{"analyses":[{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.03","estimateComment":"Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.04125","pValueComment":"One-sided p-value based on log-rank test with stratification","paramType":"Hazard Ratio (HR)","paramValue":"0.82","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit not reached at time of data cut-off due to insufficient number of participants with an event","groupId":"OG000","lowerLimit":"44.9","upperLimit":"NA","value":"66.1"},{"comment":"Upper limit not reached at time of data cut-off due to insufficient number of participants with an event","groupId":"OG001","lowerLimit":"27.6","upperLimit":"NA","value":"44.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"306"}],"units":"Participants"}],"description":"DFS was defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause and was based on RECIST 1.1 as assessed by the investigator.","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 who had surgery, as pre-specified per protocol.","reportingStatus":"POSTED","timeFrame":"Up to approximately 75 months","title":"Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms","type":"SECONDARY","unitOfMeasure":"Months"}