{"groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.","id":"FG000","title":"Part 1: Pembrolizumab + Nab-Paclitaxel"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.","id":"FG001","title":"Part 1: Pembrolizumab + Paclitaxel"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.","id":"FG002","title":"Part 1: Pembrolizumab + Gemcitabine/Carboplatin"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \\~1 year).","id":"FG003","title":"Part 2: Pembrolizumab + Chemotherapy"},{"description":"Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle","id":"FG004","title":"Part 2: Placebo + Chemotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"475"},{"groupId":"FG004","numSubjects":"244"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"25"},{"groupId":"FG004","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"34"},{"groupId":"FG004","numSubjects":"17"}],"type":"Sponsor Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"32"},{"groupId":"FG004","numSubjects":"11"}],"type":"Transferred to extension study"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"566"},{"groupId":"FG004","numSubjects":"281"}],"type":"STARTED"},{"achievements":[{"comment":"One participant randomized did not receive treatment. 3 participants randomized to Pembrolizumab + Paclitaxel group received Pembrolizumab + Nab-Paclitaxel treatment in error","groupId":"FG000","numSubjects":"13"},{"comment":"3 participants randomized to Pembrolizumab + Paclitaxel received pembrolizumab + Nab-Paclitaxel in error; 1 participant received pembrolizumab Gemcitabine/Carboplatin in error","groupId":"FG001","numSubjects":"10"},{"comment":"1 participant randomized to Pembrolizumab + Paclitaxel group received Pembrolizumab + Gemcitabine/Carboplatin in error","groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"562"},{"groupId":"FG004","numSubjects":"281"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"566"},{"groupId":"FG004","numSubjects":"281"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"35 participants were randomized to Part 1 (Safety Run-in) of the study, and 847 participants were randomized in Part 2 (phase 3) of the study. 12 participants randomized to the Part 2: Pembrolizumab + Chemotherapy arm received a second course of pembrolizumab at the investigator's discretion. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures respectively."}