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treated.","confidence":1,"confidence_rate":1},{"cnt":[[242,1007],[1821,1007],[1821,1062],[242,1062]],"region":{"top_left_x":242,"top_left_y":1007,"width":1579,"height":56},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc080380da964e68b484392f29eae8b0","type":"text","conversion_output":true,"text":"A protocol violation (PV) is defined as important, if it affects the rights or safety of the trial","text_display":"\nA protocol violation (PV) is defined as important, if it affects the rights or safety of the trial","confidence":0.9668128490447998,"confidence_rate":0.9996723804755159},{"cnt":[[242,1062],[1821,1062],[1821,1117],[242,1117]],"region":{"top_left_x":242,"top_left_y":1062,"width":1579,"height":56},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"408e9622d9c04630bdfac7bc76f7ab39","type":"text","conversion_output":true,"text":"patients or if it can potentially influence the primary endpoint for the respective patients in a","text_display":" patients or if it can potentially influence the primary endpoint for the respective patients in a","confidence":1,"confidence_rate":1},{"cnt":[[242,1117],[1455,1117],[1455,1172],[242,1172]],"region":{"top_left_x":242,"top_left_y":1117,"width":1214,"height":55},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"410b7c5bff5b450cae495c48c75708b6","type":"text","conversion_output":true,"text":"way that is neither negligible nor in accordance with the trial objectives.","text_display":" way that is neither negligible nor in accordance with the trial objectives.","confidence":1,"confidence_rate":1},{"cnt":[[242,1229],[1821,1229],[1821,1284],[242,1284]],"region":{"top_left_x":242,"top_left_y":1228,"width":1579,"height":56},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8d36f57b943f4cecb74690e70abe9ac8","type":"text","conversion_output":true,"text":"The category of important PVs, which can potentially influence the primary or key secondary","text_display":"\n\nThe category of important PVs, which can potentially influence the primary or key secondary","confidence":1,"confidence_rate":1},{"cnt":[[242,1284],[1823,1284],[1823,1336],[242,1336]],"region":{"top_left_x":242,"top_left_y":1283,"width":1581,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"497752caece2474e9709e138a2c2c3a0","type":"text","conversion_output":true,"text":"outcome measures, forms the basis for the decision of whether a patient belongs to a patient","text_display":" outcome measures, forms the basis for the decision of whether a patient belongs to a patient","confidence":1,"confidence_rate":1},{"cnt":[[242,1339],[455,1339],[455,1391],[242,1391]],"region":{"top_left_x":242,"top_left_y":1338,"width":213,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3f569ac164184456a8af33ed87234897","type":"text","conversion_output":true,"text":"analysis set.","text_display":" analysis set.","confidence":1,"confidence_rate":1},{"cnt":[[242,1393],[1825,1393],[1825,1446],[242,1446]],"region":{"top_left_x":242,"top_left_y":1393,"width":1584,"height":54},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90d8b00438e848b68c85dbc7af54abfc","type":"text","conversion_output":true,"text":"The following table displays the categories considered to be important protocol violations. If","text_display":"\nThe following table displays the categories considered to be important protocol violations. If","confidence":1,"confidence_rate":1},{"cnt":[[242,1444],[1821,1444],[1821,1494],[242,1494]],"region":{"top_left_x":242,"top_left_y":1443,"width":1579,"height":51},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f9e662cd3d674063b2cbb7fd3a03cdb2","type":"text","conversion_output":true,"text":"the data indicate further important PVs, this table will be supplemented accordingly, with the","text_display":" the data indicate further important PVs, this table will be supplemented accordingly, with the","confidence":1,"confidence_rate":1},{"cnt":[[242,1489],[1044,1489],[1044,1542],[242,1542]],"region":{"top_left_x":242,"top_left_y":1489,"width":802,"height":53},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"187262fabe6b4f31bcd54d86bf12b633","type":"text","conversion_output":true,"text":"latest modification made prior to database lock.","text_display":" latest modification made prior to database lock.","confidence":1,"confidence_rate":1},{"cnt":[[242,1585],[1821,1585],[1821,1638],[242,1638]],"region":{"top_left_x":242,"top_left_y":1585,"width":1579,"height":53},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"517586b26d0a4371b9653849053b11a7","type":"text","conversion_output":true,"text":"The important PVs will be described in the Clinical Trial Report (CTR). A listing of patients","text_display":"\n\nThe important PVs will be described in the Clinical Trial Report (CTR). A listing of patients","confidence":1,"confidence_rate":1},{"cnt":[[242,1640],[1163,1640],[1163,1693],[242,1693]],"region":{"top_left_x":242,"top_left_y":1640,"width":921,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4fdcc7736a1d4d4184ce321e36137137","type":"text","conversion_output":true,"text":"who had the medication code broken will be provided.","text_display":" who had the medication code broken will be provided.","confidence":0.99658203125,"confidence_rate":0.9999399347276827},{"cnt":[[242,1750],[1821,1750],[1821,1802],[242,1802]],"region":{"top_left_x":242,"top_left_y":1749,"width":1579,"height":54},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e4b4ec7ffb5c4371be1a3807f6804f36","type":"text","conversion_output":true,"text":"A table showing the number of patients and frequency with violation of in- or exclusion","text_display":"\n\nA table showing the number of patients and frequency with violation of in- or exclusion","confidence":1,"confidence_rate":1},{"cnt":[[242,1805],[665,1805],[665,1859],[242,1859]],"region":{"top_left_x":242,"top_left_y":1804,"width":423,"height":56},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c6fca57cf69548f7927061b5f4357a2b","type":"text","conversion_output":true,"text":"criteria will be provided.","text_display":" criteria will be provided.","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2068,"languages_detected":[]},{"image_id":"f2663f48-b276-415c-aa34-bc8f0eff2c5d-26","page":26,"lines":[{"cnt":[[247,128],[642,128],[642,176],[247,176]],"region":{"top_left_x":246,"top_left_y":127,"width":396,"height":49},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3735e5b0b15445229ac7f1db644081c4","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,176],[797,176],[797,217],[247,217]],"region":{"top_left_x":246,"top_left_y":175,"width":552,"height":43},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"92fed850d632407cac07b7e6b6028fc1","type":"page_info","conversion_output":false,"text":"TSAP for BI Trial No: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1567,174],[1812,174],[1812,222],[1567,222]],"region":{"top_left_x":1567,"top_left_y":173,"width":245,"height":49},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c565ccc329974df8a951604a23094d42","type":"page_info","conversion_output":false,"text":"Page 26 of 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\\multicolumn{2}{|c|}{Category / Code} & Description & Comment/Example & Affects rights (R)/ safety (S) or primary/ key secondary outcome (E) & Excluded from \\\\\n\\hline A & & \\multicolumn{2}{|l|}{Entrance Criteria Not Met} & & \\\\\n\\hline & A. 1 & \\multicolumn{2}{|l|}{Inclusion criteria violated} & & \\\\\n\\hline & A1.1 & No type 2 diabetes & Inclusion criterion IN1 ticked \"No\" & E & PPS \\\\\n\\hline & A. 2 & \\multicolumn{2}{|l|}{Exclusion criteria violated} & & \\\\\n\\hline & A.2.1 & Type I diabetes & Exclusion criterion EX1 ticked \"Yes\" & E & PPS \\\\\n\\hline & A.2.2 & Severe renal impairment (eGFR < 15 \\(ml / min / 1.73 m^{2}\\) ) or ESRD at Visit 1 and/or the need