{"analyses":[{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","estimateComment":"Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.81","testedNonInferiority":false},{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.83","estimateComment":"Cox model for Hazard ratios (HR) were stratified by 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","paramType":"Hazard Ratio (HR)","paramValue":"0.64","testedNonInferiority":false},{"ciLowerLimit":"1.01","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.53","estimateComment":"Cox model for Hazard ratios (HR) were stratified by 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","paramType":"Hazard Ratio (HR)","paramValue":"1.25","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.73","upperLimit":"2.79","value":"2.76"},{"groupId":"OG001","lowerLimit":"2.76","upperLimit":"3.02","value":"2.86"},{"groupId":"OG002","lowerLimit":"2.73","upperLimit":"2.83","value":"2.76"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"136"}],"units":"Participants"}],"description":"TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.","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 time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks])","title":"Time to Progression (TTP)","type":"SECONDARY","unitOfMeasure":"months"}