{"analyses":[{"ciLowerLimit":"2.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.5","estimateComment":"Pembrolizumab minus Placebo","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Difference in Survival Rate","paramValue":"7.4"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"78.1","upperLimit":"84.9","value":"81.8"},{"groupId":"OG001","lowerLimit":"70.3","upperLimit":"78.0","value":"74.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"529"},{"groupId":"OG001","value":"531"}],"units":"Participants"}],"description":"OS is the time from randomization to death due to any cause. The analysis was performed via Kaplan-Meier approach to estimate the OS rate at Month 36. The percentage of participants with OS at Month 36 is presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).","id":"OG000","title":"Chemoradiotherapy + Pembrolizumab"},{"description":"Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).","id":"OG001","title":"Chemoradiotherapy + Placebo for Pembrolizumab"}],"paramType":"NUMBER","populationDescription":"All randomized participants analyzed in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"36 months","title":"Overall Survival (OS) at Month 36","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}