{"analyses":[{"ciLowerLimit":"-1.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.3","estimateComment":"Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-OES18 Dysphagia Score at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1372","paramType":"Least Squares (LS) Mean Difference","paramValue":"4.4","statisticalComment":"Two-sided p-value estimated from a mixed effect model","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-2.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.7","estimateComment":"Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-OES18 Eating Score at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7130","paramType":"LS Mean Difference","paramValue":"0.6","statisticalComment":"Two-sided p-value estimated from a mixed effect model","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-4.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.3","estimateComment":"Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-OES18 Reflux Score at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3001","paramType":"LS Mean Difference","paramValue":"-1.4","statisticalComment":"Two-sided p-value estimated from a mixed effect model","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-3.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.2","estimateComment":"Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-OES18 Pain Score at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.9"},{"ciLowerLimit":"-2.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.4","estimateComment":"Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-OES18 Index Score at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-0.4"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.7","upperLimit":"3.7","value":"-0.5"},{"groupId":"OG001","lowerLimit":"-9.4","upperLimit":"-0.5","value":"-4.9"}]}],"title":"Dysphagia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.1","upperLimit":"1.3","value":"-0.9"},{"groupId":"OG001","lowerLimit":"-3.8","upperLimit":"0.9","value":"-1.5"}]}],"title":"Eating"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.2","upperLimit":"0.7","value":"-1.3"},{"groupId":"OG001","lowerLimit":"-1.9","upperLimit":"2.2","value":"0.2"}]}],"title":"Reflux"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6.7","upperLimit":"-3.7","value":"-5.2"},{"groupId":"OG001","lowerLimit":"-4.9","upperLimit":"-1.8","value":"-3.3"}]}],"title":"Pain"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.2","upperLimit":"0.3","value":"-1.0"},{"groupId":"OG001","lowerLimit":"-1.9","upperLimit":"0.7","value":"-0.6"}]}],"title":"Index Score"}],"denoms":[{"counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"309"}],"units":"Participants"}],"description":"The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (trouble swallowing saliva, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.","id":"OG000","title":"Tislelizumab + Chemotherapy"},{"description":"Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at Baseline and at least one post-baseline measurement.","reportingStatus":"POSTED","timeFrame":"Baseline, Cycle 6 (Week 15)","title":"Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores","type":"SECONDARY","unitOfMeasure":"score on a scale"}