{"analyses":[{"ciLowerLimit":"0.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.95","groupDescription":"Global Health Status/QoL (Week 12)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.0302","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons. Statistical significance predefined at α = 0.05.","paramType":"Least squares mean difference","paramValue":"6.4","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-6.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.18","groupDescription":"Global Health Status/QoL (Week 24)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.9356","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"-0.3","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-2.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.21","groupDescription":"Physical Function (Week 12)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.3161","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"2.2","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-3.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.35","groupDescription":"Physical Function (Week 24)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.7199","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"0.8","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-6.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.72","groupDescription":"Role Function (Week 12)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.8424","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"0.7","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-2.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"13.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.02","groupDescription":"Role Function (Week 24)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.1637","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"5.6","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-11.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.9","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.28","groupDescription":"Fatigue (Week 12)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.1614","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least Squares Mean Difference","paramValue":"-4.6","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-11.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.50","groupDescription":"Fatigue (Week 24)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.1817","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"-4.7","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-9.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.65","groupDescription":"Pain (Week 12)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.5870","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"-2.0","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-12.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.91","groupDescription":"Pain (Week 24)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.2148","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"-4.9","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-5.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.58","groupDescription":"Nausea/Vomiting (Week 12)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.0729","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"-2.8","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-5.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.69","groupDescription":"Nausea/Vomiting (Week 24)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.2766","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"-1.8","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-5.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.62","groupDescription":"Diarrhea (Week 12)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.6520","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"1.6","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-7.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.86","groupDescription":"Diarrhea (Week 24)","groupIds":["OG000","OG001"],"nonInferiorityComment":"The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \\[2-3 vs \\>3\\] and rituximab-refractory status \\[yes vs no\\]). Random participant effects were included as a random intercept.","nonInferiorityType":"OTHER","pValue":"0.8944","pValueComment":"Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.","paramType":"Least squares mean difference","paramValue":"0.5","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.9856","value":"-2.222"},{"groupId":"OG001","spread":"16.2440","value":"4.023"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"title":"Global Health Status/QOL: Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.1458","value":"4.955"},{"groupId":"OG001","spread":"17.3623","value":"2.577"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Global Health Status/QOL: Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.2526","value":"-1.449"},{"groupId":"OG001","spread":"13.8192","value":"0.361"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"117"}],"units":"Participants"}],"title":"Physical Function: Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.2553","value":"0.270"},{"groupId":"OG001","spread":"11.4186","value":"0.412"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Physical Function: Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.6347","value":"1.812"},{"groupId":"OG001","spread":"22.9412","value":"2.730"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"title":"Role Function: Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.1352","value":"-0.901"},{"groupId":"OG001","spread":"17.4022","value":"3.093"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Role Function: Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.3424","value":"2.657"},{"groupId":"OG001","spread":"19.5647","value":"-1.947"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"117"}],"units":"Participants"}],"title":"Fatigue: Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.0722","value":"-0.150"},{"groupId":"OG001","spread":"18.4911","value":"-2.291"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"95"}],"units":"Participants"}],"title":"Fatigue: Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.1993","value":"1.087"},{"groupId":"OG001","spread":"22.9448","value":"-1.580"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"title":"Pain: Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.0332","value":"-1.351"},{"groupId":"OG001","spread":"16.3450","value":"-4.983"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Pain: Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.2250","value":"1.812"},{"groupId":"OG001","spread":"10.9085","value":"-0.855"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"117"}],"units":"Participants"}],"title":"Nausea/Vomiting: Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.7895","value":"0.450"},{"groupId":"OG001","spread":"8.9412","value":"-1.031"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Nausea/Vomiting: Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.4049","value":"0.758"},{"groupId":"OG001","spread":"19.3197","value":"2.609"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"115"}],"units":"Participants"}],"title":"Diarrhea: Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.6416","value":"0.901"},{"groupId":"OG001","spread":"20.4124","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Diarrhea: Week 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom scores indicate better quality of life.","dispersionType":"Standard Deviation","groups":[{"description":"Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.","id":"OG000","title":"Obinutuzumab"},{"description":"Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.","id":"OG001","title":"Zanubrutinib + Obinutuzumab"}],"paramType":"MEAN","populationDescription":"ITT Analysis Set. Only participants with data at both baseline and each post-baseline visit were included in the calculation of change from baseline.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 12, and Week 24","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, Role Functioning, and Symptom Scores","type":"SECONDARY","unitOfMeasure":"Score on a scale"}