{"analyses":[{"ciLowerLimit":"0.64","ciNumSides":"TWO_SIDED","ciPctValue":"99.1","ciUpperLimit":"1.05","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0331","paramType":"Hazard Ratio (HR)","paramValue":"0.82","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.71","upperLimit":"15.51","value":"11.56"},{"groupId":"OG001","lowerLimit":"7.03","upperLimit":"10.81","value":"8.38"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"422"}],"units":"Participants"}],"description":"PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.","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":"MEDIAN","populationDescription":"All Intermediate/Poor-Risk Participants","reportingStatus":"POSTED","timeFrame":"From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)","title":"Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)","type":"PRIMARY","unitOfMeasure":"months"}