for maintenance dialysis & \\begin{tabular}{l}\nExclusion criterion EX4 ticked \"Yes\" \\\\\nOr eGFR \\(<15 ml / min / 1.73 m ^{2}\\) at visit 1\n\\end{tabular} & E & PPS \\\\\n\\hline & A.2.3 & Pre-planned coronary artery re-vascularisation (PCI, CABG) & Exclusion criterion EX6 ticked \"Yes\" & E & PPS 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data}","confidence":1,"confidence_rate":1},{"cnt":[[244,918],[1720,918],[1720,971],[244,971]],"region":{"top_left_x":244,"top_left_y":918,"width":1477,"height":53},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1c00f10ff3ee4a1db5b82a0f8f4fdcd4","type":"text","conversion_output":true,"text":"Beforehand the missing or partially missing date of first drug administration is imputed.","text_display":"\n\nBeforehand the missing or partially missing date of first drug administration is imputed.","confidence":1,"confidence_rate":1},{"cnt":[[244,964],[1711,964],[1711,1021],[244,1021]],"region":{"top_left_x":244,"top_left_y":964,"width":1467,"height":58},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b95b2cca044b43c2a3ed87bfb336f899","type":"text","conversion_output":true,"text":"For the handling of AE partial and missing dates the following definitions will be used:","text_display":" For the handling of AE partial and missing dates the following definitions will be used:","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[242,1051],[1254,1051],[1254,1108],[242,1108]],"region":{"top_left_x":242,"top_left_y":1050,"width":1013,"height":58},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"49952097a39746a792e2625d11fa1e8d","type":"text","conversion_output":true,"text":"First possible \\(=\\) first possible date of an incomplete AE date","text_display":"\n\nFirst possible \\(=\\) first possible date of an incomplete AE date","confidence":0.9897589683532715,"confidence_rate":0.9998627583277525},{"cnt":[[391,1142],[1220,1142],[1220,1199],[391,1199]],"region":{"top_left_x":390,"top_left_y":1142,"width":830,"height":58},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3a1e6644c85f4ec88b82ba054da2c5c7","type":"text","conversion_output":true,"text":"- if only month and year are given: day is set to 1","text_display":"\n- if only month and year are given: day is set to 1","confidence":1,"confidence_rate":1},{"cnt":[[393,1234],[1478,1234],[1478,1288],[393,1288]],"region":{"top_left_x":392,"top_left_y":1233,"width":1086,"height":56},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6760da95b7de4d20a2a5548e7fadc20c","type":"text","conversion_output":true,"text":"- if only year is given: day is set to 1 and month is set to January","text_display":"\n- if only year is given: day is set to 1 and month is set to January","confidence":1,"confidence_rate":1},{"cnt":[[242,1325],[1240,1325],[1240,1377],[242,1377]],"region":{"top_left_x":242,"top_left_y":1324,"width":999,"height":54},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"71107bf24a0049788a7d2068dea87ed4","type":"text","conversion_output":true,"text":"Last possible \\(=\\) last possible date of an incomplete AE date","text_display":"\n\nLast possible \\(=\\) last possible date of an incomplete AE date","confidence":0.9805681265424937,"confidence_rate":0.9997312257929856},{"cnt":[[393,1412],[1761,1412],[1761,1469],[393,1469]],"region":{"top_left_x":392,"top_left_y":1411,"width":1370,"height":58},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cf0676fac1894c64bc074b30e5af47d7","type":"text","conversion_output":true,"text":"- if only month and year are given: day is set to the last possible day of the month","text_display":"\n- if only month and year are given: day is set to the last possible day of the month","confidence":1,"confidence_rate":1},{"cnt":[[393,1503],[1542,1503],[1542,1556],[393,1556]],"region":{"top_left_x":392,"top_left_y":1503,"width":1150,"height":53},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"95c5b1d717eb49779264be2f86497a99","type":"text","conversion_output":true,"text":"- if only year is given: day is set to 31 and month is set to December","text_display":"\n- if only year is given: day is set to 31 and month is set to December","confidence":1,"confidence_rate":1},{"cnt":[[242,1681],[1222,1681],[1222,1738],[242,1738]],"region":{"top_left_x":242,"top_left_y":1681,"width":981,"height":58},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"82bf10a75f4949249e540f44c5c82a15","type":"text","conversion_output":true,"text":"The imputation must be performed in the following order:","text_display":"\n\nThe imputation must be performed in the following order:","confidence":1,"confidence_rate":1},{"cnt":[[356,1759],[1222,1759],[1222,1816],[356,1816]],"region":{"top_left_x":356,"top_left_y":1758,"width":867,"height":59},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"63eda61569924c119f7e709517b9c504","type":"text","conversion_output":true,"text":"1) Imputation of completely missing AE end dates","text_display":"\n1) Imputation of completely missing AE end dates","confidence":0.9877986907958984,"confidence_rate":0.9997919478111107},{"cnt":[[354,1841],[1172,1841],[1172,1894],[354,1894]],"region":{"top_left_x":354,"top_left_y":1841,"width":818,"height":53},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fc7e06a16041404fb74dfbebb44d463c","type":"text","conversion_output":true,"text":"2) Imputation of missing/partial AE onset dates","text_display":"\n2) Imputation of missing/partial AE onset dates","confidence":0.8310546875,"confidence_rate":0.996814400736355},{"cnt":[[354,1919],[1007,1919],[1007,1971],[354,1971]],"region":{"top_left_x":354,"top_left_y":1918,"width":654,"height":54},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b5b6f43f1971400897bee5fe83edd40a","type":"text","conversion_output":true,"text":"3) Imputation of partial AE end dates","text_display":"\n3) Imputation of partial AE end dates","confidence":0.68603515625,"confidence_rate":0.991068071555891},{"cnt":[[338,2079],[962,2079],[962,2147],[338,2147]],"region":{"top_left_x":338,"top_left_y":2078,"width":624,"height":70},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6a9f7dd7674147478c120e467031e11d","type":"section_header","conversion_output":false,"children_ids":["95ff6824362243ec802b4e8c09867084"],"text":"","text_display":""},{"cnt":[[343,2088],[957,2088],[957,2143],[343,2143]],"region":{"top_left_x":342,"top_left_y":2087,"width":616,"height":56},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"95ff6824362243ec802b4e8c09867084","type":"text","conversion_output":true,"parent_id":"6a9f7dd7674147478c120e467031e11d","text":"1) Completely missing AE end dates","text_display":"\n\n\\section*{1) Completely missing AE end dates}","confidence":0.88232421875,"confidence_rate":0.9967950009695917},{"cnt":[[244,2166],[1823,2166],[1823,2218],[244,2218]],"region":{"top_left_x":244,"top_left_y":2165,"width":1579,"height":54},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c8bbf1fb5ab4243b32433d10ea406d9","type":"text","conversion_output":true,"text":"When an AE end date is missing but there is another AE occurrence with the same lowest","text_display":"\n\nWhen an AE end date is missing but there is another AE occurrence with the same lowest","confidence":0.994140625,"confidence_rate":0.999935423969858},{"cnt":[[244,2216],[1821,2216],[1821,2268],[244,2268]],"region":{"top_left_x":244,"top_left_y":2215,"width":1577,"height":54},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0b0480c0de5c4ce499ab1053700ed59b","type":"text","conversion_output":true,"text":"level term (LLT) and onset date and with an end date, this end date will be used for the","text_display":" level term (LLT) and onset date and with an end date, this end date will be used for