{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.88","groupIds":["OG000","OG001"],"nonInferiorityComment":"HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.","nonInferiorityType":"SUPERIORITY","pValue":"0.00217","paramType":"Hazard Ratio (HR)","paramValue":"0.66","statisticalComment":"One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.","statisticalMethod":"Stratified Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = upper limit not reached due to insufficient number of participants with an event.","groupId":"OG000","lowerLimit":"41.1","upperLimit":"NA","value":"59.7"},{"groupId":"OG001","lowerLimit":"18.3","upperLimit":"51.5","value":"26.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"description":"EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥10 was presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).","id":"OG000","title":"Pembrolizumab + Standard of Care (SOC)"},{"description":"Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).","id":"OG001","title":"Standard of Care (SOC)"}],"paramType":"MEDIAN","populationDescription":"Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.","reportingStatus":"POSTED","timeFrame":"Up to ~66 months","title":"EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10","type":"PRIMARY","unitOfMeasure":"Months"}