{"analyses":[{"ciLowerLimit":"0.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.80","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Stratified Hazard Ratio","paramValue":"0.65","statisticalComment":"Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.","statisticalMethod":"Stratified Log-rank Test"},{"ciLowerLimit":"0.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.49","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Stratified Hazard Ratio","paramValue":"0.39","statisticalComment":"Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.","statisticalMethod":"Stratified Log-rank Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.1","upperLimit":"16.7","value":"14.7"},{"groupId":"OG001","lowerLimit":"20.8","upperLimit":"27.7","value":"23.9"},{"groupId":"OG002","lowerLimit":"6.0","upperLimit":"11.0","value":"9.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"355"},{"groupId":"OG002","value":"357"}],"units":"Participants"}],"description":"PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) 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. PFS was analyzed using Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.","id":"OG000","title":"Lenvatinib 18 mg Plus Everolimus 5 mg"},{"description":"Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.","id":"OG001","title":"Lenvatinib 20 mg Plus Pembrolizumab 200 mg"},{"description":"Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.","id":"OG002","title":"Sunitinib 50 mg"}],"paramType":"MEDIAN","populationDescription":"The FAS included all randomized participants regardless of the treatment actually received.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)","title":"Progression-free Survival (PFS) by Independent Imaging Review (IIR)","type":"PRIMARY","unitOfMeasure":"months"}