{"analyses":[{"ciLowerLimit":"0.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.77","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 24. A 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":"0.0338","paramType":"Least Squares (LS) Mean Difference","paramValue":"3.00","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-1.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.06","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 48. A 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":"0.3304","paramType":"LS Mean Difference","paramValue":"1.34","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-0.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.12","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning 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":"0.1189","paramType":"LS Mean Difference","paramValue":"1.82","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-1.15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.44","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning 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":"0.3274","paramType":"LS Mean Difference","paramValue":"1.15","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-2.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.66","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning 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":"0.6821","paramType":"LS Mean Difference","paramValue":"0.63","statisticalMethod":"Mixed model for repeated measures (MMRM)"},{"ciLowerLimit":"-1.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.00","groupDescription":"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning 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":"0.2701","paramType":"LS Mean Difference","paramValue":"1.80","statisticalMethod":"Mixed model for repeated measures (MMRM)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.25","upperLimit":"10.12","value":"8.18"},{"groupId":"OG001","lowerLimit":"3.20","upperLimit":"7.17","value":"5.18"}]}],"title":"GHS/QoL Scale at Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.41","upperLimit":"9.15","value":"7.28"},{"groupId":"OG001","lowerLimit":"3.97","upperLimit":"7.89","value":"5.93"}]}],"title":"GHS/QoL Scale at Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.96","upperLimit":"8.15","value":"6.55"},{"groupId":"OG001","lowerLimit":"3.08","upperLimit":"6.38","value":"4.73"}]}],"title":"Physical Functioning Scale at Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.87","upperLimit":"7.04","value":"5.46"},{"groupId":"OG001","lowerLimit":"2.65","upperLimit":"5.97","value":"4.31"}]}],"title":"Physical Functioning Scale at Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.85","upperLimit":"9.06","value":"6.95"},{"groupId":"OG001","lowerLimit":"4.14","upperLimit":"8.50","value":"6.32"}]}],"title":"Role Functioning Scale at Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.61","upperLimit":"9.02","value":"6.81"},{"groupId":"OG001","lowerLimit":"2.69","upperLimit":"7.33","value":"5.01"}]}],"title":"Role Functioning 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. Higher scores in GHS and functional 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 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores","type":"SECONDARY","unitOfMeasure":"score on a scale"}