{"analyses":[{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"98.5","ciUpperLimit":"1.43","estimateComment":"Stratified Cox proportional hazard model","groupDescription":"Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8958","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":"1.02","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.78","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.34","estimateComment":"Stratified Cox proportional hazard model","groupDescription":"Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8958","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":"1.02","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.46","ciNumSides":"TWO_SIDED","ciPctValue":"98.5","ciUpperLimit":"0.92","estimateComment":"Stratified Cox proportional hazard model","groupDescription":"Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0023","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":"0.65","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.86","estimateComment":"Stratified Cox proportional hazard model","groupDescription":"Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0023","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":"0.65","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.40","upperLimit":"4.93","value":"4.04"},{"groupId":"OG001","lowerLimit":"5.68","upperLimit":"8.34","value":"6.93"},{"groupId":"OG002","lowerLimit":"2.89","upperLimit":"5.82","value":"4.44"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"157"}],"units":"Participants"}],"description":"Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.","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 the first documented disease progression or death (up to approximately 9 months)","title":"Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1","type":"PRIMARY","unitOfMeasure":"Months"}