{"analyses":[{"ciLowerLimit":"0.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.87","estimateComment":"Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0026","paramType":"Hazard Ratio (HR)","paramValue":"0.66","statisticalMethod":"Stratified Log Rank","testedNonInferiority":false},{"ciLowerLimit":"0.83","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.30","estimateComment":"Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7575","paramType":"Hazard Ratio (HR)","paramValue":"1.04","statisticalMethod":"Stratified Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.48","upperLimit":"11.50","value":"9.95"},{"groupId":"OG001","lowerLimit":"8.02","upperLimit":"13.80","value":"10.12"},{"groupId":"OG002","lowerLimit":"5.49","upperLimit":"8.71","value":"6.44"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"136"}],"units":"Participants"}],"description":"OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\\[288V\\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\\[210M\\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.","id":"OG000","title":"Ipilimumab Plus gp100"},{"description":"Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.","id":"OG001","title":"Ipilimumab Monotherapy"},{"description":"Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\\[288V\\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\\[210M\\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.","id":"OG002","title":"gp100"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.","reportingStatus":"POSTED","timeFrame":"From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)","title":"Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy","type":"SECONDARY","unitOfMeasure":"months"}