{"analyses":[{"ciLowerLimit":"0.45","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.70","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \\[TPS\\] ≥1% vs. \\<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \\& geographic region (East Asia vs. non-East Asia)","paramType":"Hazard Ratio (HR)","paramValue":"0.56","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.2","upperLimit":"8.3","value":"6.4"},{"groupId":"OG001","lowerLimit":"4.3","upperLimit":"5.7","value":"4.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"281"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (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. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional).","id":"OG000","title":"Pembrolizumab + Chemotherapy Combo"},{"description":"Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional).","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 19 months","title":"Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","type":"PRIMARY","unitOfMeasure":"Months"}