{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98.4"},{"groupId":"OG001","value":"96.9"},{"groupId":"OG002","value":"97.0"}]}],"title":"Any On-Study AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.8"},{"groupId":"OG001","value":"55.0"},{"groupId":"OG002","value":"52.3"}]}],"title":"Severe (>=Grade 3) On-Study AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40.8"},{"groupId":"OG001","value":"42.0"},{"groupId":"OG002","value":"39.4"}]}],"title":"Serious On-Study AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"88.9"},{"groupId":"OG001","value":"80.2"},{"groupId":"OG002","value":"78.8"}]}],"title":"Related On-Study AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9.2"},{"groupId":"OG001","value":"13.0"},{"groupId":"OG002","value":"3.8"}]}],"title":"On-Study AEs Leading to Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6.1"},{"groupId":"OG001","value":"9.9"},{"groupId":"OG002","value":"6.1"}]}],"title":"AEs with Outcome of Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1"},{"groupId":"OG001","value":"3.1"},{"groupId":"OG002","value":"1.5"}]}],"title":"Related AE with Outcome of Death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"132"}],"units":"Participants"}],"description":"An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.","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":"All subjects who received at least 1 dose or any partial dose of study medication.","reportingStatus":"POSTED","timeFrame":"On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).","title":"Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death","type":"SECONDARY","unitOfMeasure":"percentage of participants"}