{"analyses":[{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.88","estimateComment":"Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0018","pValueComment":"One-sided p-value based on log-rank test 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).","paramType":"Hazard Ratio (HR)","paramValue":"0.66","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.6","upperLimit":"11.3","value":"9.7"},{"groupId":"OG001","lowerLimit":"5.3","upperLimit":"7.5","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"103"}],"units":"Participants"}],"description":"Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.","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":"MEDIAN","populationDescription":"Participants with PD-L1 CPS ≥10 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: PFS - Participants With PD-L1 CPS ≥10 Tumors","type":"PRIMARY","unitOfMeasure":"Months"}