{"analyses":[{"ciLowerLimit":"8.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"15.3","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.00001","paramType":"Difference in Percentage","paramValue":"11.4","statisticalComment":"Based on Miettinen \\& Nurminen method stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)","statisticalMethod":"Stratified Miettinen and Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.3","upperLimit":"17.2","value":"13.4"},{"groupId":"OG001","lowerLimit":"0.9","upperLimit":"3.9","value":"2.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"402"},{"groupId":"OG001","value":"402"}],"units":"Participants"}],"description":"PathCR rate was defined as the percentage of participants having a pathCR based on central review. pathCR was defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. The percentage of participants having pathCR 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":"NUMBER","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 9 weeks following completion of neoadjuvant treatment (up to Study Week 18)","title":"Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}