{"analyses":[{"ciLowerLimit":"-2.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"11.8","estimateComment":"Based on Miettinen \\& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \\<1) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0966","paramType":"Difference in DCR (%) vs. control","paramValue":"4.7","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"51.8","upperLimit":"60.1","value":"56.0"},{"groupId":"OG001","lowerLimit":"45.2","upperLimit":"57.2","value":"51.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"566"},{"groupId":"OG001","value":"281"}],"units":"Participants"}],"description":"Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \\[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\\]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.","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 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: Disease Control Rate (DCR) - All Participants","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}