d886fca4c","type":"text","conversion_output":true,"text":"recurrent superficial bladder tumors, then we anticipate about \\(60 \\%\\) of patients will","text_display":" recurrent superficial bladder tumors, then we anticipate about \\(60 \\%\\) of patients will","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[621,1893],[1880,1893],[1880,1934],[621,1934]],"region":{"top_left_x":620,"top_left_y":1892,"width":1260,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6fc98449a8ac471cb6442551d9a97a16","type":"text","conversion_output":true,"text":"experience recurrences by 2 years. It is assumed that 14 eligible patients per","text_display":" experience recurrences by 2 years. It is assumed that 14 eligible patients per","confidence":1,"confidence_rate":1},{"cnt":[[621,1929],[1880,1929],[1880,1970],[621,1970]],"region":{"top_left_x":620,"top_left_y":1929,"width":1260,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"038da8a0fc0a47d29f4b214fe1471332","type":"text","conversion_output":true,"text":"month will be randomized. Patients will be stratified by disease status (first","text_display":" month will be randomized. Patients will be stratified by disease status (first","confidence":1,"confidence_rate":1},{"cnt":[[621,1968],[1880,1968],[1880,2009],[621,2009]],"region":{"top_left_x":620,"top_left_y":1967,"width":1260,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5583f6b3c89146628d35e506bf27b0ff","type":"text","conversion_output":true,"text":"occurrence vs. recurrent disease), and number of tumors (one versus more than","text_display":" occurrence vs. recurrent disease), and number of tumors (one versus more than","confidence":0.99658203125,"confidence_rate":0.9999582469283965},{"cnt":[[621,2007],[1880,2007],[1880,2047],[621,2047]],"region":{"top_left_x":620,"top_left_y":2006,"width":1260,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4604028156a543afa36f774342a510a1","type":"text","conversion_output":true,"text":"one). Assuming exponential time-to-recurrence (TTR) and 40\\%60\\% TTR (40\\%","text_display":" one). Assuming exponential time-to-recurrence (TTR) and 40\\%60\\% TTR (40\\%","confidence":0.710465661458547,"confidence_rate":0.9955122755547322},{"cnt":[[621,2045],[1880,2045],[1880,2086],[621,2086]],"region":{"top_left_x":620,"top_left_y":2045,"width":1260,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85ef2d3dead849b38e26f93b7fa48532","type":"text","conversion_output":true,"text":"recurrence-free) at two years in the sterile saline group, then two years of","text_display":" recurrence-free) at two years in the sterile saline group, then two years of","confidence":1,"confidence_rate":1},{"cnt":[[621,2084],[1878,2084],[1878,2125],[621,2125]],"region":{"top_left_x":620,"top_left_y":2083,"width":1258,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d6407eab9004a36940f5a533406f1fc","type":"text","conversion_output":true,"text":"accrual ( 340 eligible patients) and two additional years of follow-up will be","text_display":" accrual ( 340 eligible patients) and two additional years of follow-up will be","confidence":0.94970703125,"confidence_rate":0.9994001598585509},{"cnt":[[621,2123],[1880,2123],[1880,2161],[621,2161]],"region":{"top_left_x":620,"top_left_y":2122,"width":1260,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c357e04395e04f96b5ef6b627ba3f2b2","type":"text","conversion_output":true,"text":"required for a one-sided 0.025 level test to have power 0.89 for detecting a","text_display":" required for a one-sided 0.025 level test to have power 0.89 for detecting a","confidence":1,"confidence_rate":1},{"cnt":[[621,2159],[1880,2159],[1880,2200],[621,2200]],"region":{"top_left_x":620,"top_left_y":2159,"width":1260,"height":41},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"367a67ee807044f5bf4dd699d8f88ad4","type":"text","conversion_output":true,"text":"hazard ratio of 1.53 (equivalent to an improvement to a \\(55 \\% 45 \\%\\) TTR \\((55 \\%\\)","text_display":" hazard ratio of 1.53 (equivalent to an improvement to a \\(55 \\% 45 \\%\\) TTR \\((55 \\%\\)","confidence":0.39120715193608024,"confidence_rate":0.9884802239390972},{"cnt":[[621,2196],[1880,2196],[1880,2239],[621,2239]],"region":{"top_left_x":620,"top_left_y":2195,"width":1260,"height":44},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d4aa0926e8cd4304bacf1f15cf595db2","type":"text","conversion_output":true,"text":"recurrence-free) rate at two years on the gemcitabine arm). The primary test","text_display":" recurrence-free) rate at two years on the gemcitabine arm). The primary test","confidence":1,"confidence_rate":1},{"cnt":[[621,2234],[1878,2234],[1878,2275],[621,2275]],"region":{"top_left_x":620,"top_left_y":2234,"width":1258,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74a02129bb7149b183c6f6aa629ffb18","type":"text","conversion_output":true,"text":"will be performed using the stratified logrank test. All eligible, randomized","text_display":" will be performed using the stratified logrank test. All eligible, randomized","confidence":1,"confidence_rate":1},{"cnt":[[621,2273],[1880,2273],[1880,2314],[621,2314]],"region":{"top_left_x":620,"top_left_y":2273,"width":1260,"height":41},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"060e6e5ac59a4c91a7837adfe187eb92","type":"text","conversion_output":true,"text":"patients will be used in the primary analysis regardless of whether they actually","text_display":" patients will be used in the primary analysis regardless of whether they actually","confidence":1,"confidence_rate":1},{"cnt":[[621,2312],[1783,2312],[1783,2357],[621,2357]],"region":{"top_left_x":620,"top_left_y":2311,"width":1164,"height":46},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ac39c424780487fad8e8c37315f8a71","type":"text","conversion_output":true,"text":"receive the treatment to which they were assigned (intent-to-treat analysis).","text_display":" receive the treatment to which they were assigned (intent-to-treat analysis).","confidence":1,"confidence_rate":1},{"cnt":[[623,2385],[1188,2385],[1188,2430],[623,2430]],"region":{"top_left_x":623,"top_left_y":2384,"width":566,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e4cba6284584ef4ba66a207f24c320e","type":"text","conversion_output":true,"text":"Estimate of sample size: 340 eligible","text_display":"\n\nEstimate of sample size: 340 eligible","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[621,2428],[1265,2428],[1265,2469],[621,2469]],"region":{"top_left_x":620,"top_left_y":2427,"width":646,"height":42},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a5c443497f747bda383d071c86a228d","type":"text","conversion_output":true,"text":"Estimate of accrual rate: 170 eligible/year","text_display":"\nEstimate of accrual rate: 170 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80\\%","confidence":0.99853515625,"confidence_rate":0.9999823384971409},{"cnt":[[621,327],[1876,327],[1876,367],[621,367]],"region":{"top_left_x":620,"top_left_y":326,"width":1256,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50953dd9d2804ce7a8dc670b336e359b","type":"text","conversion_output":true,"text":"of the expected number of events have occurred ( 126 and 202 relapses,","text_display":" of the expected number of events have occurred ( 126 and 202 relapses,","confidence":0.9356991653330624,"confidence_rate":0.9991798271587913},{"cnt":[[621,365],[1878,365],[1878,406],[621,406]],"region":{"top_left_x":620,"top_left_y":365,"width":1258,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1bf055f481864004a6cac22f897eb92e","type":"text","conversion_output":true,"text":"respectively, assuming the alternative treatment hypothesis) which will be","text_display":" respectively, assuming the 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Page 29, Section 14.2, Master Forms: The following section has been revised","text_display":"\n4. 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Please discard any previous","text_display":"\n\nAn entire replacement protocol is attached. 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Scott, Protocol Coordinator \\\\\n\\hline \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nGROUP CHAIR'S OFFIC \\\\\nS0337, \"A Phase III Blinded Study of Immediate Post-TURBT Instillation of\n\\end{tabular}} \\\\\n\\hline 24 Frank Lloyd Wright Dr & \\multirow{8}{*}{\\begin{tabular}{l}\nMEMORANDUM \\\\\nStudy Coordinator: Edward M. Messing, M.D. \\\\\nPhone number: 585/275-3345 \\\\\nE-mail: edward_messing@urmc.rochester.edu \\\\\nIRB Review Requirements![](https://cdn.mathpix.com/cropped/418d4048-59be-4948-a117-48f8172df896-11.jpg?height=42\\&width=514\\&top_left_y=1464\\&top_left_x=687) \\\\\n( ✓ ) No review required\n\\end{tabular}} \\\\\n\\hline PO Box 483 & \\\\\n\\hline 734-998-7130 & \\\\\n\\hline ![](https://cdn.mathpix.com/cropped/418d4048-59be-4948-a117-48f8172df896-11.jpg?height=43\\&width=269\\&top_left_y=1169\\&top_left_x=119) & \\multirow{3}{*}{\\begin{tabular}{l}\nFull board review required. Reason: \\\\\n( ) Initial activation (should your institution choose to participate) \\\\\n( ) Increased risk to patient \\\\\n( ) Complete study redesign \\\\\n( ) Addition of tissue banking requirements \\\\\n( ) Study closure due to new risk information\n\\end{tabular}} \\\\\n\\hline OPERATIONS OFFICE & \\\\\n\\hline 4201 Medical Dr & \\\\\n\\hline Suite 250 & \\\\\n\\hline & \\\\\n\\hline 210-614-8808 & \\multirow[b]{2}{*}{MEMORANDUM} \\\\\n\\hline 210-614-0006 FAX & \\\\\n\\hline \\begin{tabular}{l}\nSTATIST'AL CENT R \\\\\n1730 Mi or Ave\n\\end{tabular} & The purpose of this memorandum is to inform sites of the Holiday closure of Pharmagistics/Knipper. They will be closed Friday, December 23, 2011 through \\\\\n\\hline \\begin{tabular}{l}\nSuite 1900 \\\\\nSeattle, WA 98101\n\\end{tabular} & As a reminder, if a patient consents to the optional specimen submission, you must contact Dr. Jay Reeder's lab as noted in Section 15.3 of the protocol after the patient is registered and the Month 3 visit is scheduled to order a Paxgene blood tube well in advance of the Month 3 blood draw. \\\\\n\\hline 206-652-2267 & Please attach this memorandum to the front of your copy of the protocol. \\\\\n\\hline 206-342-1616 FAX & This memorandum serves to notify the NCI and SWOG Statistical Center. \\\\\n\\hline swog.org & \\begin{tabular}{l}\nBarbra Podesta, R. Ph. - Lilly \\\\\nErin Fink - Lilly \\\\\nJoseph J. Ashland - Lilly \\\\\nKathy Brown - Pharmagistics \\\\\nThomas King - Pharmagistics\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\multirow{3}{*}{} & December 15, 2011 \\\\\n\\hline & ![](https://cdn.mathpix.com/cropped/418d4048-59be-4948-a117-48f8172df896-11.jpg?height=73\\&width=1380\\&top_left_y=468\\&top_left_x=497) \\\\\n\\hline & FROM: Jennifer I. Scott, Protocol Coordinator \\\\\n\\hline \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nGROUP CHAIR'S OFFIC \\\\\nS0337, \"A Phase III Blinded Study of Immediate Post-TURBT Instillation of\n\\end{tabular}} \\\\\n\\hline 24 Frank Lloyd Wright Dr & \\multirow{8}{*}{\\begin{tabular}{l}\nMEMORANDUM \\\\\nStudy Coordinator: Edward M. 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(1-5) Despite these data, this type of therapy has not been embraced by American","text_display":" well-tolerated. (1-5) Despite these data, this type of therapy has not been embraced by American","confidence":0.9941489696502686,"confidence_rate":0.9999419005522806},{"cnt":[[370,2004],[1833,2004],[1833,2047],[370,2047]],"region":{"top_left_x":369,"top_left_y":2004,"width":1464,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"558f477b4cae465cab68e50efb43c2a8","type":"text","conversion_output":true,"text":"urologists as part of standard care for the management of low-grade superficial bladder cancer.","text_display":" urologists as part of standard care for the management of low-grade superficial bladder cancer.","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[370,2075],[795,2075],[795,2125],[370,2125]],"region":{"top_left_x":369,"top_left_y":2075,"width":426,"height":50},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ccaa4c87feb42e2bba557aa3aaafacd","type":"section_header","conversion_output":false,"children_ids":["c20a6e9a0abe46a9a191edece17a2360"],"text":"","text_display":""},{"cnt":[[372,2080],[793,2080],[793,2121],[372,2121]],"region":{"top_left_x":371,"top_left_y":2079,"width":422,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c20a6e9a0abe46a9a191edece17a2360","type":"text","conversion_output":true,"parent_id":"4ccaa4c87feb42e2bba557aa3aaafacd","text":"Superficial Bladder Cancer","text_display":"\n\n\\section*{Superficial Bladder Cancer}","confidence":1,"confidence_rate":1},{"cnt":[[370,2157],[1878,2157],[1878,2198],[370,2198]],"region":{"top_left_x":369,"top_left_y":2157,"width":1509,"height":41},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d31b6f9612d44add9b79c8009a0ab72c","type":"text","conversion_output":true,"text":"Natural History: Bladder cancer is the fifth most common solid malignancy diagnosed annually in","text_display":"\n\nNatural History: Bladder cancer is the fifth most common solid malignancy diagnosed annually in","confidence":1,"confidence_rate":1},{"cnt":[[370,2196],[1876,2196],[1876,2237],[370,2237]],"region":{"top_left_x":369,"top_left_y":2195,"width":1507,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93ef7a01884b4dcc918553dde36734e7","type":"text","conversion_output":true,"text":"the United States. (6) Between 75-80\\% of these cancers will be superficial (Stage TIS, Ta, T1),","text_display":" the United States. (6) Between 75-80\\% of these cancers will be superficial (Stage TIS, Ta, T1),","confidence":0.92919921875,"confidence_rate":0.9992659483591892},{"cnt":[[370,2234],[1878,2234],[1878,2275],[370,2275]],"region":{"top_left_x":369,"top_left_y":2234,"width":1509,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f608b42bd1e5478d9451516eec5682da","type":"text","conversion_output":true,"text":"greater than \\(90 \\%\\) transitional cell carcinomas (urothelial cancer), and the majority well (Grade 1)","text_display":" greater than \\(90 \\%\\) transitional cell carcinomas (urothelial cancer), and the majority well (Grade 1)","confidence":0.9687795639038086,"confidence_rate":0.9997008166397221},{"cnt":[[370,2273],[1878,2273],[1878,2314],[370,2314]],"region":{"top_left_x":369,"top_left_y":2273,"width":1509,"height":41},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b7c4551dc784232866686b0a66c8582","type":"text","conversion_output":true,"text":"or moderately (Grade 2) differentiated (roughly equivalent to tumors of low malignant potential and","text_display":" or moderately (Grade 2) differentiated (roughly equivalent to tumors of low malignant potential and","confidence":1,"confidence_rate":1},{"cnt":[[370,2312],[1880,2312],[1880,2353],[370,2353]],"region":{"top_left_x":369,"top_left_y":2311,"width":1511,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff1fd0a521a34296b4380fb0d08199f3","type":"text","conversion_output":true,"text":"low-grade carcinoma by 1998 AJCC criteria, respectively). (7) If one eliminates patients with","text_display":" low-grade carcinoma by 1998 AJCC criteria, respectively). (7) If one eliminates patients with","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[372,2350],[1880,2350],[1880,2391],[372,2391]],"region":{"top_left_x":371,"top_left_y":2350,"width":1509,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7faf9bda4cdb43d188245b2538759193","type":"text","conversion_output":true,"text":"Grade III (high-grade) cancer or carcinoma-in-situ (CIS), the risk of recurrence after endoscopic","text_display":" Grade III (high-grade) cancer or carcinoma-in-situ (CIS), the risk of recurrence after endoscopic","confidence":1,"confidence_rate":1},{"cnt":[[370,2389],[1880,2389],[1880,2430],[370,2430]],"region":{"top_left_x":369,"top_left_y":2389,"width":1511,"height":41},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b17fee9fe7d74274849351f1e8b6580f","type":"text","conversion_output":true,"text":"resection alone, is quite high, but that of progression to muscle invasion, relatively","text_display":" resection alone, is quite high, but that of progression to muscle invasion, relatively","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"418d4048-59be-4948-a117-48f8172df896-25","page":25,"lines":[{"cnt":[[1772,125],[1878,125],[1878,161],[1772,161]],"region":{"top_left_x":1772,"top_left_y":124,"width":106,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fac33efc1f44bf08872bdbce0c2efad","type":"page_info","conversion_output":false,"text":"S0337","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999023008080943},{"cnt":[[1762,163],[1878,163],[1878,204],[1762,204]],"region":{"top_left_x":1761,"top_left_y":163,"width":117,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d474e2b1b13747f88501cea0f4d83d69","type":"page_info","conversion_output":false,"text":"Page 6","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1525,202],[1876,202],[1876,238],[1525,238]],"region":{"top_left_x":1525,"top_left_y":201,"width":351,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b18b47dae2ca4155b7fbb719c6db1a3b","type":"page_info","conversion_output":false,"text":"Version Date 10/29/13","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,279],[1880,279],[1880,320],[370,320]],"region":{"top_left_x":369,"top_left_y":279,"width":1511,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a2fc87d24494e329533fe628025a482","type":"text","conversion_output":true,"text":"low. (2-4) Based upon a recently completed NCI/ILEX Corporation chemoprevention study (CN-","text_display":"\nlow. (2-4) Based upon a recently completed NCI/ILEX Corporation chemoprevention study (CN","confidence":0.9643895543413237,"confidence_rate":0.999618389000586},{"cnt":[[370,318],[1880,318],[1880,359],[370,359]],"region":{"top_left_x":369,"top_left_y":317,"width":1511,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2ffdfe3605244d07b4f6c30aa42dccd2","type":"text","conversion_output":true,"text":"26534), roughly 60\\% of patients eligible for S0337 (assuming most patients have prior histories of","text_display":"26534), roughly 60\\% of patients eligible for S0337 (assuming most patients have prior histories of","confidence":0.44498158036731184,"confidence_rate":0.9921694374235371},{"cnt":[[370,357],[1880,357],[1880,397],[370,397]],"region":{"top_left_x":369,"top_left_y":356,"width":1511,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ccf99dac3599475c8d66e44673076d2b","type":"text","conversion_output":true,"text":"bladder cancer), will be expected to experience a tumor recurrence within two years, as detected","text_display":" bladder cancer), will be expected to experience a tumor recurrence within two years, as detected","confidence":1,"confidence_rate":1},{"cnt":[[370,395],[1878,395],[1878,436],[370,436]],"region":{"top_left_x":369,"top_left_y":395,"width":1509,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5bbe976b485042f78fe121d9a655a8fd","type":"text","conversion_output":true,"text":"upon every three month cystoscopy. Fewer than \\(20 \\%\\) of patients eligible for this study would be","text_display":" upon every three month cystoscopy. Fewer than \\(20 \\%\\) of patients eligible for this study would be","confidence":0.643728494644165,"confidence_rate":0.9956908968840954},{"cnt":[[370,434],[1878,434],[1878,475],[370,475]],"region":{"top_left_x":369,"top_left_y":433,"width":1509,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2cc760fd08ce43a8a32782b8e43c63b6","type":"text","conversion_output":true,"text":"expected to experience grade progression upon first failure, and far less than this stage","text_display":" expected to experience grade progression upon first failure, and far less than this stage","confidence":1,"confidence_rate":1},{"cnt":[[370,473],[797,473],[797,513],[370,513]],"region":{"top_left_x":369,"top_left_y":472,"width":429,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35323105706a49288cedaaf45ebefeb2","type":"text","conversion_output":true,"text":"progression to T2+. ( \\(\\underline{2}-\\underline{4}, \\underline{8}\\) )","text_display":" progression to T2+. ( \\(\\underline{2}-\\underline{4}, \\underline{8}\\) )","confidence":0.9970729344058782,"confidence_rate":0.9999362768602222},{"cnt":[[370,546],[1880,546],[1880,587],[370,587]],"region":{"top_left_x":369,"top_left_y":545,"width":1511,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8734d95ad8e14407ae97f20818f2a7df","type":"text","conversion_output":true,"text":"The population eligible for this trial will be patients who have low (Stage Ta, low malignant","text_display":"\n\nThe population eligible for this trial will be patients who have low (Stage Ta, low malignant","confidence":1,"confidence_rate":1},{"cnt":[[370,587],[1880,587],[1880,625],[370,625]],"region":{"top_left_x":369,"top_left_y":586,"width":1511,"height":40},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73e8a72798ce4abc94954c7193728ba5","type":"text","conversion_output":true,"text":"potential [LMP]) to moderate (Stage T1, low grade) risk urothelial cancer of the bladder and","text_display":" potential [LMP]) to moderate (Stage T1, low grade) risk urothelial cancer of the bladder and","confidence":1,"confidence_rate":1},{"cnt":[[370,623],[1880,623],[1880,664],[370,664]],"region":{"top_left_x":369,"top_left_y":623,"width":1511,"height":41},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"127b0c05f5654e2aa066b602877b9f24","type":"text","conversion_output":true,"text":"whose primary urologist believes are not candidates for more prolonged courses of intravesical or","text_display":" whose primary urologist believes are not candidates for more prolonged courses of intravesical or","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[370,662],[1880,662],[1880,703],[370,703]],"region":{"top_left_x":369,"top_left_y":661,"width":1511,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9e036ffaaee4038af23f7c37c850b8a","type":"text","conversion_output":true,"text":"more aggressive therapies based upon preoperative cystoscopic inspection, bladder cancer","text_display":" more aggressive therapies based upon preoperative cystoscopic inspection, bladder cancer","confidence":1,"confidence_rate":1},{"cnt":[[370,700],[1876,700],[1876,741],[370,741]],"region":{"top_left_x":369,"top_left_y":700,"width":1507,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24da9f5f9d8742dfb73ccdf62dd7df35","type":"text","conversion_output":true,"text":"history, and other factors (e.g. upper tract evaluation, cytology results, tumor size, multifocality,","text_display":" history, and other factors (e.g. upper tract evaluation, cytology results, tumor size, multifocality,","confidence":1,"confidence_rate":1},{"cnt":[[370,739],[1880,739],[1880,780],[370,780]],"region":{"top_left_x":369,"top_left_y":739,"width":1511,"height":41},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6b47538fd6740c7a00345519dfbd9b0","type":"text","conversion_output":true,"text":"etc.). Although cystoscopic inspection for experienced urologists is usually a reliable predictor of","text_display":" etc.). Although cystoscopic inspection for experienced urologists is usually a reliable predictor of","confidence":1,"confidence_rate":1},{"cnt":[[370,778],[1880,778],[1880,819],[370,819]],"region":{"top_left_x":369,"top_left_y":777,"width":1511,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d55da552bbec4e498df14700ca7e2df4","type":"text","conversion_output":true,"text":"tumor grade and stage, it is estimated that roughly \\(10 \\%\\) of cases will be eliminated after","text_display":" tumor grade and stage, it is estimated that roughly \\(10 \\%\\) of cases will be eliminated after","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[370,816],[1880,816],[1880,857],[370,857]],"region":{"top_left_x":369,"top_left_y":816,"width":1511,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e30cc5ea2714d8090e3fe8a80f036be","type":"text","conversion_output":true,"text":"randomization and drug/placebo instillation, because high grade cancer, TIS or muscle invading","text_display":" randomization and drug/placebo instillation, because high grade cancer, TIS or muscle invading","confidence":1,"confidence_rate":1},{"cnt":[[370,855],[1878,855],[1878,896],[370,896]],"region":{"top_left_x":369,"top_left_y":855,"width":1509,"height":41},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"680b830c894747b9980b311e28533097","type":"text","conversion_output":true,"text":"cancer (Stage T2+) is documented on final histology, mandating more aggressive therapies. (9)","text_display":" cancer (Stage T2+) is documented on final histology, mandating more aggressive therapies. (9)","confidence":0.9892578125,"confidence_rate":0.9998897989159451},{"cnt":[[370,894],[1880,894],[1880,935],[370,935]],"region":{"top_left_x":369,"top_left_y":893,"width":1511,"height":42},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d60741c5e7734697820ea5b8873cbdee","type":"text","conversion_output":true,"text":"Additionally, another \\(5-10 \\%\\) of patients would be expected to have sufficiently deep, large or","text_display":" Additionally, another \\(5-10 \\%\\) of patients would be expected to have sufficiently deep, large or","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[370,932],[1876,932],[1876,973],[370,973]],"region":{"top_left_x":369,"top_left_y":932,"width":1507,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0784ea53f6154859b6f3908510d42e93","type":"text","conversion_output":true,"text":"bloody resections that urologists would be hesitant to perform immediate post TURBT instillations.","text_display":" bloody resections that urologists would be hesitant to perform immediate post TURBT instillations.","confidence":1,"confidence_rate":1},{"cnt":[[370,1005],[1880,1005],[1880,1048],[370,1048]],"region":{"top_left_x":369,"top_left_y":1005,"width":1511,"height":44},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3efa7db4c04145f5b91dbbe03de047aa","type":"text","conversion_output":true,"text":"Mechanisms of Superficial Bladder Cancer Recurrence: Particularly for LMP and low grade","text_display":"\n\nMechanisms of Superficial Bladder Cancer Recurrence: Particularly for LMP and low grade","confidence":1,"confidence_rate":1},{"cnt":[[370,1044],[1880,1044],[1880,1085],[370,1085]],"region":{"top_left_x":369,"top_left_y":1044,"width":1511,"height":41},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6252dcbe90b44a4cafdee17136241f1a","type":"text","conversion_output":true,"text":"superficial bladder cancers, data would indicate that recurrences of seemingly completely","text_display":" superficial bladder cancers, data would indicate that recurrences of seemingly completely","confidence":1,"confidence_rate":1},{"cnt":[[370,1083],[1878,1083],[1878,1124],[370,1124]],"region":{"top_left_x":369,"top_left_y":1082,"width":1509,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"969acc44be744a7d9c36e7a964172012","type":"text","conversion_output":true,"text":"resected tumors occur because of new tumor development at other regions of the urothelium","text_display":" resected tumors occur because of new tumor development at other regions of the urothelium","confidence":1,"confidence_rate":1},{"cnt":[[372,1121],[1878,1121],[1878,1162],[372,1162]],"region":{"top_left_x":371,"top_left_y":1121,"width":1507,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42a8d5d3bd2c413ba7fe50aede78f1aa","type":"text","conversion_output":true,"text":"(field effect), implantation of tumor cells derived from the original tumor in other sites of urothelium","text_display":" (field effect), implantation of tumor cells derived from the original tumor in other sites of urothelium","confidence":1,"confidence_rate":1},{"cnt":[[372,1160],[1880,1160],[1880,1201],[372,1201]],"region":{"top_left_x":371,"top_left_y":1160,"width":1509,"height":41},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2618640222534f7ca51b2eab9f1b9eaa","type":"text","conversion_output":true,"text":"(presumably occurring spontaneously as well as because of perturbations induced by","text_display":" (presumably occurring spontaneously as well as because of perturbations induced by","confidence":1,"confidence_rate":1},{"cnt":[[370,1199],[1878,1199],[1878,1240],[370,1240]],"region":{"top_left_x":369,"top_left_y":1198,"width":1509,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3261d914deca442484819328f9500b26","type":"text","conversion_output":true,"text":"instrumentations such as cystoscopy and transurethral resection [TUR]), and because of failure to","text_display":" instrumentations such as cystoscopy and transurethral resection [TUR]), and because of failure to","confidence":1,"confidence_rate":1},{"cnt":[[370,1238],[1878,1238],[1878,1278],[370,1278]],"region":{"top_left_x":369,"top_left_y":1237,"width":1509,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfe782ac50bb432a8b38db786dfdd2ca","type":"text","conversion_output":true,"text":"resect the original malignancy. \\((\\underline{5}, \\underline{10})\\) Evidence to support implantation includes differences in","text_display":" resect the original malignancy. \\((\\underline{5}, \\underline{10})\\) Evidence to support implantation includes differences in","confidence":0.948515899532822,"confidence_rate":0.999515193456417},{"cnt":[[372,1276],[1878,1276],[1878,1317],[372,1317]],"region":{"top_left_x":371,"top_left_y":1276,"width":1507,"height":41},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f90a27464bf4bf9b54f65268e2e03eb","type":"text","conversion_output":true,"text":"locations of primary tumors compared to recurrences with the former primarily located on the","text_display":" locations of primary tumors compared to recurrences with the former primarily located on 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(11) Animal models also indicate that both spontaneous and mechanically","text_display":" anterior bladder wall. (11) Animal models also indicate that both spontaneous and mechanically","confidence":1,"confidence_rate":1},{"cnt":[[370,1390],[1880,1390],[1880,1433],[370,1433]],"region":{"top_left_x":369,"top_left_y":1390,"width":1511,"height":44},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"396479d05b2840c4b81faedf949e3315","type":"text","conversion_output":true,"text":"facilitated implantation occurs. Sites of urothelial injury are preferential sites of recurrence. ( \\(\\underline{12}-\\)","text_display":" facilitated implantation occurs. Sites of urothelial injury are preferential sites of recurrence. ( \\(\\underline{12}-\\)","confidence":0.18590151568345262,"confidence_rate":0.9848205845158251},{"cnt":[[372,1431],[1880,1431],[1880,1472],[372,1472]],"region":{"top_left_x":371,"top_left_y":1430,"width":1509,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"764a9ce7b3b34e54b05ff053d89c9073","type":"text","conversion_output":true,"text":"13) A