{"analyses":[{"ciLowerLimit":"9.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.7","groupIds":["OG000","OG001"],"nonInferiorityComment":"Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \\& Nurminen method stratified by primary tumor site and tumor stage.","nonInferiorityType":"OTHER","pValue":"<0.00001","pValueComment":"One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.","paramType":"Difference in Percentage","paramValue":"13.7","statisticalMethod":"Stratified Miettinen and Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.5","upperLimit":"18.8","value":"13.7"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"1.6","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"231"}],"units":"Participants"}],"description":"mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery 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":"NUMBER","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":"mPR Rate in Participants With PD-L1 CPS ≥10","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}