{"analyses":[{"ciLowerLimit":"0.54","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","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0015","pValueComment":"One-sided p-value","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalComment":"Stratified by planned type of external beam radiation therapy (EBRT), stage at screening, and planned total radiotherapy dose.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"NA = Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"529"},{"groupId":"OG001","value":"531"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to the first documented progressive disease (PD) on next-line treatment or death due to any cause, whichever occurs first, as assessed by the investigator. PFS 2 is measured after next-line treatment following discontinuation of study treatment administration.","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":"MEDIAN","populationDescription":"All randomized participants analyzed in the treatment group to which they were randomized","reportingStatus":"POSTED","timeFrame":"Up to approximately 55 months","title":"PFS After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment","type":"SECONDARY","unitOfMeasure":"Months"}