the","confidence":1,"confidence_rate":1},{"cnt":[[244,2262],[445,2262],[445,2316],[244,2316]],"region":{"top_left_x":244,"top_left_y":2261,"width":202,"height":56},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f8b850a6229c4c5c91b9adbb4566898d","type":"text","conversion_output":true,"text":"imputation.","text_display":" imputation.","confidence":1,"confidence_rate":1},{"cnt":[[244,2353],[1423,2353],[1423,2405],[244,2405]],"region":{"top_left_x":244,"top_left_y":2352,"width":1180,"height":54},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9623933dd0dc430c93a652cc62e52582","type":"text","conversion_output":true,"text":"Otherwise, the imputation rules described in the Table 6.6: 1 are used.","text_display":"\n\nOtherwise, the imputation rules described in the Table 6.6: 1 are 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1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1567,174],[1812,174],[1812,222],[1567,222]],"region":{"top_left_x":1567,"top_left_y":173,"width":245,"height":49},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f580c0b305c4830b67523e3024acb44","type":"page_info","conversion_output":false,"text":"Page 41 of 80","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[260,242],[1805,242],[1805,281],[260,281]],"region":{"top_left_x":260,"top_left_y":242,"width":1545,"height":39},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"325ca8ffa9334152afb6d696422c31dc","type":"page_info","conversion_output":false,"text":"Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies","text_display":"","confidence":0.9907436370849609,"confidence_rate":0.999930603383775},{"cnt":[[247,356],[1236,356],[1236,407],[247,407]],"region":{"top_left_x":246,"top_left_y":356,"width":990,"height":51},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f7904fd9001949308875db2c0ba06545","type":"figure_label","conversion_output":false,"text":"Table 6.6:1 Algorithm for missing AE end 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did not die & If follow-up performed, impute missing AE end date for on-going AEs with the latest follow-up date. Otherwise, impute missing AE end date with the date of the last available visit. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 6.6:1 Algorithm for missing AE end date}\n\\begin{tabular}{|l|l|}\n\\hline Outcome of event & Action \\\\\n\\hline Patient died & Impute all missing AE end dates with date of death \\\\\n\\hline Patient did not die & If follow-up performed, impute missing AE end date for on-going AEs with the latest follow-up date. Otherwise, impute missing AE end date with the date of the last available visit. \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":1,"confidence_rate":1},{"cnt":[[258,429],[591,429],[591,830],[258,830]],"region":{"top_left_x":257,"top_left_y":429,"width":335,"height":401},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c504a6784134971894fe510bb6edfe1","type":"table_column","conversion_output":false,"parent_id":"3c7a08ee4e2f409db346a04d41686da9","text":"","text_display":""},{"cnt":[[771,429],[1687,429],[1687,830],[771,830]],"region":{"top_left_x":770,"top_left_y":429,"width":918,"height":401},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf0f29c24b764e4b8078a20bbdfc1c9c","type":"table_column","conversion_output":false,"parent_id":"3c7a08ee4e2f409db346a04d41686da9","text":"","text_display":""},{"cnt":[[246,436],[1731,432],[1731,487],[246,490]],"region":{"top_left_x":245,"top_left_y":432,"width":1487,"height":59},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f778432a599f4162aebf050b2216f16c","type":"table_row","conversion_output":false,"parent_id":"3c7a08ee4e2f409db346a04d41686da9","text":"","text_display":""},{"cnt":[[246,526],[1731,526],[1731,583],[246,583]],"region":{"top_left_x":246,"top_left_y":525,"width":1486,"height":59},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d7b083a953a43b8a2c773ffe54edf94","type":"table_row","conversion_output":false,"parent_id":"3c7a08ee4e2f409db346a04d41686da9","text":"","text_display":""},{"cnt":[[246,586],[1731,586],[1731,823],[246,823]],"region":{"top_left_x":246,"top_left_y":585,"width":1486,"height":238},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e993c11a3d5348afa53dd99f6c9cf670","type":"table_row","conversion_output":false,"parent_id":"3c7a08ee4e2f409db346a04d41686da9","text":"","text_display":""},{"cnt":[[264,441],[587,441],[587,480],[264,480]],"region":{"top_left_x":264,"top_left_y":440,"width":323,"height":40},"line":12,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"a7dec1c2d815403bbac73b74bf9ed828","type":"simple_cell","conversion_output":false,"parent_id":"3c7a08ee4e2f409db346a04d41686da9","text":"Outcome 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Otherwise, impute missing AE end date with the date of the last available visit.","text_display":"If follow-up performed, impute missing AE end date for on-going AEs with the latest follow-up date. Otherwise, impute missing AE end date with the date of the last available visit.","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[782,595],[1669,595],[1669,643],[782,643]],"region":{"top_left_x":782,"top_left_y":594,"width":887,"height":50},"line":18,"column":0,"font_size":38,"is_printed":true,"is_handwritten":false,"id":"01b5b96979b04d058f9020b73703ca7d","type":"text","conversion_output":false,"parent_id":"b386f8486ec94e698c9995c571b9ee09","text":"If follow-up performed, impute missing AE end date","text_display":"If follow-up performed, impute missing AE end 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that the patient did not experience the condition corresponding to the endpoint at","confidence":1,"confidence_rate":1},{"cnt":[[242,2335],[1492,2335],[1492,2383],[242,2383]],"region":{"top_left_x":242,"top_left_y":2334,"width":1250,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a477e76b04054fd1bb45492e0042798d","type":"text","conversion_output":true,"text":"baseline and the patient is included in the patients at risk for this endpoint.","text_display":" baseline and the patient is included in the patients at risk for this endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[242,2380],[1821,2380],[1821,2433],[242,2433]],"region":{"top_left_x":242,"top_left_y":2380,"width":1579,"height":53},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4e8a3db6b9e44c24a02566008eccbaec","type":"text","conversion_output":true,"text":"Patients without an event and available post-baseline laboratory measurements will 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laboratory required to derive a change from baseline and","text_display":" Patients with missing baseline laboratory required to derive a change from baseline and","confidence":1,"confidence_rate":1},{"cnt":[[242,2524],[1821,2524],[1821,2574],[242,2574]],"region":{"top_left_x":242,"top_left_y":2524,"width":1579,"height":51},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d1d9b7d78f9a447b96d7053fabbebe23","type":"text","conversion_output":true,"text":"patients without laboratory data following the baseline measurement will be censored on the","text_display":" patients without laboratory data following the baseline measurement will be censored on 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\\%\\).","confidence":1,"confidence_rate":1},{"cnt":[[244,2166],[1622,2166],[1622,2220],[244,2220]],"region":{"top_left_x":244,"top_left_y":2165,"width":1378,"height":56},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"53d863f5f83647b5899f16d0d909c425","type":"text","conversion_output":true,"text":"The hazard function of an event for patient j at time t is assumed to have the form:","text_display":"\n\nThe hazard function of an event for patient j at time t is assumed to have the form:","confidence":0.9882867336273193,"confidence_rate":0.9998833493080145},{"cnt":[[690,2298],[1375,2298],[1375,2364],[690,2364]],"region":{"top_left_x":689,"top_left_y":2298,"width":687,"height":67},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91c3658abcc441108140564a845e9391","type":"math","conversion_output":true,"text":"\\[\nh_{j}(t)=\\exp \\left(\\beta_{1} x 1_{j}+\\beta_{2} x 2_{j}\\right) h_{0}(t), j=1, \\ldots, n\n\\]","text_display":"\n\\[\nh_{j}(t)=\\exp \\left(\\beta_{1} x 1_{j}+\\beta_{2} x 2_{j}\\right) h_{0}(t), j=1, \\ldots, n\n\\]","confidence":0.6971187688832288,"confidence_rate":0.9955001612164127},{"cnt":[[244,2408],[356,2408],[356,2451],[244,2451]],"region":{"top_left_x":244,"top_left_y":2407,"width":113,"height":45},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f19b7aa5b3844a1e8e1e5fde3bbf7d54","type":"text","conversion_output":true,"text":"where","text_display":"\nwhere","confidence":1,"confidence_rate":1},{"cnt":[[306,2453],[1823,2453],[1823,2506],[306,2506]],"region":{"top_left_x":306,"top_left_y":2453,"width":1517,"height":53},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"12b7ce93e0154d978b966a0edf310965","type":"text","conversion_output":true,"text":"- \\(h _{0}( t )\\) is the non-negative baseline hazard function for a patient with a value of zero for","text_display":"\n- \\(h _{0}( t )\\) is the non-negative baseline hazard function for a patient with a value of zero for","confidence":1,"confidence_rate":1},{"cnt":[[368,2501],[925,2501],[925,2556],[368,2556]],"region":{"top_left_x":367,"top_left_y":2501,"width":559,"height":56},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b219dbb771524d68825d063e97fea72b","type":"text","conversion_output":true,"text":"the explanatory value \\(x 1_{ j }\\) and \\(x 2_{ j }\\)","text_display":" the explanatory value \\(x 1_{ j }\\) and \\(x 2_{ j }\\)","confidence":0.8797616958618164,"confidence_rate":0.9980609096160367},{"cnt":[[306,2549],[1409,2549],[1409,2602],[306,2602]],"region":{"top_left_x":306,"top_left_y":2549,"width":1104,"height":53},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0e84d1f62fe5431c9805ad3206c75306","type":"text","conversion_output":true,"text":"- \\(\\beta 1\\) is the (unknown) coefficient of the explanatory variable x 1","text_display":"\n- \\(\\beta 1\\) is the (unknown) coefficient of the explanatory variable x 1","confidence":0.8815708323381841,"confidence_rate":0.9982980725448661},{"cnt":[[306,2600],[1695,2600],[1695,2652],[306,2652]],"region":{"top_left_x":306,"top_left_y":2599,"width":1390,"height":54},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"641bd8926fa9446dad7fed98b1c37ee8","type":"text","conversion_output":true,"text":"- \\(x 1_{ j }\\) is an indicator variable representing the treatment group for patient \\(j =1, \\ldots, n\\)","text_display":"\n- \\(x 1_{ j }\\) is an indicator variable representing the treatment group for patient \\(j =1, \\ldots, n\\)","confidence":0.6269263606186541,"confidence_rate":0.9957254355332321}],"page_height":2924,"page_width":2068,"languages_detected":[]},{"image_id":"f2663f48-b276-415c-aa34-bc8f0eff2c5d-57","page":57,"lines":[{"cnt":[[244,123],[646,123],[646,176],[244,176]],"region":{"top_left_x":244,"top_left_y":123,"width":403,"height":53},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01ef8cbb149f4e96be780ea7799dbcea","type":"page_info","conversion_output":false,"text":"Boehringer Ingelheim","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[242,174],[802,174],[802,222],[242,222]],"region":{"top_left_x":242,"top_left_y":173,"width":560,"height":49},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2832d2c4be3d457e945abe74f5bb14c6","type":"page_info","conversion_output":false,"text":"TSAP for BI Trial No: 1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1567,174],[1816,174],[1816,226],[1567,226]],"region":{"top_left_x":1567,"top_left_y":173,"width":250,"height":54},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a59a3532417f438ea3bfaf98420189d5","type":"page_info","conversion_output":false,"text":"Page 57 of 80","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[260,240],[1807,240],[1807,281],[260,281]],"region":{"top_left_x":260,"top_left_y":239,"width":1547,"height":42},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"15dd42fb81a04c5a95c8a92d06bf6aeb","type":"page_info","conversion_output":false,"text":"Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies","text_display":"","confidence":0.998535871389322,"confidence_rate":0.9999890657202698},{"cnt":[[311,356],[1414,356],[1414,407],[311,407]],"region":{"top_left_x":310,"top_left_y":356,"width":1105,"height":51},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a6db015aff1a47c1a4ebd4da223edcc2","type":"text","conversion_output":true,"text":"- \\(\\beta 2\\) is the (unknown) coefficient of the explanatory variable x 2","text_display":"\n- \\(\\beta 2\\) is the (unknown) coefficient of the explanatory variable x 2","confidence":0.9883200731239867,"confidence_rate":0.9998412467506528},{"cnt":[[311,404],[1761,404],[1761,455],[311,455]],"region":{"top_left_x":310,"top_left_y":404,"width":1452,"height":51},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c8982c5bfd684528b0d65b4e476ed4bb","type":"text","conversion_output":true,"text":"- \\(x 2_{ j }\\) is an indicator variable representing the geographical region for patient \\(j =1, \\ldots, n\\)","text_display":"\n- \\(x 2_{ j }\\) is an indicator variable representing the geographical region for patient \\(j =1, \\ldots, n\\)","confidence":0.945830397570204,"confidence_rate":0.999507271786578},{"cnt":[[244,500],[1821,500],[1821,551],[244,551]],"region":{"top_left_x":244,"top_left_y":500,"width":1577,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"63acd1e4ee86485db11ad4c9a4625d69","type":"text","conversion_output":true,"text":"The hazard ratio (HR) for the effect of treatment (linagliptin vs. placebo), adjusted for","text_display":"\n\nThe hazard ratio (HR) for the effect of treatment (linagliptin vs. placebo), adjusted for","confidence":1,"confidence_rate":1},{"cnt":[[244,548],[1821,548],[1821,599],[244,599]],"region":{"top_left_x":244,"top_left_y":548,"width":1577,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eda3d32c4ff04948bb11200f138c8a1c","type":"text","conversion_output":true,"text":"geographical region, will be presented with the \\(95 \\%\\) confidence interval, the","text_display":" geographical region, will be presented with the \\(95 \\%\\) confidence interval, the","confidence":0.99755859375,"confidence_rate":0.999970900526472},{"cnt":[[247,596],[1821,596],[1821,646],[247,646]],"region":{"top_left_x":246,"top_left_y":596,"width":1575,"height":51},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f27291ede56240d8b89527855e7ab454","type":"text","conversion_output":true,"text":"\\(99 \\%\\) confidence interval and the p-values based on the Wald Chi-Square statistic: one-sided","text_display":" \\(99 \\%\\) confidence interval and the p-values based on the Wald Chi-Square statistic: one-sided","confidence":0.9824716842267662,"confidence_rate":0.9998118926329261},{"cnt":[[244,644],[1821,644],[1821,697],[244,697]],"region":{"top_left_x":244,"top_left_y":644,"width":1577,"height":53},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb858d2baa70403da111b5ef6299dabd","type":"text","conversion_output":true,"text":"p -value for the non-inferiority test ( NI margin 1.3), the one-sided p -value for the superiority","text_display":" p -value for the non-inferiority test ( NI margin 1.3), the one-sided p -value for the superiority","confidence":0.97147273825644,"confidence_rate":0.9997526624557564},{"cnt":[[247,690],[761,690],[761,742],[247,742]],"region":{"top_left_x":246,"top_left_y":689,"width":515,"height":54},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3b12c26fbf194b728a56470cc54065a3","type":"text","conversion_output":true,"text":"test and the two-sided p-value.","text_display":" test and the two-sided p-value.","confidence":0.64404296875,"confidence_rate":0.9878524447390331},{"cnt":[[244,786],[1825,786],[1825,838],[244,838]],"region":{"top_left_x":244,"top_left_y":785,"width":1582,"height":54},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fd837a870ad49cea43b522d6e51f51f","type":"text","conversion_output":true,"text":"Non-inferiority