{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Clinically Meaningful Vital Sign Changes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Clinically Meaningful Physical Examination Changes"}],"denoms":[{"counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"132"}],"units":"Participants"}],"description":"Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure.","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":"vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter","title":"Clinically Meaningful Changes in Vital Signs and Physical Examinations","type":"SECONDARY","unitOfMeasure":"participants"}