{"classes":[{"categories":[{"measurements":[{"comment":"Here \"NA\" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG000","lowerLimit":"8.38","upperLimit":"NA","value":"14.95"},{"comment":"Here \"NA\" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG001","lowerLimit":"13.86","upperLimit":"NA","value":"24.18"}]}],"title":"Global Health Status"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.95","upperLimit":"24.05","value":"11.07"},{"comment":"Here \"NA\" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG001","lowerLimit":"7.16","upperLimit":"NA","value":"14.03"}]}],"title":"Cognitive Functioning"},{"categories":[{"measurements":[{"comment":"Here \"NA\" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG000","lowerLimit":"17.31","upperLimit":"NA","value":"NA"},{"comment":"Here \"NA\" indicates that upper limit of 95% CI was not estimable due to insufficient number of events","groupId":"OG001","lowerLimit":"16.62","upperLimit":"NA","value":"25.00"}]}],"title":"Emotional Functioning"},{"categories":[{"measurements":[{"comment":"Here \"NA\" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG000","lowerLimit":"19.42","upperLimit":"NA","value":"NA"},{"comment":"Here \"NA\" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG001","lowerLimit":"14.03","upperLimit":"NA","value":"NA"}]}],"title":"Physical Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.28","upperLimit":"14.95","value":"11.10"},{"groupId":"OG001","lowerLimit":"5.62","upperLimit":"16.69","value":"8.48"}]}],"title":"Role Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.34","upperLimit":"16.69","value":"11.10"},{"groupId":"OG001","lowerLimit":"11.07","upperLimit":"25.30","value":"17.87"}]}],"title":"Social Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.62","upperLimit":"14.95","value":"8.38"},{"comment":"Here \"NA\" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG001","lowerLimit":"8.44","upperLimit":"NA","value":"17.87"}]}],"title":"Fatigue (Symptom Scale)"},{"categories":[{"measurements":[{"comment":"Here \"NA\" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG000","lowerLimit":"8.28","upperLimit":"NA","value":"11.07"},{"comment":"Here \"NA\" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG001","lowerLimit":"20.44","upperLimit":"NA","value":"NA"}]}],"title":"Nausea/Vomiting (Symptom Scale)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.45","upperLimit":"13.90","value":"8.31"},{"groupId":"OG001","lowerLimit":"5.65","upperLimit":"17.87","value":"11.01"}]}],"title":"Pain (Symptom Scale)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"105"}],"units":"Participants"}],"description":"Time to worsening= time interval from randomization to first observation of deterioration. EORTC QLQ-C30 includes 30 separate items: 5 functional scales (physical, role, emotional, cognitive, and social Functioning), 1 global health status (GHS) and QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each item, except GHS, is answered on 4-point scale (1=not at all to 4=very much) and GHS is measured on 1-7 scale: 1=very poor and 7=excellent. Scores derived using validated scoring algorithms as per EORTC QLQ-C30 Manual and linearly transformed in a range from 0-100. For functional and global QoL scales, higher scores=better level of functioning/QoL. For symptom-oriented scales, higher score=more severe symptoms. Worsening in functional and global health scores=decrease of \\>=10 points (on 0-100 scale) and in symptom scores=increase of \\>=10 points (on 0-100 scale).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.","id":"OG000","title":"Treatment Arm A (Ibrutinib + Venetoclax)"},{"description":"Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.","id":"OG001","title":"Treatment Arm B (Chlorambucil + Obinutuzumab)"}],"paramType":"MEDIAN","populationDescription":"The ITT analysis set included all randomized participants who were analyzed according to assigned treatment group, regardless of the actual treatment received.","reportingStatus":"POSTED","timeFrame":"Up to 2 years 10 months","title":"Time to Worsening Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)","type":"SECONDARY","unitOfMeasure":"Months"}