{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"223"}]}],"title":"No. of deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"128"}]}],"title":"No. of participants with SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"441"},{"groupId":"OG001","value":"382"}]}],"title":"No of participants with NSAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"471"},{"groupId":"OG001","value":"474"}],"units":"Participants"}],"description":"AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. 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.","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":"SAEs and NSAEs: Day 1 up to 70 days after last dose(safety window). Deaths: All deaths regardless of 70 day safety window.Up to 10 years","title":"Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study","type":"SECONDARY","unitOfMeasure":"Participants"}