{"analyses":[{"ciLowerLimit":"0.63","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.86","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","paramType":"Stratified Cox Proportional hazard Model","paramValue":"0.74","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.21","upperLimit":"29.77","value":"25.82"},{"groupId":"OG001","lowerLimit":"17.64","upperLimit":"21.88","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.\n\nThis outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.","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","reportingStatus":"POSTED","timeFrame":"from randomization up to disease progression or death (approximately up to 105 months)","title":"Extended Collection to Post Hoc Overall Survival (OS)","type":"POST_HOC","unitOfMeasure":"Months"}