{"analyses":[{"ciLowerLimit":"-3.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.15","estimateComment":"Mixed effect model analysis with QLQ-C30 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 Fatigue at Cycle 4","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-1.32"},{"ciLowerLimit":"-5.78","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.24","estimateComment":"Mixed effect model analysis with QLQ-C30 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 Fatigue at Cycle 6","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"LS Mean Difference","paramValue":"-3.01"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.09","upperLimit":"3.60","value":"1.75"},{"groupId":"OG001","lowerLimit":"1.23","upperLimit":"4.91","value":"3.07"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"388"},{"groupId":"OG001","value":"380"}],"units":"Participants"}],"title":"Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.32","upperLimit":"3.75","value":"1.71"},{"groupId":"OG001","lowerLimit":"2.68","upperLimit":"6.77","value":"4.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"359"},{"groupId":"OG001","value":"339"}],"units":"Participants"}],"title":"Cycle 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"467"}],"units":"Participants"}],"description":"The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms.","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-C30 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 EORTC QLQ-C30 Fatigue Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}