single, immediately post TURBT intravesical instillation of chemotherapy is primarily","text_display":" 13) A single, immediately post TURBT intravesical instillation of chemotherapy is primarily","confidence":1,"confidence_rate":1},{"cnt":[[370,1470],[1880,1470],[1880,1508],[370,1508]],"region":{"top_left_x":369,"top_left_y":1469,"width":1511,"height":40},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90b6a6c785ab41b0a426f9b5d1b803bb","type":"text","conversion_output":true,"text":"directed at reducing the rate of implantation, although it may have a beneficial effect on","text_display":" directed at reducing the rate of implantation, although it may have a beneficial effect on","confidence":1,"confidence_rate":1},{"cnt":[[370,1504],[1609,1504],[1609,1549],[370,1549]],"region":{"top_left_x":369,"top_left_y":1503,"width":1241,"height":47},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b598de44977a4c4aaa180f6929229872","type":"text","conversion_output":true,"text":"eliminating field effect tumors or persistent (incompletely resected) ones, as well.","text_display":" eliminating field effect tumors or persistent (incompletely resected) ones, as well.","confidence":1,"confidence_rate":1},{"cnt":[[372,1581],[1880,1581],[1880,1622],[372,1622]],"region":{"top_left_x":371,"top_left_y":1581,"width":1509,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3728f59c147a4c7aa66ee79e34c03cbc","type":"text","conversion_output":true,"text":"Intravesical Therapy: To reduce the frequency of recurrences in these individuals at low risk for","text_display":"\n\nIntravesical Therapy: To reduce the frequency of recurrences in these individuals at low risk for","confidence":0.98291015625,"confidence_rate":0.9998310185875988},{"cnt":[[370,1620],[1880,1620],[1880,1661],[370,1661]],"region":{"top_left_x":369,"top_left_y":1619,"width":1511,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3af57747bb742478688c4a6f19b8b80","type":"text","conversion_output":true,"text":"bladder cancer progression and at high risk for recurrence, intravesical therapy with a variety of","text_display":" bladder cancer progression and at high risk for recurrence, intravesical therapy with a variety of","confidence":1,"confidence_rate":1},{"cnt":[[372,1659],[1880,1659],[1880,1699],[372,1699]],"region":{"top_left_x":371,"top_left_y":1658,"width":1509,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9cef58176fee40e9a150aac952683b77","type":"text","conversion_output":true,"text":"chemo- and immunotherapeutic agents have been used. Agents have included BCG, mitomycin-","text_display":" chemo- and immunotherapeutic agents have been used. Agents have included BCG, mitomycin","confidence":1,"confidence_rate":1},{"cnt":[[370,1697],[1876,1697],[1876,1738],[370,1738]],"region":{"top_left_x":369,"top_left_y":1697,"width":1507,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8c417991dae44118d9a7a46cc6f616e","type":"text","conversion_output":true,"text":"C, doxorubicin, and thiotepa in the United States, as well as epirubicin and epodyl in Europe.","text_display":"C, doxorubicin, and thiotepa in the United States, as well as epirubicin and epodyl in Europe.","confidence":1,"confidence_rate":1},{"cnt":[[372,1736],[1878,1736],[1878,1777],[372,1777]],"region":{"top_left_x":371,"top_left_y":1735,"width":1507,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"764f0e856a804b97a9d1d4e0db3d9cf8","type":"text","conversion_output":true,"text":"Courses of instillation therapy starting days and weeks after the TURBT can reduce recurrences","text_display":" Courses of instillation therapy starting days and weeks after the TURBT can reduce recurrences","confidence":1,"confidence_rate":1},{"cnt":[[372,1775],[1880,1775],[1880,1815],[372,1815]],"region":{"top_left_x":371,"top_left_y":1774,"width":1509,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d223b068ffb403caf480eb68ce966cc","type":"text","conversion_output":true,"text":"by 17 to \\(44 \\%\\) compared with controls. (14-16) These treatments, however, are not without","text_display":" by 17 to \\(44 \\%\\) compared with controls. (14-16) These treatments, however, are not without","confidence":0.5060768127441406,"confidence_rate":0.9930744316498701},{"cnt":[[370,1813],[1878,1813],[1878,1854],[370,1854]],"region":{"top_left_x":369,"top_left_y":1813,"width":1509,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50012537467148f19e0be9f83755c6a1","type":"text","conversion_output":true,"text":"considerable inconvenience, expense, and morbidities for patients with side effects including","text_display":" considerable inconvenience, expense, and morbidities for patients with side effects including","confidence":1,"confidence_rate":1},{"cnt":[[370,1850],[1876,1850],[1876,1893],[370,1893]],"region":{"top_left_x":369,"top_left_y":1849,"width":1507,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"95a9aa74f6504f84af9f73332899d511","type":"text","conversion_output":true,"text":"thrombocytopenia and leukopenia with thiotepa in \\(9 \\%\\) of patients, genital rash due to mitomycin in","text_display":" thrombocytopenia and leukopenia with thiotepa in \\(9 \\%\\) of patients, genital rash due to mitomycin in","confidence":0.998046875,"confidence_rate":0.9999813807939509},{"cnt":[[370,1886],[1878,1886],[1878,1931],[370,1931]],"region":{"top_left_x":369,"top_left_y":1886,"width":1509,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd79fc7bb3884c26a88197a242c74ad6","type":"text","conversion_output":true,"text":"\\(6 \\%\\) of patients, and bladder contracture in as many as \\(16 \\%\\) of those treated with doxorubicin and","text_display":" \\(6 \\%\\) of patients, and bladder contracture in as many as \\(16 \\%\\) of those treated with doxorubicin and","confidence":0.9113438129425049,"confidence_rate":0.9990902664976139},{"cnt":[[370,1929],[1878,1929],[1878,1970],[370,1970]],"region":{"top_left_x":369,"top_left_y":1929,"width":1509,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1014b4c6680b4f658939f0354c42933f","type":"text","conversion_output":true,"text":"a smaller percentage of those treated with mitomycin. Side effects from BCG therapy occur in 20","text_display":" a smaller percentage of those treated with mitomycin. Side effects from BCG therapy occur in 20","confidence":1,"confidence_rate":1},{"cnt":[[370,1966],[1878,1966],[1878,2007],[370,2007]],"region":{"top_left_x":369,"top_left_y":1965,"width":1509,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28eaa7bcac4f44daae051d8d5af15f13","type":"text","conversion_output":true,"text":"- \\(45 \\%\\) of patients and can include high fever, granulomatous prostatitis, pneumonitis, and","text_display":" - \\(45 \\%\\) of patients and can include high fever, granulomatous prostatitis, pneumonitis, and","confidence":0.9985356330871582,"confidence_rate":0.9999848924837492},{"cnt":[[370,2007],[513,2007],[513,2047],[370,2047]],"region":{"top_left_x":369,"top_left_y":2006,"width":145,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6f3b31caafb43a599626dfe5bf55891","type":"text","conversion_output":true,"text":"hepatitis.","text_display":" hepatitis.","confidence":1,"confidence_rate":1},{"cnt":[[370,2080],[1876,2080],[1876,2121],[370,2121]],"region":{"top_left_x":369,"top_left_y":2079,"width":1507,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c274a1589ec4921af020f214d203042","type":"text","conversion_output":true,"text":"To reduce these sources of morbidity, inconvenience and expense immediately following TURBT,","text_display":"\n\nTo reduce these sources of morbidity, inconvenience and expense immediately following TURBT,","confidence":1,"confidence_rate":1},{"cnt":[[372,2118],[1876,2118],[1876,2159],[372,2159]],"region":{"top_left_x":371,"top_left_y":2118,"width":1505,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a66e68230904073b81e5840d5434b91","type":"text","conversion_output":true,"text":"intravesical instillations of a variety of chemotherapeutic agents have been tested in prospective","text_display":" intravesical instillations of a variety of chemotherapeutic agents have been tested in prospective","confidence":1,"confidence_rate":1},{"cnt":[[370,2157],[1878,2157],[1878,2198],[370,2198]],"region":{"top_left_x":369,"top_left_y":2157,"width":1509,"height":41},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9587b240b6494db98635871e7de6a723","type":"text","conversion_output":true,"text":"randomized studies. These studies are summarized in Table 1. The agents have included","text_display":" randomized studies. These studies are summarized in Table 1. The agents have included","confidence":1,"confidence_rate":1},{"cnt":[[370,2196],[1878,2196],[1878,2237],[370,2237]],"region":{"top_left_x":369,"top_left_y":2195,"width":1509,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a470c251f654f7c9bdf316a7085d859","type":"text","conversion_output":true,"text":"thiotepa, mitomycin-C, epirubicin, doxorubicin, and epodyl. While patients, drug dosages, times","text_display":" thiotepa, mitomycin-C, epirubicin, doxorubicin, and epodyl. While patients, drug dosages, times","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[370,2234],[1878,2234],[1878,2275],[370,2275]],"region":{"top_left_x":369,"top_left_y":2234,"width":1509,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b702ba4bd98e4b3db020e9a7eb3d32d1","type":"text","conversion_output":true,"text":"of instillation after TURBT, and durations of follow-up have varied, most studies have shown a 40","text_display":" of instillation after TURBT, and durations of follow-up have varied, most studies have shown a 40","confidence":1,"confidence_rate":1},{"cnt":[[370,2273],[1454,2273],[1454,2314],[370,2314]],"region":{"top_left_x":369,"top_left_y":2273,"width":1086,"height":41},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"32d1c6bb7de941b3984b309deef554ea","type":"text","conversion_output":true,"text":"\\(-50 \\%\\) reduction in tumor recurrences with active agents (see Table 1).","text_display":" \\(-50 \\%\\) reduction in tumor recurrences with active agents (see Table 1).","confidence":0.9907269477844238,"confidence_rate":0.9998723873949391}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"418d4048-59be-4948-a117-48f8172df896-26","page":26,"lines":[{"cnt":[[1770,125],[1880,125],[1880,161],[1770,161]],"region":{"top_left_x":1770,"top_left_y":124,"width":110,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d84c94264893490aa8c1e227f34f4c43","type":"page_info","conversion_output":false,"text":"S0337","text_display":"","confidence":0.99755859375,"confidence_rate":0.9997555907386334},{"cnt":[[1762,163],[1878,163],[1878,204],[1762,204]],"region":{"top_left_x":1761,"top_left_y":163,"width":117,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4bc2f554ea442be93635eef72aeb520","type":"page_info","conversion_output":false,"text":"Page 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& AGENT DOSE CONTROL & \\# Pts & STAGE & NEW VS RECURRENT & RECURRENCE RATE 2 YR \\\\\n\\hline MRC, Br J Urol 57:6810, 1985 & Ttp \\(30 mg / 50 ml\\) vs obs & 256 & TaT1 & N only & 41.3\\% 35.4\\% \\(p =.7\\) \\\\\n\\hline MRC, Br J Urol 73:632, 1994 & \\multicolumn{5}{|l|}{Long term \\(f / u -8.75 \\rightarrow\\) no diff time to \\(1^{\\text {st }}\\) recurrence, recurrence rate, or failure free interval} \\\\\n\\hline Solsona, et al Br J Urol 161:1120, 1999 & MMC \\(30 mg / 50 ml\\) NS vs obs & 121 & TaT1 & 90\\% new 10\\% recurrent & \\begin{tabular}{l}\nRR 1yr \\\\\n22\\% 59\\% p<. 005 no diff in recurrences after 1 yr\n\\end{tabular} \\\\\n\\hline Oosterlinck, et al J Urol 149:749, 1993 & Epirub 80 mg in 50cc NS vs 50 \\(ml H _{2} O\\) & 399 & TaT1 & 80\\% new 20\\% recurrent & \\begin{tabular}{l}\nRR 1yr \\\\\n17\\% 32\\% p<. 0001 10-15\\% 31\\% p<. 0001 \\\\\nRecurrent 26\\% 35\\% p = . 38 but after \\(12-18 mo\\) recurrences were \\(=\\) \\& continued in each arm after \\(18 mo \\rightarrow 4 yr\\)\n\\end{tabular} \\\\\n\\hline Burnand, et al Br J Urol 48:55, 1976 & Ttp \\(90 mg / 100 cc\\) & 51 & TaT1 & Unknown & \\begin{tabular}{l}\nRecurrences ( \\(2-5 yr\\) f/u) \\\\\n57.9\\%* 96.8\\% p<. 005 *no recurrence at vault alone vs 21.9\\% at vault alone for control\n\\end{tabular} \\\\\n\\hline Ali-el-dein, et al Br J Urol 79:731, 1997 & Epirub 50 \\(mg / 50 ml\\) NS vs obs & 109 (19\\% G3) & TaT1 & 55\\% new 45\\% recurrent (24\\% interval to tumor recur) & RR at mean 2.5 yr 52\\% \\(p <.002 16 mo 7 mo p <.05\\) \\\\\n\\hline Rajala, et al J Urol 161:1133, 1999 & Epirub 100 mg vs Ifα2b 50 M unit (3 arm) vs obs & 200 ( \\(12 \\% G 3\\) ) & TaT1 & All new Single tumor Multiple tumors & RR at 2 year Epi If \\(\\alpha\\) Cont 32\\% 62\\% 60\\% p<. 05 27\\% 63\\% 55\\% 56\\% 67\\% 74\\% \\\\\n\\hline Tolley, et al J Urol 155:1233, 1996 & MMC \\(40 mg / 40\\) ml \\(H _{2} O\\) vs obs & 306 & TaT1 & \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nAll new RR at 2 year\n\\[\n\\frac{\\text { MMC }}{42 \\%} \\quad \\frac{\\text { Cont }}{55 \\% p}=.05\n\\] \\\\\nAfter 18 mo no further improvement from MMC hazard rate MMC . 66 control for recurrent\n\\end{tabular}} \\\\\n\\hline Zincke, et al J Urol 129:505, 1983 & Ttp \\(60 mg / 60 ml\\) Dox \\(50 mg / 60 ml H _{2} O 60 ml\\) & 45 (roughly) & Ta, T1, TIS & 21\\% new 79\\% recur & \\begin{tabular}{l}\nRR at \\(3 mo -4 mo\\)\n\\(\\frac{\\text { Ttp }}{30 \\%} \\quad \\frac{\\text { Dox }}{32 \\%} \\quad \\frac{ H _{2} O }{71 \\%}\\) \\\\\n43\\% 0 43\\% 26\\% 38\\% 81\\%\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 1}\n\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline & AGENT DOSE CONTROL & \\# Pts & STAGE & NEW VS RECURRENT & RECURRENCE RATE 2 YR \\\\\n\\hline MRC, Br J Urol 57:6810, 1985 & Ttp \\(30 mg / 50 ml\\) vs obs & 256 & TaT1 & N only & 41.3\\% 35.4\\% \\(p =.7\\) \\\\\n\\hline MRC, Br J Urol 73:632, 1994 & \\multicolumn{5}{|l|}{Long term \\(f / u -8.75 \\rightarrow\\) no diff time to \\(1^{\\text {st }}\\) recurrence, recurrence rate, or failure free interval} \\\\\n\\hline Solsona, et al Br J Urol 161:1120, 1999 & MMC \\(30 mg / 50 ml\\) NS vs obs & 121 & TaT1 & 90\\% new 10\\% recurrent & \\begin{tabular}{l}\nRR 1yr \\\\\n22\\% 59\\% p<. 005 no diff in recurrences after 1 yr\n\\end{tabular} \\\\\n\\hline Oosterlinck, et al J Urol 149:749, 1993 & Epirub 80 mg in 50cc NS vs 50 \\(ml H _{2} O\\) & 399 & TaT1 & 80\\% new 20\\% recurrent & \\begin{tabular}{l}\nRR 1yr \\\\\n17\\% 32\\% p<. 0001 10-15\\% 31\\% p<. 0001 \\\\\nRecurrent 26\\% 35\\% p = . 38 but after \\(12-18 mo\\) recurrences were \\(=\\) \\& continued in each arm after \\(18 mo \\rightarrow 4 yr\\)\n\\end{tabular} \\\\\n\\hline Burnand, et al Br J Urol 48:55, 1976 & Ttp \\(90 mg / 100 cc\\) & 51 & TaT1 & Unknown & \\begin{tabular}{l}\nRecurrences ( \\(2-5 yr\\) f/u) \\\\\n57.9\\%* 96.8\\% p<. 005 *no recurrence at vault alone vs 21.9\\% at vault alone for control\n\\end{tabular} \\\\\n\\hline Ali-el-dein, et al Br J Urol 79:731, 1997 & Epirub 50 \\(mg / 50 ml\\) NS vs obs & 109 (19\\% G3) & TaT1 & 55\\% new 45\\% recurrent (24\\% interval to tumor recur) & RR at mean 2.5 yr 52\\% \\(p <.002 16 mo 7 mo p <.05\\) \\\\\n\\hline Rajala, et al J Urol 161:1133, 1999 & Epirub 100 mg vs Ifα2b 50 M unit (3 arm) vs obs & 200 ( \\(12 \\% G 3\\) ) & TaT1 & All new Single tumor Multiple tumors & RR at 2 year Epi If \\(\\alpha\\) Cont 32\\% 62\\% 60\\% p<. 05 27\\% 63\\% 55\\% 56\\% 67\\% 74\\% \\\\\n\\hline Tolley, et al J Urol 155:1233, 1996 & MMC \\(40 mg / 40\\) ml \\(H _{2} O\\) vs obs & 306 & TaT1 & \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nAll new RR at 2 year\n\\[\n\\frac{\\text { MMC }}{42 \\%} \\quad \\frac{\\text { Cont }}{55 \\% p}=.05\n\\] \\\\\nAfter 18 mo no further improvement from MMC hazard rate MMC . 66 control for recurrent\n\\end{tabular}} \\\\\n\\hline Zincke, et al J Urol 129:505, 1983 & Ttp \\(60 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(20) Thus, this agent has efficacy both","text_display":" with less toxicity for the gemcitabine plus cisplatin arm. (20) Thus, this agent has efficacy both","confidence":1,"confidence_rate":1},{"cnt":[[372,1276],[1229,1276],[1229,1313],[372,1313]],"region":{"top_left_x":371,"top_left_y":1276,"width":858,"height":37},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"60ca397f6d2343098de10064de55ed07","type":"text","conversion_output":true,"text":"alone and in combination in advanced urothelial cancer.","text_display":" alone and in combination in advanced urothelial cancer.","confidence":1,"confidence_rate":1},{"cnt":[[372,1351],[1880,1351],[1880,1394],[372,1394]],"region":{"top_left_x":371,"top_left_y":1351,"width":1509,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"214f8004809c425ca38f6c85cea93a0d","type":"text","conversion_output":true,"text":"Intravesical Gemcitabine: Based on these observations, Dalbagni and colleagues have in a","text_display":"\n\nIntravesical Gemcitabine: Based on these observations, Dalbagni and colleagues have in a","confidence":1,"confidence_rate":1},{"cnt":[[372,1388],[1880,1388],[1880,1433],[372,1433]],"region":{"top_left_x":371,"top_left_y":1387,"width":1509,"height":47},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b86820a3de244787bf3be22a6f4d07ea","type":"text","conversion_output":true,"text":"Phase I study tested various concentrations of this agent in an intensive regimen (biweekly","text_display":" Phase I study tested various concentrations of this agent in an intensive regimen (biweekly","confidence":1,"confidence_rate":1},{"cnt":[[372,1431],[1878,1431],[1878,1472],[372,1472]],"region":{"top_left_x":371,"top_left_y":1430,"width":1507,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19492f6dd3814282bb8c77ae72dd96d2","type":"text","conversion_output":true,"text":"instillations for three weeks followed by a one week hiatus in which patients were cystoscoped,","text_display":" instillations for three weeks followed by a one week hiatus in which patients were cystoscoped,","confidence":1,"confidence_rate":1},{"cnt":[[372,1467],[1878,1467],[1878,1508],[372,1508]],"region":{"top_left_x":371,"top_left_y":1467,"width":1507,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b76ff78584f041bf85877cf952876d73","type":"text","conversion_output":true,"text":"and then received three more weeks of biweekly instillations in dosages ranging from 500 to 2,000","text_display":" and then received three more weeks of biweekly instillations in dosages ranging from 500 to 2,000","confidence":0.99560546875,"confidence_rate":0.9999576526698952},{"cnt":[[372,1504],[1880,1504],[1880,1547],[372,1547]],"region":{"top_left_x":371,"top_left_y":1503,"width":1509,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f43c1e374c94fe786d4d57eb4ff5384","type":"text","conversion_output":true,"text":"mg of gemcitabine in 100 ml of buffered water). (21) The 18 patients taking part in this Phase I","text_display":" mg of gemcitabine in 100 ml of buffered water). (21) The 18 patients taking part in this Phase I","confidence":0.9980475902557373,"confidence_rate":0.9999823936848974},{"cnt":[[372,1543],[1876,1543],[1876,1586],[372,1586]],"region":{"top_left_x":371,"top_left_y":1542,"width":1505,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28197d5d0f754edaa3d4c4c1c2bb0115","type":"text","conversion_output":true,"text":"study were at very high risk, having highly refractory TIS or more advanced superficial TCC.","text_display":" study were at very high risk, having highly refractory TIS or more advanced superficial TCC.","confidence":1,"confidence_rate":1},{"cnt":[[370,1581],[1878,1581],[1878,1624],[370,1624]],"region":{"top_left_x":369,"top_left_y":1581,"width":1509,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b298c0bfe8e84244b0e4fd936537d485","type":"text","conversion_output":true,"text":"Thirty-nine percent of the patients achieved complete pathologic and cytologic responses and","text_display":" Thirty-nine percent of the patients achieved complete pathologic and cytologic responses and","confidence":1,"confidence_rate":1},{"cnt":[[370,1620],[1878,1620],[1878,1661],[370,1661]],"region":{"top_left_x":369,"top_left_y":1619,"width":1509,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d9d93f87b1a4f8da996bcff79103a96","type":"text","conversion_output":true,"text":"another \\(22 \\%\\) had mixed responses (negative biopsies but positive cytologies). The responses","text_display":" another \\(22 \\%\\) had mixed responses (negative biopsies but positive cytologies). The responses","confidence":0.98095703125,"confidence_rate":0.9998038292302832},{"cnt":[[370,1659],[1880,1659],[1880,1699],[370,1699]],"region":{"top_left_x":369,"top_left_y":1658,"width":1511,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e67cd217a12341d1838fd3da08324d9d","type":"text","conversion_output":true,"text":"were not clearly dose related when dosages of \\(\\geq 10 mg / ml\\) were administered. There was no","text_display":" were not clearly dose related when dosages of \\(\\geq 10 mg / ml\\) were administered. There was no","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[372,1697],[1878,1697],[1878,1738],[372,1738]],"region":{"top_left_x":371,"top_left_y":1697,"width":1507,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae50a6b6a92a40769f5d99a21fd2424b","type":"text","conversion_output":true,"text":"response seen, however, at the lowest dose, \\(5 mg / ml\\). At the \\(10 mg / ml\\) dose, 3 of 6 patients","text_display":" response seen, however, at the lowest dose, \\(5 mg / ml\\). At the \\(10 mg / ml\\) dose, 3 of 6 patients","confidence":1,"confidence_rate":1},{"cnt":[[374,1736],[1878,1736],[1878,1777],[374,1777]],"region":{"top_left_x":373,"top_left_y":1735,"width":1505,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"978df226fb6e4df19ff1a3fa7ff2aa78","type":"text","conversion_output":true,"text":"experienced a complete response, 2 of 6 had a mixed response as defined above and 1 of 6 had","text_display":" experienced a complete response, 2 of 6 had a mixed response as defined above and 1 of 6 had","confidence":1,"confidence_rate":1},{"cnt":[[374,1775],[1876,1775],[1876,1815],[374,1815]],"region":{"top_left_x":373,"top_left_y":1774,"width":1503,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebdeff16af974eab80f97c4744d84f85","type":"text","conversion_output":true,"text":"persistent tumor. Encouraged by these findings in an extremely high risk group of patients,","text_display":" persistent tumor. Encouraged by these findings in an extremely high risk group of patients,","confidence":1,"confidence_rate":1},{"cnt":[[372,1813],[1880,1813],[1880,1854],[372,1854]],"region":{"top_left_x":371,"top_left_y":1813,"width":1509,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a886d567c726491ba259fc7309670d3e","type":"text","conversion_output":true,"text":"Dalbagni, et al, are carrying out a Phase II trial of this regimen in highly refractory high risk","text_display":" Dalbagni, et al, are carrying out a Phase II trial of this regimen in highly refractory high risk","confidence":0.99609375,"confidence_rate":0.9999616291742071},{"cnt":[[372,1852],[913,1852],[913,1893],[372,1893]],"region":{"top_left_x":371,"top_left_y":1851,"width":543,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"523991504f5c4511a53d5a85a43db0aa","type":"text","conversion_output":true,"text":"superficial bladder cancer patients.","text_display":" superficial bladder cancer patients.","confidence":1,"confidence_rate":1},{"cnt":[[374,1927],[1876,1927],[1876,1968],[374,1968]],"region":{"top_left_x":373,"top_left_y":1927,"width":1503,"height":41},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d17ca7a1df540e68d0cdf9a7ae1a0e5","type":"text","conversion_output":true,"text":"Gemcitabine when dissolved in water or saline reduces the pH of the solution to the 2 to 3 range.","text_display":"\n\nGemcitabine when dissolved in water or saline reduces the pH of the solution to the 2 to 3 range.","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[374,1968],[1878,1968],[1878,2007],[374,2007]],"region":{"top_left_x":373,"top_left_y":1967,"width":1505,"height":40},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"570653d9b7b54463a231fdbb02b95193","type":"text","conversion_output":true,"text":"Because at least in in vitro studies, acidification to this degree alone has toxic effects on human","text_display":" Because at least in in vitro studies, acidification to this degree alone has toxic effects on human","confidence":1,"confidence_rate":1},{"cnt":[[372,2004],[1880,2004],[1880,2047],[372,2047]],"region":{"top_left_x":371,"top_left_y":2004,"width":1509,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c554b9d9d861433eb0a5f2cdf9eae561","type":"text","conversion_output":true,"text":"urothelial cells in culture, some authors have suggested buffering the solution with sodium","text_display":" urothelial cells in culture, some authors have suggested buffering the solution with sodium","confidence":1,"confidence_rate":1},{"cnt":[[372,2041],[1880,2041],[1880,2084],[372,2084]],"region":{"top_left_x":371,"top_left_y":2041,"width":1509,"height":43},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"752094f389194423b051196e29e40d7f","type":"text","conversion_output":true,"text":"bicarbonate to reach a pH of \\(5-6\\), which is physiologic in the bladder. (O'Donnell, personal","text_display":" bicarbonate to reach a pH of \\(5-6\\), which is physiologic in the bladder. (O'Donnell, personal","confidence":0.9627720583230257,"confidence_rate":0.999642152771254},{"cnt":[[372,2080],[1878,2080],[1878,2121],[372,2121]],"region":{"top_left_x":371,"top_left_y":2079,"width":1507,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"951ee965db5643ba9378f979a55f0c8b","type":"text","conversion_output":true,"text":"communication, (22) In the clinical study performed by Dalbagni, et al, such buffering was","text_display":" communication, (22) In the clinical study performed by Dalbagni, et al, such buffering was","confidence":1,"confidence_rate":1},{"cnt":[[372,2118],[1755,2118],[1755,2161],[372,2161]],"region":{"top_left_x":371,"top_left_y":2118,"width":1385,"height":44},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0bd5351633d14610bd355e632b1bbd7a","type":"text","conversion_output":true,"text":"performed. (21) However, in no other studies (described below) has buffering been used.","text_display":" performed. (21) However, in no other studies (described below) has buffering been used.","confidence":1,"confidence_rate":1},{"cnt":[[372,2196],[1880,2196],[1880,2237],[372,2237]],"region":{"top_left_x":371,"top_left_y":2195,"width":1509,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21d6adbb4b6746fda77d6c15ce9de696","type":"text","conversion_output":true,"text":"In a separate Phase I study, Laufer, et al, studied 15 patients with recurrent superficial bladder","text_display":"\n\nIn a separate Phase I study, Laufer, et al, studied 15 patients with recurrent superficial bladder","confidence":0.9990234375,"confidence_rate":0.9999907826873115},{"cnt":[[372,2234],[1880,2234],[1880,2275],[372,2275]],"region":{"top_left_x":371,"top_left_y":2234,"width":1509,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f23f745048cd49f687557659ffec4967","type":"text","conversion_output":true,"text":"cancer (heavily pretreated with intravesical therapies) with six weekly instillations of gemcitabine","text_display":" cancer (heavily pretreated with intravesical therapies) with six weekly instillations of gemcitabine","confidence":1,"confidence_rate":1},{"cnt":[[372,2273],[1880,2273],[1880,2314],[372,2314]],"region":{"top_left_x":371,"top_left_y":2273,"width":1509,"height":41},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c63b8931c8f34ff881b79d234be8b8f1","type":"text","conversion_output":true,"text":"dissolved in \\(0.9 \\%\\) saline beginning \\(2-4\\) weeks after TURBT. ( \\(\\underline{23}\\) ) Three patient cohorts were","text_display":" dissolved in \\(0.9 \\%\\) saline beginning \\(2-4\\) weeks after TURBT. ( \\(\\underline{23}\\) ) Three patient cohorts were","confidence":0.6614338350786763,"confidence_rate":0.9961800431597512},{"cnt":[[372,2312],[1880,2312],[1880,2353],[372,2353]],"region":{"top_left_x":371,"top_left_y":2311,"width":1509,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6309322ee4d5417ea20ea6e2a4c76974","type":"text","conversion_output":true,"text":"enrolled sequentially, receiving doses of \\(500,1,000\\) and \\(1,500 mg\\) in \\(100 ml 0.9 \\%\\) saline. An","text_display":" enrolled sequentially, receiving doses of \\(500,1,000\\) and \\(1,500 mg\\) in \\(100 ml 0.9 \\%\\) saline. An","confidence":0.3553595783887431,"confidence_rate":0.9903772047649061},{"cnt":[[372,2350],[1878,2350],[1878,2391],[372,2391]],"region":{"top_left_x":371,"top_left_y":2350,"width":1507,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e5b96168fed48b58c2a7883ff855f43","type":"text","conversion_output":true,"text":"additional six patients received \\(2,000 mg\\) in 100 ml or 50 ml . Nine of 13 evaluable patients had","text_display":" additional six patients received \\(2,000 mg\\) in 100 ml or 50 ml . Nine of 13 evaluable patients had","confidence":1,"confidence_rate":1},{"cnt":[[372,2385],[1880,2385],[1880,2430],[372,2430]],"region":{"top_left_x":371,"top_left_y":2384,"width":1509,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"450fc94479d84ca5922a7e60e12f994b","type":"text","conversion_output":true,"text":"complete responses at six weeks after completion of therapy - all responders receiving \\(\\geq 1,000\\)","text_display":" complete responses at six weeks after completion of therapy - all responders receiving \\(\\geq 1,000\\)","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"418d4048-59be-4948-a117-48f8172df896-28","page":28,"lines":[{"cnt":[[1772,125],[1878,125],[1878,161],[1772,161]],"region":{"top_left_x":1772,"top_left_y":124,"width":106,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"76150356f4a344e6b8adbf058a0c4e04","type":"page_info","conversion_output":false,"text":"S0337","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999023008080943},{"cnt":[[1764,163],[1878,163],[1878,204],[1764,204]],"region":{"top_left_x":1763,"top_left_y":163,"width":115,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e1b205660bc42c692dbc0f8a14923fd","type":"page_info","conversion_output":false,"text":"Page 9","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1525,202],[1876,202],[1876,238],[1525,238]],"region":{"top_left_x":1525,"top_left_y":201,"width":351,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e921505f10a142878f4cad11c256f3fd","type":"page_info","conversion_output":false,"text":"Version Date 