{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95.1","ciUpperLimit":"0.88","groupDescription":"Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \\>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0013","paramType":"Hazard Ratio (HR)","paramValue":"0.72","statisticalComment":"stratified 2-sided log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit was not reached because the number of participants with a followup of more than 7 years was too small","groupId":"OG000","lowerLimit":"86.60","upperLimit":"NA","value":"86.60"},{"comment":"Median and upper limit were not reached because the number of participants with a followup of more than 7 years was too small","groupId":"OG001","lowerLimit":"59.30","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"475"},{"groupId":"OG001","value":"476"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).","id":"OG000","title":"Ipilimumab 10mg/kg"},{"description":"Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization","reportingStatus":"POSTED","timeFrame":"From June 2008 to January 2016 (approximately 90 months)","title":"Overall Survival in the Intent to Treat (ITT) Population","type":"SECONDARY","unitOfMeasure":"Months"}