{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1171.8"},{"groupId":"OG001","value":"465.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"471"},{"groupId":"OG001","value":"474"}],"units":"Participants"}],"description":"P-Y = person-years of exposure. Incidence rate per 100 person-years of exposure (IR/100 P-Y) was calculated as event count \\* 100 /person-years of exposure. MedDRA Version: 19. Duplicate AEs have been eliminated and overlapping and contiguous occurrences of the same event have been collapsed.","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":"NUMBER","populationDescription":"All participants who received at least one dose of ipilimumab or placebo, adjusted for person-years (P-Y) of exposure; P-Y=467.4; P-Y=781.7 for ipilimumab and placebo, respectively.","reportingStatus":"POSTED","timeFrame":"Day 1 up to 70 days after last dose; up to 5 years","title":"Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events","type":"SECONDARY","unitOfMeasure":"Events per 100 person-years of exposure"}