10/29/13","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,271],[1878,271],[1878,320],[370,320]],"region":{"top_left_x":369,"top_left_y":270,"width":1509,"height":51},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ba71b5f927f4df9bc9046b7444ec388","type":"text","conversion_output":true,"text":"mg doses. Pharmacokinetic studies demonstrated gemcitabine or its metabolite, \\(2^{1} 2^{1}\\)","text_display":"\nmg doses. Pharmacokinetic studies demonstrated gemcitabine or its metabolite, \\(2^{1} 2^{1}\\)","confidence":0.9917030334472656,"confidence_rate":0.9999183211990407},{"cnt":[[372,318],[1880,318],[1880,359],[372,359]],"region":{"top_left_x":371,"top_left_y":317,"width":1509,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86d4ca7a06d5430fa001bd18565c2755","type":"text","conversion_output":true,"text":"difluorodeoxyuridure in plasma of patients transiently in doses \\(\\geq 1,500 mg / 100 ml\\). No Grade 4","text_display":" difluorodeoxyuridure in plasma of patients transiently in doses \\(\\geq 1,500 mg / 100 ml\\). No Grade 4","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[370,357],[1880,357],[1880,397],[370,397]],"region":{"top_left_x":369,"top_left_y":356,"width":1511,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7c3c9dd414545f29d15c9b8bd365723","type":"text","conversion_output":true,"text":"toxicities were seen but one patient receiving \\(2,000 mg / 100 ml\\) experienced reversible significant","text_display":" toxicities were seen but one patient receiving \\(2,000 mg / 100 ml\\) experienced reversible significant","confidence":1,"confidence_rate":1},{"cnt":[[370,395],[1878,395],[1878,436],[370,436]],"region":{"top_left_x":369,"top_left_y":395,"width":1509,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"efcce975b5154db895508d9a4e0cf448","type":"text","conversion_output":true,"text":"urinary frequency (stopped treatment). While these patients received six weekly instillations, none","text_display":" urinary frequency (stopped treatment). While these patients received six weekly instillations, none","confidence":1,"confidence_rate":1},{"cnt":[[370,434],[1880,434],[1880,473],[370,473]],"region":{"top_left_x":369,"top_left_y":433,"width":1511,"height":40},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dcb5265b6404ad5a519c3e0757d7a93","type":"text","conversion_output":true,"text":"were started for at least two weeks after TURBT. Two other presentations of Phase I studies of","text_display":" were started for at least two weeks after TURBT. Two other presentations of Phase I studies of","confidence":1,"confidence_rate":1},{"cnt":[[370,471],[1880,471],[1880,511],[370,511]],"region":{"top_left_x":369,"top_left_y":470,"width":1511,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de7f375863a647ed979b4c7c487ab1cd","type":"text","conversion_output":true,"text":"escalating doses of gemcitabine in \\(50 ml 0.9 \\% NaCl\\) have been presented, using six weekly","text_display":" escalating doses of gemcitabine in \\(50 ml 0.9 \\% NaCl\\) have been presented, using six weekly","confidence":0.762374137644656,"confidence_rate":0.9972631676344638},{"cnt":[[370,509],[1876,509],[1876,552],[370,552]],"region":{"top_left_x":369,"top_left_y":509,"width":1507,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddfe98ef7f864ecaab84d5bebfde79e4","type":"text","conversion_output":true,"text":"instillations starting 2-4 weeks after TURBT. (24-25) Each had a minimal intensity of side effects,","text_display":" instillations starting 2-4 weeks after TURBT. (24-25) Each had a minimal intensity of side effects,","confidence":0.9805104732513428,"confidence_rate":0.9998107683694354},{"cnt":[[369,589],[370,544],[1399,546],[1399,591]],"region":{"top_left_x":369,"top_left_y":543,"width":1030,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf44058e465548a391c253cf11826882","type":"text","conversion_output":true,"text":"primarily minor dysuria in 7 of 10 and 1 of 12 patients, respectively.","text_display":" primarily minor dysuria in 7 of 10 and 1 of 12 patients, respectively.","confidence":1,"confidence_rate":1},{"cnt":[[370,619],[1214,619],[1214,668],[370,668]],"region":{"top_left_x":369,"top_left_y":618,"width":845,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b00874a8f5ad40ec883a8cade1c2d752","type":"section_header","conversion_output":false,"children_ids":["8d25c3c6eb5e4697902fb14b6210dac7"],"text":"","text_display":""},{"cnt":[[372,623],[1210,623],[1210,664],[372,664]],"region":{"top_left_x":371,"top_left_y":623,"width":839,"height":41},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d25c3c6eb5e4697902fb14b6210dac7","type":"text","conversion_output":true,"parent_id":"b00874a8f5ad40ec883a8cade1c2d752","text":"Tolerability of Post TURBT Instillations of Gemcitabine","text_display":"\n\n\\section*{Tolerability of Post TURBT Instillations of Gemcitabine}","confidence":0.9217529117327103,"confidence_rate":0.9986429535721396},{"cnt":[[372,700],[1880,700],[1880,741],[372,741]],"region":{"top_left_x":371,"top_left_y":700,"width":1509,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"beda8f0698284d148ac0ccb7d813d8eb","type":"text","conversion_output":true,"text":"Germane to the above comments, which are the rationale for this large proposed study, is that","text_display":"\n\nGermane to the above comments, which are the rationale for this large proposed study, is that","confidence":1,"confidence_rate":1},{"cnt":[[370,739],[1880,739],[1880,780],[370,780]],"region":{"top_left_x":369,"top_left_y":739,"width":1511,"height":41},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"80fbe93d1db34126934e340619803b60","type":"text","conversion_output":true,"text":"there have been several reports about tolerability of various dosages of gemcitabine. In one study","text_display":" there have been several reports about tolerability of various dosages of gemcitabine. In one study","confidence":1,"confidence_rate":1},{"cnt":[[372,778],[1880,778],[1880,819],[372,819]],"region":{"top_left_x":371,"top_left_y":777,"width":1509,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"623f4c866d3640faaef5b29df6edd515","type":"text","conversion_output":true,"text":"not yet reported, O'Donnell from the University of lowa instilled immediate post-TURBT","text_display":" not yet reported, O'Donnell from the University of lowa instilled immediate post-TURBT","confidence":0.9087796211242676,"confidence_rate":0.9989494241624275},{"cnt":[[370,816],[1878,816],[1878,857],[370,857]],"region":{"top_left_x":369,"top_left_y":816,"width":1509,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51ee6fedbf824774af8fe324a7e408ea","type":"text","conversion_output":true,"text":"gemcitabine - five patients received \\(1,500 mg / 100 ml 0.9 \\%\\) saline and five received","text_display":" gemcitabine - five patients received \\(1,500 mg / 100 ml 0.9 \\%\\) saline and five received","confidence":0.7303526364266872,"confidence_rate":0.9966269081738325},{"cnt":[[370,855],[1878,855],[1878,896],[370,896]],"region":{"top_left_x":369,"top_left_y":855,"width":1509,"height":41},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c95178730cb4a27bfc1218c86fac65e","type":"text","conversion_output":true,"text":"\\(2,000 mg / 100 ml\\) for 60 minutes. Hematuria occurred in 2 of 10 and 10 of 10 respectively. All","text_display":" \\(2,000 mg / 100 ml\\) for 60 minutes. Hematuria occurred in 2 of 10 and 10 of 10 respectively. All","confidence":0.955078125,"confidence_rate":0.9996004091136722},{"cnt":[[372,894],[1394,894],[1394,935],[372,935]],"region":{"top_left_x":371,"top_left_y":893,"width":1024,"height":42},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4089a9986ddd427bad04109a6bc07901","type":"text","conversion_output":true,"text":"other side effects were mild, transient, and unrelated to dose. ( \\(\\underline{22}\\) )","text_display":" other side effects were mild, transient, and unrelated to dose. ( \\(\\underline{22}\\) )","confidence":0.47584163338979124,"confidence_rate":0.9908731372881204},{"cnt":[[372,970],[1880,968],[1880,1010],[372,1012]],"region":{"top_left_x":371,"top_left_y":967,"width":1509,"height":45},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d50de05db95498db472210481c197bd","type":"text","conversion_output":true,"text":"In a separate study, Buettner and Boehle performed a small Phase I study of immediate post-","text_display":"\n\nIn a separate study, Buettner and Boehle performed a small Phase I study of immediate post","confidence":1,"confidence_rate":1},{"cnt":[[372,1008],[1876,1008],[1876,1048],[372,1048]],"region":{"top_left_x":371,"top_left_y":1007,"width":1505,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"241eb20a251c4fd6a81f233c356ffd47","type":"text","conversion_output":true,"text":"TURBT instillations of gemcitabine in dosages of \\(500 mg / 50 ml , 800 mg / 50 ml , 1,000 mg / 50 ml\\),","text_display":"TURBT instillations of gemcitabine in dosages of \\(500 mg / 50 ml , 800 mg / 50 ml , 1,000 mg / 50 ml\\),","confidence":0.9902389049530029,"confidence_rate":0.9999116341132185},{"cnt":[[374,1044],[1880,1044],[1880,1087],[374,1087]],"region":{"top_left_x":373,"top_left_y":1044,"width":1507,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b24d26a5e13b4949b1a05a7f612d7536","type":"text","conversion_output":true,"text":"\\(1,000 mg / 100 ml , 1,500 mg / 100 ml\\) and \\(2,000 mg / 100 ml\\) of \\(0.9 \\% NaCl\\). ( 26 ) No systemic","text_display":" \\(1,000 mg / 100 ml , 1,500 mg / 100 ml\\) and \\(2,000 mg / 100 ml\\) of \\(0.9 \\% NaCl\\). ( 26 ) No systemic","confidence":0.5588577368365577,"confidence_rate":0.994818290062529},{"cnt":[[372,1085],[1880,1085],[1880,1126],[372,1126]],"region":{"top_left_x":371,"top_left_y":1084,"width":1509,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d41f0cab471a4be2b59961b3f5b17cba","type":"text","conversion_output":true,"text":"absorption of the drug was found for any of the dosages yet tested (based on pharmacokinetic","text_display":" absorption of the drug was found for any of the dosages yet tested (based on pharmacokinetic","confidence":1,"confidence_rate":1},{"cnt":[[372,1121],[1878,1121],[1878,1162],[372,1162]],"region":{"top_left_x":371,"top_left_y":1121,"width":1507,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e14046935084839bf34444a23299ad2","type":"text","conversion_output":true,"text":"data). Moreover, all dosages were well tolerated except for \\(1,000 mg / 50 ml\\) which appeared to","text_display":" data). Moreover, all dosages were well tolerated except for \\(1,000 mg / 50 ml\\) which appeared to","confidence":0.9970703125,"confidence_rate":0.9999717889802962},{"cnt":[[372,1160],[1878,1160],[1878,1201],[372,1201]],"region":{"top_left_x":371,"top_left_y":1160,"width":1507,"height":41},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50a96588c5e046efa9cd0d97be28de04","type":"text","conversion_output":true,"text":"cause considerable bladder irritative symptoms that were relieved as soon as the fluid was","text_display":" cause considerable bladder irritative symptoms that were relieved as soon as the fluid was","confidence":1,"confidence_rate":1},{"cnt":[[372,1199],[1880,1199],[1880,1240],[372,1240]],"region":{"top_left_x":371,"top_left_y":1198,"width":1509,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e4753a266ac4d15bf8cfe42052f806f","type":"text","conversion_output":true,"text":"drained from the bladder by unclamping the catheter. Since this was not found at similar","text_display":" drained from the bladder by unclamping the catheter. Since this was not found at similar","confidence":1,"confidence_rate":1},{"cnt":[[372,1238],[1878,1238],[1878,1278],[372,1278]],"region":{"top_left_x":371,"top_left_y":1237,"width":1507,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56c882fce7ea4a5eb560a60467ce2698","type":"text","conversion_output":true,"text":"concentrations with higher volumes, even the authors are perplexed by these results. Mild (Grade","text_display":" concentrations with higher volumes, even the authors are perplexed by these results. Mild (Grade","confidence":1,"confidence_rate":1},{"cnt":[[374,1276],[1880,1276],[1880,1317],[374,1317]],"region":{"top_left_x":373,"top_left_y":1276,"width":1507,"height":41},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1df6ef5b4df2400085b0e110d4d76aa6","type":"text","conversion_output":true,"text":"1 or 2 ) hematuria and/or dysuria that was quite transient were the only other side effects (in 9 of","text_display":" 1 or 2 ) hematuria and/or dysuria that was quite transient were the only other side effects (in 9 of","confidence":0.9975605006329715,"confidence_rate":0.9999777958847536},{"cnt":[[372,1315],[1876,1315],[1876,1356],[372,1356]],"region":{"top_left_x":371,"top_left_y":1314,"width":1505,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3292bc2494244f7caa2ed7690d7d52ba","type":"text","conversion_output":true,"text":"26 patients). (26) In addition, Maddineni and colleagues from the University of Manchester,","text_display":" 26 patients). (26) In addition, Maddineni and colleagues from the University of Manchester,","confidence":0.9248046875,"confidence_rate":0.9991774678082321},{"cnt":[[372,1354],[1880,1354],[1880,1394],[372,1394]],"region":{"top_left_x":371,"top_left_y":1353,"width":1509,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4281665a95fb4d679ac43ba2c5b6df37","type":"text","conversion_output":true,"text":"England administered similar dosages of gemcitabine, again finding no systemic absorption in 15","text_display":" England administered similar dosages of gemcitabine, again finding no systemic absorption in 15","confidence":1,"confidence_rate":1},{"cnt":[[372,1392],[1878,1392],[1878,1433],[372,1433]],"region":{"top_left_x":371,"top_left_y":1392,"width":1507,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddd555d17d7f48a5ab090b127a5301df","type":"text","conversion_output":true,"text":"patients with frequently recurrent superficial bladder cancer. They found the instillations to be","text_display":" patients with frequently recurrent superficial bladder cancer. They found the instillations to be","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[372,1431],[1878,1431],[1878,1472],[372,1472]],"region":{"top_left_x":371,"top_left_y":1430,"width":1507,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f5b675f140d44f7aa7eb86b8a2d7739","type":"text","conversion_output":true,"text":"quite tolerable, although at doses above \\(1,000 mg / ml\\) dwell times exceeding 40 minutes became","text_display":" quite tolerable, although at doses above \\(1,000 mg / ml\\) dwell times exceeding 40 minutes became","confidence":1,"confidence_rate":1},{"cnt":[[372,1470],[1880,1470],[1880,1508],[372,1508]],"region":{"top_left_x":371,"top_left_y":1469,"width":1509,"height":40},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fdad97f0b2214dddad299aee6c7f0708","type":"text","conversion_output":true,"text":"difficult to tolerate due to bladder spasms. However these investigators were choosing 20-24","text_display":" difficult to tolerate due to bladder spasms. However these investigators were choosing 20-24","confidence":0.97021484375,"confidence_rate":0.9996883192669926},{"cnt":[[372,1506],[1880,1506],[1880,1547],[372,1547]],"region":{"top_left_x":371,"top_left_y":1506,"width":1509,"height":41},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a4873ca8abf4dac8d1620cfde915925","type":"text","conversion_output":true,"text":"hours post TURBT for instillations, not three hours when anesthetic effects are likely to permit","text_display":" hours post TURBT for instillations, not three hours when anesthetic effects are likely to permit","confidence":1,"confidence_rate":1},{"cnt":[[370,1543],[1876,1543],[1876,1586],[370,1586]],"region":{"top_left_x":369,"top_left_y":1542,"width":1507,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d66e899941db4d8ca743f0a053068521","type":"text","conversion_output":true,"text":"greater drug retention. Ten of the 15 patients have been evaluated for recurrence, five of whom","text_display":" greater drug retention. Ten of the 15 patients have been evaluated for recurrence, five of whom","confidence":1,"confidence_rate":1},{"cnt":[[370,1581],[711,1581],[711,1622],[370,1622]],"region":{"top_left_x":369,"top_left_y":1581,"width":343,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a06e0f16d52c4cbb89dc8358887b544d","type":"text","conversion_output":true,"text":"were tumor free. (27)","text_display":" were tumor free. (27)","confidence":0.9609375,"confidence_rate":0.9984686387878827},{"cnt":[[374,1659],[1878,1659],[1878,1699],[374,1699]],"region":{"top_left_x":373,"top_left_y":1658,"width":1505,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51a39a7d016f4bd6bbdc6ca9dc1889ce","type":"text","conversion_output":true,"text":"In a separate study, Palou, et al, treated five patients each with 1,500 or \\(2,000 mg / 100 ml 0.9 \\%\\)","text_display":"\n\nIn a separate study, Palou, et al, treated five patients each with 1,500 or \\(2,000 mg / 100 ml 0.9 \\%\\)","confidence":0.7807915038429201,"confidence_rate":0.9976683157663124},{"cnt":[[372,1697],[1880,1697],[1880,1738],[372,1738]],"region":{"top_left_x":371,"top_left_y":1697,"width":1509,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8684c3bd758d436d9515b2f8a33d8f14","type":"text","conversion_output":true,"text":"NaCl , within three hours of TURBT. No significant toxicities were seen, with only one patient at","text_display":" NaCl , within three hours of TURBT. No significant toxicities were seen, with only one patient at","confidence":0.8691329956054688,"confidence_rate":0.9986522636192612},{"cnt":[[370,1736],[1880,1736],[1880,1777],[370,1777]],"region":{"top_left_x":369,"top_left_y":1735,"width":1511,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45c30e714f82465a9eb285b0e27dbaac","type":"text","conversion_output":true,"text":"the \\(2,000 mg\\) dose experiencing only self-limited minor urinary irritation and two patients at the","text_display":" the \\(2,000 mg\\) dose experiencing only self-limited minor urinary irritation and two patients at the","confidence":1,"confidence_rate":1},{"cnt":[[374,1775],[1878,1775],[1878,1815],[374,1815]],"region":{"top_left_x":373,"top_left_y":1774,"width":1505,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f124e8846ef404d9c900e64578f39eb","type":"text","conversion_output":true,"text":"\\(1,500 mg\\) dose experiencing transient Grade 1 hypogastric discomfort. ( \\(\\underline{28}\\) ) Mean maximum","text_display":" \\(1,500 mg\\) dose experiencing transient Grade 1 hypogastric discomfort. ( \\(\\underline{28}\\) ) Mean maximum","confidence":0.9456948323018644,"confidence_rate":0.999458056133864},{"cnt":[[372,1813],[1880,1813],[1880,1854],[372,1854]],"region":{"top_left_x":371,"top_left_y":1813,"width":1509,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a0d18f6b164414fb472f0eb4c1c6e70","type":"text","conversion_output":true,"text":"serum concentrations of gemcitabine were \\(1.8 ug / ml\\), and no systemic toxicity was seen. Four of","text_display":" serum concentrations of gemcitabine were \\(1.8 ug / ml\\), and no systemic toxicity was seen. 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Since this is preventing recurrence in a somewhat mixed group of patients whose","text_display":" applications. 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(21) The","text_display":" neutropenia without infection was reported in one out of six patients. (21) The","confidence":0.9965834617614746,"confidence_rate":0.9999592581164862},{"cnt":[[621,638],[1876,638],[1876,677],[621,677]],"region":{"top_left_x":620,"top_left_y":638,"width":1256,"height":39},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b05394634606481b84e58abf95ba4ef9","type":"text","conversion_output":true,"text":"remaining three Phase I studies were performed in patients immediately after,","text_display":" remaining three Phase I studies were performed in patients immediately after,","confidence":1,"confidence_rate":1},{"cnt":[[621,675],[1876,675],[1876,715],[621,715]],"region":{"top_left_x":620,"top_left_y":674,"width":1256,"height":42},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df51311289bc492c81c5502b9d88b69d","type":"text","conversion_output":true,"text":"within three hours after, and up to 24 hours after transurethral resection. (26-28)","text_display":" within three hours after, and up to 24 hours after transurethral resection. (26-28)","confidence":1,"confidence_rate":1},{"cnt":[[623,713],[1878,713],[1878,754],[623,754]],"region":{"top_left_x":623,"top_left_y":713,"width":1255,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f96ba82655cc471cb20df9de04b05a27","type":"text","conversion_output":true,"text":"No additional adverse events were noted in these patients. A few cases of renal","text_display":" No additional adverse events were noted in these patients. A few cases of renal","confidence":1,"confidence_rate":1},{"cnt":[[621,752],[1878,752],[1878,793],[621,793]],"region":{"top_left_x":620,"top_left_y":751,"width":1258,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82216af4efff4b39bbe7e188ee986a4b","type":"text","conversion_output":true,"text":"failure of uncertain etiology have been reported with intravenous gemcitabine","text_display":" failure of uncertain etiology have been reported with intravenous gemcitabine","confidence":1,"confidence_rate":1},{"cnt":[[623,791],[1878,791],[1878,831],[623,831]],"region":{"top_left_x":623,"top_left_y":790,"width":1255,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eefe254871fa46fd937cf3b00f189ebf","type":"text","conversion_output":true,"text":"administration. While on study, one patient who received prior mitomycin","text_display":" administration. While on study, one patient who received prior mitomycin","confidence":1,"confidence_rate":1},{"cnt":[[621,829],[1878,829],[1878,870],[621,870]],"region":{"top_left_x":620,"top_left_y":829,"width":1258,"height":42},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"528d46218d204c449699d8898500ab4f","type":"text","conversion_output":true,"text":"developed hemolytic uremic syndrome requiring dialysis. The relationship of this","text_display":" developed hemolytic uremic syndrome requiring dialysis. The relationship of this","confidence":1,"confidence_rate":1},{"cnt":[[621,868],[1343,868],[1343,909],[621,909]],"region":{"top_left_x":620,"top_left_y":867,"width":723,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b113150e6924c18beb11aa8792abd49","type":"text","conversion_output":true,"text":"event to intravenous gemcitabine is not known.","text_display":" event to intravenous gemcitabine is not known.","confidence":1,"confidence_rate":1},{"cnt":[[623,945],[1876,945],[1876,986],[623,986]],"region":{"top_left_x":623,"top_left_y":945,"width":1253,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1b93ff2356240829bccb9a81797636e","type":"text","conversion_output":true,"text":"Pregnancy and Lactation: Gemcitabine may cause fetal harm when administered","text_display":"\n\nPregnancy and Lactation: Gemcitabine may cause fetal harm when administered","confidence":1,"confidence_rate":1},{"cnt":[[621,984],[1876,984],[1876,1023],[621,1023]],"region":{"top_left_x":620,"top_left_y":983,"width":1256,"height":40},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f3f3af475cd4373966dacb281752346","type":"text","conversion_output":true,"text":"to a pregnant woman. This agent has produced teratogenic effects in mice and","text_display":" to a pregnant woman. This agent has produced teratogenic effects in mice and","confidence":1,"confidence_rate":1},{"cnt":[[621,1014],[1878,1014],[1878,1059],[621,1059]],"region":{"top_left_x":620,"top_left_y":1014,"width":1258,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6936497f05b4b5bb80cd4063bcfbbef","type":"text","conversion_output":true,"text":"rabbits when administered at a dose of \\(<2 mg / m ^{2}\\). Adverse effects included","text_display":" rabbits when administered at a dose of \\(<2 mg / m ^{2}\\). Adverse effects included","confidence":1,"confidence_rate":1},{"cnt":[[621,1059],[1878,1059],[1878,1102],[621,1102]],"region":{"top_left_x":620,"top_left_y":1059,"width":1258,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8a5c85590904f29807fece10ea521ad","type":"text","conversion_output":true,"text":"decreased fetal viability, weight and morphologic defects. There is no data on","text_display":" decreased fetal viability, weight and morphologic defects. There is no data on","confidence":1,"confidence_rate":1},{"cnt":[[621,1139],[621,1096],[1878,1098],[1878,1141]],"region":{"top_left_x":620,"top_left_y":1095,"width":1258,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"493bce2b7db74cfa9f5e46ed40ba25b1","type":"text","conversion_output":true,"text":"gemcitabine administration during human pregnancy, and it is not currently known","text_display":" gemcitabine administration during human pregnancy, and it is not currently known","confidence":1,"confidence_rate":1},{"cnt":[[623,1134],[1876,1134],[1876,1175],[623,1175]],"region":{"top_left_x":623,"top_left_y":1134,"width":1253,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8a0a83ff58e4681b5eb5dfd1d5acafc","type":"text","conversion_output":true,"text":"if metabolites are excreted in human milk. However, many drugs are excreted in","text_display":" if metabolites are excreted in human milk. However, many drugs are excreted in","confidence":1,"confidence_rate":1},{"cnt":[[621,1173],[1876,1173],[1876,1214],[621,1214]],"region":{"top_left_x":620,"top_left_y":1173,"width":1256,"height":41},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8bcec52c07c0412ab5fabe3fbf1aaa80","type":"text","conversion_output":true,"text":"human milk, and there is a potential for adverse effects in nursing infants.","text_display":" human milk, and there is a potential for adverse effects in nursing infants.","confidence":1,"confidence_rate":1},{"cnt":[[621,1212],[1876,1212],[1876,1253],[621,1253]],"region":{"top_left_x":620,"top_left_y":1211,"width":1256,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6ccf92eb634479aaba3f18a5b3c503a","type":"text","conversion_output":true,"text":"Therefore, the use of gemcitabine should be avoided in pregnant or nursing","text_display":" Therefore, the use of gemcitabine should be avoided in pregnant or nursing","confidence":1,"confidence_rate":1},{"cnt":[[621,1250],[1553,1250],[1553,1291],[621,1291]],"region":{"top_left_x":620,"top_left_y":1250,"width":934,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d87e74d477084e3cabf6ddb0362f8aaf","type":"text","conversion_output":true,"text":"women because of the potential hazard to the fetus or infant.","text_display":" women because of the potential hazard to the fetus or infant.","confidence":1,"confidence_rate":1},{"cnt":[[494,1323],[930,1323],[930,1369],[494,1369]],"region":{"top_left_x":494,"top_left_y":1323,"width":437,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aac8f069ce1a47b9aa3593e68cb64681","type":"section_header","conversion_output":false,"children_ids":["b151d54fa17944c2a9d6bf211813150c"],"text":"","text_display":""},{"cnt":[[498,1328],[926,1328],[926,1364],[498,1364]],"region":{"top_left_x":498,"top_left_y":1327,"width":428,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b151d54fa17944c2a9d6bf211813150c","type":"text","conversion_output":true,"parent_id":"aac8f069ce1a47b9aa3593e68cb64681","text":"c. 