{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0433","pValueComment":"P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"ciPctValue":"95","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0012","pValueComment":"P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0402","pValueComment":"P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.7","upperLimit":"8.4","value":"5.7"},{"groupId":"OG001","lowerLimit":"6.3","upperLimit":"17.4","value":"10.9"},{"groupId":"OG002","lowerLimit":"0.2","upperLimit":"5.2","value":"1.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"136"}],"units":"Participants"}],"description":"Response was based on the investigators' assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated.","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":"NUMBER","populationDescription":"Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.","reportingStatus":"POSTED","timeFrame":"Up to week 24","title":"Determination of Best Overall Response Rate (BORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}