{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.441","upperLimit":"0.539","value":"0.491"},{"groupId":"OG001","lowerLimit":"0.489","upperLimit":"0.655","value":"0.577"},{"groupId":"OG002","lowerLimit":"0.396","upperLimit":"0.567","value":"0.485"}]}],"title":"Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.129","upperLimit":"0.203","value":"0.164"},{"groupId":"OG001","lowerLimit":"0.171","upperLimit":"0.315","value":"0.240"},{"groupId":"OG002","lowerLimit":"0.056","upperLimit":"0.159","value":"0.100"}]}],"title":"Week 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"136"}],"units":"Participants"}],"description":"PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 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":"Week 12, Week 24","title":"Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24","type":"SECONDARY","unitOfMeasure":"percentage of participants"}