{"analyses":[{"ciLowerLimit":"-4.70","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.87","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.1778","paramType":"LS Mean Difference","paramValue":"-1.91","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-3.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.62","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.8174","paramType":"LS Mean Difference","paramValue":"-0.35","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-1.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.89","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.6294","paramType":"LS Mean Difference","paramValue":"-0.29","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-1.99","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.96","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.4933","paramType":"LS Mean Difference","paramValue":"-0.51","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-4.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.66","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.3643","paramType":"LS Mean Difference","paramValue":"-1.43","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-5.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.77","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.1363","paramType":"LS Mean Difference","paramValue":"-2.43","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-4.01","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.84","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.2001","paramType":"LS Mean Difference","paramValue":"-1.59","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-4.12","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.43","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.\n\nA linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.1121","paramType":"LS Mean Difference","paramValue":"-1.85","statisticalMethod":"Mixed model for repeated measures (MMRM)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-14.47","upperLimit":"-10.60","value":"-12.54"},{"groupId":"OG001","lowerLimit":"-12.63","upperLimit":"-8.62","value":"-10.63"}]}],"title":"Fatigue Symptom Scale at Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-13.19","upperLimit":"-9.08","value":"-11.13"},{"groupId":"OG001","lowerLimit":"-12.93","upperLimit":"-8.63","value":"-10.78"}]}],"title":"Fatigue Symptom Scale at Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.03","upperLimit":"-0.38","value":"-1.21"},{"groupId":"OG001","lowerLimit":"-1.77","upperLimit":"-0.07","value":"-0.92"}]}],"title":"Nausea and Vomiting Symptom Scale at Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.94","upperLimit":"0.10","value":"-0.92"},{"groupId":"OG001","lowerLimit":"-1.47","upperLimit":"0.66","value":"-0.40"}]}],"title":"Nausea and Vomiting Symptom Scale at Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.21","upperLimit":"-2.91","value":"-5.06"},{"groupId":"OG001","lowerLimit":"-5.85","upperLimit":"-1.42","value":"-3.63"}]}],"title":"Pain Symptom Scale at Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.38","upperLimit":"-2.97","value":"-5.18"},{"groupId":"OG001","lowerLimit":"-5.06","upperLimit":"-0.44","value":"-2.75"}]}],"title":"Pain Symptom Scale at Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.80","upperLimit":"-0.42","value":"-2.11"},{"groupId":"OG001","lowerLimit":"-2.27","upperLimit":"1.22","value":"-0.52"}]}],"title":"Diarrhoea Symptom Scale at Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.79","upperLimit":"-1.66","value":"-3.23"},{"groupId":"OG001","lowerLimit":"-3.03","upperLimit":"0.27","value":"-1.38"}]}],"title":"Diarrhoea Symptom Scale at Week 48"}],"denoms":[{"counts":[{"groupId":"OG000","value":"315"},{"groupId":"OG001","value":"313"}],"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 into a 0 to 100 scale via linear transformation. Lower scores in symptom scales indicate better quality of life.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.","id":"OG000","title":"Zanubrutinib"},{"description":"Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.","id":"OG001","title":"Ibrutinib"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline","reportingStatus":"POSTED","timeFrame":"Baseline and Weeks 24 and 48","title":"Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea","type":"SECONDARY","unitOfMeasure":"score on a scale"}