{"analyses":[{"ciLowerLimit":"0.60","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.88","estimateComment":"Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.00069","paramType":"Hazard Ratio (HR)","paramValue":"0.73","statisticalComment":"One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.3","upperLimit":"5.4","value":"4.8"},{"groupId":"OG001","lowerLimit":"4.2","upperLimit":"4.5","value":"4.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"225"}],"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. PD, as determined by RECIST 1.1, was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The PFS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.","dispersionType":"95% Confidence Interval","groups":[{"description":"During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \\[AUC\\] 5 IV on Day 1 OR cisplatin 75 mg/m\\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.","id":"OG000","title":"Pembrolizumab+EP"},{"description":"During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\\^2 IV on Day 1).","id":"OG001","title":"Placebo+EP"}],"paramType":"MEDIAN","populationDescription":"The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 30.5 months","title":"Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","type":"PRIMARY","unitOfMeasure":"Months"}