{"analyses":[{"ciLowerLimit":"-10.93","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.16","groupDescription":"DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0436","paramType":"Difference in LS Means","paramValue":"-5.54","statisticalMethod":"constrained Longitudinal Data Analysis"},{"ciLowerLimit":"-5.86","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.02","groupDescription":"PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0487","paramType":"Difference in LS Means","paramValue":"-2.94","statisticalMethod":"constrained Longitudinal Data Analysis"},{"ciLowerLimit":"-4.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.49","groupDescription":"REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.5932","paramType":"Difference in LS Means","paramValue":"-0.93","statisticalMethod":"constrained Longitudinal Data Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.19","upperLimit":"0.82","value":"-3.18"},{"groupId":"OG001","lowerLimit":"-1.77","upperLimit":"6.49","value":"2.36"}]}],"title":"Dysphagia subscale"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.01","upperLimit":"-2.56","value":"-4.78"},{"groupId":"OG001","lowerLimit":"-4.14","upperLimit":"0.45","value":"-1.85"}]}],"title":"Pain subscale"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.81","upperLimit":"2.36","value":"-0.22"},{"groupId":"OG001","lowerLimit":"-1.96","upperLimit":"3.38","value":"0.71"}]}],"title":"Reflux subscale"}],"denoms":[{"counts":[{"groupId":"OG000","value":"366"},{"groupId":"OG001","value":"359"}],"units":"Participants"}],"description":"The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher (\"worse\") level of symptoms. Per protocol, change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for all participants in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG000","title":"Pembrolizumab + SOC"},{"description":"Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG001","title":"Placebo + SOC"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC QLQ-OES18 assessment were analyzed.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 18","title":"Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}