{"analyses":[{"ciLowerLimit":"4.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.1","estimateComment":"Based on Miettinen \\& Nurminen method 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":"0.00009","pValueComment":"One-sided p-value based on Miettinen \\& Nurminen method 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":"Difference in Percentage","paramValue":"9.3","statisticalMethod":"Miettinen & Nurminen method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47.7","upperLimit":"54.8","value":"51.3"},{"groupId":"OG001","lowerLimit":"38.5","upperLimit":"45.5","value":"42.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"790"},{"groupId":"OG001","value":"789"}],"units":"Participants"}],"description":"ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.","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":"NUMBER","populationDescription":"The analysis population included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to 49.5 months","title":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}