{"analyses":[{"ciLowerLimit":"0.4674","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.7008","groupDescription":"TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.5723"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"2.3","value":"2.0"},{"groupId":"OG001","lowerLimit":"1.7","upperLimit":"1.9","value":"1.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"337"},{"groupId":"OG001","value":"170"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 35 mg/m\\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.","id":"OG000","title":"TAS-102+BSC"},{"description":"Participants received 35 mg/m\\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.","id":"OG001","title":"Placebo+BSC"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)","title":"Progression-Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}