{"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":"FG000","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":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"No longer meets study criteria"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"475"},{"groupId":"FG001","numSubjects":"476"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"471"},{"groupId":"FG001","numSubjects":"474"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Randomized to Study Drug"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"135"},{"groupId":"FG001","numSubjects":"282"}],"type":"Recurrence of disease"},{"reasons":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"22"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"21"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Poor/non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Pregnancy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"No longer meets study criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Other reason"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"471"},{"groupId":"FG001","numSubjects":"474"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"63"},{"groupId":"FG001","numSubjects":"143"}],"comment":"Normal Completion","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"408"},{"groupId":"FG001","numSubjects":"331"}],"type":"NOT COMPLETED"}],"title":"Treated With Study Drug"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"141"},{"groupId":"FG001","numSubjects":"143"}],"comment":"Continuing in Long Term Follow Up","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"129"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Long Term Follow-Up"}],"preAssignmentDetails":"Protocol definition of Enrolled population: All 1211 participants who signed the Informed Consent Form; 951 were randomized to treatment and 945 were treated. Reasons for not being randomized: 193 were ineligible; 42 refused; 19 could not be randomized within 12 weeks after complete lymph node dissection; 6 due to other reasons."}