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Additional metabolites have not been identified in either","text_display":"and tri-phosphates. Additional metabolites have not been identified in either","confidence":1,"confidence_rate":1},{"cnt":[[623,1474],[1880,1474],[1880,1515],[623,1515]],"region":{"top_left_x":623,"top_left_y":1473,"width":1257,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ccff5629ee041bd9eb3a2d0a3907766","type":"text","conversion_output":true,"text":"plasma or urine. The gemcitabine di- and tri-phosphates do not appear to","text_display":" plasma or urine. The gemcitabine di- and tri-phosphates do not appear to","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[623,1512],[1878,1512],[1878,1553],[623,1553]],"region":{"top_left_x":623,"top_left_y":1512,"width":1255,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b30ea733e884e8da4e761ef6d667a25","type":"text","conversion_output":true,"text":"circulate in plasma in measurable amounts. The compound is metabolized","text_display":" circulate in plasma in measurable amounts. The compound is metabolized","confidence":1,"confidence_rate":1},{"cnt":[[623,1551],[1880,1551],[1880,1592],[623,1592]],"region":{"top_left_x":623,"top_left_y":1551,"width":1257,"height":41},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f171d7813e445c79abf9ed769eb40ff","type":"text","conversion_output":true,"text":"principally by the liver to form an inactive uridine derivative (dFdU or \\(2^{\\prime}\\)-deoxy-","text_display":" principally by the liver to form an inactive uridine derivative (dFdU or \\(2^{\\prime}\\)-deoxy","confidence":0.4819401959903189,"confidence_rate":0.9925793511355455},{"cnt":[[623,1590],[1878,1590],[1878,1629],[623,1629]],"region":{"top_left_x":623,"top_left_y":1589,"width":1255,"height":40},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b412c56b35d41c889d0a5994a4b80b3","type":"text","conversion_output":true,"text":"\\(2^{\\prime}, 2^{\\prime}\\)-difluorouridine). The plasma protein binding of gemcitabine is negligible.","text_display":"\\(2^{\\prime}, 2^{\\prime}\\)-difluorouridine). The plasma protein binding of gemcitabine is negligible.","confidence":0.9049071895424277,"confidence_rate":0.9989911870373819},{"cnt":[[623,1620],[1880,1620],[1880,1669],[623,1669]],"region":{"top_left_x":623,"top_left_y":1619,"width":1257,"height":51},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f6cd1d39ad948c38d2d5055855f9f0c","type":"text","conversion_output":true,"text":"Following a single \\(1,000 mg / m ^{2} / 30 min\\) [ \\({ }^{14} C\\) ]-gemcitabine infusion, \\(92 \\%\\) to \\(98 \\%\\) of","text_display":" Following a single \\(1,000 mg / m ^{2} / 30 min\\) [ \\({ }^{14} C\\) ]-gemcitabine infusion, \\(92 \\%\\) to \\(98 \\%\\) of","confidence":0.5168337402212583,"confidence_rate":0.9946044932195431},{"cnt":[[621,1665],[1876,1665],[1876,1706],[621,1706]],"region":{"top_left_x":620,"top_left_y":1665,"width":1256,"height":41},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48a6c7d29b1c4324972c15fcbfd8103b","type":"text","conversion_output":true,"text":"the dose was recovered within one week after gemcitabine administration.","text_display":" the dose was recovered within one week after gemcitabine administration.","confidence":1,"confidence_rate":1},{"cnt":[[623,1704],[1878,1704],[1878,1742],[623,1742]],"region":{"top_left_x":623,"top_left_y":1703,"width":1255,"height":40},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f27a597eb004ae7af18ff0fcd59546d","type":"text","conversion_output":true,"text":"Urinary excretion of parent and dFdU accounted for 99\\% of the excreted dose,","text_display":" Urinary excretion of parent and dFdU accounted for 99\\% of the excreted dose,","confidence":0.9658203125,"confidence_rate":0.9995707406276014},{"cnt":[[621,1740],[1880,1740],[1880,1781],[621,1781]],"region":{"top_left_x":620,"top_left_y":1740,"width":1260,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"275ad664721e4444ac929ddf196a4df2","type":"text","conversion_output":true,"text":"and less than \\(1 \\%\\) of the dose was excreted in feces. The renal clearance of","text_display":" and less than \\(1 \\%\\) of the dose was excreted in feces. The renal clearance of","confidence":0.9033203125,"confidence_rate":0.9987607920130462},{"cnt":[[623,1779],[1880,1779],[1880,1820],[623,1820]],"region":{"top_left_x":623,"top_left_y":1778,"width":1257,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9c3d6cef68d4be48ae9f5be7f1c47ad","type":"text","conversion_output":true,"text":"gemcitabine is less than 10\\%; therefore, the parent drug appears to be almost","text_display":" gemcitabine is less than 10\\%; therefore, the parent drug appears to be almost","confidence":0.6954610347747803,"confidence_rate":0.9955807657051811},{"cnt":[[623,1818],[1313,1818],[1313,1858],[623,1858]],"region":{"top_left_x":623,"top_left_y":1817,"width":690,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"529cc4d83e2f46d78ab84b8d3ce56b70","type":"text","conversion_output":true,"text":"completely metabolized to the inactive dFdU .","text_display":" completely metabolized to the inactive dFdU .","confidence":0.98583984375,"confidence_rate":0.9997453651419856},{"cnt":[[623,1895],[1876,1895],[1876,1936],[623,1936]],"region":{"top_left_x":623,"top_left_y":1894,"width":1253,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c698b59bc5f7499681413879167fd683","type":"text","conversion_output":true,"text":"Half-life ranged from 11 to 26 minutes for patients receiving single dose infusions","text_display":"\n\nHalf-life ranged from 11 to 26 minutes for patients receiving single dose infusions","confidence":1,"confidence_rate":1},{"cnt":[[623,1927],[1878,1927],[1878,1974],[623,1974]],"region":{"top_left_x":623,"top_left_y":1927,"width":1255,"height":48},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cdd074338c844e9e92d344296e8359e6","type":"text","conversion_output":true,"text":"( \\(1,000 mg / m ^{2}\\) to \\(2,500 mg / m ^{2}\\) ) of 1.1 hours or less. Following longer duration","text_display":" ( \\(1,000 mg / m ^{2}\\) to \\(2,500 mg / m ^{2}\\) ) of 1.1 hours or less. Following longer duration","confidence":0.98583984375,"confidence_rate":0.9998770647308961},{"cnt":[[623,1972],[1878,1972],[1878,2013],[623,2013]],"region":{"top_left_x":623,"top_left_y":1972,"width":1255,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2ec4da03e6d4be9b65865083e6a6bea","type":"text","conversion_output":true,"text":"infusions ( 3.6 to 4.3 hours), the half-life ranged between 18.5 and 57.1 minutes","text_display":" infusions ( 3.6 to 4.3 hours), the half-life ranged between 18.5 and 57.1 minutes","confidence":0.9951171875,"confidence_rate":0.9999500545904081},{"cnt":[[621,2002],[1878,2002],[1878,2052],[621,2052]],"region":{"top_left_x":620,"top_left_y":2002,"width":1258,"height":50},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10873727a9ae44cb8b4212e798c5e068","type":"text","conversion_output":true,"text":"for single gemcitabine doses between \\(2,500 mg / m ^{2}\\) and \\(3,600 mg / m ^{2}\\). The","text_display":" for single gemcitabine doses between \\(2,500 mg / m ^{2}\\) and \\(3,600 mg / m ^{2}\\). The","confidence":1,"confidence_rate":1},{"cnt":[[621,2050],[1878,2050],[1878,2090],[621,2090]],"region":{"top_left_x":620,"top_left_y":2049,"width":1258,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"948706dc698c4c3ab804eda9d153c979","type":"text","conversion_output":true,"text":"increase in half-life may relate to the appearance of a possible third exponential","text_display":" increase in half-life may relate to the appearance of a possible third exponential","confidence":1,"confidence_rate":1},{"cnt":[[621,2088],[1878,2088],[1878,2129],[621,2129]],"region":{"top_left_x":620,"top_left_y":2088,"width":1258,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ecf52641145146248f33254a4146ddef","type":"text","conversion_output":true,"text":"phase (representing a deep compartment) that is not observed following the","text_display":" phase (representing a deep compartment) that is not observed following the","confidence":1,"confidence_rate":1},{"cnt":[[623,2127],[892,2127],[892,2159],[623,2159]],"region":{"top_left_x":623,"top_left_y":2126,"width":269,"height":34},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0db7a3da3fd4d62a498ea1bcd33d8e2","type":"text","conversion_output":true,"text":"shorter infusions.","text_display":" shorter infusions.","confidence":1,"confidence_rate":1},{"cnt":[[621,2194],[1880,2194],[1880,2237],[621,2237]],"region":{"top_left_x":620,"top_left_y":2193,"width":1260,"height":44},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a608b3650a345b8818c8ae04e41a849","type":"text","conversion_output":true,"text":"The population pharmacokinetic analyses of the effect of patient specific","text_display":"\n\nThe population pharmacokinetic analyses of the effect of patient specific","confidence":1,"confidence_rate":1},{"cnt":[[621,2234],[1880,2234],[1880,2275],[621,2275]],"region":{"top_left_x":620,"top_left_y":2234,"width":1260,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d45804f39d8f45168f8f322a9a6e1f59","type":"text","conversion_output":true,"text":"characteristics showed that clearance normalized for BSA was affected by","text_display":" characteristics showed that clearance normalized for BSA was affected by","confidence":1,"confidence_rate":1},{"cnt":[[621,2273],[1880,2273],[1880,2312],[621,2312]],"region":{"top_left_x":620,"top_left_y":2273,"width":1260,"height":39},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6b792783db8440b92205963c17ace3f","type":"text","conversion_output":true,"text":"gender. The clearance obtained for the female patient for all studies was 46.2","text_display":" gender. The clearance obtained for the female patient for all studies was 46.2","confidence":1,"confidence_rate":1},{"cnt":[[623,2303],[1878,2303],[1878,2350],[623,2350]],"region":{"top_left_x":623,"top_left_y":2303,"width":1255,"height":48},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"abe06b5a95d542ce95b8f91a3ab37904","type":"text","conversion_output":true,"text":"\\(L / hr / m ^{2}\\) and the male's was \\(66.8 L / hr / m ^{2}\\). These moderate to high gemcitabine","text_display":" \\(L / hr / m ^{2}\\) and the male's was \\(66.8 L / hr / m ^{2}\\). These moderate to high gemcitabine","confidence":1,"confidence_rate":1},{"cnt":[[621,2348],[1876,2348],[1876,2391],[621,2391]],"region":{"top_left_x":620,"top_left_y":2348,"width":1256,"height":44},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e63e30d03334fa7ac270662d51bb52a","type":"text","conversion_output":true,"text":"values suggest that gemcitabine may be metabolized by various tissues, including","text_display":" values suggest that gemcitabine may be metabolized by various tissues, including","confidence":1,"confidence_rate":1},{"cnt":[[621,2385],[1878,2385],[1878,2426],[621,2426]],"region":{"top_left_x":620,"top_left_y":2384,"width":1258,"height":42},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e07700107c04d0f9822060b02f778d9","type":"text","conversion_output":true,"text":"the liver. The renal clearance for gemcitabine is less than \\(10 \\%\\) of the systemic","text_display":" the liver. The renal clearance for gemcitabine is less than \\(10 \\%\\) of the systemic","confidence":0.845703125,"confidence_rate":0.9980755679256713},{"cnt":[[623,2423],[786,2423],[786,2460],[623,2460]],"region":{"top_left_x":623,"top_left_y":2423,"width":164,"height":37},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ca1f9362df64cc7b1084f3f4b9ed3a7","type":"text","conversion_output":true,"text":"clearance.","text_display":" clearance.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"418d4048-59be-4948-a117-48f8172df896-32","page":32,"lines":[{"cnt":[[1772,125],[1878,125],[1878,161],[1772,161]],"region":{"top_left_x":1772,"top_left_y":124,"width":106,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17b3fe3ea4d44196aff04e83a3325019","type":"page_info","conversion_output":false,"text":"S0337","text_display":"","confidence":0.99853515625,"confidence_rate":0.9998534189757986},{"cnt":[[1745,163],[1876,163],[1876,204],[1745,204]],"region":{"top_left_x":1744,"top_left_y":163,"width":132,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7b39c5a90124379aada61ade64c8a2b","type":"page_info","conversion_output":false,"text":"Page 13","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1525,202],[1876,202],[1876,238],[1525,238]],"region":{"top_left_x":1525,"top_left_y":201,"width":351,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79fdecbde7e44737a8bbf21f6fa3f9e1","type":"page_info","conversion_output":false,"text":"Version Date 10/29/13","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[621,279],[1878,279],[1878,320],[621,320]],"region":{"top_left_x":620,"top_left_y":279,"width":1258,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"330f675f1f9249f4adabd4ed001936ba","type":"text","conversion_output":true,"text":"The maximum dFdU plasma concentrations were achieved from 0 to 30 minutes","text_display":"\n\nThe maximum dFdU plasma concentrations were achieved from 0 to 30 minutes","confidence":1,"confidence_rate":1},{"cnt":[[623,318],[1878,318],[1878,359],[623,359]],"region":{"top_left_x":623,"top_left_y":317,"width":1255,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5d7757d0ebd409dab00b04231ceda58","type":"text","conversion_output":true,"text":"after the discontinuation of the gemcitabine infusions, ranging from 0.4 to 4.75","text_display":" after the discontinuation of the gemcitabine infusions, ranging from 0.4 to 4.75","confidence":1,"confidence_rate":1},{"cnt":[[623,357],[1878,357],[1878,397],[623,397]],"region":{"top_left_x":623,"top_left_y":356,"width":1255,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9db5b060be6435bae774664d0c8a0ca","type":"text","conversion_output":true,"text":"hours. The apparent formation of dFdU (determined from the fraction of the","text_display":" hours. The apparent formation of dFdU (determined from the fraction of the","confidence":0.96142578125,"confidence_rate":0.9995373081628945},{"cnt":[[621,395],[1880,395],[1880,436],[621,436]],"region":{"top_left_x":620,"top_left_y":395,"width":1260,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2787f35a589741bda3ba7a75972dcef3","type":"text","conversion_output":true,"text":"gemcitabine dose excreted as dFdU) ranged from \\(91.2 \\%\\) to \\(98.2 \\%\\) of","text_display":" gemcitabine dose excreted as dFdU) ranged from \\(91.2 \\%\\) to \\(98.2 \\%\\) of","confidence":0.8125913143157959,"confidence_rate":0.9972367982326474},{"cnt":[[621,434],[1878,434],[1878,475],[621,475]],"region":{"top_left_x":620,"top_left_y":433,"width":1258,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d0ccb5f55944da49f3f8bf07fe02149","type":"text","conversion_output":true,"text":"gemcitabine clearance in a single-dose study. Based on the imputed formation","text_display":" gemcitabine clearance in a single-dose study. Based on the imputed formation","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[621,471],[1880,471],[1880,509],[621,509]],"region":{"top_left_x":620,"top_left_y":470,"width":1260,"height":40},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b04119174f8847eca82634f78484e7f1","type":"text","conversion_output":true,"text":"rate of dFdU, the mean dFdU volume of distribution at steady-state was 150.4","text_display":" rate of dFdU, the mean dFdU volume of distribution at steady-state was 150.4","confidence":1,"confidence_rate":1},{"cnt":[[621,503],[1878,503],[1878,550],[621,550]],"region":{"top_left_x":620,"top_left_y":502,"width":1258,"height":48},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"772de4cb92bf4c9d9c61bc4958699dcc","type":"text","conversion_output":true,"text":"\\(L / m ^{2}\\), indicating that dFdU was extensively distributed into tissues. The","text_display":" \\(L / m ^{2}\\), indicating that dFdU was extensively distributed into tissues. The","confidence":1,"confidence_rate":1},{"cnt":[[621,546],[1876,546],[1876,591],[621,591]],"region":{"top_left_x":620,"top_left_y":545,"width":1256,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"481b0ea1027c4ea6917070863e9aac16","type":"text","conversion_output":true,"text":"metabolite was excreted in urine without undergoing further biotransformation.","text_display":" metabolite was excreted in urine without undergoing further biotransformation.","confidence":1,"confidence_rate":1},{"cnt":[[621,578],[1480,578],[1480,625],[621,625]],"region":{"top_left_x":620,"top_left_y":577,"width":861,"height":49},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1099997474544fdeb236c386e7965178","type":"text","conversion_output":true,"text":"The mean apparent clearance of dFdU was \\(2.5 L / hr / m ^{2}\\).","text_display":" The mean apparent clearance of dFdU was \\(2.5 L / hr / m ^{2}\\).","confidence":0.9897675514221191,"confidence_rate":0.9998646781046516},{"cnt":[[621,662],[1880,662],[1880,703],[621,703]],"region":{"top_left_x":620,"top_left_y":661,"width":1260,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65928db846b6490fabcde9f43d80b5dd","type":"text","conversion_output":true,"text":"Pharmacokinetics (PK) of intravesical gemcitabine and its metabolite, dFdU , were","text_display":"\n\nPharmacokinetics (PK) of intravesical gemcitabine and its metabolite, dFdU , were","confidence":0.99169921875,"confidence_rate":0.999909401663201},{"cnt":[[621,700],[1878,700],[1878,741],[621,741]],"region":{"top_left_x":620,"top_left_y":700,"width":1258,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29b51fae68f642d98d50aeef25a38f05","type":"text","conversion_output":true,"text":"studied in plasma and urine by Laufer, et al. (23) Plasma samples for PK were","text_display":" studied in plasma and urine by Laufer, et al. (23) Plasma samples for PK were","confidence":0.9990234375,"confidence_rate":0.9999880849533282},{"cnt":[[623,739],[1878,739],[1878,780],[623,780]],"region":{"top_left_x":623,"top_left_y":739,"width":1255,"height":41},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b0a8d1f07884a00abee82c17a9ea880","type":"text","conversion_output":true,"text":"collected before the instillation and 15, 30, 60, 90, and 120 minutes after the","text_display":" collected before the instillation and 15, 30, 60, 90, and 120 minutes after the","confidence":0.5614630131749436,"confidence_rate":0.9933873697465052},{"cnt":[[621,778],[1878,778],[1878,819],[621,819]],"region":{"top_left_x":620,"top_left_y":777,"width":1258,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5df6df446baf496f91f1e9cc9d133ffd","type":"text","conversion_output":true,"text":"instillation. Gemcitabine was observed in plasma of the 4 patients treated with 40","text_display":" instillation. Gemcitabine was observed in plasma of the 4 patients treated with 40","confidence":1,"confidence_rate":1},{"cnt":[[621,816],[1880,816],[1880,857],[621,857]],"region":{"top_left_x":620,"top_left_y":816,"width":1260,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ec1b3fe4ed54ac1bc817610d86842af","type":"text","conversion_output":true,"text":"\\(mg / mL\\) in 50 mL normal saline, but not in the patients treated with \\(20 mg / mL\\) in","text_display":" \\(mg / mL\\) in 50 mL normal saline, but not in the patients treated with \\(20 mg / mL\\) in","confidence":1,"confidence_rate":1},{"cnt":[[623,855],[1878,855],[1878,892],[623,892]],"region":{"top_left_x":623,"top_left_y":855,"width":1255,"height":37},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cca4870f0be4466bb80bf67682cabf4","type":"text","conversion_output":true,"text":"100 mL normal saline. Peak concentrations in this and several other studies","text_display":" 100 mL normal saline. Peak concentrations in this and several other studies","confidence":1,"confidence_rate":1},{"cnt":[[621,889],[1878,889],[1878,935],[621,935]],"region":{"top_left_x":620,"top_left_y":889,"width":1258,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ab0ee9ee3b64fb8b5f7211003f85e21","type":"text","conversion_output":true,"text":"were below \\(1 \\mu g / mL\\), which were significantly lower than the 10 to \\(30 \\mu g / mL\\)","text_display":" were below \\(1 \\mu g / mL\\), which were significantly lower than the 10 to \\(30 \\mu g / mL\\)","confidence":1,"confidence_rate":1},{"cnt":[[621,924],[1878,924],[1878,973],[621,973]],"region":{"top_left_x":620,"top_left_y":923,"width":1258,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c79f2166c9a4af08f3daf0633034dfa","type":"text","conversion_output":true,"text":"observed after a single intravenous (IV) dose of \\(1,000 mg / m ^{2}\\) (Lilly 2002). The","text_display":" observed after a single intravenous (IV) dose of \\(1,000 mg / m ^{2}\\) (Lilly 2002). The","confidence":1,"confidence_rate":1},{"cnt":[[621,969],[1880,969],[1880,1010],[621,1010]],"region":{"top_left_x":620,"top_left_y":968,"width":1260,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e8e87f74bb84a759168b5a1e0436c0b","type":"text","conversion_output":true,"text":"plasma gemcitabine concentrations declined rapidly, even during the 120 -minute","text_display":" plasma gemcitabine concentrations declined rapidly, even during the 120 -minute","confidence":0.99853515625,"confidence_rate":0.9999831505134198},{"cnt":[[623,1008],[1878,1008],[1878,1048],[623,1048]],"region":{"top_left_x":623,"top_left_y":1007,"width":1255,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6e461e91e81496b96ba945cde35abd9","type":"text","conversion_output":true,"text":"dwell time, and no gemcitabine was detectable in patient plasma beyond 60","text_display":" dwell time, and no gemcitabine was detectable in patient plasma beyond 60","confidence":1,"confidence_rate":1},{"cnt":[[623,1044],[1878,1044],[1878,1085],[623,1085]],"region":{"top_left_x":623,"top_left_y":1044,"width":1255,"height":41},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"47a72a226587483e8d0159b2be011a89","type":"text","conversion_output":true,"text":"minutes after the instillation of the drug. DFdU was also not detected in patients","text_display":" minutes after the instillation of the drug. DFdU was also not detected in patients","confidence":1,"confidence_rate":1},{"cnt":[[621,1083],[1878,1083],[1878,1124],[621,1124]],"region":{"top_left_x":620,"top_left_y":1082,"width":1258,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"849114310c8f482f9dba6ccd802de327","type":"text","conversion_output":true,"text":"treated with 500 or \\(1,000 mg\\) of gemcitabine. In the \\(1,500 mg\\) and \\(2,000 mg\\)","text_display":" treated with 500 or \\(1,000 mg\\) of gemcitabine. In the \\(1,500 mg\\) and \\(2,000 mg\\)","confidence":1,"confidence_rate":1},{"cnt":[[621,1121],[1880,1121],[1880,1162],[621,1162]],"region":{"top_left_x":620,"top_left_y":1121,"width":1260,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b01b8ae9fc424b89b508421764f6d8f0","type":"text","conversion_output":true,"text":"groups, plasma concentrations of dFdU increased progressively during the first","text_display":" groups, plasma concentrations of dFdU increased progressively during the first","confidence":1,"confidence_rate":1},{"cnt":[[621,1160],[1878,1160],[1878,1201],[621,1201]],"region":{"top_left_x":620,"top_left_y":1160,"width":1258,"height":41},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac0fcbf98ece4555bfa82f1fd836ea8e","type":"text","conversion_output":true,"text":"60 to 90 minutes of dwell time, after which they remained constant during the","text_display":" 60 to 90 minutes of dwell time, after which they remained constant during the","confidence":1,"confidence_rate":1},{"cnt":[[623,1199],[922,1199],[922,1240],[623,1240]],"region":{"top_left_x":623,"top_left_y":1198,"width":299,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebd698f7fd4a47f886e1ee9c859a4942","type":"text","conversion_output":true,"text":"observation period.","text_display":" observation period.","confidence":1,"confidence_rate":1},{"cnt":[[621,1276],[1878,1276],[1878,1313],[621,1313]],"region":{"top_left_x":620,"top_left_y":1276,"width":1258,"height":37},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e816d18e4d43428a8908faa652ff49dc","type":"text","conversion_output":true,"text":"The authors estimated that based on their PK results and the 120 -minute dwell","text_display":"\n\nThe authors estimated that based on their PK results and the 120 -minute dwell","confidence":0.81982421875,"confidence_rate":0.9976926041736975},{"cnt":[[621,1315],[1878,1315],[1878,1356],[621,1356]],"region":{"top_left_x":620,"top_left_y":1314,"width":1258,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d16769621724db4981afafc8b75841f","type":"text","conversion_output":true,"text":"time, the predicted amounts of gemcitabine absorbed from the bladder ranged","text_display":" time, the predicted amounts of gemcitabine absorbed from the bladder ranged","confidence":1,"confidence_rate":1},{"cnt":[[621,1354],[1878,1354],[1878,1394],[621,1394]],"region":{"top_left_x":620,"top_left_y":1353,"width":1258,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf514e165f4f45e29f8ad3bd9edbb430","type":"text","conversion_output":true,"text":"from 10 to 110 mg , corresponding to \\(0.52 \\%\\) to \\(5.52 \\%\\) of the total gemcitabine","text_display":" from 10 to 110 mg , corresponding to \\(0.52 \\%\\) to \\(5.52 \\%\\) of the total gemcitabine","confidence":0.9887747764587402,"confidence_rate":0.999881178619305},{"cnt":[[621,1390],[1878,1390],[1878,1429],[621,1429]],"region":{"top_left_x":620,"top_left_y":1390,"width":1258,"height":39},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"022cd7c53b9d44a09eccca22c0f343fa","type":"text","conversion_output":true,"text":"dose instilled. No dFdU was measured in voided urine, and \\(61 \\%\\) to \\(100 \\%\\) of the","text_display":" dose instilled. No dFdU was measured in voided urine, and \\(61 \\%\\) to \\(100 \\%\\) of the","confidence":1,"confidence_rate":1},{"cnt":[[621,1427],[1878,1427],[1878,1467],[621,1467]],"region":{"top_left_x":620,"top_left_y":1426,"width":1258,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0184cfd56cf54a9aa89174a5b2b3ab20","type":"text","conversion_output":true,"text":"gemcitabine was accounted for in the voided urine. The authors also studied the","text_display":" gemcitabine was accounted for in the voided urine. The authors also studied the","confidence":1,"confidence_rate":1},{"cnt":[[621,1465],[1878,1465],[1878,1508],[621,1508]],"region":{"top_left_x":620,"top_left_y":1465,"width":1258,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f3281aa5cdc42f6bda8162aee4ec0aa","type":"text","conversion_output":true,"text":"in vitro decomposition at \\(37^{\\circ} C\\) with gemcitabine incubated with three control urine","text_display":" in vitro decomposition at \\(37^{\\circ} C\\) with gemcitabine incubated with three control urine","confidence":0.986328125,"confidence_rate":0.999862347517331},{"cnt":[[623,1504],[1878,1504],[1878,1545],[623,1545]],"region":{"top_left_x":623,"top_left_y":1503,"width":1255,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec4c8dff5d3c49bea99e5af29e86b0fc","type":"text","conversion_output":true,"text":"samples. They found no reduction in the concentration of gemcitabine, nor was","text_display":" samples. They found no reduction in the concentration of gemcitabine, nor was","confidence":1,"confidence_rate":1},{"cnt":[[623,1543],[1878,1543],[1878,1583],[623,1583]],"region":{"top_left_x":623,"top_left_y":1542,"width":1255,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a96e1a78b904ce681288d81727e63e3","type":"text","conversion_output":true,"text":"any production of dFdU observed. Minimal systemic absorption based on","text_display":" any production of dFdU observed. Minimal systemic absorption based on","confidence":1,"confidence_rate":1},{"cnt":[[623,1581],[1878,1581],[1878,1622],[623,1622]],"region":{"top_left_x":623,"top_left_y":1581,"width":1255,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01cb7a38c76141f6997e3b7e3d8ad4b0","type":"text","conversion_output":true,"text":"measured serum gemcitabine levels following intravesical gemcitabine","text_display":" measured serum gemcitabine levels following intravesical gemcitabine","confidence":1,"confidence_rate":1},{"cnt":[[623,1620],[1755,1620],[1755,1661],[623,1661]],"region":{"top_left_x":623,"top_left_y":1619,"width":1133,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"598ad1744e964d00ac2a86ebb1598c64","type":"text","conversion_output":true,"text":"administration was confirmed by the other six Phase I studies. (21,24-28)","text_display":" administration was confirmed by the other six Phase I studies. (21,24-28)","confidence":0.7955996990203857,"confidence_rate":0.9970727656744367},{"cnt":[[623,1697],[1878,1697],[1878,1738],[623,1738]],"region":{"top_left_x":623,"top_left_y":1697,"width":1255,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e0411cc1e5c4b548de75261d4403d18","type":"text","conversion_output":true,"text":"Formulation; Storage and Stability; and Reconstitution: Gemcitabine is supplied","text_display":"\n\nFormulation; Storage and Stability; and Reconstitution: Gemcitabine is supplied","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[623,1736],[1878,1736],[1878,1777],[623,1777]],"region":{"top_left_x":623,"top_left_y":1735,"width":1255,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed3c373f248a41de944a278fc2b377e1","type":"text","conversion_output":true,"text":"as a lyophilized powder in sterile vials containing \\(1,000 mg\\) of gemcitabine as the","text_display":" as a lyophilized powder in sterile vials containing \\(1,000 mg\\) of gemcitabine as the","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[621,1775],[1876,1775],[1876,1815],[621,1815]],"region":{"top_left_x":620,"top_left_y":1774,"width":1256,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"109110631e0c4675858a0e559e0f74d3","type":"text","conversion_output":true,"text":"hydrochloride salt (expressed as the free base), mannitol, and sodium acetate.","text_display":" hydrochloride salt (expressed as the free base), mannitol, and sodium acetate.","confidence":1,"confidence_rate":1},{"cnt":[[621,1813],[1442,1813],[1442,1854],[621,1854]],"region":{"top_left_x":620,"top_left_y":1813,"width":822,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebb1b6845f804b9f9f8e2bb1d282e9bb","type":"text","conversion_output":true,"text":"The lyophilized product should be stored below \\(30^{\\circ} C\\).","text_display":" The lyophilized product should be stored below \\(30^{\\circ} C\\).","confidence":0.99951171875,"confidence_rate":0.9999931211434043},{"cnt":[[621,1931],[621,1886],[1878,1888],[1878,1933]],"region":{"top_left_x":620,"top_left_y":1886,"width":1258,"height":48},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ed2a5e59c284e45920d933cb78816bb","type":"text","conversion_output":true,"text":"The drug will be reconstituted with 25 mL of \\(0.9 \\%\\) Sodium Chloride Injection to","text_display":"\n\nThe drug will be reconstituted with 25 mL of \\(0.9 \\%\\) Sodium Chloride Injection to","confidence":1,"confidence_rate":1},{"cnt":[[621,1929],[1878,1929],[1878,1970],[621,1970]],"region":{"top_left_x":620,"top_left_y":1929,"width":1258,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25e04b54b9874191a49cf5e377140214","type":"text","conversion_output":true,"text":"the 1 gram vial. The vial will be shaken to dissolve. This dilution yields a","text_display":" the 1 gram vial. The vial will be shaken to dissolve. This dilution yields a","confidence":1,"confidence_rate":1},{"cnt":[[621,1966],[1880,1966],[1880,2007],[621,2007]],"region":{"top_left_x":620,"top_left_y":1965,"width":1260,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b7d95298072408886445ff0b7695e0c","type":"text","conversion_output":true,"text":"gemcitabine concentration of \\(38 mg / mL\\) which includes accounting for the","text_display":" gemcitabine concentration of \\(38 mg / mL\\) which includes accounting for the","confidence":0.9990234375,"confidence_rate":0.9999883686432659},{"cnt":[[621,2002],[1878,2002],[1878,2045],[621,2045]],"region":{"top_left_x":620,"top_left_y":2002,"width":1258,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d999bee4b8646be9f8b891c85f964bd","type":"text","conversion_output":true,"text":"displacement volume of the lyophilized powder ( 1.3 mL for the 1 gram vial). The","text_display":" displacement volume of the lyophilized powder ( 1.3 mL for the 1 gram vial). The","confidence":0.9371445212053897,"confidence_rate":0.9993022030314233},{"cnt":[[621,2041],[1878,2041],[1878,2082],[621,2082]],"region":{"top_left_x":620,"top_left_y":2041,"width":1258,"height":41},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1923d2d94d1849d18c6175cde20c8fe1","type":"text","conversion_output":true,"text":"total volume upon reconstitution will be 26.3 mL . Complete withdrawal of the vial","text_display":" total volume upon reconstitution will be 26.3 mL . Complete withdrawal of the vial","confidence":1,"confidence_rate":1},{"cnt":[[621,2080],[1880,2080],[1880,2121],[621,2121]],"region":{"top_left_x":620,"top_left_y":2079,"width":1260,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c95db421211c4ba88a99d73cc74fa8ab","type":"text","conversion_output":true,"text":"contents will provide 1 gram of gemcitabine. The procedure will be repeated with","text_display":" contents will provide 1 gram of gemcitabine. The procedure will be repeated with","confidence":0.99853515625,"confidence_rate":0.9999833419832633},{"cnt":[[621,2118],[1878,2118],[1878,2159],[621,2159]],"region":{"top_left_x":620,"top_left_y":2118,"width":1258,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75f20c17f1414ac98072f5325f81d29c","type":"text","conversion_output":true,"text":"a second 1 gram vial to reach the 2 gram dose for treatment. The appropriate","text_display":" a second 1 gram vial to reach the 2 gram dose for treatment. The appropriate","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[623,2157],[1878,2157],[1878,2198],[623,2198]],"region":{"top_left_x":623,"top_left_y":2157,"width":1255,"height":41},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14598bf2d73c4cf185f293515c1b656d","type":"text","conversion_output":true,"text":"amount of drug may be administered as prepared or further diluted with \\(0.9 \\%\\)","text_display":" amount of drug may be administered as prepared or further diluted with \\(0.9 \\%\\)","confidence":0.8628597259521484,"confidence_rate":0.9981346136016531},{"cnt":[[623,2196],[1878,2196],[1878,2237],[623,2237]],"region":{"top_left_x":623,"top_left_y":2195,"width":1255,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"444baaa1e7bf488c922464ca15b23c56","type":"text","conversion_output":true,"text":"Sodium Chloride Injection to concentrations as low as \\(0.1 mg / mL\\). For this trial,","text_display":" Sodium Chloride Injection to concentrations as low as \\(0.1 mg / mL\\). For this trial,","confidence":1,"confidence_rate":1},{"cnt":[[621,2234],[1876,2234],[1876,2275],[621,2275]],"region":{"top_left_x":620,"top_left_y":2234,"width":1256,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a96fc306a674c08a0e4aebb47a72a44","type":"text","conversion_output":true,"text":"gemcitabine will be reconstituted according to above guidelines and the 2 gram","text_display":" gemcitabine will be reconstituted according to above guidelines and the 2 gram","confidence":0.998046875,"confidence_rate":0.9999772672951848},{"cnt":[[621,2273],[1878,2273],[1878,2314],[621,2314]],"region":{"top_left_x":620,"top_left_y":2273,"width":1258,"height":41},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf700fd534ed43728d0d4ebb29d29f46","type":"text","conversion_output":true,"text":"treatment dose volume (approximately 52.6 mL ) will be loaded into a syringe and","text_display":" treatment dose volume (approximately 52.6 mL ) will be loaded into a syringe and","confidence":1,"confidence_rate":1},{"cnt":[[621,2312],[1880,2312],[1880,2350],[621,2350]],"region":{"top_left_x":620,"top_left_y":2311,"width":1260,"height":40},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48ac205488b041929de8c6a19c3e5ede","type":"text","conversion_output":true,"text":"additional 0.9\\% Sodium Chloride for injection will be added to reach a 100 mL","text_display":" additional 0.9\\% Sodium Chloride for injection will be added to reach a 100 mL","confidence":0.92431640625,"confidence_rate":0.9990522465715276},{"cnt":[[621,2348],[1880,2348],[1880,2387],[621,2387]],"region":{"top_left_x":620,"top_left_y":2348,"width":1260,"height":39},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a68532f662884254afb4b3744e4caed9","type":"text","conversion_output":true,"text":"volume. Rationale for the 100 mL volume is addressed in Section 2.0 of the","text_display":" volume. 