{"analyses":[{"ciLowerLimit":"-8.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.48","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":"0.1763","pValueComment":"Two-sided p-value based on cLDA model.","paramType":"Difference in Least Square Means","paramValue":"-3.28","statisticalMethod":"cLDA model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.50","upperLimit":"7.58","value":"4.04"},{"groupId":"OG001","lowerLimit":"3.69","upperLimit":"10.95","value":"7.32"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"356"},{"groupId":"OG001","value":"306"}],"units":"Participants"}],"description":"EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants 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 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.","reportingStatus":"POSTED","timeFrame":"Baseline and Week 25","title":"Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25","type":"SECONDARY","unitOfMeasure":"Score on a scale"}