{"analyses":[{"ciLowerLimit":"0.63","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.82","estimateComment":"Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region 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 and chemotherapy regimen with small strata collapsed.","paramType":"Hazard Ratio (HR)","paramValue":"0.72","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.0","upperLimit":"7.2","value":"6.9"},{"groupId":"OG001","lowerLimit":"5.4","upperLimit":"5.7","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"618"},{"groupId":"OG001","value":"617"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS 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 randomized participants with a PD-L1 CPS ≥1.","reportingStatus":"POSTED","timeFrame":"Up to 49.5 months","title":"Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1","type":"SECONDARY","unitOfMeasure":"Months"}