{"groups":[{"description":"Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study","id":"FG000","title":"Treatment 1"},{"description":"Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study","id":"FG001","title":"Treatment 2"},{"description":"Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study","id":"FG002","title":"Treatment 3"},{"description":"Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study","id":"FG003","title":"Treatment 4"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"5"}],"type":"Other Reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"}],"type":"Participant No Longer Meets Study Criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Participant Request to Discontinue Study Treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"349"},{"groupId":"FG001","numSubjects":"357"},{"groupId":"FG002","numSubjects":"304"},{"groupId":"FG003","numSubjects":"304"}],"comment":"Started = Randomized","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"345"},{"comment":"13 participants were randomized to Treatment 2; however, they received the sub-study treatment (Treatment 4)","groupId":"FG001","numSubjects":"338"},{"groupId":"FG002","numSubjects":"304"},{"comment":"3 participants were randomized to Treatment 4; however, they received the primary study treatment (Treatment 2)","groupId":"FG003","numSubjects":"291"}],"comment":"Completed = Treated","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"13"}],"type":"NOT COMPLETED"}],"title":"Pre-Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"168"},{"groupId":"FG003","numSubjects":"50"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"95"},{"groupId":"FG001","numSubjects":"45"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"22"}],"type":"Study Drug Toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"14"}],"type":"Adverse Event Unrelated to Study Drug"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"18"}],"type":"Participant Request to Discontinue Study Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"10"}],"type":"Maximum Clinical Benefit"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Poor/Non Compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}],"type":"Participant No Longer Meets Study Criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}],"type":"Administrative Reason by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"21"},{"groupId":"FG003","numSubjects":"8"}],"type":"Other Reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"23"},{"groupId":"FG003","numSubjects":"0"}],"type":"Ongoing Treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"345"},{"groupId":"FG001","numSubjects":"325"},{"groupId":"FG002","numSubjects":"304"},{"groupId":"FG003","numSubjects":"288"}],"comment":"Started = Treated","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"13 participants were randomized in primary study (Treatment 2); however, they received the sub-study treatment (Treatment 4)","groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"},{"comment":"3 participants were randomized in sub-study (Treatment 4); however, they received the primary study treatment (Treatment 2)","groupId":"FG003","numSubjects":"3"}],"type":"Received Different Treatment Than Originally Assigned"},{"achievements":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"149"},{"groupId":"FG002","numSubjects":"29"},{"groupId":"FG003","numSubjects":"157"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"299"},{"groupId":"FG001","numSubjects":"176"},{"groupId":"FG002","numSubjects":"275"},{"groupId":"FG003","numSubjects":"131"}],"type":"NOT COMPLETED"}],"title":"Treatment"}],"preAssignmentDetails":"The study was conducted as a primary study and a sub-study. In the primary study, 706 participants were randomized, and 673 participants received treatment. Of these 673 treated participants, 3 were randomized in the sub-study. In the sub-study, 608 participants were randomized, and 605 participants received treatment. Of these 605 treated participants, 13 were randomized in the primary study."}