{"analyses":[{"ciLowerLimit":"-3.46","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.26","groupDescription":"Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \\[0 vs. 1\\], HPV status \\[Positive vs. Negative\\] and PD-L1 TPS status \\[Strongly Positive, Not Strongly Positive\\]) as covariates.","groupIds":["OG001","OG002"],"nonInferiorityType":"OTHER","pValue":"0.839","pValueComment":"No formal hypothesis testing performed; nominal p-value provided for treatment comparison.","paramType":"Difference in LS Means","paramValue":"0.40","statisticalMethod":"constrained Longitudinal Data Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"-1.79","upperLimit":"4.12","value":"1.17"},{"groupId":"OG002","lowerLimit":"-2.22","upperLimit":"3.76","value":"0.77"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"268"},{"groupId":"OG002","value":"259"}],"units":"Participants"}],"description":"The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question \"How would you rate your overall health during the past week?\" (Item 29) and the Quality of Life (QoL) question \"How would you rate your overall quality of life during the past week?\" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score, for the first course of treatment, was compared between all participants of the pembro combo arm and the control arm as a pre-specified secondary analysis. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years).","id":"OG000","title":"Pembrolizumab Monotherapy (Pembro Mono)"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years); plus cisplatin 100 mg/m\\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","id":"OG001","title":"Pembrolizumab + Chemotherapy (Pembro Combo)"},{"description":"Participants received cetuximab on Day 1 at a dose of 400 mg/m\\^2 IV, and then 250 mg/m\\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\] for platinum-based therapy); plus 5-FU 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","id":"OG002","title":"Cetuximab + Chemotherapy (Control)"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Participants in pembro combo arm and control arm who received ≥1 dose of study drug and with EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. 20 in control arm enrolled during enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm compared to control arm separately and not included here.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 15","title":"Pembro Combo vs Control: Change From Baseline to Week 15 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}