{"analyses":[{"ciLowerLimit":"-5.20","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.67","groupIds":["OG000","OG001"],"nonInferiorityComment":"Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.","nonInferiorityType":"OTHER","pValue":"0.3138","pValueComment":"Two-sided p-value based on cLDA model.","paramType":"Difference in Least Square Means","paramValue":"-1.76","statisticalMethod":"cLDA model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-9.32","upperLimit":"-4.43","value":"-6.87"},{"groupId":"OG001","lowerLimit":"-7.69","upperLimit":"-2.54","value":"-5.11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"291"}],"units":"Participants"}],"description":"EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 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":"LEAST_SQUARES_MEAN","populationDescription":"All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.","reportingStatus":"POSTED","timeFrame":"Baseline and Week 51","title":"Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51","type":"SECONDARY","unitOfMeasure":"Score on a scale"}