{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"99.5","ciUpperLimit":"0.76","estimateComment":"Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.57","statisticalMethod":"Stratified Log Rank test"},{"ciLowerLimit":"0.31","ciNumSides":"TWO_SIDED","ciPctValue":"99.5","ciUpperLimit":"0.57","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":"0.42","statisticalMethod":"Stratified Log Rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.34","upperLimit":"9.46","value":"6.87"},{"groupId":"OG001","lowerLimit":"8.90","upperLimit":"16.72","value":"11.50"},{"groupId":"OG002","lowerLimit":"2.79","upperLimit":"3.42","value":"2.89"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"316"},{"groupId":"OG001","value":"314"},{"groupId":"OG002","value":"315"}],"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 Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.","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 until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}