{"analyses":[{"ciLowerLimit":"0.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.54","estimateComment":"Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.","groupDescription":"PFS Median analysis: A hierarchical testing method was used to control type I error and handle key secondary endpoint analysis. When the primary outcome measure significant testing was then performed sequentially on the key secondary outcome measure. statistically significant at 0.05 level.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Stratified log-rank test, with a target p-value \\< 0.025 for level of significance.","paramType":"Hazard Ratio (HR)","paramValue":"0.44","statisticalMethod":"Stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.50","upperLimit":"5.88","value":"5.55"},{"groupId":"OG001","lowerLimit":"2.07","upperLimit":"3.22","value":"2.40"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"246"}],"units":"Participants"}],"description":"PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.","id":"OG000","title":"Trifluridine/Tipiracil + Bevacizumab"},{"description":"Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.","id":"OG001","title":"Trifluridine/Tipiracil"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on FAS population.","reportingStatus":"POSTED","timeFrame":"From randomization to the date of radiological tumour progression or death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}