{"analyses":[{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"98","ciUpperLimit":"0.78","estimateComment":"Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.63","statisticalComment":"Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.42","ciNumSides":"TWO_SIDED","ciPctValue":"98","ciUpperLimit":"0.72","estimateComment":"Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.55","statisticalComment":"Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median OS was not reached","groupId":"OG000","lowerLimit":"29.08","upperLimit":"NA","value":"NA"},{"comment":"Median OS was not reached","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG002","lowerLimit":"17.08","upperLimit":"24.61","value":"19.98"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"316"},{"groupId":"OG001","value":"314"},{"groupId":"OG002","value":"315"}],"units":"Participants"}],"description":"OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity","id":"OG000","title":"Nivolumab"},{"description":"Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity","id":"OG001","title":"Nivolumab + Ipilimumab"},{"description":"Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses","id":"OG002","title":"Ipilimumab"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization to date of death (Assessed up to September 2016, approximately 39 months)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}