{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.97","upperLimit":"12.71","value":"11.83"},{"groupId":"OG001","lowerLimit":"9.56","upperLimit":"13.54","value":"11.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"409"}],"units":"Participants"}],"title":"All randomized participants"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.48","upperLimit":"12.65","value":"11.47"},{"groupId":"OG001","lowerLimit":"9.49","upperLimit":"13.54","value":"11.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"322"}],"units":"Participants"}],"title":"Participants with CPS ≥ 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.05","upperLimit":"12.71","value":"11.63"},{"groupId":"OG001","lowerLimit":"9.17","upperLimit":"13.40","value":"11.24"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"234"}],"units":"Participants"}],"title":"Participants with CPS ≥ 5"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.92","upperLimit":"12.65","value":"11.33"},{"groupId":"OG001","lowerLimit":"9.26","upperLimit":"13.54","value":"11.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"181"}],"units":"Participants"}],"title":"Participants with CPS ≥ 10"}],"denoms":[{"counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"409"}],"units":"Participants"}],"description":"Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 1, 5, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.","dispersionType":"95% Confidence Interval","groups":[{"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. Comparison group to Arm 3.","id":"OG000","title":"Arm 2b: 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":"OG001","title":"Arm 3: Nivolumab + Ipilimumab"}],"paramType":"MEDIAN","populationDescription":"All randomized participants with available measurements in various subsets as determined by PD-L1 CPS status","reportingStatus":"POSTED","timeFrame":"From the date of randomization up to the date of death, up to approximately 14 months","title":"OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy","type":"SECONDARY","unitOfMeasure":"Months"}