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Since it is not possible","text_display":"\n\nControl drug will consist of \\(0.9 \\%\\) sodium chloride solution. 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The Study Chair must be contacted if there are","confidence":1,"confidence_rate":1},{"cnt":[[494,1276],[1248,1276],[1248,1317],[494,1317]],"region":{"top_left_x":494,"top_left_y":1276,"width":755,"height":41},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e27a6acac20f4185a612d18f6db3b2c9","type":"text","conversion_output":true,"text":"significant deviations in the values of these tests.","text_display":" significant deviations in the values of these tests.","confidence":1,"confidence_rate":1},{"cnt":[[494,1349],[922,1349],[922,1394],[494,1394]],"region":{"top_left_x":494,"top_left_y":1349,"width":428,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92c56c9e3dcb4c85a3479183737d7a8a","type":"text","conversion_output":true,"text":"a. \\(\\quad WBC \\geq 3,000 / mcL\\),","text_display":"\na. \\(\\quad WBC \\geq 3,000 / mcL\\),","confidence":0.93017578125,"confidence_rate":0.9978090189046935},{"cnt":[[494,1427],[1510,1427],[1510,1472],[494,1472]],"region":{"top_left_x":494,"top_left_y":1426,"width":1017,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c68193a1438f41888a577ea4b10f4966","type":"text","conversion_output":true,"text":"b. 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SGOT or SGPT, Alkaline phosphatase, and total bilirubin \\(\\leq 2 x\\) institutional upper","confidence":0.9297215938568115,"confidence_rate":0.9992167574420586},{"cnt":[[619,1697],[853,1697],[853,1738],[619,1738]],"region":{"top_left_x":618,"top_left_y":1697,"width":235,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71a444cc055c417d8e3cff4d8c8212f1","type":"text","conversion_output":true,"text":"limit of normal.","text_display":" limit of normal.","confidence":1,"confidence_rate":1},{"cnt":[[494,1770],[1880,1770],[1880,1815],[494,1815]],"region":{"top_left_x":494,"top_left_y":1770,"width":1386,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59aa8dcd0742405abd3ebedb777c6513","type":"text","conversion_output":true,"text":"f. Patients should be believed based upon endoscopic inspection not to have","text_display":"\nf. Patients should be believed based upon endoscopic inspection not to have","confidence":1,"confidence_rate":1},{"cnt":[[619,1811],[1880,1809],[1880,1852],[619,1854]],"region":{"top_left_x":618,"top_left_y":1808,"width":1262,"height":47},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"641421f6098d4dc3b2bf57fb4c0fa7aa","type":"text","conversion_output":true,"text":"urothelial cancer of the prostate or more distal urethra (or urethra at all in","text_display":" urothelial cancer of the prostate or more distal urethra (or urethra at all in","confidence":1,"confidence_rate":1},{"cnt":[[619,1850],[1811,1850],[1811,1893],[619,1893]],"region":{"top_left_x":618,"top_left_y":1849,"width":1194,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4631cd1ae4164f05a651d57bdf2092d8","type":"text","conversion_output":true,"text":"women). Endoscopy should be performed within 56 days prior to registration.","text_display":" women). Endoscopy should be performed within 56 days prior to registration.","confidence":1,"confidence_rate":1},{"cnt":[[494,1925],[1880,1925],[1880,1970],[494,1970]],"region":{"top_left_x":494,"top_left_y":1925,"width":1386,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a719c1bae9bf4f3db34ed60b74040957","type":"text","conversion_output":true,"text":"g. Patients should have negative upper tract imaging studies obtained within 365","text_display":"\ng. Patients should have negative upper tract imaging studies obtained within 365","confidence":1,"confidence_rate":1},{"cnt":[[619,1964],[1880,1964],[1880,2009],[619,2009]],"region":{"top_left_x":618,"top_left_y":1963,"width":1262,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2067a68b5d9476bbcab8257c7d67aaa","type":"text","conversion_output":true,"text":"days prior to registration. Imaging studies may be performed after registration,","text_display":" days prior to registration. Imaging studies may be performed after registration,","confidence":1,"confidence_rate":1},{"cnt":[[619,2002],[1291,2002],[1291,2047],[619,2047]],"region":{"top_left_x":618,"top_left_y":2002,"width":674,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59b8045ec53246a18253e7548a27eb07","type":"text","conversion_output":true,"text":"but prior to TURBT on the day of treatment.","text_display":" but prior to TURBT on the day of treatment.","confidence":0.99951171875,"confidence_rate":0.999989825041388},{"cnt":[[365,2075],[668,2075],[668,2121],[365,2121]],"region":{"top_left_x":365,"top_left_y":2075,"width":304,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37045e44cc244f2b98830c3f59aaa2a0","type":"section_header","conversion_output":false,"children_ids":["4229945a8907472abf551fdf6f2a673c"],"text":"","text_display":""},{"cnt":[[370,2080],[664,2080],[664,2116],[370,2116]],"region":{"top_left_x":369,"top_left_y":2079,"width":295,"height":38},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4229945a8907472abf551fdf6f2a673c","type":"text","conversion_output":true,"parent_id":"37045e44cc244f2b98830c3f59aaa2a0","text":"7.2 Treatment","text_display":"\n\n\\subsection*{7.2 Treatment}","confidence":0.99951171875,"confidence_rate":0.9999728670071003},{"cnt":[[494,2153],[1880,2153],[1880,2198],[494,2198]],"region":{"top_left_x":494,"top_left_y":2152,"width":1386,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"341744cd5e3b409e81cebd94f8e62c14","type":"text","conversion_output":true,"text":"Within 28 working days after randomization, patient will have a complete resection of all","text_display":"\n\nWithin 28 working days after randomization, patient will have a complete resection of all","confidence":1,"confidence_rate":1},{"cnt":[[494,2196],[1880,2196],[1880,2237],[494,2237]],"region":{"top_left_x":494,"top_left_y":2195,"width":1386,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cc05bef21fb42c1beca9b7027f6ec18","type":"text","conversion_output":true,"text":"visible index bladder tumors (TURBT). The investigator, treating urologist and patient will","text_display":" visible index bladder tumors (TURBT). The investigator, treating urologist and patient will","confidence":1,"confidence_rate":1},{"cnt":[[494,2234],[1545,2234],[1545,2275],[494,2275]],"region":{"top_left_x":494,"top_left_y":2234,"width":1051,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f88c3f4deee34181a6f90e495c52374f","type":"text","conversion_output":true,"text":"be blinded to treatment, but the local institutional pharmacist will not.","text_display":" be blinded to treatment, but the local institutional pharmacist will not.","confidence":1,"confidence_rate":1},{"cnt":[[494,2307],[1412,2307],[1412,2353],[494,2353]],"region":{"top_left_x":494,"top_left_y":2307,"width":918,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4108af6836b441e68c8abd487f522f36","type":"text","conversion_output":true,"text":"Patients will be randomized to one of two treatment groups.","text_display":"\n\nPatients will be randomized to one of two treatment groups.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"418d4048-59be-4948-a117-48f8172df896-38","page":38,"lines":[{"cnt":[[245,125],[522,125],[522,161],[245,161]],"region":{"top_left_x":244,"top_left_y":124,"width":279,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"caaa6b2afdea448f860570bdd8e4cd27","type":"page_info","conversion_output":false,"text":"Revised 12/30/08","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1770,125],[1880,125],[1880,161],[1770,161]],"region":{"top_left_x":1770,"top_left_y":124,"width":110,"height":38},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9632e65e8c14feaa85874db544b007b","type":"page_info","conversion_output":false,"text":"S0337","text_display":"","confidence":0.9970703125,"confidence_rate":0.9997066442937235},{"cnt":[[245,163],[505,163],[505,200],[245,200]],"region":{"top_left_x":244,"top_left_y":163,"width":261,"height":37},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01f67adb0c324770a6945eb4b069e9bb","type":"page_info","conversion_output":false,"text":"Revised 6/19/12","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1745,163],[1880,163],[1880,204],[1745,204]],"region":{"top_left_x":1744,"top_left_y":163,"width":136,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2ca523684614ad0bbdcb69898117765","type":"page_info","conversion_output":false,"text":"Page 19","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1525,202],[1880,202],[1880,243],[1525,243]],"region":{"top_left_x":1525,"top_left_y":201,"width":355,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"979cbdaf864c4379a183fd96314ebabd","type":"page_info","conversion_output":false,"text":"Version Date 10/29/13","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[494,277],[1880,277],[1880,320],[494,320]],"region":{"top_left_x":494,"top_left_y":277,"width":1386,"height":44},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"414b659aa98a47a3bbfa015b79a89690","type":"text","conversion_output":true,"text":"Arm 1 - Within three hours following complete TURBT of index tumor(s) patients will","text_display":"\n\nArm 1 - Within three hours following complete TURBT of index tumor(s) patients will","confidence":1,"confidence_rate":1},{"cnt":[[494,316],[1880,316],[1880,359],[494,359]],"region":{"top_left_x":494,"top_left_y":315,"width":1386,"height":44},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a09dc9487664458a9c26e50ff230518d","type":"text","conversion_output":true,"text":"receive intravesical gemcitabine \\(-2,000 mg\\) in 100 ml of \\(0.9 \\% NaCl\\). Solution is to be held","text_display":" receive intravesical gemcitabine \\(-2,000 mg\\) in 100 ml of \\(0.9 \\% NaCl\\). Solution is to be held","confidence":0.9761475823079309,"confidence_rate":0.9997805559666444},{"cnt":[[494,354],[1880,354],[1880,397],[494,397]],"region":{"top_left_x":494,"top_left_y":354,"width":1386,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c54f6fa273d464fb0e3eda675db7b49","type":"text","conversion_output":true,"text":"in the bladder for one hour by clamping foley catheter. If this is not tolerable based on","text_display":" in the bladder for one hour by clamping foley catheter. If this is not tolerable based on","confidence":1,"confidence_rate":1},{"cnt":[[494,391],[1880,391],[1880,436],[494,436]],"region":{"top_left_x":494,"top_left_y":391,"width":1386,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddacef33dd7740e18be5882ac9db9802","type":"text","conversion_output":true,"text":"pain or other signs or symptoms, the duration of time held, and reason for premature","text_display":" pain or other signs or symptoms, the duration of time held, and reason for premature","confidence":1,"confidence_rate":1},{"cnt":[[494,432],[1880,432],[1880,475],[494,475]],"region":{"top_left_x":494,"top_left_y":431,"width":1386,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50c15bbb0d014815acec3553b67347c7","type":"text","conversion_output":true,"text":"release must be reported on the \\(S 0 3 3 7\\) Treatment Summary Form. After one hour, the","text_display":" release must be reported on the \\(S 0 3 3 7\\) Treatment Summary Form. After one hour, the","confidence":0.8150502435705675,"confidence_rate":0.9977795827045932},{"cnt":[[494,468],[1880,468],[1880,511],[494,511]],"region":{"top_left_x":494,"top_left_y":468,"width":1386,"height":44},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5457bb15ce41450da3a65de1500e07f3","type":"text","conversion_output":true,"text":"catheter will be unclamped and allowed to drain. Irrigation of the bladder will not be","text_display":" catheter will be unclamped and allowed to drain. Irrigation of the bladder will not be","confidence":1,"confidence_rate":1},{"cnt":[[494,507],[1880,507],[1880,552],[494,552]],"region":{"top_left_x":494,"top_left_y":507,"width":1386,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e337581d0acb46b5b8540b8e8065ee55","type":"text","conversion_output":true,"text":"performed immediately after unclamping (unless as is clinically indicated to assure","text_display":" performed immediately after unclamping (unless as is clinically indicated to assure","confidence":1,"confidence_rate":1},{"cnt":[[494,546],[780,546],[780,591],[494,591]],"region":{"top_left_x":494,"top_left_y":545,"width":286,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d66834d4cf048fdaf5417adffd3fc25","type":"text","conversion_output":true,"text":"catheter patency).","text_display":" catheter patency).","confidence":1,"confidence_rate":1},{"cnt":[[494,623],[1880,623],[1880,666],[494,666]],"region":{"top_left_x":494,"top_left_y":623,"width":1386,"height":44},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e1c02b63a5e4fe8860fb781ec169d56","type":"text","conversion_output":true,"text":"Arm 2-within 3 hours following complete TURBT of index tumor(s), patients will receive","text_display":"\n\nArm 2-within 3 hours following complete TURBT of index tumor(s), patients will receive","confidence":0.7453651428222656,"confidence_rate":0.9968784878676689},{"cnt":[[494,662],[1880,662],[1880,707],[494,707]],"region":{"top_left_x":494,"top_left_y":661,"width":1386,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c38e6dede8a4961b02374d41ef96143","type":"text","conversion_output":true,"text":"100 ml of sterile \\(0.9 \\% NaCl\\). Solution is to be held in the bladder for one hour by clamping","text_display":" 100 ml of sterile \\(0.9 \\% NaCl\\). Solution is to be held in the bladder for one hour by clamping","confidence":1,"confidence_rate":1},{"cnt":[[494,700],[1880,700],[1880,741],[494,741]],"region":{"top_left_x":494,"top_left_y":700,"width":1386,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73fd718fe32a42d78566456ba2590322","type":"text","conversion_output":true,"text":"foley catheter. If this is not tolerable based on pain or other signs or symptoms, the","text_display":" foley catheter. If this is not tolerable based on pain or other signs or symptoms, the","confidence":1,"confidence_rate":1},{"cnt":[[494,735],[1880,735],[1880,780],[494,780]],"region":{"top_left_x":494,"top_left_y":734,"width":1386,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e84ebec5058246b0a1c1a4139e98765a","type":"text","conversion_output":true,"text":"duration of time held, and reason for premature release must be reported on the \\(\\underline{ S 0 3 3 7 }\\)","text_display":" duration of time held, and reason for premature release must be reported on the \\(\\underline{ S 0 3 3 7 }\\)","confidence":0.8215240663451963,"confidence_rate":0.9979959490997842},{"cnt":[[494,776],[1880,776],[1880,819],[494,819]],"region":{"top_left_x":494,"top_left_y":775,"width":1386,"height":44},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c2cfd2291324976b7701fab7347f55a","type":"text","conversion_output":true,"text":"Treatment Summary Form. After one hour, the catheter will be unclamped and allowed to","text_display":" Treatment Summary Form. After one hour, the catheter will be unclamped and allowed to","confidence":1,"confidence_rate":1},{"cnt":[[494,812],[1880,812],[1880,857],[494,857]],"region":{"top_left_x":494,"top_left_y":812,"width":1386,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adc0730430f444e78a9b1844fabdf22d","type":"text","conversion_output":true,"text":"drain. Irrigation of the bladder will not be performed immediately after unclamping (unless","text_display":" drain. 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Positive cystoscopies should be biopsied and","text_display":" every 6 months for an additional two years. Positive cystoscopies should be biopsied and","confidence":1,"confidence_rate":1},{"cnt":[[494,1199],[1880,1199],[1880,1242],[494,1242]],"region":{"top_left_x":494,"top_left_y":1198,"width":1386,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b6ef11f7aa1489db9ca67c75289d111","type":"text","conversion_output":true,"text":"pathology reports submitted to the Data Operations Center. Tissue from the first positive","text_display":" pathology reports submitted to the Data Operations Center. Tissue from the first positive","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[494,1238],[1624,1238],[1624,1280],[494,1280]],"region":{"top_left_x":494,"top_left_y":1237,"width":1131,"height":44},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f479710bb94d46b9b3d95a827bc3d5d2","type":"text","conversion_output":true,"text":"biopsy should be submitted per Section 15.0 if the patient has consented.","text_display":" biopsy should be submitted per Section 15.0 if the patient has consented.","confidence":1,"confidence_rate":1},{"cnt":[[494,1311],[1880,1311],[1880,1356],[494,1356]],"region":{"top_left_x":494,"top_left_y":1310,"width":1386,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0268689636d74a0b95f1c15cc8058e7e","type":"text","conversion_output":true,"text":"Because non-malignant lesions can be mistaken for recurrence, suspected recurrences","text_display":"\n\nBecause non-malignant lesions can be mistaken for recurrence, suspected recurrences","confidence":1,"confidence_rate":1},{"cnt":[[494,1349],[776,1349],[776,1394],[494,1394]],"region":{"top_left_x":494,"top_left_y":1349,"width":282,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bac5cc99bbdb4572989b5c2ecd67f174","type":"text","conversion_output":true,"text":"must be biopsied.","text_display":" must be biopsied.","confidence":1,"confidence_rate":1},{"cnt":[[370,1427],[1188,1427],[1188,1472],[370,1472]],"region":{"top_left_x":369,"top_left_y":1426,"width":820,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"536e4b3793c34cc2b4ff446048a1a89f","type":"text","conversion_output":true,"text":"7.3 NMP-22 Bladder Chek and BTA Stat Testing","text_display":"\n7.3 NMP-22 Bladder Chek and BTA Stat Testing","confidence":1,"confidence_rate":1},{"cnt":[[494,1504],[1880,1504],[1880,1549],[494,1549]],"region":{"top_left_x":494,"top_left_y":1503,"width":1386,"height":47},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fdf5d5e4231e4edfa43192b567580017","type":"text","conversion_output":true,"text":"Urine samples will be collected pre-treatment and then every three months for two years","text_display":"\n\nUrine samples will be collected pre-treatment and then every three months for two years","confidence":1,"confidence_rate":1},{"cnt":[[494,1543],[1880,1543],[1880,1588],[494,1588]],"region":{"top_left_x":494,"top_left_y":1542,"width":1386,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19cff7dbfae04da49b307e8026edf746","type":"text","conversion_output":true,"text":"for NMP-22 Bladder Chek and BTA Stat testing. These tests are commercially available","text_display":" for NMP-22 Bladder Chek and BTA Stat testing. These tests are commercially available","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[494,1581],[1880,1581],[1880,1624],[494,1624]],"region":{"top_left_x":494,"top_left_y":1581,"width":1386,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3af5038ee61476297caf3c46c6cf59a","type":"text","conversion_output":true,"text":"and the tests must be performed at the local site and the results reported to the Data","text_display":" and the tests must be performed at the local site and the results reported to the Data","confidence":1,"confidence_rate":1},{"cnt":[[494,1620],[1878,1620],[1878,1661],[494,1661]],"region":{"top_left_x":494,"top_left_y":1619,"width":1384,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84acad19715645b9975786c7763e1097","type":"text","conversion_output":true,"text":"Operations Center in Seattle on the S0337 Cystoscopy and Urine Markers Form.","text_display":" Operations Center in Seattle on the S0337 Cystoscopy and Urine Markers Form.","confidence":0.9800702525832321,"confidence_rate":0.9997514997260322},{"cnt":[[494,1659],[1536,1659],[1536,1704],[494,1704]],"region":{"top_left_x":494,"top_left_y":1658,"width":1043,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"edef9e314d75449089557b3f151bcd57","type":"text","conversion_output":true,"text":"Instructions for sample processing are included in each of the tests.","text_display":" Instructions for sample processing are included in each of the tests.","confidence":1,"confidence_rate":1},{"cnt":[[370,1732],[1199,1732],[1199,1777],[370,1777]],"region":{"top_left_x":369,"top_left_y":1731,"width":830,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c98cc29ac2014009b58d1576ad779db8","type":"text","conversion_output":true,"text":"7.4 Criteria for Removal from Protocol Treatment","text_display":"\n7.4 Criteria for Removal from Protocol Treatment","confidence":1,"confidence_rate":1},{"cnt":[[494,1809],[1192,1809],[1192,1854],[494,1854]],"region":{"top_left_x":494,"top_left_y":1808,"width":699,"height":47},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e6169c1f1bf40f18397ef56153e19a9","type":"text","conversion_output":true,"text":"a. Completion of intravesical instillation.","text_display":"\na. Completion of intravesical instillation.","confidence":1,"confidence_rate":1},{"cnt":[[494,1886],[1880,1886],[1880,1931],[494,1931]],"region":{"top_left_x":494,"top_left_y":1886,"width":1386,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2894462765cf439196b230637d49010f","type":"text","conversion_output":true,"text":"b. Unacceptable toxicity - however, patients will be analyzed for outcome and","text_display":"\nb. Unacceptable toxicity - however, patients will be analyzed for outcome and","confidence":1,"confidence_rate":1},{"cnt":[[619,1925],[1880,1925],[1880,1970],[619,1970]],"region":{"top_left_x":618,"top_left_y":1925,"width":1262,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b328de9c99304d00b38186ca3774cbe7","type":"text","conversion_output":true,"text":"toxicity even if the instillation is ended in less than 1 hour because of side","text_display":" toxicity even if the instillation is ended in less than 1 hour because of side","confidence":0.9990236759185791,"confidence_rate":0.9999886419133848},{"cnt":[[619,1964],[930,1964],[930,2009],[619,2009]],"region":{"top_left_x":618,"top_left_y":1963,"width":313,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42a6374cc818413e9b3a833af8a4a26d","type":"text","conversion_output":true,"text":"effects/intolerability.","text_display":" effects/intolerability.","confidence":1,"confidence_rate":1},{"cnt":[[494,2041],[1476,2041],[1476,2086],[494,2086]],"region":{"top_left_x":494,"top_left_y":2041,"width":982,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"881d98ae13874ec49d2f210b95b31b5e","type":"text","conversion_output":true,"text":"c. Delay of instillation more than three hours post-TURBT.","text_display":"\nc. Delay of instillation more than three hours post-TURBT.","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[494,2118],[1876,2118],[1876,2161],[494,2161]],"region":{"top_left_x":494,"top_left_y":2118,"width":1382,"height":44},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3487eb7beb04267b277f7cb2706a38f","type":"text","conversion_output":true,"text":"d. Urologist believes at the end of the TURBT, because of depth of tumor resection,","text_display":"\nd. Urologist believes at the end of the TURBT, because of depth of tumor resection,","confidence":1,"confidence_rate":1},{"cnt":[[619,2157],[1794,2157],[1794,2202],[619,2202]],"region":{"top_left_x":618,"top_left_y":2157,"width":1176,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fba71eac723a4e338eb964c3fae37b4a","type":"text","conversion_output":true,"text":"degree of bleeding, medical instability, etc. that instillation is contraindicated.","text_display":" degree of bleeding, medical instability, etc. that instillation is contraindicated.","confidence":1,"confidence_rate":1},{"cnt":[[494,2230],[1665,2230],[1665,2275],[494,2275]],"region":{"top_left_x":494,"top_left_y":2230,"width":1172,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a64994ca8e054a05936f59f0a19182fb","type":"text","conversion_output":true,"text":"e. The patient may withdraw from the study at any time for any reason.","text_display":"\ne. The patient may withdraw from the study at any time for any reason.","confidence":1,"confidence_rate":1},{"cnt":[[370,2307],[851,2307],[851,2353],[370,2353]],"region":{"top_left_x":369,"top_left_y":2307,"width":482,"height":46},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"333a3f4c81ef471baf262ed2fb4ff811","type":"text","conversion_output":true,"text":"7.5 Emergency Unblinding","text_display":"\n7.5 Emergency Unblinding","confidence":1,"confidence_rate":1},{"cnt":[[494,2385],[1878,2385],[1878,2430],[494,2430]],"region":{"top_left_x":494,"top_left_y":2384,"width":1384,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0201a489f1404de68d18b2fcefb0077e","type":"text","conversion_output":true,"text":"Procedures for emergency unblinding of the gemcitabine/saline treatment assignment are","text_display":"\n\nProcedures for emergency unblinding of the gemcitabine/saline treatment assignment 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REQUIRED STUDIES & \\multirow{2}{*}{PRE STUDY} & \\multirow{2}{*}{PRE TREATMENT} & Wk & Wk & Wk & Wk & Mo & Mo & Mo & Mo & Mo & Mo & Mo & Mo & Mo & Mo & Mo & Mo \\\\\n\\hline & & & 1 & 2 & 3 & 4 & 3 & 6 & 9 & 12 & 15 & 18 & 21 & 24 & 30 & 36 & 42 & 48 \\\\\n\\hline PHYSICAL & & & & & & & & & & & & & & & & & & \\\\\n\\hline History and Physical Exam & X & & & X & & & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Weight and Performance Status & X & & & & & & & & & & & & & & & & & X \\\\\n\\hline Disease Assessment & X¥ & & & & & & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Toxicity Notation £ & & & X & X & & X & & & & & & & & & & & & \\\\\n\\hline LABORATORY & & & & & & & & & & & & & & & & & & \\\\\n\\hline CBC/Differential/Platelets å & X & & & \\(X _{\\mu}\\) & & & & & & & & & & & & & & \\\\\n\\hline Serum Creatinine å & X & & & & & & & & & & & & & & & & & \\\\\n\\hline Urine Analysis & X & & & & & & & & & & & & & & & & & \\\\\n\\hline SGOT/SGPT å & X & & 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CBC/Differential/Platelets å & X & & & \\(X _{\\mu}\\) & & & & & & & & & & & & & & \\\\\n\\hline Serum Creatinine å & X & & & & & & & & & & & & & & & & & \\\\\n\\hline Urine Analysis & X & & & & & & & & & & & & & & & & & \\\\\n\\hline SGOT/SGPT å & X & & & \\(X _{\\mu}\\) & & & & & & & & & & & & & & \\\\\n\\hline Alkaline Phosphatase å & X & & & \\(X _{\\mu}\\) & & & & & & & & & & & & & & \\\\\n\\hline Bilirubin å & X & & & \\(X _{\\mu}\\) & & & & & & & & & & & & & & \\\\\n\\hline NMP-22 Bladder Check & & X & & & & & X & X & X & X & X & X & X & X & & & & \\\\\n\\hline BTA Stat & & X & & & & & X & X & X & X & X & X & X & X & & & & \\\\\n\\hline OPTIONAL SPECIMEN SAMPLES (BANKING) & & & & & & & & & & & & & & & & & & \\\\\n\\hline Tissue (see Section 15.1) \\(\\Omega\\) & & & X & & & & & & & & & & & & & & & \\\\\n\\hline Whole blood (see Section 15.2) & & & & & & & X & & & & & & & & & & & \\\\\n\\hline X-RAYS \\& SCANS & & & & & & & & & & & & & & & & & & \\\\\n\\hline IVP for Retrogrades 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Patients who die without any evidence of disease recurrence, will be","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[494,700],[904,700],[904,737],[494,737]],"region":{"top_left_x":494,"top_left_y":700,"width":411,"height":37},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"560e889ee48842d2a5d6ba8ffcfe76ee","type":"text","conversion_output":true,"text":"censored at time of death.","text_display":" censored at time of death.","confidence":1,"confidence_rate":1},{"cnt":[[494,776],[1880,776],[1880,819],[494,819]],"region":{"top_left_x":494,"top_left_y":775,"width":1386,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cdf834f56b14407b163b4ab19998464","type":"text","conversion_output":true,"text":"If one assumes roughly equal numbers of patients with newly diagnosed and recurrent","text_display":"\n\nIf one assumes roughly equal numbers of patients with newly diagnosed and