{"analyses":[{"ciLowerLimit":"0.70","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.87","estimateComment":"Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \\<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \\[CPS\\] \\<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.9","upperLimit":"14.0","value":"12.9"},{"groupId":"OG001","lowerLimit":"10.6","upperLimit":"12.1","value":"11.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"790"},{"groupId":"OG001","value":"789"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).\n\nParticipants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).","id":"OG000","title":"Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)"},{"description":"Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\\^2 IV on Day 1 Q3W and 5FU 800 mg/m\\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).","id":"OG001","title":"Placebo + Chemotherapy (FP or CAPOX Regimen)"}],"paramType":"MEDIAN","populationDescription":"The analysis population included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to 45.9 months","title":"Overall Survival (OS) in All Participants","type":"PRIMARY","unitOfMeasure":"Months"}