{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.3","upperLimit":"27.1","value":"20.1"},{"groupId":"OG001","lowerLimit":"34.1","upperLimit":"49.7","value":"41.7"},{"groupId":"OG002","lowerLimit":"26.6","upperLimit":"41.5","value":"33.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"163"},{"groupId":"OG002","value":"166"}],"units":"Participants"}],"title":"Participants with baseline PD-L1 status < 1%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.0","upperLimit":"43.4","value":"35.4"},{"groupId":"OG001","lowerLimit":"45.1","upperLimit":"61.1","value":"53.2"},{"groupId":"OG002","lowerLimit":"13.9","upperLimit":"27.0","value":"19.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"156"}],"units":"Participants"}],"title":"Participants with baseline PD-L1 status >= 1%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.7","upperLimit":"28.6","value":"22.3"},{"groupId":"OG001","lowerLimit":"37.8","upperLimit":"51.9","value":"44.8"},{"groupId":"OG002","lowerLimit":"24.7","upperLimit":"37.7","value":"30.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"202"},{"groupId":"OG001","value":"201"},{"groupId":"OG002","value":"207"}],"units":"Participants"}],"title":"Participants with baseline PD-L1 status < 5%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.1","upperLimit":"45.9","value":"36.7"},{"groupId":"OG001","lowerLimit":"42.4","upperLimit":"60.9","value":"51.7"},{"groupId":"OG002","lowerLimit":"13.1","upperLimit":"28.5","value":"20.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"115"}],"units":"Participants"}],"title":"Participants with baseline PD-L1 status >= 5%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"17.9","upperLimit":"29.5","value":"23.3"},{"groupId":"OG001","lowerLimit":"39.4","upperLimit":"53.0","value":"46.1"},{"groupId":"OG002","lowerLimit":"23.5","upperLimit":"35.8","value":"29.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"219"},{"groupId":"OG001","value":"219"},{"groupId":"OG002","value":"225"}],"units":"Participants"}],"title":"Participants with baseline PD-L1 status < 10%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.6","upperLimit":"47.0","value":"36.9"},{"groupId":"OG001","lowerLimit":"39.9","upperLimit":"60.1","value":"50.0"},{"groupId":"OG002","lowerLimit":"13.9","upperLimit":"31.2","value":"21.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"102"},{"groupId":"OG002","value":"97"}],"units":"Participants"}],"title":"Participants with baseline PD-L1 status >= 10%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.8","upperLimit":"90.6","value":"33.3"},{"groupId":"OG002","lowerLimit":"0.0","upperLimit":"84.2","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"title":"Participants with baseline PD-L1 status indeterminate, not evaluable, or missing"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.6","upperLimit":"32.6","value":"27.4"},{"groupId":"OG001","lowerLimit":"41.8","upperLimit":"53.0","value":"47.4"},{"groupId":"OG002","lowerLimit":"22.1","upperLimit":"32.0","value":"26.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"321"},{"groupId":"OG002","value":"324"}],"units":"Participants"}],"title":"All randomized participants"}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"321"},{"groupId":"OG002","value":"324"}],"units":"Participants"}],"description":"Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \\<10 mm.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.","id":"OG000","title":"Arm A: Nivolumab + Ipilimumab"},{"description":"Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.","id":"OG001","title":"Arm B: Nivolumab + Chemotherapy"},{"description":"Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.","id":"OG002","title":"Arm C: Chemotherapy"}],"paramType":"NUMBER","populationDescription":"All randomized PD-L1 expressing participants and all randomized participants","reportingStatus":"POSTED","timeFrame":"From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)","title":"Objective Response Rate (ORR) as Assessed by BICR","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}