{"analyses":[{"ciLowerLimit":"0.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.57","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.48","statisticalMethod":"Stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"2.1","value":"2.0"},{"groupId":"OG001","lowerLimit":"1.7","upperLimit":"1.8","value":"1.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"534"},{"groupId":"OG001","value":"266"}],"units":"Participants"}],"description":"Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received TAS-102 orally with a starting dose of 35 mg/m\\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.","id":"OG000","title":"TAS-102"},{"description":"Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed in ITT population.","reportingStatus":"POSTED","timeFrame":"Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)","title":"Progression-free Survival","type":"SECONDARY","unitOfMeasure":"months"}