{"analyses":[{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.95","estimateComment":"Hazard Ratio (HR) and associated 95% confidence interval (CI) was calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0034","pValueComment":"One-sided p-value was calculated based on log rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.5","upperLimit":"13.6","value":"12.7"},{"groupId":"OG001","lowerLimit":"9.9","upperLimit":"11.6","value":"10.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"536"}],"units":"Participants"}],"description":"Overall survival was defined as the time from randomization to death due to any cause.","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":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 38 months","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"Months"}