{"analyses":[{"ciLowerLimit":"0.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.68","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","pValueComment":"One-sided p-value based on log-rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.50","statisticalComment":"Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53.8","upperLimit":"69.4","value":"62.1"},{"groupId":"OG001","lowerLimit":"41.9","upperLimit":"58.2","value":"50.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"151"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then 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 (approximately 1 additional year).","id":"OG001","title":"SOC Chemotherapy"}],"paramType":"NUMBER","populationDescription":"The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.","reportingStatus":"POSTED","timeFrame":"Month 6","title":"Progression Free Survival (PFS) Rate at Month 6","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}