{"analyses":[{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.84","estimateComment":"HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.00012","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.6","upperLimit":"17.7","value":"15.1"},{"groupId":"OG001","lowerLimit":"8.7","upperLimit":"12.5","value":"11.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"432"},{"groupId":"OG001","value":"429"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.","id":"OG000","title":"Pembrolizumab + Axitinib"},{"description":"Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.","id":"OG001","title":"Sunitinib"}],"paramType":"MEDIAN","populationDescription":"The analysis population consisted of all randomized participants.","reportingStatus":"POSTED","timeFrame":"Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)","title":"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review","type":"PRIMARY","unitOfMeasure":"Months"}