{"analyses":[{"ciLowerLimit":"-2.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.0","estimateComment":"Based on Miettinen \\& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0725","paramType":"Difference in ORR (%) vs. Control","paramValue":"6.1","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"40.1","upperLimit":"49.8","value":"44.9"},{"groupId":"OG001","lowerLimit":"32.2","upperLimit":"45.8","value":"38.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"211"}],"units":"Participants"}],"description":"Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","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":"OG001","title":"Part 2: Placebo + Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment","reportingStatus":"POSTED","timeFrame":"Up to approximately 53 months","title":"Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}