{"analyses":[{"ciLowerLimit":"-2.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.31","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Index-Score at Cycle 4","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.11"},{"ciLowerLimit":"-3.12","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.12","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Index-Score at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.62"},{"ciLowerLimit":"-3.13","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.11","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.51"},{"ciLowerLimit":"-2.31","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.76","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-0.77"},{"ciLowerLimit":"-4.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.20","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Pain/Discomfort Scale at Cycle 4","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-2.23"},{"ciLowerLimit":"-4.03","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.27","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Pain/Discomfort Scale at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.88"},{"ciLowerLimit":"-2.85","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.99","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Dietary Restrictions Scale at Cycle 4","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-0.93"},{"ciLowerLimit":"-3.42","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.77","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Dietary Restrictions Scale at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.32"},{"ciLowerLimit":"-3.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.09","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.59"},{"ciLowerLimit":"-3.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.06","estimateComment":"Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 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 QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.74"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.77","upperLimit":"-0.66","value":"-1.71"},{"groupId":"OG001","lowerLimit":"-1.66","upperLimit":"0.45","value":"-0.61"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"387"},{"groupId":"OG001","value":"379"}],"units":"Participants"}],"title":"Index Score: Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.95","upperLimit":"-0.74","value":"-1.84"},{"groupId":"OG001","lowerLimit":"-1.34","upperLimit":"0.89","value":"-0.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"339"}],"units":"Participants"}],"title":"Index Score: Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.99","upperLimit":"-1.57","value":"-2.78"},{"groupId":"OG001","lowerLimit":"-2.48","upperLimit":"-0.06","value":"-1.27"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"387"},{"groupId":"OG001","value":"379"}],"units":"Participants"}],"title":"Dysphagia/Odynophagia Scale: Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.93","upperLimit":"-1.64","value":"-2.79"},{"groupId":"OG001","lowerLimit":"-3.17","upperLimit":"-0.86","value":"-2.01"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"339"}],"units":"Participants"}],"title":"Dysphagia/Odynophagia Scale: Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-8.39","upperLimit":"-5.36","value":"-6.88"},{"groupId":"OG001","lowerLimit":"-6.16","upperLimit":"-3.13","value":"-4.64"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"387"},{"groupId":"OG001","value":"379"}],"units":"Participants"}],"title":"Pain/Discomfort Scale: Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.56","upperLimit":"-4.38","value":"-5.97"},{"groupId":"OG001","lowerLimit":"-5.69","upperLimit":"-2.49","value":"-4.09"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"339"}],"units":"Participants"}],"title":"Pain/Discomfort Scale: Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.75","upperLimit":"1.12","value":"-0.31"},{"groupId":"OG001","lowerLimit":"-0.82","upperLimit":"2.05","value":"0.61"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"387"},{"groupId":"OG001","value":"379"}],"units":"Participants"}],"title":"Dietary Restrictions Scale: Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.79","upperLimit":"1.30","value":"-0.25"},{"groupId":"OG001","lowerLimit":"-0.48","upperLimit":"2.63","value":"1.08"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"339"}],"units":"Participants"}],"title":"Dietary Restrictions Scale: Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.40","upperLimit":"-1.87","value":"-3.14"},{"groupId":"OG001","lowerLimit":"-2.80","upperLimit":"-0.28","value":"-1.54"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"387"},{"groupId":"OG001","value":"379"}],"units":"Participants"}],"title":"Upper Gastro-Intestinal Symptoms: Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.58","upperLimit":"-1.90","value":"-3.24"},{"groupId":"OG001","lowerLimit":"-2.84","upperLimit":"-0.14","value":"-1.49"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"339"}],"units":"Participants"}],"title":"Upper Gastro-Intestinal Symptoms: Cycle 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"467"}],"units":"Participants"}],"description":"EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales: Dysphagia/odynophagia (4 items), Pain/discomfort (3 items), Dietary restrictions (5 items), Upper gastro-intestinal (GI) symptoms (3 items), Specific emotional problems (3 items) and 4 single items. Each question is answered on a scale from 0 (Not at all) to 4 (Very Much), where lower scores indicate fewer symptoms/better QoL.\n\nRaw scores were transformed to a scale from 0 to 100, where lower scores indicate better QoL.\n\nThe QLQ-STO22 Index score is the mean of the 6 domain scores and 4 single items.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.","id":"OG000","title":"Tislelizumab + Chemotherapy"},{"description":"Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Participants in the ITT Analysis Set who completed the EORTC QLQ-STO22 at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point.","reportingStatus":"POSTED","timeFrame":"Baseline and Cycles 4 and 6","title":"Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)","type":"SECONDARY","unitOfMeasure":"units on a scale"}