of the primary endpoint will be investigated by comparing the upper limit of","text_display":"\n\nNon-inferiority of the primary endpoint will be investigated by comparing the upper limit of","confidence":1,"confidence_rate":1},{"cnt":[[247,836],[1825,836],[1825,884],[247,884]],"region":{"top_left_x":246,"top_left_y":836,"width":1580,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03556581c35842ecaad1513d47638f6b","type":"text","conversion_output":true,"text":"the two sided \\(95 \\%\\) confidence interval of the hazard ratio with the non-inferiority margin of","text_display":" the two sided \\(95 \\%\\) confidence interval of the hazard ratio with the non-inferiority margin of","confidence":0.98876953125,"confidence_rate":0.9998870663113015},{"cnt":[[247,882],[1528,882],[1528,934],[247,934]],"region":{"top_left_x":246,"top_left_y":881,"width":1283,"height":54},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6295b1dd5d174a1f88f522dc176dcc64","type":"text","conversion_output":true,"text":"1.3: if the upper limit is less than 1.3, non-inferiority has been demonstrated.","text_display":" 1.3: if the upper limit is less than 1.3, non-inferiority has been demonstrated.","confidence":0.955742359161377,"confidence_rate":0.9994675900036194},{"cnt":[[247,978],[1821,978],[1821,1030],[247,1030]],"region":{"top_left_x":246,"top_left_y":977,"width":1575,"height":54},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3e4a8df3cf64855820cf7f568c3acc8","type":"text","conversion_output":true,"text":"In case non-inferiority of the primary endpoint is demonstrated, then superiority of the","text_display":"\n\nIn case non-inferiority of the primary endpoint is demonstrated, then superiority of the","confidence":1,"confidence_rate":1},{"cnt":[[244,1028],[1661,1028],[1661,1081],[244,1081]],"region":{"top_left_x":244,"top_left_y":1027,"width":1417,"height":54},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e210e07bc685497593310e3d93bfec5b","type":"text","conversion_output":true,"text":"primary endpoint and superiority of the key secondary endpoint will be investigated:","text_display":" primary endpoint and superiority of the key secondary endpoint will be investigated:","confidence":1,"confidence_rate":1},{"cnt":[[247,1074],[1821,1074],[1821,1126],[247,1126]],"region":{"top_left_x":246,"top_left_y":1073,"width":1575,"height":54},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c2ff0b18d6fa43ec83e81120a818be1c","type":"text","conversion_output":true,"text":"For the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be","text_display":"\nFor the final analysis, the first hypothesis (non-inferiority of the primary endpoint) will be","confidence":1,"confidence_rate":1},{"cnt":[[247,1124],[1821,1124],[1821,1172],[247,1172]],"region":{"top_left_x":246,"top_left_y":1123,"width":1575,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d0e800c953884548943b1ad979ea5ee7","type":"text","conversion_output":true,"text":"tested at the one-sided alpha-level of \\(2.5 \\%\\). In case of significance, the null hypothesis is","text_display":" tested at the one-sided alpha-level of \\(2.5 \\%\\). In case of significance, the null hypothesis is","confidence":0.9873046875,"confidence_rate":0.9998735071436784},{"cnt":[[247,1170],[1821,1170],[1821,1222],[247,1222]],"region":{"top_left_x":246,"top_left_y":1169,"width":1575,"height":54},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14d66be6dd214abca70bf8fb33bb8fd9","type":"text","conversion_output":true,"text":"rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests)","text_display":" rejected in a confirmatory sense and the next set of hypotheses (two separate hypothesis tests)","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[247,1220],[1821,1220],[1821,1268],[247,1268]],"region":{"top_left_x":246,"top_left_y":1219,"width":1575,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd79a5b719e7459db57d11a5c09df284","type":"text","conversion_output":true,"text":"will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal","text_display":" will be tested: a) test of the primary endpoint for superiority and b) test of the composite renal","confidence":0.9407230515498668,"confidence_rate":0.999406909000202},{"cnt":[[247,1266],[660,1266],[660,1318],[247,1318]],"region":{"top_left_x":246,"top_left_y":1265,"width":415,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86e05283d64a41a39765bf539399b500","type":"text","conversion_output":true,"text":"endpoint for superiority.","text_display":" endpoint for superiority.","confidence":1,"confidence_rate":1},{"cnt":[[247,1316],[1821,1316],[1821,1364],[247,1364]],"region":{"top_left_x":246,"top_left_y":1315,"width":1575,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"90207a729f3047c3b4de80796299ff32","type":"text","conversion_output":true,"text":"To adjust for multiplicity a sequentially rejective multiple test procedure will be applied (3).","text_display":"\nTo adjust for multiplicity a sequentially rejective multiple test procedure will be applied (3).","confidence":1,"confidence_rate":1},{"cnt":[[247,1361],[1821,1361],[1821,1414],[247,1414]],"region":{"top_left_x":246,"top_left_y":1361,"width":1575,"height":54},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"df295bb5154b42ee9fe9327584541756","type":"text","conversion_output":true,"text":"Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately, at the initial","text_display":" Both one-sided hypotheses H0(Sup1) and H0(Sup2) will be tested separately, at the initial","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[247,1412],[1821,1412],[1821,1462],[247,1462]],"region":{"top_left_x":246,"top_left_y":1411,"width":1575,"height":51},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"713b5e2c8acf4842b3faff97a7f14ea5","type":"text","conversion_output":true,"text":"alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite renal endpoint,","text_display":" alpha-levels of 0.2*alpha for 3-point MACE and 0.8*alpha for the composite renal endpoint,","confidence":0.9395675659179688,"confidence_rate":0.9993440515880238},{"cnt":[[247,1457],[1821,1457],[1821,1510],[247,1510]],"region":{"top_left_x":246,"top_left_y":1457,"width":1575,"height":53},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9d9da84f2f64dca97155c88d725537c","type":"text","conversion_output":true,"text":"respectively. If both null hypotheses cannot be rejected at these initial alpha-levels, the","text_display":" respectively. If both null hypotheses cannot be rejected at these initial alpha-levels, the","confidence":1,"confidence_rate":1},{"cnt":[[247,1508],[1821,1508],[1821,1558],[247,1558]],"region":{"top_left_x":246,"top_left_y":1507,"width":1575,"height":51},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e172e3a5f2e4b4a9821bf35b0a03d72","type":"text","conversion_output":true,"text":"procedure stops and for none of these endpoints superiority can be declared. After having","text_display":" procedure stops and for none of these endpoints superiority can be declared. After having","confidence":1,"confidence_rate":1},{"cnt":[[247,1553],[1821,1553],[1821,1606],[247,1606]],"region":{"top_left_x":246,"top_left_y":1553,"width":1575,"height":53},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71b6b440ad3a47a98de385ddb1f4840a","type":"text","conversion_output":true,"text":"shown superiority for one of these endpoints, the used alpha can be shuffled to the other test:","text_display":" shown superiority for one of these endpoints, the used alpha can be shuffled to the other test:","confidence":1,"confidence_rate":1},{"cnt":[[247,1601],[1821,1601],[1821,1652],[247,1652]],"region":{"top_left_x":246,"top_left_y":1601,"width":1575,"height":51},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"995098d105614f99988b1afaffddbda4","type":"text","conversion_output":true,"text":"If H0(Sup2) is rejected at the alpha-level of 0.8*alpha, then H0(Sup1) can be tested at the full","text_display":" If H0(Sup2) is rejected at the alpha-level of 0.8*alpha, then H0(Sup1) can be tested at the full","confidence":0.5608294818684953,"confidence_rate":0.9942902404820283},{"cnt":[[247,1649],[1821,1649],[1821,1702],[247,1702]],"region":{"top_left_x":246,"top_left_y":1649,"width":1575,"height":53},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4d9266813ecc4afea4abe63429c47475","type":"text","conversion_output":true,"text":"alpha-level of \\(2.5 \\%\\) (one-sided). If H0(Sup1) is rejected at the alpha-level of \\(0.2 *\\) alpha, then","text_display":" alpha-level of \\(2.5 \\%\\) (one-sided). 