{"analyses":[{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0225","pValueComment":"One-sided p-value was calculated based on log rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.86","statisticalComment":"HR and associated 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.7","upperLimit":"6.9","value":"6.5"},{"groupId":"OG001","lowerLimit":"5.1","upperLimit":"6.6","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"536"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.","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 26 months","title":"Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)","type":"SECONDARY","unitOfMeasure":"Months"}