{"analyses":[{"ciLowerLimit":"9.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"22.2","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Stratified Difference","paramValue":"16.0","statisticalMethod":"DerSimonian and Laird Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36.9","upperLimit":"46.5","value":"41.6"},{"groupId":"OG001","lowerLimit":"22.4","upperLimit":"31.0","value":"26.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"422"}],"units":"Participants"}],"description":"ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends","id":"OG000","title":"Nivolumab + Ipilimumab"},{"description":"Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks","id":"OG001","title":"Sunitinib"}],"paramType":"NUMBER","populationDescription":"All Intermediate/Poor-Risk Participants","reportingStatus":"POSTED","timeFrame":"From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)","title":"Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1","type":"PRIMARY","unitOfMeasure":"percentage of participants"}