{"analyses":[{"ciLowerLimit":"-5.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.6","estimateComment":"Difference in percentage was calculated using Miettinen \\& Nurminen method. Difference in percentage=Arm A minus Arm B","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4735","pValueComment":"One-sided p-value was based on Miettinen \\& Nurminen method.","paramType":"Difference in Percentages","paramValue":"0.2","statisticalMethod":"Miettinen & Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"24.9","upperLimit":"32.8","value":"28.7"},{"groupId":"OG001","lowerLimit":"24.8","upperLimit":"32.6","value":"28.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"536"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \\[SOD\\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.","id":"OG000","title":"Arm A: Pembrolizumab + Chemotherapy"},{"description":"Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.","id":"OG001","title":"Arm B: Placebo + Chemotherapy"}],"paramType":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 26 months","title":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}