recurrent","confidence":1,"confidence_rate":1},{"cnt":[[494,816],[1880,816],[1880,857],[494,857]],"region":{"top_left_x":494,"top_left_y":816,"width":1386,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bae08dc2bcb6495e805dcd33679ae6ca","type":"text","conversion_output":true,"text":"superficial bladder tumors, then we anticipate about \\(60 \\%\\) of patients will experience","text_display":" superficial bladder tumors, then we anticipate about \\(60 \\%\\) of patients will experience","confidence":1,"confidence_rate":1},{"cnt":[[494,855],[1880,855],[1880,896],[494,896]],"region":{"top_left_x":494,"top_left_y":855,"width":1386,"height":41},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d95b01ed26b747ce85c746e9c811b7dd","type":"text","conversion_output":true,"text":"recurrences by 2 years. It is assumed that 14 eligible patients per month will be","text_display":" recurrences by 2 years. It is assumed that 14 eligible patients per month will be","confidence":1,"confidence_rate":1},{"cnt":[[494,889],[1880,889],[1880,935],[494,935]],"region":{"top_left_x":494,"top_left_y":889,"width":1386,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f952e57f64c40a6a639a8a452b93a3c","type":"text","conversion_output":true,"text":"randomized. Patients will be stratified by disease status (first occurrence vs. recurrent","text_display":" randomized. Patients will be stratified by disease status (first occurrence vs. recurrent","confidence":1,"confidence_rate":1},{"cnt":[[494,930],[1880,930],[1880,973],[494,973]],"region":{"top_left_x":494,"top_left_y":930,"width":1386,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"432dcf05ce5a49179e5f0d7c3cb02139","type":"text","conversion_output":true,"text":"disease), and number of tumors (one versus more than one). Assuming exponential","text_display":" disease), and number of tumors (one versus more than one). Assuming exponential","confidence":1,"confidence_rate":1},{"cnt":[[494,969],[1880,969],[1880,1010],[494,1010]],"region":{"top_left_x":494,"top_left_y":968,"width":1386,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"511c6c771b7444f986b234fdb9c887af","type":"text","conversion_output":true,"text":"time-to-recurrence (TTR) and 60\\% TTR (40\\% recurrence-free) at two years in the sterile","text_display":" time-to-recurrence (TTR) and 60\\% TTR (40\\% recurrence-free) at two years in the sterile","confidence":0.5088001413969323,"confidence_rate":0.9926022246412499},{"cnt":[[494,1005],[1880,1005],[1880,1048],[494,1048]],"region":{"top_left_x":494,"top_left_y":1005,"width":1386,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b539e71ce6e54848b899e79dca0b8d8e","type":"text","conversion_output":true,"text":"saline group, then two years of accrual ( 340 eligible patients) and two additional years of","text_display":" saline group, then two years of accrual ( 340 eligible patients) and two additional years of","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[494,1044],[1880,1044],[1880,1085],[494,1085]],"region":{"top_left_x":494,"top_left_y":1044,"width":1386,"height":41},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"138e60bd36e842c2958fc2aafb8e21ae","type":"text","conversion_output":true,"text":"follow-up will be required for a one-sided 0.025 level test to have power 0.89 for detecting","text_display":" follow-up will be required for a one-sided 0.025 level test to have power 0.89 for detecting","confidence":0.9980480668600649,"confidence_rate":0.9999810308532753},{"cnt":[[494,1083],[1880,1083],[1880,1124],[494,1124]],"region":{"top_left_x":494,"top_left_y":1082,"width":1386,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1ebe5925c4843c8b0320dad1d27b005","type":"text","conversion_output":true,"text":"a hazard ratio of 1.53 (equivalent to an improvement to a \\(45 \\%\\) TTR ( \\(55 \\%\\) recurrence-free)","text_display":" a hazard ratio of 1.53 (equivalent to an improvement to a \\(45 \\%\\) TTR ( \\(55 \\%\\) recurrence-free)","confidence":0.9683060646057129,"confidence_rate":0.9996842943628025},{"cnt":[[494,1121],[1878,1121],[1878,1162],[494,1162]],"region":{"top_left_x":494,"top_left_y":1121,"width":1384,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c614a54ee1c4cc4a7f051a1865e3f71","type":"text","conversion_output":true,"text":"rate at two years on the gemcitabine arm). The primary test will be performed using the","text_display":" rate at two years on the gemcitabine arm). The primary test will be performed using the","confidence":1,"confidence_rate":1},{"cnt":[[494,1160],[1880,1160],[1880,1201],[494,1201]],"region":{"top_left_x":494,"top_left_y":1160,"width":1386,"height":41},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0162c9ca37084f57b3c20e9ea263c552","type":"text","conversion_output":true,"text":"stratified logrank test. All eligible, randomized patients will be used in the primary analysis","text_display":" stratified logrank test. All eligible, randomized patients will be used in the primary analysis","confidence":1,"confidence_rate":1},{"cnt":[[494,1199],[1878,1199],[1878,1240],[494,1240]],"region":{"top_left_x":494,"top_left_y":1198,"width":1384,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8f4e41e5bfa42c9a908a18f97db75a0","type":"text","conversion_output":true,"text":"regardless of whether they actually receive the treatment to which they were assigned","text_display":" regardless of whether they actually receive the treatment to which they were assigned","confidence":1,"confidence_rate":1},{"cnt":[[494,1238],[874,1238],[874,1278],[494,1278]],"region":{"top_left_x":494,"top_left_y":1237,"width":381,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eda64e5ff8c84c4ba737fe0c2d2654b0","type":"text","conversion_output":true,"text":"(intent-to-treat analysis).","text_display":" (intent-to-treat analysis).","confidence":1,"confidence_rate":1},{"cnt":[[494,1311],[1072,1311],[1072,1354],[494,1354]],"region":{"top_left_x":494,"top_left_y":1310,"width":579,"height":44},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad3946e4f96644ecb2f6a465874397ac","type":"text","conversion_output":true,"text":"Estimate of sample size: 340 eligible","text_display":"\n\nEstimate of sample size: 340 eligible","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[494,1351],[1149,1351],[1149,1394],[494,1394]],"region":{"top_left_x":494,"top_left_y":1351,"width":656,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83e0e490697049f5ad958732e0e92193","type":"text","conversion_output":true,"text":"Estimate of accrual rate: 170 eligible/year","text_display":"\nEstimate of accrual rate: 170 eligible/year","confidence":0.9960954189300537,"confidence_rate":0.9999232926706348},{"cnt":[[494,1427],[1880,1427],[1880,1470],[494,1470]],"region":{"top_left_x":494,"top_left_y":1426,"width":1386,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78c21e7c498d447dba70ddbe8a1ba1b7","type":"text","conversion_output":true,"text":"Two interim analyses of time-to-recurrence will be performed after \\(50 \\%\\) and \\(80 \\%\\) of the","text_display":"\nTwo interim analyses of time-to-recurrence will be performed after \\(50 \\%\\) and \\(80 \\%\\) of the","confidence":0.6887798309326172,"confidence_rate":0.9961238483308669},{"cnt":[[494,1465],[1880,1465],[1880,1508],[494,1508]],"region":{"top_left_x":494,"top_left_y":1465,"width":1386,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae9f52834c5341ef97b4d66a707588e0","type":"text","conversion_output":true,"text":"expected number of events have occurred ( 113 and 181 relapses, respectively, assuming","text_display":" expected number of events have occurred ( 113 and 181 relapses, respectively, assuming","confidence":0.5726104485802352,"confidence_rate":0.9942685533483141},{"cnt":[[494,1504],[1878,1504],[1878,1547],[494,1547]],"region":{"top_left_x":494,"top_left_y":1503,"width":1384,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f7ca4f830eb413c9fdc13422208fd54","type":"text","conversion_output":true,"text":"the alternative treatment hypothesis) which will be approximately at the time accrual is","text_display":" the alternative treatment hypothesis) which will be approximately at the time accrual is","confidence":1,"confidence_rate":1},{"cnt":[[494,1543],[1880,1543],[1880,1583],[494,1583]],"region":{"top_left_x":494,"top_left_y":1542,"width":1386,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"209a7c65f8dc4947bc8141373c35b501","type":"text","conversion_output":true,"text":"completed and one year later. Consideration will be given to reporting early at either time","text_display":" completed and one year later. Consideration will be given to reporting early at either time","confidence":1,"confidence_rate":1},{"cnt":[[494,1581],[1880,1581],[1880,1622],[494,1622]],"region":{"top_left_x":494,"top_left_y":1581,"width":1386,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"517d99a4936741b9956feedd1ae3c8af","type":"text","conversion_output":true,"text":"if (1) TTR on the gemcitabine arm is superior at the one-sided 0.005 level or if (2) the","text_display":" if (1) TTR on the gemcitabine arm is superior at the one-sided 0.005 level or if (2) the","confidence":0.989750862121582,"confidence_rate":0.9998926930291961},{"cnt":[[494,1620],[1878,1620],[1878,1661],[494,1661]],"region":{"top_left_x":494,"top_left_y":1619,"width":1384,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3720cf2b76ed4d788502012471d27d2c","type":"text","conversion_output":true,"text":"hypothesis \\(\\lambda=1.53\\) (where \\(\\lambda\\) is the sterile water/gemcitabine hazard ratio) is rejected in","text_display":" hypothesis \\(\\lambda=1.53\\) (where \\(\\lambda\\) is the sterile water/gemcitabine hazard ratio) is rejected in","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[494,1659],[1880,1659],[1880,1699],[494,1699]],"region":{"top_left_x":494,"top_left_y":1658,"width":1386,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90a17cd624804ebe9b85d94ff39e768d","type":"text","conversion_output":true,"text":"favor of \\(\\lambda<1.53\\) at the one-sided 0.005 level (testing using a proportional hazards score","text_display":" favor of \\(\\lambda<1.53\\) at the one-sided 0.005 level (testing using a proportional hazards score","confidence":1,"confidence_rate":1},{"cnt":[[494,1697],[1081,1697],[1081,1738],[494,1738]],"region":{"top_left_x":494,"top_left_y":1697,"width":587,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebeb98d488ca4770bfc05a5948a1e297","type":"text","conversion_output":true,"text":"test, an extension of the logrank test).","text_display":" test, an extension of the logrank test).","confidence":1,"confidence_rate":1},{"cnt":[[494,1772],[1880,1772],[1880,1815],[494,1815]],"region":{"top_left_x":494,"top_left_y":1772,"width":1386,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09b015b736734ff19403cf4b6ffa3fea","type":"text","conversion_output":true,"text":"Assuming the study does not terminate early and the alternative treatment hypothesis, the","text_display":"\n\nAssuming the study does not terminate early and the alternative treatment hypothesis, the","confidence":1,"confidence_rate":1},{"cnt":[[494,1813],[1880,1813],[1880,1854],[494,1854]],"region":{"top_left_x":494,"top_left_y":1813,"width":1386,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"887c3a6587184fd58c8a302bb4dd5aeb","type":"text","conversion_output":true,"text":"final analysis will occur when approximately 226 recurrences have been reported","text_display":" final analysis will occur when approximately 226 recurrences have been reported","confidence":1,"confidence_rate":1},{"cnt":[[494,1850],[1880,1850],[1880,1893],[494,1893]],"region":{"top_left_x":494,"top_left_y":1849,"width":1386,"height":44},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"effe481c38164200916ca0f225fe831f","type":"text","conversion_output":true,"text":"(estimated to be about two years after completion of accrual). The final analysis will be","text_display":" (estimated to be about two years after completion of accrual). The final analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[494,1886],[1880,1886],[1880,1929],[494,1929]],"region":{"top_left_x":494,"top_left_y":1886,"width":1386,"height":44},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed43e57cec7041faa596bc2645986481","type":"text","conversion_output":true,"text":"based on the stratified logrank test with stratification factors as specified in Section 6.0","text_display":" based on the stratified logrank test with stratification factors as specified in Section 6.0","confidence":0.9824302196502686,"confidence_rate":0.9998153716186499},{"cnt":[[494,1927],[1880,1927],[1880,1968],[494,1968]],"region":{"top_left_x":494,"top_left_y":1927,"width":1386,"height":41},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f2459e6bac3046adae49da498aa72135","type":"text","conversion_output":true,"text":"with a one-sided 0.020 level to adjust for the two interim analyses, for an overall level of","text_display":" with a one-sided 0.020 level to adjust for the two interim analyses, for an overall level of","confidence":1,"confidence_rate":1},{"cnt":[[494,1964],[1880,1964],[1880,2007],[494,2007]],"region":{"top_left_x":494,"top_left_y":1963,"width":1386,"height":44},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70a45e0214fd474993bcde5fe93f34fd","type":"text","conversion_output":true,"text":"0.025 (one-sided). In addition, the trial will be monitored for safety every six months and","text_display":" 0.025 (one-sided). In addition, the trial will be monitored for safety every six months and","confidence":1,"confidence_rate":1},{"cnt":[[494,2002],[1154,2002],[1154,2047],[494,2047]],"region":{"top_left_x":494,"top_left_y":2002,"width":660,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53e6196724b5489d9eb751083a77cb06","type":"text","conversion_output":true,"text":"assuming the alternative hypothesis holds.","text_display":" assuming the alternative hypothesis holds.","confidence":1,"confidence_rate":1},{"cnt":[[370,2075],[836,2075],[836,2127],[370,2127]],"region":{"top_left_x":369,"top_left_y":2075,"width":467,"height":52},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ded0668a3b045aa92dbae3301390ea8","type":"section_header","conversion_output":false,"children_ids":["bbc9887488b84e9e8234803348c6bd98"],"text":"","text_display":""},{"cnt":[[374,2080],[831,2080],[831,2121],[374,2121]],"region":{"top_left_x":373,"top_left_y":2079,"width":459,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbc9887488b84e9e8234803348c6bd98","type":"text","conversion_output":true,"parent_id":"3ded0668a3b045aa92dbae3301390ea8","text":"11.2 Secondary Endpoints","text_display":"\n\n\\subsection*{11.2 Secondary Endpoints}","confidence":0.9985356330871582,"confidence_rate":0.9999494688579158},{"cnt":[[494,2157],[1880,2157],[1880,2198],[494,2198]],"region":{"top_left_x":494,"top_left_y":2157,"width":1386,"height":41},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9bb31e1ce51b4c92b6f924b78f0ea5c6","type":"text","conversion_output":true,"text":"A sample of 170 patients per arm is sufficient to estimate the probability of a specific","text_display":"\n\nA sample of 170 patients per arm is sufficient to estimate the probability of a specific","confidence":1,"confidence_rate":1},{"cnt":[[494,2196],[1880,2196],[1880,2237],[494,2237]],"region":{"top_left_x":494,"top_left_y":2195,"width":1386,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7e5b6abbdc3d43158e96d66aa7c84da2","type":"text","conversion_output":true,"text":"toxicity to within at worst \\(= \\pm 0.077\\). There is power of 0.81 for a one-sided 0.025 level","text_display":" toxicity to within at worst \\(= \\pm 0.077\\). There is power of 0.81 for a one-sided 0.025 level","confidence":1,"confidence_rate":1},{"cnt":[[494,2234],[1794,2234],[1794,2275],[494,2275]],"region":{"top_left_x":494,"top_left_y":2234,"width":1300,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18a18f5285904698b2f95f466ef14b39","type":"text","conversion_output":true,"text":"test to detect a 0.16 difference in a specific toxicity probability between the two arms.","text_display":" test to detect a 0.16 difference in a specific toxicity probability between the two arms.","confidence":1,"confidence_rate":1},{"cnt":[[494,2307],[1880,2307],[1880,2353],[494,2353]],"region":{"top_left_x":494,"top_left_y":2307,"width":1386,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8091461ba8604332979280e33b6b4f69","type":"text","conversion_output":true,"text":"The logrank test will be used to evaluate whether worsening-free survival (see Section","text_display":"\n\nThe logrank test will be used to evaluate whether worsening-free survival (see Section","confidence":1,"confidence_rate":1},{"cnt":[[494,2350],[1880,2350],[1880,2391],[494,2391]],"region":{"top_left_x":494,"top_left_y":2350,"width":1386,"height":42},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"710ddc3a3f3646d4ac4671f4b03f00b4","type":"text","conversion_output":true,"text":"10.0 for definition) is better on the gemcitabine arm relative to the saline arm. Descriptive","text_display":" 10.0 for definition) is better on the gemcitabine arm relative to the saline arm. Descriptive","confidence":0.81689453125,"confidence_rate":0.9979171691688263},{"cnt":[[494,2385],[1880,2385],[1880,2430],[494,2430]],"region":{"top_left_x":494,"top_left_y":2384,"width":1386,"height":46},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5dd27262a844e0c91f391238aa0c797","type":"text","conversion_output":true,"text":"statistics will be used to evaluate the number of diagnostic tests required for individuals","text_display":" statistics will be used to evaluate the number of diagnostic tests required for individuals","confidence":1,"confidence_rate":1},{"cnt":[[494,2426],[862,2426],[862,2464],[494,2464]],"region":{"top_left_x":494,"top_left_y":2425,"width":368,"height":40},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f4e9260cb51e47f6be1548daa077b33b","type":"text","conversion_output":true,"text":"on each treatment arm.","text_display":" on each treatment arm.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"418d4048-59be-4948-a117-48f8172df896-45","page":45,"lines":[{"cnt":[[1772,125],[1876,125],[1876,161],[1772,161]],"region":{"top_left_x":1772,"top_left_y":124,"width":104,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30d33f970e9b4652b5fd290aab608c86","type":"page_info","conversion_output":false,"text":"S0337","text_display":"","confidence":0.99853515625,"confidence_rate":0.9998534189757986},{"cnt":[[1745,163],[1876,163],[1876,204],[1745,204]],"region":{"top_left_x":1744,"top_left_y":163,"width":132,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee36d0aa74c546d4bd20b0150a4b45a9","type":"page_info","conversion_output":false,"text":"Page 26","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1525,202],[1876,202],[1876,238],[1525,238]],"region":{"top_left_x":1525,"top_left_y":201,"width":351,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5dd0185c9bba4533b15e3715e48fa1e0","type":"page_info","conversion_output":false,"text":"Version Date 10/29/13","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1624,241],[1876,241],[1876,277],[1624,277]],"region":{"top_left_x":1624,"top_left_y":240,"width":252,"height":38},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0bf8930df19493990b9f7924b2a55b1","type":"page_info","conversion_output":false,"text":"Revised 8/29/13","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,350],[1454,350],[1454,402],[370,402]],"region":{"top_left_x":369,"top_left_y":350,"width":1086,"height":52},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ebf86efd0344e8ab5016a7fe7e53bf8","type":"section_header","conversion_output":false,"children_ids":["fd05f6a0a3a44fcba8617590f2ea487b"],"text":"","text_display":""},{"cnt":[[374,352],[1450,352],[1450,397],[374,397]],"region":{"top_left_x":373,"top_left_y":352,"width":1078,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd05f6a0a3a44fcba8617590f2ea487b","type":"text","conversion_output":true,"parent_id":"9ebf86efd0344e8ab5016a7fe7e53bf8","text":"11.3 Sensitivity and Specificity of Assays for Predicting Recurrence","text_display":"\n\n\\subsection*{11.3 Sensitivity and Specificity of Assays for Predicting Recurrence}","confidence":1,"confidence_rate":1},{"cnt":[[494,430],[1880,430],[1880,473],[494,473]],"region":{"top_left_x":494,"top_left_y":429,"width":1386,"height":44},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb8ac2c997e5438a8da851f2c95d72e8","type":"text","conversion_output":true,"text":"Sensitivity and specificity of the BTA Stat and the NMP-22 Bladder Chek alone and in","text_display":"\n\nSensitivity and specificity of the BTA Stat and the NMP-22 Bladder Chek alone and in","confidence":1,"confidence_rate":1},{"cnt":[[494,471],[1880,471],[1880,511],[494,511]],"region":{"top_left_x":494,"top_left_y":470,"width":1386,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6e9102c388841058316ef2f23ec3dae","type":"text","conversion_output":true,"text":"combination are the primary endpoints of this correlative study. The gold standard to","text_display":" combination are the primary endpoints of this correlative study. The gold standard to","confidence":1,"confidence_rate":1},{"cnt":[[494,507],[1880,507],[1880,552],[494,552]],"region":{"top_left_x":494,"top_left_y":507,"width":1386,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5778d0dcc09046b99edb17852226f57d","type":"text","conversion_output":true,"text":"define a recurrence is a positive biopsy prompted by a cystoscopy. Absence of","text_display":" define a recurrence is a positive biopsy prompted by a cystoscopy. Absence of","confidence":1,"confidence_rate":1},{"cnt":[[494,546],[1880,546],[1880,589],[494,589]],"region":{"top_left_x":494,"top_left_y":545,"width":1386,"height":44},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa1ccd0b115849219c7ca5b1143d198a","type":"text","conversion_output":true,"text":"recurrence will be confirmed by a negative complete diagnostic work-up. Disease status","text_display":" recurrence will be confirmed by a negative complete diagnostic work-up. Disease status","confidence":1,"confidence_rate":1},{"cnt":[[494,584],[1880,584],[1880,625],[494,625]],"region":{"top_left_x":494,"top_left_y":584,"width":1386,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc7b7f6a7f4245fe8d7679dfe6cb5d47","type":"text","conversion_output":true,"text":"will be evaluated every three months for two years and then every six months for an","text_display":" will be evaluated every three months for two years and then every six months for an","confidence":1,"confidence_rate":1},{"cnt":[[494,623],[1880,623],[1880,664],[494,664]],"region":{"top_left_x":494,"top_left_y":623,"width":1386,"height":41},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5736b8777a1412e80af4eff1b011e66","type":"text","conversion_output":true,"text":"additional two years. Recurrence information over time is not independent within an","text_display":" additional two years. Recurrence information over time is not independent within an","confidence":1,"confidence_rate":1},{"cnt":[[494,662],[1880,662],[1880,703],[494,703]],"region":{"top_left_x":494,"top_left_y":661,"width":1386,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e4c586f0cc14a9a914563dc477f45c6","type":"text","conversion_output":true,"text":"individual. To account for this correlation, a GEE approach will be used to estimate","text_display":" individual. To account for this correlation, a GEE approach will be used to estimate","confidence":1,"confidence_rate":1},{"cnt":[[494,700],[1880,700],[1880,741],[494,741]],"region":{"top_left_x":494,"top_left_y":700,"width":1386,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a97b7b13513349eba1fa13a4e7fb9206","type":"text","conversion_output":true,"text":"sensitivity and specificity. GEE accounts for correlation within participants when","text_display":" sensitivity and specificity. GEE accounts for correlation within participants when","confidence":1,"confidence_rate":1},{"cnt":[[494,739],[1880,739],[1880,780],[494,780]],"region":{"top_left_x":494,"top_left_y":739,"width":1386,"height":41},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd109e910aed4672afe778833a7cae83","type":"text","conversion_output":true,"text":"estimating parameters and the corresponding standard errors are adjusted. Logistic","text_display":" estimating parameters and the corresponding standard errors are adjusted. Logistic","confidence":1,"confidence_rate":1},{"cnt":[[494,778],[1880,778],[1880,819],[494,819]],"region":{"top_left_x":494,"top_left_y":777,"width":1386,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5877bb14d3f54db392c1c44e5e67f828","type":"text","conversion_output":true,"text":"regression using general estimating equation methodology (to account for repeated","text_display":" regression using general estimating equation methodology (to account for repeated","confidence":1,"confidence_rate":1},{"cnt":[[494,816],[1880,816],[1880,857],[494,857]],"region":{"top_left_x":494,"top_left_y":816,"width":1386,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a267aa4c01d74e0291bc21347b40a303","type":"text","conversion_output":true,"text":"evaluations of an individual) will be used to assess and compare sensitivity and specificity","text_display":" evaluations of an individual) will be used to assess and compare sensitivity and specificity","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[494,853],[1880,853],[1880,896],[494,896]],"region":{"top_left_x":494,"top_left_y":852,"width":1386,"height":44},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3ad801748fe4c7bb0ae6e495c2481b0","type":"text","conversion_output":true,"text":"of accurately classifying recurrence status using information from each individual urinary","text_display":" of accurately classifying recurrence status using information from each individual urinary","confidence":1,"confidence_rate":1},{"cnt":[[494,894],[621,894],[621,930],[494,930]],"region":{"top_left_x":494,"top_left_y":893,"width":127,"height":38},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83ffb04372c443ab99fc8889d89be411","type":"text","conversion_output":true,"text":"marker.","text_display":" marker.","confidence":1,"confidence_rate":1},{"cnt":[[494,967],[1876,967],[1876,1010],[494,1010]],"region":{"top_left_x":494,"top_left_y":966,"width":1382,"height":44},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2206fb4d4bd6436f80f55ea78927a45a","type":"text","conversion_output":true,"text":"The BTA Stat test and the NMP-22 Bladder Chek test will have responses positive,","text_display":"\n\nThe BTA Stat test and the NMP-22 Bladder Chek test will have responses positive,","confidence":1,"confidence_rate":1},{"cnt":[[494,1005],[1876,1005],[1876,1051],[494,1051]],"region":{"top_left_x":494,"top_left_y":1005,"width":1382,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8df7e68390134f439e38036f772d7fe9","type":"text","conversion_output":true,"text":"negative or invalid. Invalid tests at a given time will not be used in the GEE analyses.","text_display":" negative or invalid. Invalid tests at a given time will not be used in the GEE analyses.","confidence":1,"confidence_rate":1},{"cnt":[[494,1044],[1532,1044],[1532,1087],[494,1087]],"region":{"top_left_x":494,"top_left_y":1044,"width":1038,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c705f3e08e53492f8827d9c2ffa90785","type":"text","conversion_output":true,"text":"Two types of analyses will be performed using these urine markers.","text_display":" Two types of analyses will be performed using these urine markers.","confidence":1,"confidence_rate":1},{"cnt":[[494,1121],[1880,1121],[1880,1162],[494,1162]],"region":{"top_left_x":494,"top_left_y":1121,"width":1386,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5106f1a4d4864f81a1b43c6672337aea","type":"text","conversion_output":true,"text":"The following information was obtained from the Early Detection Research Network","text_display":"\n\nThe following information was obtained from the Early Detection Research Network","confidence":1,"confidence_rate":1},{"cnt":[[494,1160],[1880,1160],[1880,1201],[494,1201]],"region":{"top_left_x":494,"top_left_y":1160,"width":1386,"height":41},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c9e09e254de4642b1d33c0703b2834d","type":"text","conversion_output":true,"text":"(EDRN) protocol entitled, \"Detection of bladder cancer by microsatellite analysis of urinary","text_display":" (EDRN) protocol entitled, \"Detection of bladder cancer by microsatellite analysis of urinary","confidence":1,"confidence_rate":1},{"cnt":[[494,1199],[1880,1199],[1880,1240],[494,1240]],"region":{"top_left_x":494,"top_left_y":1198,"width":1386,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33f76ea1d24e49149888be727edb3f4d","type":"text","conversion_output":true,"text":"sediment: Multi-Institutional Study, Version \\(1.5^{\\prime \\prime}\\) with Mark Schoenberg, M.D. as the","text_display":" sediment: Multi-Institutional Study, Version \\(1.5^{\\prime \\prime}\\) with Mark Schoenberg, M.D. as the","confidence":0.7465083323791077,"confidence_rate":0.9970513407076481},{"cnt":[[494,1238],[1497,1238],[1497,1278],[494,1278]],"region":{"top_left_x":494,"top_left_y":1237,"width":1004,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bec99625e8654856b3678a2b4c4d303e","type":"text","conversion_output":true,"text":"Study Chair and Mark Thornquist, Ph.D., as the study statistician.","text_display":" Study Chair and Mark Thornquist, Ph.D., as the study statistician.","confidence":1,"confidence_rate":1},{"cnt":[[494,1311],[1880,1311],[1880,1356],[494,1356]],"region":{"top_left_x":494,"top_left_y":1310,"width":1386,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0a6fd6c06fe437db14dffcae26c7fea","type":"text","conversion_output":true,"text":"In that EDRN study, they assumed that 270 patients will have follow-up data, and 81 of","text_display":"\n\nIn that EDRN study, they assumed that 270 patients will have follow-up data, and 81 of","confidence":1,"confidence_rate":1},{"cnt":[[494,1351],[1878,1351],[1878,1394],[494,1394]],"region":{"top_left_x":494,"top_left_y":1351,"width":1384,"height":44},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"acc2c4e76f7e4f27a45f916f425c0ebe","type":"text","conversion_output":true,"text":"the 270 would have a recurrence during the two year surveillance period. Those numbers","text_display":" the 270 would have a recurrence during the two year surveillance period. Those numbers","confidence":0.99609375,"confidence_rate":0.9999583636399967},{"cnt":[[494,1388],[1880,1388],[1880,1433],[494,1433]],"region":{"top_left_x":494,"top_left_y":1387,"width":1386,"height":47},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54fd6bb1fb1b44028b427cc9cc9af698","type":"text","conversion_output":true,"text":"are lower than the 300 patients and 120 recurrences that we would expect during the","text_display":" are lower than