{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58.2"},{"groupId":"OG001","value":"61.1"},{"groupId":"OG002","value":"31.8"}]}],"title":"Any On-Study irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11.3"},{"groupId":"OG001","value":"15.3"},{"groupId":"OG002","value":"3.0"}]}],"title":"On-Study Severe irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10.5"},{"groupId":"OG001","value":"13.0"},{"groupId":"OG002","value":"0.8"}]}],"title":"On-Study Serious irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.8"},{"groupId":"OG001","value":"8.4"},{"groupId":"OG002","value":"0.8"}]}],"title":"On-Study irAEs Leading to Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.3"},{"groupId":"OG001","value":"1.5"},{"groupId":"OG002","value":"0"}]}],"title":"Death Due to irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32.1"},{"groupId":"OG001","value":"29.0"},{"groupId":"OG002","value":"14.4"}]}],"title":"Gastrointestinal irAEs (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6.3"},{"groupId":"OG001","value":"7.6"},{"groupId":"OG002","value":"0.8"}]}],"title":"Severe (>= Grade 3) Gastrointestinal irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1"},{"groupId":"OG001","value":"3.8"},{"groupId":"OG002","value":"4.5"}]}],"title":"Liver irAEs (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.1"},{"groupId":"OG001","value":"0.8"},{"groupId":"OG002","value":"2.3"}]}],"title":"Severe (>= Grade 3) Liver irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.9"},{"groupId":"OG001","value":"7.6"},{"groupId":"OG002","value":"1.5"}]}],"title":"Endocrine irAEs (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.1"},{"groupId":"OG001","value":"3.8"},{"groupId":"OG002","value":"0"}]}],"title":"Severe (>= Grade 3) Endocrine irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40.0"},{"groupId":"OG001","value":"43.5"},{"groupId":"OG002","value":"16.7"}]}],"title":"Skin irAEs (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.4"},{"groupId":"OG001","value":"1.5"},{"groupId":"OG002","value":"0"}]}],"title":"Severe (>= Grade 3) Skin irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Neurological irAEs (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Severe (>= Grade 3) Neurological irAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.2"},{"groupId":"OG001","value":"4.6"},{"groupId":"OG002","value":"2.3"}]}],"title":"Other irAEs (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"2.3"},{"groupId":"OG002","value":"0.8"}]}],"title":"Severe (>= Grade 3) Other irAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"132"}],"units":"Participants"}],"description":"An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of \"Other irAEs\" includes blood, eye, immune, infections, renal, and respiratory systems.","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 Immune-Related Adverse Events (irAEs)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}