{"groups":[{"description":"Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks\n\nNivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks","id":"FG000","title":"Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)"},{"description":"Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.","id":"FG001","title":"Arm 2: Chemotherapy (XELOX or FOLFOX)"},{"description":"1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.","id":"FG002","title":"Arm 3: Nivolumab + Ipilimumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse event unrelated to study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Participants request to discontinue study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"3"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Participant no longer meets study criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Other reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"789"},{"groupId":"FG001","numSubjects":"833"},{"groupId":"FG002","numSubjects":"409"}],"comment":"= Randomized","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"782"},{"groupId":"FG001","numSubjects":"806"},{"groupId":"FG002","numSubjects":"403"}],"comment":"= Moving to treatment period","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Pre-Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"121"},{"groupId":"FG001","numSubjects":"94"},{"groupId":"FG002","numSubjects":"68"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"40"},{"groupId":"FG002","numSubjects":"8"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"5"}],"type":"Other reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"782"},{"groupId":"FG001","numSubjects":"806"},{"groupId":"FG002","numSubjects":"403"}],"comment":"Treated","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"623"},{"groupId":"FG001","numSubjects":"653"},{"groupId":"FG002","numSubjects":"319"}],"comment":"Continuing in the study","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"153"},{"groupId":"FG002","numSubjects":"84"}],"type":"NOT COMPLETED"}],"title":"Treatment"}],"preAssignmentDetails":"2031 Participants Randomized and 1991 Treated"}