{"groups":[{"description":"Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.","id":"FG000","title":"Nivolumab"},{"description":"Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Other reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant no longer meets study criteria"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"526"},{"groupId":"FG001","numSubjects":"264"}],"comment":"Started=randomized","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"524"},{"groupId":"FG001","numSubjects":"264"}],"comment":"Completed=treated","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Pre-Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"7"}],"type":"Other reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"41"}],"type":"Disease recurrence"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse event unrelated to study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"94"},{"groupId":"FG001","numSubjects":"7"}],"type":"Study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant no longer meets study criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant request to discontinue study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"39"}],"type":"Ongoing treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Maximum clinical benefit"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"524"},{"groupId":"FG001","numSubjects":"264"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"257"},{"groupId":"FG001","numSubjects":"158"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"267"},{"groupId":"FG001","numSubjects":"106"}],"type":"NOT COMPLETED"}],"title":"Blinded Treatment Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Participant withdrew consent after re-baseline visit"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"30"}],"comment":"Started=Number of participants enrolled in the open-label phase\n\nEligible participants received open-label Nivolumab treatment during a follow-up phase.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"28"}],"comment":"Completed=received treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Optional Open-Label Phase Pre-Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"}],"type":"Disease progression/recurrence"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Decision by Principal Investigator"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"17"}],"type":"Ongoing treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"28"}],"comment":"Started=received optional open-label treatment","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"25"}],"type":"NOT COMPLETED"}],"title":"Optional Open-Label Phase Treatment"}],"preAssignmentDetails":"980 participants were screened, of which 790 participants were randomized (526 nivolumab/264 placebo) into the study and 788 received either the Nivolumab treatment (524 participants) or placebo (264 participants). 30 eligible participants (2 from the Nivolumab treatment arm and 28 from the placebo arm) received open-label Nivolumab treatment during an optional open-label phase."}