the 300 patients and 120 recurrences that we would expect during the","confidence":1,"confidence_rate":1},{"cnt":[[494,1429],[1876,1429],[1876,1472],[494,1472]],"region":{"top_left_x":494,"top_left_y":1428,"width":1382,"height":44},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b28d22ecce9c42f7aca7be240a363a53","type":"text","conversion_output":true,"text":"same period if we assume \\(10 \\%\\) loss to follow-up and a \\(40 \\%\\) recurrence rate at two years.","text_display":" same period if we assume \\(10 \\%\\) loss to follow-up and a \\(40 \\%\\) recurrence rate at two years.","confidence":0.9468584433197975,"confidence_rate":0.9994372133100554},{"cnt":[[494,1465],[1656,1465],[1656,1510],[494,1510]],"region":{"top_left_x":494,"top_left_y":1465,"width":1163,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51f5f8f7b1fb4582a0ea89544bef8096","type":"text","conversion_output":true,"text":"So the estimates that they simulated would be expected to be conservative.","text_display":" So the estimates that they simulated would be expected to be conservative.","confidence":1,"confidence_rate":1},{"cnt":[[494,1543],[1878,1543],[1878,1583],[494,1583]],"region":{"top_left_x":494,"top_left_y":1542,"width":1384,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5c17227f38647739a46877909874a48","type":"text","conversion_output":true,"text":"They generated 250 datasets for each sensitivity and specificity pair. The data are","text_display":"\n\nThey generated 250 datasets for each sensitivity and specificity pair. The data are","confidence":1,"confidence_rate":1},{"cnt":[[494,1581],[1878,1581],[1878,1622],[494,1622]],"region":{"top_left_x":494,"top_left_y":1581,"width":1384,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2023710efeef448280579e5279b949df","type":"text","conversion_output":true,"text":"summarized by looking at the distribution of sensitivities and specificities. The table","text_display":" summarized by looking at the distribution of sensitivities and specificities. The table","confidence":1,"confidence_rate":1},{"cnt":[[494,1620],[1878,1620],[1878,1661],[494,1661]],"region":{"top_left_x":494,"top_left_y":1619,"width":1384,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a0a1ed509da442f9496ebb67ac1c7ea","type":"text","conversion_output":true,"text":"below shows the result when the simulations assumed exchangeable correlation between","text_display":" below shows the result when the simulations assumed exchangeable correlation between","confidence":1,"confidence_rate":1},{"cnt":[[494,1659],[965,1659],[965,1699],[494,1699]],"region":{"top_left_x":494,"top_left_y":1658,"width":471,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1883dca42a984d9d923ee61a1b1bc8d8","type":"text","conversion_output":true,"text":"observations within a patients.","text_display":" observations within a 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In order to test the","text_display":" negative given that the patient is without recurrence. In order to test the","confidence":1,"confidence_rate":1},{"cnt":[[621,1160],[1880,1160],[1880,1201],[621,1201]],"region":{"top_left_x":620,"top_left_y":1160,"width":1260,"height":41},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aef441a457a24cd3869cc847ee013c55","type":"text","conversion_output":true,"text":"differences between the area underneath the curves (AUCs) for the single marker","text_display":" differences between the area underneath the curves (AUCs) for the single marker","confidence":1,"confidence_rate":1},{"cnt":[[621,1199],[1876,1199],[1876,1240],[621,1240]],"region":{"top_left_x":620,"top_left_y":1198,"width":1256,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ea12e62c57a45c9b48df346ad9efae1","type":"text","conversion_output":true,"text":"versus combined marker approach, we will compute the U-statistic of DeLong et.","text_display":" versus combined marker approach, we will compute the U-statistic of DeLong et.","confidence":1,"confidence_rate":1},{"cnt":[[623,1238],[746,1238],[746,1278],[623,1278]],"region":{"top_left_x":623,"top_left_y":1237,"width":123,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"910aff7bf8e24e82a56f03144b76ffaf","type":"text","conversion_output":true,"text":"al. (30)","text_display":" al. (30)","confidence":0.99951171875,"confidence_rate":0.9999624314366309},{"cnt":[[494,1313],[1878,1313],[1878,1356],[494,1356]],"region":{"top_left_x":494,"top_left_y":1312,"width":1384,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d4b7328dcbf48be873cbe7a02bf34c1","type":"text","conversion_output":true,"text":"b. A second type of analysis will be the anticipatory estimate of sensitivity and","text_display":"\nb. A second type of analysis will be the anticipatory estimate of sensitivity and","confidence":1,"confidence_rate":1},{"cnt":[[621,1354],[1878,1354],[1878,1394],[621,1394]],"region":{"top_left_x":620,"top_left_y":1353,"width":1258,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd367d9db9b84968908c2dce636843aa","type":"text","conversion_output":true,"text":"specificity of each of the urine markers and the combination. It has been","text_display":" specificity of each of the urine markers and the combination. It has been","confidence":1,"confidence_rate":1},{"cnt":[[621,1388],[1880,1388],[1880,1433],[621,1433]],"region":{"top_left_x":620,"top_left_y":1387,"width":1260,"height":47},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b0a627f76804462995cd183a8457724","type":"text","conversion_output":true,"text":"hypothesized that the BTA Stat or NMP-22 Bladder Chek may be able to detect","text_display":" hypothesized that the BTA Stat or NMP-22 Bladder Chek may be able to detect","confidence":1,"confidence_rate":1},{"cnt":[[621,1431],[1880,1431],[1880,1472],[621,1472]],"region":{"top_left_x":620,"top_left_y":1430,"width":1260,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0756ba6b19445ea8b566ec00a39f5c6","type":"text","conversion_output":true,"text":"the presence of cancer earlier than cystoscopy. If this is true, then we'd expect a","text_display":" the presence of cancer earlier than cystoscopy. If this is true, then we'd expect a","confidence":1,"confidence_rate":1},{"cnt":[[621,1467],[1880,1467],[1880,1508],[621,1508]],"region":{"top_left_x":620,"top_left_y":1467,"width":1260,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4395a9084f7e4950b6f5d526345dc093","type":"text","conversion_output":true,"text":"fair number of false positives since the clinical diagnosis might not follow for","text_display":" fair number of false positives since the clinical diagnosis might not follow for","confidence":1,"confidence_rate":1},{"cnt":[[621,1504],[1878,1504],[1878,1549],[621,1549]],"region":{"top_left_x":620,"top_left_y":1503,"width":1258,"height":47},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ee0c89c5f054d6eb9d52612e7c1b256","type":"text","conversion_output":true,"text":"several months. To evaluate whether this hypothesis is true, an analysis will be","text_display":" several months. To evaluate whether this hypothesis is true, an analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[621,1543],[1878,1543],[1878,1586],[621,1586]],"region":{"top_left_x":620,"top_left_y":1542,"width":1258,"height":44},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"397f1ef896fb4b488d18f74fb5d8c421","type":"text","conversion_output":true,"text":"performed on the time course of the follow-up BTA Stat and NMP-22 tests and","text_display":" performed on the time course of the follow-up BTA Stat and NMP-22 tests and","confidence":0.998046875,"confidence_rate":0.9999755623631563},{"cnt":[[621,1581],[1880,1581],[1880,1622],[621,1622]],"region":{"top_left_x":620,"top_left_y":1581,"width":1260,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0d9ed7e5b614e92aad58e00339fa676","type":"text","conversion_output":true,"text":"cystoscopy. In this case, sensitivity and specificity will not be based on","text_display":" cystoscopy. In this case, sensitivity and specificity will not be based on","confidence":1,"confidence_rate":1},{"cnt":[[621,1620],[1878,1620],[1878,1656],[621,1656]],"region":{"top_left_x":620,"top_left_y":1619,"width":1258,"height":38},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd8b072211324ed7bccffd7639940328","type":"text","conversion_output":true,"text":"concurrent disease status but instead disease status at a future time t . The","text_display":" concurrent disease status but instead disease status at a future time t . The","confidence":0.6827216148376465,"confidence_rate":0.9956722543632135},{"cnt":[[621,1659],[1878,1659],[1878,1702],[621,1702]],"region":{"top_left_x":620,"top_left_y":1658,"width":1258,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8473e0799e840a6ba3bac3594dc46c9","type":"text","conversion_output":true,"text":"anticipatory period can be varied to assess the lead-time provided by each of the","text_display":" anticipatory period can be varied to assess the lead-time provided by each of the","confidence":1,"confidence_rate":1},{"cnt":[[619,1697],[711,1697],[711,1734],[619,1734]],"region":{"top_left_x":618,"top_left_y":1697,"width":94,"height":37},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a19ddce94b6345ad8b9d30ce744911d1","type":"text","conversion_output":true,"text":"tests.","text_display":" tests.","confidence":1,"confidence_rate":1},{"cnt":[[370,1766],[1261,1766],[1261,1820],[370,1820]],"region":{"top_left_x":369,"top_left_y":1766,"width":893,"height":54},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41b3354dfed0466991ee454ab3478d1a","type":"section_header","conversion_output":false,"children_ids":["ec9173be535146b28b5904cc397a5480"],"text":"","text_display":""},{"cnt":[[374,1772],[1257,1772],[1257,1815],[374,1815]],"region":{"top_left_x":373,"top_left_y":1772,"width":884,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec9173be535146b28b5904cc397a5480","type":"text","conversion_output":true,"parent_id":"41b3354dfed0466991ee454ab3478d1a","text":"11.4 Data and Safety Monitoring Committee Oversight","text_display":"\n\n\\subsection*{11.4 Data and Safety Monitoring Committee Oversight}","confidence":1,"confidence_rate":1},{"cnt":[[494,1848],[1880,1848],[1880,1893],[494,1893]],"region":{"top_left_x":494,"top_left_y":1847,"width":1386,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2ecf4f8b95f416599718afb8378dc82","type":"text","conversion_output":true,"text":"a. Regular study monitoring (described in more detail below) includes an","text_display":"\na. Regular study monitoring (described in more detail below) includes an","confidence":1,"confidence_rate":1},{"cnt":[[621,1886],[1880,1886],[1880,1929],[621,1929]],"region":{"top_left_x":620,"top_left_y":1886,"width":1260,"height":44},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae7fb06382c349faa60b5eacae0b0a79","type":"text","conversion_output":true,"text":"assessment of accrual, adverse events and study outcome. In particular, the","text_display":" assessment of accrual, adverse events and study outcome. In particular, the","confidence":1,"confidence_rate":1},{"cnt":[[621,1927],[1880,1925],[1880,1970],[621,1972]],"region":{"top_left_x":620,"top_left_y":1924,"width":1260,"height":49},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d99b056e40f4c1797d22aabbf7bb943","type":"text","conversion_output":true,"text":"SWOG Data and Safety Monitoring Committee monitors accrual, and studies with","text_display":" SWOG Data and Safety Monitoring Committee monitors accrual, and studies with","confidence":1,"confidence_rate":1},{"cnt":[[621,1966],[1880,1966],[1880,2004],[621,2004]],"region":{"top_left_x":620,"top_left_y":1965,"width":1260,"height":40},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdac3ed61de34cb4bde12998aa129738","type":"text","conversion_output":true,"text":"accrual concerns are targeted for discussion at the bi-annual meetings. In","text_display":" accrual concerns are targeted for discussion at the bi-annual meetings. In","confidence":1,"confidence_rate":1},{"cnt":[[621,2002],[1880,2002],[1880,2045],[621,2045]],"region":{"top_left_x":620,"top_left_y":2002,"width":1260,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a1ea2403d3c468cb95fe88701074722","type":"text","conversion_output":true,"text":"addition, NCl guidelines for study monitoring will be followed, recognizing that it","text_display":" addition, NCl guidelines for study monitoring will be followed, recognizing that it","confidence":0.5809120442718267,"confidence_rate":0.9942384075323016},{"cnt":[[621,2041],[1880,2041],[1880,2084],[621,2084]],"region":{"top_left_x":620,"top_left_y":2041,"width":1260,"height":43},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6cdd6ee328de4329908d1a81350b5f88","type":"text","conversion_output":true,"text":"often takes approximately 6 months for regulatory approvals at the institutions","text_display":" often takes approximately 6 months for regulatory approvals at the institutions","confidence":0.9970722198486328,"confidence_rate":0.9999662985623472},{"cnt":[[621,2080],[1880,2080],[1880,2121],[621,2121]],"region":{"top_left_x":620,"top_left_y":2079,"width":1260,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7944efd60a4d4d7494ec9a445baeb927","type":"text","conversion_output":true,"text":"before an accrual rate can accurately be assessed. During quarters 5 and 6 , if","text_display":" before an accrual rate can accurately be assessed. During quarters 5 and 6 , if","confidence":0.998046875,"confidence_rate":0.9999782776266475},{"cnt":[[621,2118],[1878,2118],[1878,2159],[621,2159]],"region":{"top_left_x":620,"top_left_y":2118,"width":1258,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d64b253f7814a6fa0f7e0cb0b84ff73","type":"text","conversion_output":true,"text":"the accrual is less than \\(20 \\%\\) of projected, the study will be considered infeasible,","text_display":" the accrual is less than \\(20 \\%\\) of projected, the study will be considered infeasible,","confidence":0.92626953125,"confidence_rate":0.9991587055568398},{"cnt":[[621,2157],[1869,2157],[1869,2198],[621,2198]],"region":{"top_left_x":620,"top_left_y":2157,"width":1250,"height":41},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ac7fb391cf64d6c8fbe8db2e8de1c25","type":"text","conversion_output":true,"text":"and closure will be recommended to the Data and Safety Monitoring Committee.","text_display":" and closure will be recommended to the Data and Safety Monitoring Committee.","confidence":1,"confidence_rate":1},{"cnt":[[621,2196],[1880,2196],[1880,2237],[621,2237]],"region":{"top_left_x":620,"top_left_y":2195,"width":1260,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3ddcc7d803143d9b6f8ae988c93d764","type":"text","conversion_output":true,"text":"If accrual is between \\(20 \\%\\) and \\(50 \\%\\) of projected, then attempts will be made to","text_display":" If accrual is between \\(20 \\%\\) and \\(50 \\%\\) of projected, then attempts will be made to","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[621,2230],[1880,2230],[1880,2275],[621,2275]],"region":{"top_left_x":620,"top_left_y":2230,"width":1260,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a236dea381d441aa7dbbf1d2c6df67a","type":"text","conversion_output":true,"text":"improve accrual in the next six month period. By quarter 8 (at the latest), if","text_display":" improve accrual in the next six month period. 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You are granted permission to use the Patient Registration program at","confidence":1,"confidence_rate":1},{"cnt":[[743,623],[973,623],[973,660],[743,660]],"region":{"top_left_x":743,"top_left_y":623,"width":231,"height":37},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b8d1b29711f4a7ca3597a211c448d81","type":"text","conversion_output":true,"text":"that institution.","text_display":" that institution.","confidence":1,"confidence_rate":1},{"cnt":[[623,700],[1880,700],[1880,741],[623,741]],"region":{"top_left_x":623,"top_left_y":700,"width":1257,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6839d7c0a38a486d9adb53ccae96a866","type":"text","conversion_output":true,"text":"For assistance with points 1 and 2 call the SWOG Operations Office at 210/614-","text_display":"\n\nFor assistance with points 1 and 2 call the SWOG Operations Office at 210/614","confidence":0.9941475370433182,"confidence_rate":0.9999340509867444},{"cnt":[[623,739],[1878,739],[1878,780],[623,780]],"region":{"top_left_x":623,"top_left_y":739,"width":1255,"height":41},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98bf411ac39a4da6acad2281381c0a80","type":"text","conversion_output":true,"text":"8808. 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Once Internet connectivity is restored, a 24 -hour notification","confidence":0.88232421875,"confidence_rate":0.998578333168389},{"cnt":[[621,1044],[1880,1044],[1880,1089],[621,1089]],"region":{"top_left_x":620,"top_left_y":1044,"width":1260,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"500dec446a794075807e5581a6335737","type":"text","conversion_output":true,"text":"that was made by phone or using adr@swog.org must be entered electronically","text_display":" that was made by phone or using adr@swog.org must be entered electronically","confidence":1,"confidence_rate":1},{"cnt":[[619,1083],[1373,1083],[1373,1128],[619,1128]],"region":{"top_left_x":618,"top_left_y":1082,"width":755,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec0c825806b0437aaf709623a143a5a2","type":"text","conversion_output":true,"text":"into AdEERS by the original submitter at the site.","text_display":" into AdEERS by the original submitter at the site.","confidence":1,"confidence_rate":1},{"cnt":[[619,1158],[1880,1158],[1880,1201],[619,1201]],"region":{"top_left_x":618,"top_left_y":1158,"width":1262,"height":43},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8f4690fa3914f7a81680e4e44392a4c","type":"text","conversion_output":true,"text":"When the adverse event requires expedited reporting, submit the report within the","text_display":"\n\nWhen the adverse event requires expedited reporting, submit the report within the","confidence":1,"confidence_rate":1},{"cnt":[[621,1199],[1790,1199],[1790,1242],[621,1242]],"region":{"top_left_x":620,"top_left_y":1198,"width":1170,"height":44},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39d0269265ab474ea629910217437f07","type":"text","conversion_output":true,"text":"number of calendar days of learning of the event, as specified in Table 16.1.","text_display":" number of calendar days of learning of the event, as specified in Table 16.1.","confidence":1,"confidence_rate":1},{"cnt":[[494,1274],[1257,1274],[1257,1317],[494,1317]],"region":{"top_left_x":494,"top_left_y":1274,"width":763,"height":43},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed27a90d80b24beb930566b5d96f7dad","type":"text","conversion_output":true,"text":"d. Other recipients of adverse event reports","text_display":"\nd. Other recipients of adverse event reports","confidence":1,"confidence_rate":1},{"cnt":[[621,1351],[1880,1351],[1880,1394],[621,1394]],"region":{"top_left_x":620,"top_left_y":1351,"width":1260,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88c676ff0c8c48ac92f9f9b57f23204b","type":"text","conversion_output":true,"text":"The SWOG Operations Office will forward reports and documentation to the","text_display":"\n\nThe SWOG Operations Office will forward reports and documentation to the","confidence":0.97509765625,"confidence_rate":0.9996725516392377},{"cnt":[[619,1388],[1626,1388],[1626,1433],[619,1433]],"region":{"top_left_x":618,"top_left_y":1387,"width":1009,"height":47},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8aa8ea95a8544fd5b69d02ed10fd2825","type":"text","conversion_output":true,"text":"appropriate regulatory agencies and drug companies as required.","text_display":" appropriate regulatory agencies and drug companies as required.","confidence":0.955078125,"confidence_rate":0.9993243146199433},{"cnt":[[619,1465],[1880,1465],[1880,1508],[619,1508]],"region":{"top_left_x":618,"top_left_y":1465,"width":1262,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6f3e5c006164e49aad19b5c2f6fb580","type":"text","conversion_output":true,"text":"Adverse events determined to be reportable to the Institutional Review Board","text_display":"\n\nAdverse events determined to be reportable to the Institutional Review Board","confidence":1,"confidence_rate":1},{"cnt":[[621,1504],[1880,1504],[1880,1549],[621,1549]],"region":{"top_left_x":620,"top_left_y":1503,"width":1260,"height":47},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"811c6121c7f743d58883da4b0f931bcf","type":"text","conversion_output":true,"text":"responsible for oversight of the patient must be reported according to local policy","text_display":" responsible for oversight of the patient must be reported according to local policy","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[621,1543],[879,1543],[879,1588],[621,1588]],"region":{"top_left_x":620,"top_left_y":1542,"width":259,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6566a3e722eb4dccaabc7387b10aed13","type":"text","conversion_output":true,"text":"and procedures.","text_display":" and procedures.","confidence":1,"confidence_rate":1},{"cnt":[[494,1618],[1386,1618],[1386,1663],[494,1663]],"region":{"top_left_x":494,"top_left_y":1617,"width":892,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44365d5745e44c888d29174f7c6e89d8","type":"section_header","conversion_output":false,"children_ids":["ea8acfaa34bc402593356ce72bd6759d"],"text":"","text_display":""},{"cnt":[[494,1620],[1386,1620],[1386,1661],[494,1661]],"region":{"top_left_x":494,"top_left_y":1619,"width":892,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea8acfaa34bc402593356ce72bd6759d","type":"text","conversion_output":true,"parent_id":"44365d5745e44c888d29174f7c6e89d8","text":"e. Expedited reporting for investigational agents","text_display":"\n\n\\section*{e. Expedited reporting for investigational agents}","confidence":1,"confidence_rate":1},{"cnt":[[623,1697],[1880,1697],[1880,1738],[623,1738]],"region":{"top_left_x":623,"top_left_y":1697,"width":1257,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33d4deb7bffb48569ba82bc6d6b59d9b","type":"text","conversion_output":true,"text":"Expedited reporting is required if the patient has received at least one dose of the","text_display":"\n\nExpedited reporting is required if the patient has received at least one dose of the","confidence":1,"confidence_rate":1},{"cnt":[[621,1736],[1880,1736],[1880,1777],[621,1777]],"region":{"top_left_x":620,"top_left_y":1735,"width":1260,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b291642914554204a9e0bd87f9b567d8","type":"text","conversion_output":true,"text":"investigational agent as part of the trial. Reporting requirements are provided in","text_display":" investigational agent as part of the trial. Reporting requirements are provided in","confidence":1,"confidence_rate":1},{"cnt":[[621,1775],[1880,1775],[1880,1815],[621,1815]],"region":{"top_left_x":620,"top_left_y":1774,"width":1260,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc5d1578e7f744b0b6decdffe41cfc75","type":"text","conversion_output":true,"text":"Table 16.1. The investigational agent used in this study is gemcitabine. If there is","text_display":" Table 16.1. The investigational agent used in this study is gemcitabine. 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\\multicolumn{4}{|c|}{\\begin{tabular}{l}\nFDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312) \\\\\nNOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64) \\\\\nAn adverse event is considered serious if it results in ANY of the following outcomes: \\\\\n1) Death \\\\\n2) A life-threatening adverse event \\\\\n3) An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization for \\(\\geq 24\\) hours \\\\\n4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions \\\\\n5) A congenital anomaly/birth defect. \\\\\n6) Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).\n\\end{tabular}} \\\\\n\\hline & ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to the NCI via AdEERS within the timeframes detailed in the table below. & & \\\\\n\\hline \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nHospitalization \\\\\nGrade 1 \\\\\nGrade 2 \\\\\n\\begin{tabular}{c|c|c}\n\\(\\begin{array}{c}\\text { Grade 1 } \\\\\n\\text { Timeframes }\\end{array}\\) & \\(\\begin{array}{c}\\text { Grade 2 } \\\\\n\\text { Timeframes }\\end{array}\\) & Grade 3 Timeframes\n\\end{tabular} \\\\\nGrade 3 Timeframes \\\\\nGrade 4 \\& 5 Timeframes Timeframes Timeframes\n\\end{tabular}} \\\\\n\\hline Resulting in Hospitalization \\(\\geq 24 hrs\\) & & & \\multirow{2}{*}{24-Hour 5 Calendar Days} \\\\\n\\hline Not resulting in Hospitalization \\(\\geq 24 hrs\\) & Not required & 10 Calendar Days & \\\\\n\\hline \\multicolumn{4}{|r|}{\\begin{tabular}{l}\nNOTE: Protocol specific exceptions to expedited reporting of serious adverse events are found in the Section 16.1f. \\\\\nExpedited AE reporting timelines are defined as: \\\\\n- \"24-Hour; 5 Calendar Days\" - The AE must initially be reported via AdEERS within 24 hours of learning of the AE, followed by a complete expedited report within 5 calendar days of the initial 24-hour report. \\\\\n- \"10 Calendar Days\" - A complete expedited report on the AE must be submitted within 10 calendar days of learning of the AE.\n\\end{tabular}} \\\\\n\\hline \\multicolumn{4}{|l|}{\\begin{tabular}{l}\n\\({ }^{1}\\) Serious adverse events that occur more than 30 days after the last administration of investigational agent/intervention and have an attribution of possible, probable, or definite require reporting as follows: \\\\\nExpedited 24-hour notification followed by complete report within \\(5\\) calendar days for: \\\\\n- All Grade 4, and Grade 5 AEs \\\\\nExpedited \\(1 0\\) calendar day reports for: \\\\\n- Grade 2 adverse events resulting in hospitalization or prolongation of hospitalization \\\\\n- Grade 3 adverse events \\\\\nMay 5, 2011\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 16.1:\nLate Phase 2 and Phase 3 Studies: Expedited Reporting Requirements for Adverse Events that Occur on Studies under a Non-CTEP IND within 30 Days of the Last Administration of the Investigational Agent Gemcitabine.}\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nFDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312) \\\\\nNOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64) \\\\\nAn adverse event is considered serious if it results in ANY of the following outcomes: \\\\\n1) Death \\\\\n2) A life-threatening adverse event \\\\\n3) An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization for \\(\\geq 24\\) hours \\\\\n4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions \\\\\n5) A congenital anomaly/birth defect. \\\\\n6) Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).\n\\end{tabular}} \\\\\n\\hline & ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to the NCI via AdEERS within the timeframes detailed in the table below. & & \\\\\n\\hline \\multicolumn{4}{|c|}{\\begin{tabular}{l}\nHospitalization \\\\\nGrade 1 \\\\\nGrade 2 \\\\\n\\begin{tabular}{c|c|c}\n\\(\\begin{array}{c}\\text { Grade 1 } \\\\\n\\text { Timeframes }\\end{array}\\) & \\(\\begin{array}{c}\\text { Grade 2 } \\\\\n\\text { Timeframes }\\end{array}\\) & Grade 3 Timeframes\n\\end{tabular} \\\\\nGrade 3 Timeframes \\\\\nGrade 4 \\& 5 Timeframes Timeframes Timeframes\n\\end{tabular}} \\\\\n\\hline Resulting in Hospitalization \\(\\geq 24 hrs\\) & & & \\multirow{2}{*}{24-Hour 5 Calendar Days} \\\\\n\\hline Not resulting in Hospitalization \\(\\geq 24 hrs\\) & Not required & 10 Calendar Days & \\\\\n\\hline \\multicolumn{4}{|r|}{\\begin{tabular}{l}\nNOTE: Protocol specific exceptions to expedited reporting of serious adverse events are found in the Section 16.1f. \\\\\nExpedited AE reporting timelines are defined as: \\\\\n- \"24-Hour; 5 Calendar Days\" - The AE must initially be reported via AdEERS within 24 hours of learning of the AE, followed by a complete expedited report within 5 calendar days of the initial 24-hour report. \\\\\n- \"10 Calendar Days\" - A complete expedited report on the AE must be submitted within 10 calendar days of learning of the AE.