{"analyses":[{"ciLowerLimit":"0.71","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.06","estimateComment":"Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.07503","pValueComment":"One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)","paramType":"Hazard Ratio (HR)","paramValue":"0.86","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = Upper limit was not reached at time of data cut-off due to insufficient number of participants with an event","groupId":"OG000","lowerLimit":"52.5","upperLimit":"NA","value":"71.8"},{"comment":"NA = Upper limit was not reached at time of data cut-off due to insufficient number of participants with an event","groupId":"OG001","lowerLimit":"41.7","upperLimit":"NA","value":"55.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"402"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.","dispersionType":"95% Confidence Interval","groups":[{"description":"XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants received 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.\n\nAdjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.","id":"OG000","title":"Pembrolizumab + XP/FP"},{"description":"Neoadjuvant: Prior to surgery, participants received 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.\n\nAdjuvant: 4 to 10 weeks post-surgery, participants received 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.","id":"OG001","title":"Placebo + XP/FP"}],"paramType":"MEDIAN","populationDescription":"The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms, as pre-specified per protocol.","reportingStatus":"POSTED","timeFrame":"Up to approximately 75 months","title":"Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms","type":"PRIMARY","unitOfMeasure":"Months"}