{"analyses":[{"ciLowerLimit":"0.46","ciNumSides":"TWO_SIDED","ciPctValue":"98.6","ciUpperLimit":"0.90","estimateComment":"Stratified Cox proportional hazard model.","groupDescription":"Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0010","pValueComment":"Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\\<= 1 vs. \\>= 2) as recorded in IRT.","paramType":"Hazard Ratio (HR)","paramValue":"0.64","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.84","estimateComment":"Stratified Cox proportional hazard model","groupDescription":"Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0010","pValueComment":"Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\\<= 1 vs. \\>= 2) as recorded in IRT.","paramType":"Hazard Ratio (HR)","paramValue":"0.64","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.37","ciNumSides":"TWO_SIDED","ciPctValue":"99.5","ciUpperLimit":"0.80","estimateComment":"Stratified Cox proportional hazard model","groupDescription":"Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\\<= 1 vs. \\>= 2) as recorded in IRT.","paramType":"Hazard Ratio (HR)","paramValue":"0.54","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.71","estimateComment":"Stratified Cox proportional hazard model","groupDescription":"Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\\<= 1 vs. \\>= 2) as recorded in IRT.","paramType":"Hazard Ratio (HR)","paramValue":"0.54","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.24","upperLimit":"17.02","value":"13.70"},{"groupId":"OG001","lowerLimit":"11.93","upperLimit":"19.52","value":"15.44"},{"groupId":"OG002","lowerLimit":"7.69","upperLimit":"9.95","value":"9.07"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"157"}],"units":"Participants"}],"description":"Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.","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":"MEDIAN","populationDescription":"All randomized PD-L1 expressing participants","reportingStatus":"POSTED","timeFrame":"From the date of randomization to up to the date of death (up to approximately 20 months)","title":"Overall Survival (OS) in Participants With Tumor Cell PD-L1","type":"PRIMARY","unitOfMeasure":"Months"}