{"analyses":[{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.98","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":"0.01501","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":"0.81","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.0","upperLimit":"69.8","value":"44.4"},{"groupId":"OG001","lowerLimit":"20.8","upperLimit":"36.5","value":"25.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"402"}],"units":"Participants"}],"description":"EFS was based on RECIST 1.1 as assessed by the investigator and was defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), were not considered EFS events.","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":"Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms","type":"PRIMARY","unitOfMeasure":"Months"}