\n\\end{tabular}} \\\\\n\\hline \\multicolumn{4}{|l|}{\\begin{tabular}{l}\n\\({ }^{1}\\) Serious adverse events that occur more than 30 days after the last administration of investigational agent/intervention and have an attribution of possible, probable, or definite require reporting as follows: \\\\\nExpedited 24-hour notification followed by complete report within \\(5\\) calendar days for: \\\\\n- All Grade 4, and Grade 5 AEs \\\\\nExpedited \\(1 0\\) calendar day reports for: \\\\\n- Grade 2 adverse events resulting in hospitalization or prolongation of hospitalization \\\\\n- Grade 3 adverse events \\\\\nMay 5, 2011\n\\end{tabular}} 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REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312) \\\\\nNOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64) \\\\\nAn adverse event is considered serious if it results in ANY of the following outcomes: \\\\\n1) Death \\\\\n2) A life-threatening adverse event \\\\\n3) An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization for \\(\\geq 24\\) hours \\\\\n4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions \\\\\n5) A congenital anomaly/birth defect. \\\\\n6) Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":4},{"cnt":[[264,513],[1810,513],[1810,1134],[264,1134]],"region":{"top_left_x":263,"top_left_y":512,"width":1547,"height":623},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d13c464ed45e4a5dbfdff6ad8310ed74","type":"complex_cell","conversion_output":false,"parent_id":"8a4d8a61105f4e69afe2e7d76ae9d7ea","children_ids":["b6ba4f045fe741a5a3d51b2f54f0b8fe","cb4674b00e2b41b190208eeafd924c73","33971edc15c04c90859189a0794538bc","1476be81c33b46d295e70c531807b4f3","38a250345f5d42b3a9765513fd220676","17bd450600be450f9474cd3cd5438a13","fba60118d92f4148ba0080b4c229d024","585ed4f9165845df87ac15bd5a6beb50","b55d7b1ab0ad4aeaaac0b414adbb24db","8ef22e208c4242868cf25116fceace60","d56f198ab18943aba2b6f2e9808e6166","2cb43acb8c7a4b94b0f76b22ea5c6450","233119ae440346debd88c7838da0ab06","ea88e5214c7547d39cbcf95f9a6d9749","1b9f50bc0ea54174992911275a925aeb"],"text":"\\begin{tabular}{l}\nFDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312) \\\\\nNOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64) \\\\\nAn adverse event is considered serious if it results in ANY of the following outcomes: \\\\\n1) Death \\\\\n2) A life-threatening adverse event \\\\\n3) An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization for \\(\\geq 24\\) hours \\\\\n4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions \\\\\n5) A congenital anomaly/birth defect. \\\\\n6) Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nFDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312) \\\\\nNOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64) \\\\\nAn adverse event is considered serious if it results in ANY of the following outcomes: \\\\\n1) Death \\\\\n2) A life-threatening adverse event \\\\\n3) An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization for \\(\\geq 24\\) hours \\\\\n4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions \\\\\n5) A congenital anomaly/birth defect. \\\\\n6) Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":4,"confidence":0.7864443243015558,"confidence_rate":0.9996870150459335},{"cnt":[[268,515],[1578,515],[1578,556],[268,556]],"region":{"top_left_x":267,"top_left_y":514,"width":1312,"height":43},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6ba4f045fe741a5a3d51b2f54f0b8fe","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"FDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312)","text_display":"FDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312)","confidence":0.7864443243015558,"confidence_rate":0.996844025482827},{"cnt":[[266,554],[1808,554],[1808,595],[266,595]],"region":{"top_left_x":265,"top_left_y":553,"width":1543,"height":43},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb4674b00e2b41b190208eeafd924c73","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"NOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or","text_display":"\nNOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or","confidence":0.92626953125,"confidence_rate":0.9992910845824631},{"cnt":[[402,593],[1678,593],[1678,634],[402,634]],"region":{"top_left_x":402,"top_left_y":592,"width":1276,"height":43},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33971edc15c04c90859189a0794538bc","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64)","text_display":" not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64)","confidence":0.9239380003418773,"confidence_rate":0.9991847622932765},{"cnt":[[272,667],[1461,667],[1461,708],[272,708]],"region":{"top_left_x":272,"top_left_y":666,"width":1190,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1476be81c33b46d295e70c531807b4f3","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"An adverse event is considered serious if it results in ANY of the following outcomes:","text_display":"\nAn adverse event is considered serious if it results in ANY of the following outcomes:","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[329,706],[480,706],[480,747],[329,747]],"region":{"top_left_x":328,"top_left_y":705,"width":153,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38a250345f5d42b3a9765513fd220676","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"1) Death","text_display":"\n1) Death","confidence":1,"confidence_rate":1},{"cnt":[[329,747],[842,747],[842,786],[329,786]],"region":{"top_left_x":328,"top_left_y":746,"width":514,"height":40},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17bd450600be450f9474cd3cd5438a13","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"2) A life-threatening adverse event","text_display":"\n2) A life-threatening adverse 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hours","text_display":" \\(\\geq 24\\) hours","confidence":1,"confidence_rate":1},{"cnt":[[329,861],[1725,861],[1725,898],[329,898]],"region":{"top_left_x":328,"top_left_y":861,"width":1398,"height":38},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b55d7b1ab0ad4aeaaac0b414adbb24db","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life","text_display":"\n4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[389,896],[521,896],[521,933],[389,933]],"region":{"top_left_x":389,"top_left_y":896,"width":133,"height":37},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ef22e208c4242868cf25116fceace60","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"functions","text_display":" functions","confidence":1,"confidence_rate":1},{"cnt":[[329,939],[870,939],[870,976],[329,976]],"region":{"top_left_x":328,"top_left_y":939,"width":542,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d56f198ab18943aba2b6f2e9808e6166","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"5) A congenital anomaly/birth defect.","text_display":"\n5) A congenital anomaly/birth defect.","confidence":1,"confidence_rate":1},{"cnt":[[329,974],[1647,974],[1647,1015],[329,1015]],"region":{"top_left_x":328,"top_left_y":974,"width":1320,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2cb43acb8c7a4b94b0f76b22ea5c6450","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"6) Important Medical Events (IME) that may not result in death, be life threatening, or require","text_display":"\n6) Important Medical Events (IME) that may not result in death, be life threatening, or require","confidence":1,"confidence_rate":1},{"cnt":[[389,1013],[1803,1013],[1803,1054],[389,1054]],"region":{"top_left_x":389,"top_left_y":1013,"width":1415,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"233119ae440346debd88c7838da0ab06","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"hospitalization may be considered serious when, based upon medical judgment, they may jeopardize","text_display":" hospitalization may be considered serious when, based upon medical judgment, they may jeopardize","confidence":1,"confidence_rate":1},{"cnt":[[389,1052],[1665,1052],[1665,1093],[389,1093]],"region":{"top_left_x":389,"top_left_y":1052,"width":1276,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea88e5214c7547d39cbcf95f9a6d9749","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"the patient or subject and may require medical or surgical intervention to prevent one of the","text_display":" the patient or subject and may require medical or surgical intervention to prevent one of the","confidence":1,"confidence_rate":1},{"cnt":[[389,1091],[1491,1091],[1491,1130],[389,1130]],"region":{"top_left_x":389,"top_left_y":1091,"width":1103,"height":39},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b9f50bc0ea54174992911275a925aeb","type":"text","conversion_output":false,"parent_id":"d13c464ed45e4a5dbfdff6ad8310ed74","text":"outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).","text_display":" outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).","confidence":1,"confidence_rate":1},{"cnt":[[259,1261],[259,1179],[1743,1182],[1743,1263]],"region":{"top_left_x":259,"top_left_y":1179,"width":1484,"height":85},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2819ac612925438a8036762356fe2142","type":"complex_cell","conversion_output":false,"parent_id":"653ed527bdf347caa7003e5e85cf47b5","children_ids":["4ee9ef742e6a4c5b855889ff264df0d0","b953b6a428fa4a82b2f6d4d14d50a882"],"text":"ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to the NCI via AdEERS within the timeframes detailed in the table below.","text_display":"ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to the NCI via AdEERS within the timeframes detailed in the table below.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999976519234388},{"cnt":[[264,1184],[1738,1184],[1738,1223],[264,1223]],"region":{"top_left_x":263,"top_left_y":1184,"width":1476,"height":40},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ee9ef742e6a4c5b855889ff264df0d0","type":"text","conversion_output":false,"parent_id":"2819ac612925438a8036762356fe2142","text":"ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to the NCI via","text_display":"ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to the NCI via","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[264,1221],[1082,1221],[1082,1258],[264,1258]],"region":{"top_left_x":263,"top_left_y":1220,"width":820,"height":38},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b953b6a428fa4a82b2f6d4d14d50a882","type":"text","conversion_output":false,"parent_id":"2819ac612925438a8036762356fe2142","text":"AdEERS within the timeframes detailed in the table below.","text_display":" AdEERS within the timeframes detailed in the table below.","confidence":1,"confidence_rate":1},{"cnt":[[264,1273],[1823,1273],[1823,1370],[264,1370]],"region":{"top_left_x":263,"top_left_y":1272,"width":1560,"height":99},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ce4f750a753406a9026c86aeb32115b","type":"table_spanning_cell","conversion_output":false,"parent_id":"653ed527bdf347caa7003e5e85cf47b5","children_ids":["3dabeccea3fd4888bd1ef46b21a65894"],"text":"","text_display":"\\begin{tabular}{l}\nHospitalization \\\\\nGrade 1 \\\\\nGrade 2 \\\\\n\\begin{tabular}{c|c|c}\n\\(\\begin{array}{c}\\text { Grade 1 } \\\\\n\\text { Timeframes }\\end{array}\\) & \\(\\begin{array}{c}\\text { Grade 2 } \\\\\n\\text { Timeframes }\\end{array}\\) & Grade 3 Timeframes\n\\end{tabular} \\\\\nGrade 3 Timeframes \\\\\nGrade 4 \\& 5 Timeframes Timeframes 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Klan R, Loy V, Huland H. Residual tumor discovered in routine second transurethral resection in","text_display":"\n10. Klan R, Loy V, Huland H. Residual tumor discovered in routine second transurethral resection in","confidence":1,"confidence_rate":1},{"cnt":[[370,1581],[1760,1581],[1760,1622],[370,1622]],"region":{"top_left_x":369,"top_left_y":1581,"width":1391,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5642c733cd84404b0100c3bb4b975e6","type":"text","conversion_output":true,"text":"patients with stage T1 transitional cell carcinoma of the bladder. J Urol 146:316-318, 1991.","text_display":" patients with stage T1 transitional cell carcinoma of the bladder. 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Adverse events are reported in a routine","text_display":" will enroll in future studies using similar agents. Adverse events are reported in a routine","confidence":1,"confidence_rate":1},{"cnt":[[494,509],[1878,509],[1878,550],[494,550]],"region":{"top_left_x":494,"top_left_y":509,"width":1384,"height":41},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b89db7c64de34e50b5339d1c99b3f36a","type":"text","conversion_output":true,"text":"manner at scheduled times during a trial. (Directions for routine reporting are provided in","text_display":" manner at scheduled times during a trial. 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For example, if the patient begins the study on the","text_display":" of agent being given. 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Criteria for Emergency Unblinding}","confidence":0.99560546875,"confidence_rate":0.9998925858769944},{"cnt":[[623,739],[1878,739],[1878,780],[623,780]],"region":{"top_left_x":623,"top_left_y":739,"width":1255,"height":41},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a46335d55564f36a2f55191c4f428db","type":"text","conversion_output":true,"text":"In general, treatment assignments will not be unblinded unless there is a","text_display":"\n\nIn general, treatment assignments will not be unblinded unless there is a","confidence":1,"confidence_rate":1},{"cnt":[[621,778],[1878,778],[1878,819],[621,819]],"region":{"top_left_x":620,"top_left_y":777,"width":1258,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1eea1f546b7a43ef8394688e07fc2e03","type":"text","conversion_output":true,"text":"compelling medical or ethical reason that the treatment should be identified. In","text_display":" compelling medical or ethical reason that the treatment should be identified. In","confidence":1,"confidence_rate":1},{"cnt":[[623,816],[1878,816],[1878,857],[623,857]],"region":{"top_left_x":623,"top_left_y":816,"width":1255,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43a413092c004606b28c8187e5fc64a9","type":"text","conversion_output":true,"text":"most circumstances it will be appropriate to treat the patient or person who","text_display":" most circumstances it will be appropriate to treat the patient or person who","confidence":1,"confidence_rate":1},{"cnt":[[623,855],[1880,855],[1880,896],[623,896]],"region":{"top_left_x":623,"top_left_y":855,"width":1257,"height":41},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed354bd49763455899ebdd838ef6b006","type":"text","conversion_output":true,"text":"received blinded drug as though he or she received gemcitabine, irrespective of","text_display":" received blinded drug as though he or she received gemcitabine, irrespective of","confidence":0.9990234375,"confidence_rate":0.9999883686432659},{"cnt":[[621,894],[1830,894],[1830,935],[621,935]],"region":{"top_left_x":620,"top_left_y":893,"width":1211,"height":42},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc225ad2e3934502aee3c1ca130c03f7","type":"text","conversion_output":true,"text":"the drug actually received. Therefore, unblinding should seldom be necessary.","text_display":" the drug actually received. Therefore, unblinding should seldom be necessary.","confidence":1,"confidence_rate":1},{"cnt":[[621,967],[1876,967],[1876,1010],[621,1010]],"region":{"top_left_x":620,"top_left_y":966,"width":1256,"height":44},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"987fb866369b4c65ac0914fe60c0aa77","type":"text","conversion_output":true,"text":"The following events MAY require unblinding of treatment assignments in this","text_display":"\n\nThe following events MAY require unblinding of treatment assignments in this","confidence":1,"confidence_rate":1},{"cnt":[[623,1010],[720,1010],[720,1051],[623,1051]],"region":{"top_left_x":623,"top_left_y":1009,"width":97,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"189af91f61f54812b9608e2c26dd7a16","type":"text","conversion_output":true,"text":"study:","text_display":" study:","confidence":1,"confidence_rate":1},{"cnt":[[623,1074],[1876,1074],[1876,1115],[623,1115]],"region":{"top_left_x":623,"top_left_y":1074,"width":1253,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56e37d60d48f4781b99ae854793ecaaf","type":"text","conversion_output":true,"text":"1. 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Administration of blinded drug to a person other than the patient.","text_display":"\n2. Administration of blinded drug to a person other than the patient.","confidence":1,"confidence_rate":1},{"cnt":[[494,1289],[1244,1289],[1244,1338],[494,1338]],"region":{"top_left_x":494,"top_left_y":1289,"width":750,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23082a852575481bb86de421ce1be124","type":"section_header","conversion_output":false,"children_ids":["43bf91d2169246739609ed78de47dffc"],"text":"","text_display":""},{"cnt":[[494,1293],[1240,1293],[1240,1334],[494,1334]],"region":{"top_left_x":494,"top_left_y":1293,"width":746,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43bf91d2169246739609ed78de47dffc","type":"text","conversion_output":true,"parent_id":"23082a852575481bb86de421ce1be124","text":"c. Procedure for Emergency Unblinding","text_display":"\n\n\\section*{c. 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All requests for emergency unblinding must be made by the registering","text_display":"\n1. All requests for emergency unblinding must be made by the registering","confidence":1,"confidence_rate":1},{"cnt":[[746,1629],[1205,1629],[1205,1669],[746,1669]],"region":{"top_left_x":745,"top_left_y":1628,"width":461,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"368dd18ccb8e4c2ea5f933a4557af576","type":"text","conversion_output":true,"text":"physician or his/her designee.","text_display":" physician or his/her designee.","confidence":1,"confidence_rate":1},{"cnt":[[621,1693],[1880,1693],[1880,1734],[621,1734]],"region":{"top_left_x":620,"top_left_y":1692,"width":1260,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b42a94fa565c4a6b8c85519206449f96","type":"text","conversion_output":true,"text":"2. Call the WPC collect at 206/526-2121 from outside Washington State or","text_display":"\n2. Call the WPC collect at 206/526-2121 from outside Washington State or","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[746,1732],[1876,1732],[1876,1772],[746,1772]],"region":{"top_left_x":745,"top_left_y":1731,"width":1131,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a599896d6eb64d72adf5345fbf342230","type":"text","conversion_output":true,"text":"toll free at \\(800 / 222-1222\\) from within Washington State. The WPC is","text_display":" toll free at \\(800 / 222-1222\\) from within Washington State. 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(4) For","text_display":" using these markers in monitoring superficial bladder cancer can be modeled. (4) For","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[494,1237],[1878,1237],[1878,1278],[494,1278]],"region":{"top_left_x":494,"top_left_y":1237,"width":1384,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad4e31848a184970996dd39db79639ad","type":"text","conversion_output":true,"text":"instance, if the initial recurrence is most likely to happen at the first or second surveillance","text_display":" instance, if the initial recurrence is most likely to happen at the first or second surveillance","confidence":1,"confidence_rate":1},{"cnt":[[494,1276],[1691,1276],[1691,1317],[494,1317]],"region":{"top_left_x":494,"top_left_y":1276,"width":1197,"height":41},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b03776666baa4c3ca10f52c8ba78cec7","type":"text","conversion_output":true,"text":"cystoscopy, these tests might be best suited for use after those examinations.","text_display":" cystoscopy, these tests might be best suited for use after those examinations.","confidence":1,"confidence_rate":1},{"cnt":[[494,1349],[640,1349],[640,1394],[494,1394]],"region":{"top_left_x":494,"top_left_y":1349,"width":147,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f2a5220d5a4148e69ea0ba2ea3f4c0bb","type":"section_header","conversion_output":false,"children_ids":["f0daeb80153144be958d7c7acf2ac559"],"text":"","text_display":""},{"cnt":[[494,1354],[634,1354],[634,1390],[494,1390]],"region":{"top_left_x":494,"top_left_y":1353,"width":140,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0daeb80153144be958d7c7acf2ac559","type":"text","conversion_output":true,"parent_id":"f2a5220d5a4148e69ea0ba2ea3f4c0bb","text":"Methods","text_display":"\n\n\\section*{Methods}","confidence":1,"confidence_rate":1},{"cnt":[[494,1429],[1876,1429],[1876,1472],[494,1472]],"region":{"top_left_x":494,"top_left_y":1428,"width":1382,"height":44},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9e9bbc8aceb4a78abc5651da9c3cdde","type":"text","conversion_output":true,"text":"BTA Stat and NMP-22 Bladder Chek will each be performed prior to the TURBT of the","text_display":"\n\nBTA Stat and NMP-22 Bladder Chek will each be performed prior to the TURBT of the","confidence":1,"confidence_rate":1},{"cnt":[[494,1467],[1880,1467],[1880,1508],[494,1508]],"region":{"top_left_x":494,"top_left_y":1467,"width":1386,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26caef9bfd2a4108aa5d41d5d753cfd9","type":"text","conversion_output":true,"text":"index tumor and with each surveillance cystoscopy for 2 years, or until first histologically","text_display":" index tumor and with each surveillance cystoscopy for 2 years, or until first histologically","confidence":1,"confidence_rate":1},{"cnt":[[494,1506],[1880,1506],[1880,1549],[494,1549]],"region":{"top_left_x":494,"top_left_y":1506,"width":1386,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c661ae22d0ce44868733e0e7c32ba65d","type":"text","conversion_output":true,"text":"confirmed recurrence (whichever is sooner). Each test will be performed as per","text_display":" confirmed recurrence (whichever is sooner). Each test will be performed as per","confidence":1,"confidence_rate":1},{"cnt":[[494,1543],[1876,1543],[1876,1586],[494,1586]],"region":{"top_left_x":494,"top_left_y":1542,"width":1382,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3085013981440acbb1c9c6ded484612","type":"text","conversion_output":true,"text":"manufacturer's instructions by the research nurse with each institution's investigators and","text_display":" manufacturer's instructions by the research nurse with each institution's investigators and","confidence":1,"confidence_rate":1},{"cnt":[[494,1581],[1878,1581],[1878,1622],[494,1622]],"region":{"top_left_x":494,"top_left_y":1581,"width":1384,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f88bbcb76f774763a6c35665c936a70c","type":"text","conversion_output":true,"text":"results will be reported to the Southwest Oncology Group Data Operations Office on the","text_display":" results will be reported to the Southwest Oncology Group Data Operations Office on the","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[494,1620],[930,1620],[930,1661],[494,1661]],"region":{"top_left_x":494,"top_left_y":1619,"width":437,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a8ea35ae66a426996a4a386eb0416c6","type":"text","conversion_output":true,"text":"S0337 Urine Markers Form.","text_display":" S0337 Urine Markers Form.","confidence":0.9868593215942383,"confidence_rate":0.9995591711595969},{"cnt":[[494,1693],[831,1693],[831,1740],[494,1740]],"region":{"top_left_x":494,"top_left_y":1692,"width":338,"height":49},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5a4c3e27fab4cbdab916564fe504461","type":"section_header","conversion_output":false,"children_ids":["87245549afaf4b4b82b540fc10f804b9"],"text":"","text_display":""},{"cnt":[[494,1697],[827,1697],[827,1738],[494,1738]],"region":{"top_left_x":494,"top_left_y":1697,"width":334,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87245549afaf4b4b82b540fc10f804b9","type":"text","conversion_output":true,"parent_id":"f5a4c3e27fab4cbdab916564fe504461","text":"Interpretation of Data","text_display":"\n\n\\section*{Interpretation of Data}","confidence":1,"confidence_rate":1},{"cnt":[[494,1772],[1876,1772],[1876,1815],[494,1815]],"region":{"top_left_x":494,"top_left_y":1772,"width":1382,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd4a48a716e64bab85b08509af61cef8","type":"text","conversion_output":true,"text":"Statistical considerations appear in Section 11.0. With this information, the ability of each","text_display":"\n\nStatistical considerations appear in Section 11.0. 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Saline (salt water) is a placebo, not a form of treatment for","text_display":" bladder tumor) procedure. Saline (salt water) is a placebo, not a form of treatment for","confidence":1,"confidence_rate":1},{"cnt":[[305,2243],[1871,2243],[1871,2292],[305,2292]],"region":{"top_left_x":305,"top_left_y":2242,"width":1567,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caee01082d31498d8602e409d0e95be5","type":"text","conversion_output":true,"text":"superficial bladder cancer. It does not contain any medication. You will have a catheter tube","text_display":" superficial bladder cancer. It does not contain any medication. 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After about 1 hour the liquid will be drained","text_display":"\nthe liquid in your bladder for about 1 hour. After about 1 hour the liquid will be drained","confidence":1,"confidence_rate":1},{"cnt":[[305,327],[1803,327],[1803,376],[305,376]],"region":{"top_left_x":305,"top_left_y":326,"width":1498,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30713e8d0a8149718212444bcd64b48d","type":"text","conversion_output":true,"text":"from the bladder through the catheter. If you experience discomfort while the liquid is in","text_display":" from the bladder through the catheter. If you experience discomfort while the liquid is in","confidence":1,"confidence_rate":1},{"cnt":[[305,374],[1858,374],[1858,423],[305,423]],"region":{"top_left_x":305,"top_left_y":373,"width":1554,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7210d01c16374d608bc69c70acb67851","type":"text","conversion_output":true,"text":"your bladder, you should notify your urologist who may choose to drain your bladder earlier","text_display":" your bladder, you should notify your urologist who may choose to drain your bladder earlier","confidence":1,"confidence_rate":1},{"cnt":[[305,421],[1747,421],[1747,471],[305,471]],"region":{"top_left_x":305,"top_left_y":421,"width":1442,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2ca3b3712ab47f4a666a9b210044ec2","type":"text","conversion_output":true,"text":"than the 1 hour dwell time. Similarly, if you wish the liquid to be drained earlier than","text_display":" than the 1 hour dwell time. 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If the urine becomes clear within 3","text_display":" urologist may choose to irrigate your bladder with liquid. 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your liver function.","text_display":" performed to evaluate your white cells and platelets and to test your liver function.","confidence":1,"confidence_rate":1},{"cnt":[[245,997],[1781,997],[1781,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":996,"width":1538,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15ca058493394ea78ca1b431bfb4e6ba","type":"text","conversion_output":true,"text":"- Every 3 months for the first two years, then every 6 months for the next two years, your","text_display":"\n- Every 3 months for the first two years, then every 6 months for the next two years, your","confidence":1,"confidence_rate":1},{"cnt":[[305,1044],[1594,1044],[1594,1094],[305,1094]],"region":{"top_left_x":305,"top_left_y":1044,"width":1290,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b435a48457804a5ea7c5ccfe0a47bb70","type":"text","conversion_output":true,"text":"doctor will review your medical history and perform a physical examination.","text_display":" doctor will review your medical history and perform a physical examination.","confidence":1,"confidence_rate":1},{"cnt":[[245,1094],[1781,1094],[1781,1145],[245,1145]],"region":{"top_left_x":244,"top_left_y":1093,"width":1538,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4472390e34774a77ac181d95ddaed994","type":"text","conversion_output":true,"text":"- Every 3 months for the first two years, then every 6 months for the next two years, your","text_display":"\n- Every 3 months for the first two years, then every 6 months for the next two years, your","confidence":1,"confidence_rate":1},{"cnt":[[305,1143],[1869,1143],[1869,1190],[305,1190]],"region":{"top_left_x":305,"top_left_y":1142,"width":1565,"height":49},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de53f0f8bc274a04affd83b51a05761f","type":"text","conversion_output":true,"text":"doctor will perform a cystoscopy (looking into the bladder with a flexible or rigid endoscope,","text_display":" doctor will perform a cystoscopy (looking into the bladder with a flexible or rigid endoscope,","confidence":1,"confidence_rate":1},{"cnt":[[305,1188],[1876,1188],[1876,1238],[305,1238]],"region":{"top_left_x":305,"top_left_y":1188,"width":1571,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a47320d4b7649c6909680db44cffb8a","type":"text","conversion_output":true,"text":"usually in the clinic under local anesthesia) to look inside your bladder, with the collection of","text_display":" usually in the clinic under local anesthesia) to look inside your bladder, with the collection of","confidence":1,"confidence_rate":1},{"cnt":[[305,1233],[1854,1233],[1854,1283],[305,1283]],"region":{"top_left_x":305,"top_left_y":1233,"width":1550,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"743f470d347b4527b9cf7cb98ae1f703","type":"text","conversion_output":true,"text":"urine for cytology (a laboratory evaluation for cancer cells in the urine). At each evaluation,","text_display":" urine for cytology (a laboratory evaluation for cancer cells in the urine). At each evaluation,","confidence":1,"confidence_rate":1},{"cnt":[[305,1280],[1876,1280],[1876,1330],[305,1330]],"region":{"top_left_x":305,"top_left_y":1280,"width":1571,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7288d820fd3a4a54b023301b32fc2cb7","type":"text","conversion_output":true,"text":"if either test is abnormal your doctor will arrange for you to have a bladder biopsy performed.","text_display":" if either test is abnormal your doctor will arrange for you to have a bladder biopsy performed.","confidence":1,"confidence_rate":1},{"cnt":[[305,1328],[1813,1328],[1813,1377],[305,1377]],"region":{"top_left_x":305,"top_left_y":1327,"width":1509,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ef245e309a24634958dd1402c88f1be","type":"text","conversion_output":true,"text":"If the cancer comes back, your doctor will discuss with you other options for treatment of","text_display":" If the cancer comes back, your doctor will discuss with you other options for treatment of","confidence":1,"confidence_rate":1},{"cnt":[[305,1375],[1876,1375],[1876,1424],[305,1424]],"region":{"top_left_x":305,"top_left_y":1375,"width":1571,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"136b244d31e941b2a5bc4a04bea8c8b1","type":"text","conversion_output":true,"text":"your cancer at that point. We will continue to follow you to see how you are doing for up to 4","text_display":" your cancer at that point. We will continue to follow you to see how you are doing for up to 4","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[305,1422],[816,1422],[816,1472],[305,1472]],"region":{"top_left_x":305,"top_left_y":1422,"width":512,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7450ba40ee97415aa782ae9bad2ffe84","type":"text","conversion_output":true,"text":"years after you start the study.","text_display":" years after you start the study.","confidence":1,"confidence_rate":1},{"cnt":[[241,1530],[975,1530],[975,1601],[241,1601]],"region":{"top_left_x":240,"top_left_y":1529,"width":736,"height":72},"line":29,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"042c9a800bc64589ae94f1ec5213b82b","type":"section_header","conversion_output":false,"children_ids":["4d9a1e5e14cf42729eb997cd9d68fd2a"],"text":"","text_display":""},{"cnt":[[245,1534],[969,1534],[969,1596],[245,1596]],"region":{"top_left_x":244,"top_left_y":1533,"width":725,"height":64},"line":30,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"4d9a1e5e14cf42729eb997cd9d68fd2a","type":"text","conversion_output":true,"parent_id":"042c9a800bc64589ae94f1ec5213b82b","text":"How long will I be in the study?","text_display":"\n\n\\section*{How long will I be in the study?}","confidence":1,"confidence_rate":1},{"cnt":[[245,1611],[1846,1611],[1846,1661],[245,1661]],"region":{"top_left_x":244,"top_left_y":1611,"width":1602,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c4ff235ade84fdca4c23e1b5196ea4f","type":"text","conversion_output":true,"text":"You will continue as detailed above for up to 4 years from the start of the study. You will need","text_display":"\n\nYou will continue as detailed above for up to 4 years from the start of the study. 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