{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"96.85","ciUpperLimit":"0.81","estimateComment":"Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0002","pValueComment":"Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).","paramType":"Hazard Ratio (HR)","paramValue":"0.59","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.33","upperLimit":"13.27","value":"9.23"},{"groupId":"OG001","lowerLimit":"5.13","upperLimit":"7.33","value":"6.01"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"137"}],"units":"Participants"}],"description":"OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.","id":"OG000","title":"Nivolumab"},{"description":"Docetaxel 75mg/m\\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.","id":"OG001","title":"Docetaxel"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"Randomization until 199 deaths, up to November 2014, approximately 25 months","title":"Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint","type":"PRIMARY","unitOfMeasure":"months"}