{"analyses":[{"ciLowerLimit":"0.14","ciNumSides":"TWO_SIDED","ciPctValue":"99","ciUpperLimit":"0.31","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Cox Proportional Hazard","paramValue":"0.21"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of the 95% confidence interval was not estimable because an insufficient number of participants reached the event at the final assessment time point.","groupId":"OG000","lowerLimit":"15.1","upperLimit":"NA","value":"18.3"},{"groupId":"OG001","lowerLimit":"2.2","upperLimit":"3.7","value":"3.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"description":"PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded IIR using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.","id":"OG000","title":"Randomization Phase: Lenvatinib 24 mg"},{"description":"Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.","id":"OG001","title":"Randomization Phase: Placebo"}],"paramType":"MEDIAN","populationDescription":"The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}