{"analyses":[{"ciLowerLimit":"0.57","ciNumSides":"TWO_SIDED","ciPctValue":"98.52","ciUpperLimit":"0.93","estimateComment":"Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0018","pValueComment":"The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.","paramType":"Hazard Ratio (HR)","paramValue":"0.73","statisticalComment":"Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"N.A.: Not Available: Too few events to estimate the upper limit of the confidence interval","groupId":"OG000","lowerLimit":"21.75","upperLimit":"NA","value":"25.00"},{"groupId":"OG001","lowerLimit":"17.64","upperLimit":"23.06","value":"19.55"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"410"},{"groupId":"OG001","value":"411"}],"units":"Participants"}],"description":"Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p \\< 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.","id":"OG000","title":"Nivolumab"},{"description":"Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.","id":"OG001","title":"Everolimus"}],"paramType":"MEDIAN","populationDescription":"All randomized participants; any participants that was randomized to any treatment group in the study.","reportingStatus":"POSTED","timeFrame":"Randomization until 398 deaths, up to May 2015 (approximately 30 months)","title":"Overall Survival (OS) at Primary Endpoint","type":"PRIMARY","unitOfMeasure":"months"}