{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"125"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"529"},{"groupId":"OG001","value":"534"}],"units":"Participants"}],"description":"An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who discontinued study intervention due to an AE were reported.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention.","reportingStatus":"POSTED","timeFrame":"Up to approximately 63 months","title":"Number of Participants Who Discontinued Study Intervention Due to an AE","type":"SECONDARY","unitOfMeasure":"Participants"}