{"analyses":[{"ciLowerLimit":"0.62","ciNumSides":"TWO_SIDED","ciPctValue":"0.95","ciUpperLimit":"0.86","estimateComment":"HR \\& 95% CI is based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by planned bevacizumab use (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \\<1 vs CPS 1 to \\<10 vs CPS \\>=10).","groupDescription":"The hazard ratio (HR) and 95% confidence interval (CI) is based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \\<1 vs CPS 1 to \\<10 vs CPS \\>=10). One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \\<1 vs CPS 1 to \\<10 vs CPS \\>=10).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","pValueComment":"One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \\<1 vs CPS 1 to \\<10 vs CPS \\>=10).","paramType":"Hazard Ratio (HR)","paramValue":"0.73","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.2","upperLimit":"8.6","value":"8.3"},{"groupId":"OG001","lowerLimit":"6.2","upperLimit":"8.1","value":"6.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"321"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment 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 demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\\^2 every 3 weeks \\[Q3W\\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.","id":"OG000","title":"Pembrolizumab + Paclitaxel ± Bevacizumab"},{"description":"Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\\^2 every 3 weeks \\[Q3W\\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.","id":"OG001","title":"Placebo + Paclitaxel ± Bevacizumab"}],"paramType":"MEDIAN","populationDescription":"The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized.","reportingStatus":"POSTED","timeFrame":"Up to ~38 months","title":"PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants","type":"PRIMARY","unitOfMeasure":"Months"}