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In addition, certain quantiles of the failure times (e.g. \\(2.5 \\%, 5 \\%, 7.5 \\%\\) and \\(10 \\%\\)","text_display":" graphically. In addition, certain quantiles of the failure times (e.g. \\(2.5 \\%, 5 \\%, 7.5 \\%\\) and \\(10 \\%\\)","confidence":0.9878039360046387,"confidence_rate":0.9998747930812183},{"cnt":[[247,1978],[1821,1978],[1821,2031],[247,2031]],"region":{"top_left_x":246,"top_left_y":1978,"width":1575,"height":53},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb3a57984a5a42aeb87eaef0fd95f60d","type":"text","conversion_output":true,"text":"quantiles) will be provided per treatment group. Kaplan-Meier estimates for failure rates at 6","text_display":" quantiles) will be provided per treatment group. 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companies","text_display":"","confidence":0.9868383407592773,"confidence_rate":0.9999011314441271},{"cnt":[[240,350],[1007,350],[1007,411],[240,411]],"region":{"top_left_x":239,"top_left_y":349,"width":769,"height":63},"line":5,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8da8c2dc90604e4f901119a32536ede3","type":"section_header","conversion_output":false,"children_ids":["3b72a0228aa04692bb024559a06c8f94"],"text":"","text_display":""},{"cnt":[[247,356],[1003,356],[1003,404],[247,404]],"region":{"top_left_x":246,"top_left_y":356,"width":757,"height":49},"line":6,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3b72a0228aa04692bb024559a06c8f94","type":"text","conversion_output":true,"parent_id":"8da8c2dc90604e4f901119a32536ede3","text":"7.8.1.5.2 Adverse event incidence rates","text_display":"\n\n\\subsection*{7.8.1.5.2 Adverse event incidence rates}","confidence":0.9965848922729492,"confidence_rate":0.9999222541014986},{"cnt":[[244,452],[1821,452],[1821,505],[244,505]],"region":{"top_left_x":244,"top_left_y":452,"width":1577,"height":53},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5f8cf39a3b3c4af28556f23862f66659","type":"text","conversion_output":true,"text":"In addition to the frequency tabulations, time-adjusted adverse event analyses will be","text_display":"\n\nIn addition to the frequency tabulations, time-adjusted adverse event analyses will be","confidence":1,"confidence_rate":1},{"cnt":[[244,503],[1821,503],[1821,551],[244,551]],"region":{"top_left_x":244,"top_left_y":502,"width":1577,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3f9e923898f6446a8de0b6ffd319f060","type":"text","conversion_output":true,"text":"performed by SOC and PT, or respectively HLT and PT for TEAEs, severe TEAEs,","text_display":" performed by SOC and PT, or respectively HLT and PT for TEAEs, severe TEAEs,","confidence":1,"confidence_rate":1},{"cnt":[[247,551],[1821,551],[1821,601],[247,601]],"region":{"top_left_x":246,"top_left_y":550,"width":1575,"height":51},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8943b0d8fa5b476dbc63b7dedbc30c9a","type":"text","conversion_output":true,"text":"investigator defined drug-related TEAEs, other significant TEAEs, TEAEs leading to","text_display":" investigator defined drug-related TEAEs, other significant TEAEs, TEAEs leading to","confidence":1,"confidence_rate":1},{"cnt":[[247,596],[1823,596],[1823,646],[247,646]],"region":{"top_left_x":246,"top_left_y":596,"width":1577,"height":51},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"49626bd53a624255862380780fde9c68","type":"text","conversion_output":true,"text":"discontinuation of trial drug, serious TEAEs, TEAE leading to death and AESI and further","text_display":" discontinuation of trial drug, serious TEAEs, TEAE leading to death and AESI and further","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[247,644],[857,644],[857,697],[247,697]],"region":{"top_left_x":246,"top_left_y":644,"width":611,"height":53},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4e5fa8d8f4c24939bc141ed0c11d1643","type":"text","conversion_output":true,"text":"events (defined in Section 7.8.1.11).","text_display":" events (defined in Section 7.8.1.11).","confidence":1,"confidence_rate":1},{"cnt":[[244,733],[1147,733],[1147,788],[244,788]],"region":{"top_left_x":244,"top_left_y":733,"width":903,"height":56},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"13a7ff93e895461087140e61c2ee8506","type":"text","conversion_output":true,"text":"The time at risk in patient years is derived as follows:","text_display":"\n\nThe time at risk in patient years is derived as 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+1","confidence":0.6741437930613756,"confidence_rate":0.9962157184325945},{"cnt":[[244,964],[601,964],[601,1017],[244,1017]],"region":{"top_left_x":244,"top_left_y":964,"width":357,"height":53},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c9b27cd9645f493d917037bb85bc66c1","type":"text","conversion_output":true,"text":"Patients without AE:","text_display":"\nPatients without AE:","confidence":1,"confidence_rate":1},{"cnt":[[244,1014],[1812,1014],[1812,1067],[244,1067]],"region":{"top_left_x":244,"top_left_y":1014,"width":1568,"height":53},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91551fcf73ff4ec986140c7088e9179d","type":"text","conversion_output":true,"text":"time at risk (AE) in days \\(=\\) end date of time at risk - study treatment start date +1 , where end","text_display":"\ntime at risk (AE) in days \\(=\\) end date of time at risk - study treatment start date +1 , where end","confidence":0.973361548686271,"confidence_rate":0.999754578444146},{"cnt":[[244,1065],[1823,1065],[1823,1117],[244,1117]],"region":{"top_left_x":244,"top_left_y":1064,"width":1579,"height":54},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8aca771f408a4c9291ba317a8c1ce72c","type":"text","conversion_output":true,"text":"date of time at risk is the minimum of date of last study drug intake + x days and date of","text_display":" date of time at risk is the minimum of date of last study drug intake + x days and date of","confidence":0.56201171875,"confidence_rate":0.9942542445815824},{"cnt":[[247,1110],[580,1110],[580,1163],[247,1163]],"region":{"top_left_x":246,"top_left_y":1110,"width":335,"height":53},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1c2bb21205fc47978e9ae13c859acbd0","type":"text","conversion_output":true,"text":"death, if applicable.","text_display":" death, if 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=","confidence":0.99853515625,"confidence_rate":0.9999541911216807},{"cnt":[[459,1480],[1610,1480],[1610,1592],[459,1592]],"region":{"top_left_x":459,"top_left_y":1480,"width":1152,"height":113},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0c9741259fca4709a938be4a625d6417","type":"math","conversion_output":true,"text":"\\[\n\\frac{\\text { Sum of time at risk [days] over all patients in a treatment group }}{365.25}\n\\]","text_display":"\n\\[\n\\frac{\\text { Sum of time at risk [days] over all patients in a treatment group }}{365.25}\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[242,1668],[1825,1668],[1825,1720],[242,1720]],"region":{"top_left_x":242,"top_left_y":1667,"width":1584,"height":54},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4390e91763cc43a7914f92de8c278c1c","type":"text","conversion_output":true,"text":"For 'each row of a table' (e.g. displaying an SOC), time at risk is calculated using 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\\(=\\) start date of AE with specified PT in a SOC - treatment start date +1 .","text_display":"\nTime at risk \\(=\\) start date of AE with specified PT in a SOC - treatment start date +1 .","confidence":0.8798001215669728,"confidence_rate":0.9986806594270515},{"cnt":[[242,1859],[1556,1859],[1556,1912],[242,1912]],"region":{"top_left_x":242,"top_left_y":1859,"width":1314,"height":54},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8a71b4b4cc7f42bcabb4aa8f1b75c247","type":"text","conversion_output":true,"text":"The AE incidence rate per 100 patient years can then be calculated as follows:","text_display":"\nThe AE incidence rate per 100 patient years can then be calculated as follows:","confidence":0.6259765625,"confidence_rate":0.9945678039735174},{"cnt":[[242,1955],[1017,1955],[1017,2013],[242,2013]],"region":{"top_left_x":242,"top_left_y":1955,"width":775,"height":58},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7c4f6c43c6aa459d94fa8cf094131545","type":"text","conversion_output":true,"text":"Incidence rate [1/100 Patient years (pt-yrs)] =","text_display":"\nIncidence rate [1/100 Patient years (pt-yrs)] =","confidence":0.8214628272689879,"confidence_rate":0.9962250547734213},{"cnt":[[706,2042],[1357,2042],[1357,2168],[706,2168]],"region":{"top_left_x":705,"top_left_y":2042,"width":652,"height":126},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"00dd67857fd749d8a0ab6d533c4e8771","type":"math","conversion_output":true,"text":"\\[\n\\frac{100 * \\text { number of patients with AE }}{\\text { time at risk (AE) [years] }}\n\\]","text_display":"\n\\[\n\\frac{100 * \\text { number of patients with AE }}{\\text { time at risk (AE) [years] }}\n\\]","confidence":0.9970715045928955,"confidence_rate":0.9999581038513841},{"cnt":[[240,2275],[1199,2275],[1199,2344],[240,2344]],"region":{"top_left_x":239,"top_left_y":2275,"width":961,"height":69},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f2222e6b312b4294ae28ae84537137a6","type":"section_header","conversion_output":false,"children_ids":["a9dc22669b69488191bc64ffcd8ee766"],"text":"","text_display":""},{"cnt":[[247,2284],[1195,2284],[1195,2337],[247,2337]],"region":{"top_left_x":246,"top_left_y":2284,"width":949,"height":53},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a9dc22669b69488191bc64ffcd8ee766","type":"text","conversion_output":true,"parent_id":"f2222e6b312b4294ae28ae84537137a6","text":"7.8.1.6 Adverse events of special interest (AESI)","text_display":"\n\n\\subsection*{7.8.1.6 Adverse events of special interest 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updated MedDRA version corresponding term for that )","confidence":0.994140625,"confidence_rate":0.9999283366107606},{"cnt":[[247,704],[1761,704],[1761,752],[247,752]],"region":{"top_left_x":246,"top_left_y":703,"width":1516,"height":49},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0503408985cf453f82de91ac9781e723","type":"text","conversion_output":true,"text":"- Thyroid neoplasm (benign) (BIcMQ Thyroid Neoplasms narrow BIcMQs, restricted to","text_display":"\n- Thyroid neoplasm (benign) (BIcMQ Thyroid Neoplasms narrow BIcMQs, restricted to","confidence":1,"confidence_rate":1},{"cnt":[[306,749],[1318,749],[1318,797],[306,797]],"region":{"top_left_x":306,"top_left_y":749,"width":1013,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c08f559f85694e25ac2d4d91afd2ac8e","type":"text","conversion_output":true,"text":"diagnoses (exclude symptoms) by TM DS (manual review))","text_display":" diagnoses (exclude symptoms) by TM DS (manual review))","confidence":1,"confidence_rate":1},{"cnt":[[247,800],[1752,800],[1752,848],[247,848]],"region":{"top_left_x":246,"top_left_y":799,"width":1507,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dcb63e6887254328acf51da7ecd8a79c","type":"text","conversion_output":true,"text":"- Thyroid cancer (presentation in table of cancer events by HLT and PT; and also under","text_display":"\n- Thyroid cancer (presentation in table of cancer events by HLT and PT; and also under","confidence":1,"confidence_rate":1},{"cnt":[[306,850],[962,850],[962,898],[306,898]],"region":{"top_left_x":306,"top_left_y":849,"width":656,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1f0ea0c44b9c48a1b71a37952e9d565d","type":"text","conversion_output":true,"text":"\"Thyroid neoplasm\" as defined above)","text_display":" \"Thyroid neoplasm\" as defined 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cancer, pancreatic cancer as always-serious events) and adverse","confidence":1,"confidence_rate":1},{"cnt":[[247,1154],[1364,1154],[1364,1202],[247,1202]],"region":{"top_left_x":246,"top_left_y":1153,"width":1118,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c04ba59706aa45919435265e49775d51","type":"text","conversion_output":true,"text":"events leading to discontinuation from trial drug will be presented.","text_display":" events leading to discontinuation from trial drug will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[247,1243],[1821,1243],[1821,1286],[247,1286]],"region":{"top_left_x":246,"top_left_y":1242,"width":1575,"height":45},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3dc19b8bc298492b9df3c80b482212dc","type":"text","conversion_output":true,"text":"The most recent version of the definitions of these AESIs at the time of the DBL will be used","text_display":"\n\nThe most recent version of the definitions of these AESIs at the time of the DBL will be used","confidence":1,"confidence_rate":1},{"cnt":[[247,1293],[1818,1293],[1818,1341],[247,1341]],"region":{"top_left_x":246,"top_left_y":1292,"width":1573,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0a046213edee4d5da06c93eee3e35fc1","type":"text","conversion_output":true,"text":"to be in line with the respective most recent AESI definition in the current MedDRA version.","text_display":" to be in line with the respective most recent AESI definition in the current MedDRA version.","confidence":1,"confidence_rate":1},{"cnt":[[247,1339],[827,1339],[827,1382],[247,1382]],"region":{"top_left_x":246,"top_left_y":1338,"width":581,"height":45},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b02e28d88db34e169d9bf1f1d7cb4ef0","type":"text","conversion_output":true,"text":"These will be stored in the CTMF.","text_display":" These 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manually","text_display":" specified Standardized MedDRA Queries (SMQs) according to CEC charter and manually","confidence":1,"confidence_rate":1},{"cnt":[[247,1613],[1821,1613],[1821,1661],[247,1661]],"region":{"top_left_x":246,"top_left_y":1612,"width":1575,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96a0aa5662584bb0a13360552d596d39","type":"text","conversion_output":true,"text":"identified) will be provided by treatment group and overall, by primary SOC and preferred","text_display":" identified) will be provided by treatment group and overall, by primary SOC and preferred","confidence":1,"confidence_rate":1},{"cnt":[[247,1663],[1816,1663],[1816,1711],[247,1711]],"region":{"top_left_x":246,"top_left_y":1663,"width":1571,"height":48},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"060e4bb1a1e94e98b3b74779a3a35fdd","type":"text","conversion_output":true,"text":"term. All events will be taken into account from first study drug intake up to study end.","text_display":" term. All events will be taken into account from first study drug intake up to study end.","confidence":1,"confidence_rate":1},{"cnt":[[247,1709],[1821,1709],[1821,1757],[247,1757]],"region":{"top_left_x":246,"top_left_y":1708,"width":1575,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74cd2df72b5e4ad29f95067616c34a79","type":"text","conversion_output":true,"text":"This