{"analyses":[{"ciLowerLimit":"0.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"17.4","estimateComment":"Based on Miettinen \\& Nurminen method stratified by platinum chemotherapy, ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \\>ULN were combined into one stratum because of small sample size","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.02270","paramType":"Percent Difference","paramValue":"8.9","statisticalComment":"One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \\> 0.","statisticalMethod":"Miettinen & Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"64.2","upperLimit":"76.4","value":"70.6"},{"groupId":"OG001","lowerLimit":"55.1","upperLimit":"68.2","value":"61.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"225"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants who achieve a best objective response of complete response (CR) or partial response (PR) per RECIST 1.1. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. In 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 ORR was calculated using the Miettinen \\& Nurminen method stratified by type of platinum therapy (carboplatin or cisplatin), baseline ECOG performance status (0 or 1), and baseline LDH (≤ or \\> upper limit of normal) 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":"NUMBER","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":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}