{"analyses":[{"ciLowerLimit":"17.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"29.9","estimateComment":"Difference in percentages based on Miettinen \\& Nurminen method 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":"<0.0001","paramType":"Difference in percentages","paramValue":"23.6","statisticalComment":"H0: difference in %=0 versus H1: difference in % \\>0","statisticalMethod":"Miettinen & Nurminen method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"54.5","upperLimit":"63.9","value":"59.3"},{"groupId":"OG001","lowerLimit":"31.1","upperLimit":"40.4","value":"35.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"432"},{"groupId":"OG001","value":"429"}],"units":"Participants"}],"description":"ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR was calculated using the Miettinen \\& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR or PR 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":"NUMBER","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":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}