table will be provided separately for cardio/neuro, renal, pancreatic adjudication and","text_display":" This table will be provided separately for cardio/neuro, renal, pancreatic adjudication and","confidence":1,"confidence_rate":1},{"cnt":[[247,1759],[651,1759],[651,1807],[247,1807]],"region":{"top_left_x":246,"top_left_y":1758,"width":406,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"500296041f834f2280ef4315572cb139","type":"text","conversion_output":true,"text":"oncological assessment.","text_display":" oncological assessment.","confidence":1,"confidence_rate":1},{"cnt":[[247,1848],[1821,1848],[1821,1896],[247,1896]],"region":{"top_left_x":246,"top_left_y":1848,"width":1575,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c6df048af224c2b913ddec794519012","type":"text","conversion_output":true,"text":"Further, outcome events captured by the investigators will be contrasted with those defined","text_display":"\n\nFurther, outcome events captured by the investigators will be contrasted with those defined","confidence":1,"confidence_rate":1},{"cnt":[[247,1896],[770,1896],[770,1944],[247,1944]],"region":{"top_left_x":246,"top_left_y":1896,"width":524,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"989974a1447242d69c672662999a1d26","type":"text","conversion_output":true,"text":"by the adjudication committee.","text_display":" by the adjudication committee.","confidence":1,"confidence_rate":1},{"cnt":[[247,2074],[1821,2074],[1821,2122],[247,2122]],"region":{"top_left_x":246,"top_left_y":2074,"width":1575,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"951fed89837f4b19a938b521f89e65e4","type":"text","conversion_output":true,"text":"For cardio- and cerebrovascular events the components as listed in Section 5.3.1 as well as","text_display":"\n\nFor cardio- and cerebrovascular events the components as listed in Section 5.3.1 as well as","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[247,2124],[1821,2124],[1821,2170],[247,2170]],"region":{"top_left_x":246,"top_left_y":2124,"width":1575,"height":47},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3012840755fa45069388f78feb448760","type":"text","conversion_output":true,"text":"the types of CV deaths, the types of non-fatal MIs, types of fatal and non-fatal strokes, stent","text_display":" the types of CV deaths, the types of non-fatal MIs, types of fatal and non-fatal strokes, stent","confidence":1,"confidence_rate":1},{"cnt":[[247,2170],[1821,2170],[1821,2218],[247,2218]],"region":{"top_left_x":246,"top_left_y":2170,"width":1575,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e54e1878c48e4b35a8e0191c798e856e","type":"text","conversion_output":true,"text":"thrombosis and all not assessable cases will be presented. 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The category of other","confidence":1,"confidence_rate":1},{"cnt":[[247,2220],[1821,2220],[1821,2268],[247,2268]],"region":{"top_left_x":246,"top_left_y":2220,"width":1575,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ed6321806a24e1694abc29d1fe79551","type":"text","conversion_output":true,"text":"cardiovascular causes will be presented with subcategories of \"other assessable CV causes\"","text_display":" cardiovascular causes will be presented with subcategories of \"other assessable CV causes\"","confidence":1,"confidence_rate":1},{"cnt":[[247,2266],[701,2266],[701,2314],[247,2314]],"region":{"top_left_x":246,"top_left_y":2266,"width":456,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"72d009058aa044ee9e72cb2e4b8c52cf","type":"text","conversion_output":true,"text":"and \"presumed CV death\".","text_display":" and \"presumed CV 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1218.22","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1567,171],[1816,169],[1817,223],[1567,226]],"region":{"top_left_x":1566,"top_left_y":168,"width":251,"height":58},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2143be0469b04b62afdcc0aa998eebef","type":"page_info","conversion_output":false,"text":"Page 72 of 80","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[258,238],[1807,238],[1807,281],[258,281]],"region":{"top_left_x":258,"top_left_y":237,"width":1549,"height":44},"line":4,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"e8a1188363054feeac4ff91f3e82c186","type":"page_info","conversion_output":false,"text":"Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies","text_display":"","confidence":0.9873256683349609,"confidence_rate":0.9999048154543171},{"cnt":[[242,352],[1821,352],[1821,409],[242,409]],"region":{"top_left_x":242,"top_left_y":351,"width":1579,"height":58},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb32c7944d98449f9328dd65135261c7","type":"text","conversion_output":true,"text":"7.8.1.8 Events qualifying for external adjudication by the Clinical Event Committee (CEC)","text_display":"\n7.8.1.8 Events qualifying for external adjudication by the Clinical Event Committee (CEC)","confidence":0.9873106479644775,"confidence_rate":0.9998641523186664},{"cnt":[[397,402],[902,402],[902,459],[397,459]],"region":{"top_left_x":397,"top_left_y":402,"width":506,"height":58},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"78b02ee5556b4829a0afca283dc14763","type":"text","conversion_output":true,"text":"for pancreatic events (CECP)","text_display":" for pancreatic 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frequency tables (overall and by adjudication trigger i.e. lab or","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[242,589],[336,589],[336,642],[242,642]],"region":{"top_left_x":242,"top_left_y":589,"width":94,"height":53},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca656ac62086467486d7a52ff5a35fa9","type":"text","conversion_output":true,"text":"AE):","text_display":" AE):","confidence":1,"confidence_rate":1},{"cnt":[[306,635],[1017,635],[1017,688],[306,688]],"region":{"top_left_x":306,"top_left_y":635,"width":711,"height":53},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"98ae0e9620ed45d1a9cf31688aa7f159","type":"text","conversion_output":true,"text":"- Acute pancreatitis (with organ failure)","text_display":"\n- Acute pancreatitis (with organ failure)","confidence":1,"confidence_rate":1},{"cnt":[[304,685],[1071,685],[1071,738],[304,738]],"region":{"top_left_x":303,"top_left_y":685,"width":769,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7c934c707e94c6495f00cf86492ce7a","type":"text","conversion_output":true,"text":"- Acute pancreatitis (without organ failure)","text_display":"\n- Acute pancreatitis (without organ failure)","confidence":1,"confidence_rate":1},{"cnt":[[306,733],[1053,733],[1053,784],[306,784]],"region":{"top_left_x":306,"top_left_y":733,"width":748,"height":51},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5c15b6a6a5d14f949d58c19a8becc3e6","type":"text","conversion_output":true,"text":"- Chronic pancreatitis (with organ failure)","text_display":"\n- Chronic pancreatitis (with organ failure)","confidence":1,"confidence_rate":1},{"cnt":[[306,781],[1103,781],[1103,834],[306,834]],"region":{"top_left_x":306,"top_left_y":781,"width":798,"height":53},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9d722396766c44ed8cb097c4f0997355","type":"text","conversion_output":true,"text":"- Asymptomatic pancreatic hyperenzymemia","text_display":"\n- Asymptomatic pancreatic hyperenzymemia","confidence":1,"confidence_rate":1},{"cnt":[[306,829],[758,829],[758,879],[306,879]],"region":{"top_left_x":306,"top_left_y":829,"width":453,"height":51},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6cb7a673d2244215800b515894a98927","type":"text","conversion_output":true,"text":"- Pancreatic malignancy","text_display":"\n- Pancreatic 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