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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":"EG000","otherNumAffected":513,"otherNumAtRisk":529,"seriousNumAffected":280,"seriousNumAtRisk":529,"title":"First Course: Arm A: Pembrolizumab + Chemotherapy"},{"deathsNumAffected":505,"deathsNumAtRisk":536,"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":"EG001","otherNumAffected":522,"otherNumAtRisk":534,"seriousNumAffected":264,"seriousNumAtRisk":534,"title":"First Course: Arm B: Placebo + Chemotherapy"},{"deathsNumAffected":4,"deathsNumAtRisk":10,"description":"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 200 mg 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":"EG002","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"title":"Second Course: Arm A: Pembrolizumab + Chemotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":315,"numAtRisk":529,"numEvents":530},{"groupId":"EG001","numAffected":307,"numAtRisk":534,"numEvents":488},{"groupId":"EG002","numAffected":0,"numAtRisk":10,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 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