{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"43"}]}],"title":"On-study AE leading to Discontinuation (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"128"}]}],"title":"On-study SAE (At least 5%, Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"10"}]}],"title":"On-study D-R SAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"426"},{"groupId":"OG001","value":"188"}]}],"title":"On-study irAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"85"}]}],"title":"On-study gastrointestinal irAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"178"},{"groupId":"OG001","value":"38"}]}],"title":"On-study endocrine irAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"20"}]}],"title":"On-study liver irAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"99"}]}],"title":"On-study skin irAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"9"}]}],"title":"On-study neurological irAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"23"}]}],"title":"On-study other irAE (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"16"}]}],"title":"On-study imAR (Grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"On-study imAR (Grade 5)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"On-study enterocolitis imAR (Grade 5)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"4"}]}],"title":"On-study enterocolitis imAR (Grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"1"}]}],"title":"On-study endocrinopathy imAR (Grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"1"}]}],"title":"On-study hepatitis imAR (Grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"2"}]}],"title":"On-study dermatitis imAR (Grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"0"}]}],"title":"On-study neuropathy imAR (Grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"9"}]}],"title":"On-study other imAR (Grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"214"}]}],"title":"Any Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}]}],"title":"Death within 70 days of last dose study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Death within 30 days of last dose study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}]}],"title":"Drug-related Deaths"}],"denoms":[{"counts":[{"groupId":"OG000","value":"471"},{"groupId":"OG001","value":"474"}],"units":"Participants"}],"description":"AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator's assessment of immune-mediated etiology \\[excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)\\]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.","groups":[{"description":"Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).","id":"OG000","title":"Ipilimumab 10mg/kg"},{"description":"Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population: All randomized participants who received at least 1 dose of study therapy","reportingStatus":"POSTED","timeFrame":"Day 1 up to 70 days after last dose; up to 5 years","title":"Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population","type":"SECONDARY","unitOfMeasure":"Participants"}