{"analyses":[{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.13","estimateComment":"Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.216","pValueComment":"One-sided p-value based on stratified log-rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.92","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"3.2","value":"2.2"},{"groupId":"OG001","lowerLimit":"2.2","upperLimit":"3.9","value":"3.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"203"}],"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 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. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with SCC of the esophagus.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received Investigator's choice of paclitaxel 80-100 mg/m\\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).","id":"OG001","title":"Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)","title":"Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus","type":"SECONDARY","unitOfMeasure":"Months"}