Trial Outcomes & Findings for A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma (NCT NCT03332017)
NCT ID: NCT03332017
Last Updated: 2026-02-18
Results Overview
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
217 participants
Primary outcome timeframe
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
Results posted on
2026-02-18
Participant Flow
Participants were enrolled in multiple study centers in Australia, Europe, Asia, and North America.
After enrollment, participants were randomized 2:1 to zanubrutinib plus obinutuzumab or obinutuzumab alone, stratified by prior therapy, rituximab-refractory status, and region. Treatment began within 5 days, in 28-day cycles. At investigator discretion, those on obinutuzumab monotherapy could cross over to zanubrutinib plus obinutuzumab if progressive disease or non-response was confirmed by independent central review.
Participant milestones
| Measure |
Obinutuzumab
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.
Participants who experienced progressive disease or did not respond to therapy within 12 months may have received crossover treatment with zanubrutinib plus obinutuzumab at the investigator's discretion.
|
Zanubrutinib + Obinutuzumab
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.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
145
|
|
Overall Study
Treated
|
71
|
143
|
|
Overall Study
Crossover to Combination Treatment
|
36
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
72
|
145
|
Reasons for withdrawal
| Measure |
Obinutuzumab
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.
Participants who experienced progressive disease or did not respond to therapy within 12 months may have received crossover treatment with zanubrutinib plus obinutuzumab at the investigator's discretion.
|
Zanubrutinib + Obinutuzumab
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.
|
|---|---|---|
|
Overall Study
Death
|
33
|
51
|
|
Overall Study
Study Closed by Sponsor
|
20
|
55
|
|
Overall Study
Withdrawal by Subject
|
14
|
30
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Other
|
3
|
3
|
|
Overall Study
Remained on Study
|
0
|
1
|
Baseline Characteristics
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 12.81 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 11.98
|
61.7 years
STANDARD_DEVIATION 12.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=4 Participants
|
70 Participants
|
109 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=4 Participants
|
75 Participants
|
108 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=4 Participants
|
4 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=4 Participants
|
116 Participants
|
176 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=4 Participants
|
25 Participants
|
35 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=4 Participants
|
92 Participants
|
139 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=4 Participants
|
30 Participants
|
47 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
8 Participants
n=4 Participants
|
23 Participants
|
31 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: Intent-To-Treat (ITT) analysis set includes all randomized participants.
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
Outcome measures
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
|---|---|---|
|
Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment
|
45.8 percentage of participants
Interval 34.0 to 58.0
|
68.3 percentage of participants
Interval 60.0 to 75.7
|
SECONDARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: ITT Analysis Set
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
Outcome measures
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
|---|---|---|
|
Overall Response Rate (ORR) as Assessed by the Investigator
|
41.7 Percentage of Participants
Interval 30.2 to 53.9
|
66.2 Percentage of Participants
Interval 57.9 to 73.8
|
SECONDARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: The ITT analysis set for this endpoint only included participants with a confirmed response (CR or PR) before disease progression per investigator assessment.
DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Obinutuzumab
n=30 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=95 Participants
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.
|
|---|---|---|
|
Duration of Response (DOR) as Determined by Investigator Assessment
|
9.2 Months
Interval 3.8 to
Not estimable due to insufficient number of participants with events
|
30.6 Months
Interval 24.7 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: The ITT analysis set for this endpoint only included participants with a confirmed (CR or PR) per ICR assessment.
DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Obinutuzumab
n=33 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=99 Participants
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.
|
|---|---|---|
|
DOR as Determined by ICR
|
NA Months
Interval 9.0 to
Not estimable due to insufficient number of participants with events
|
NA Months
Interval 24.7 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: ITT Analysis Set
PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
|---|---|---|
|
Progression-free Survival (PFS)
ICR
|
11.2 Months
Interval 6.5 to 15.7
|
27.4 Months
Interval 16.1 to
Not estimable due to insufficient number of participants with events
|
|
Progression-free Survival (PFS)
Investigator
|
5.8 Months
Interval 3.7 to 8.2
|
22.2 Months
Interval 11.3 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: ITT Analysis Set
OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 26.8 to
Not estimable due to insufficient number of participants with events
|
NA Months
Interval 31.4 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: ITT Analysis Set
CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy.
Outcome measures
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
|---|---|---|
|
Complete Response Rate
ICR
|
19.4 Percentage of Participants
Interval 11.1 to 30.5
|
37.2 Percentage of Participants
Interval 29.4 to 45.7
|
|
Complete Response Rate
Investigator
|
19.4 Percentage of Participants
Interval 11.1 to 30.5
|
29.0 Percentage of Participants
Interval 21.7 to 37.1
|
SECONDARY outcome
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.Population: ITT Analysis Set. Only participants who achieved an overall response were included in the analysis.
TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation.
Outcome measures
| Measure |
Obinutuzumab
n=33 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=99 Participants
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.
|
|---|---|---|
|
Time to Response (TTR)
ICR
|
2.83 Months
Interval 2.5 to 6.5
|
2.83 Months
Interval 2.0 to 14.0
|
|
Time to Response (TTR)
Investigator
|
2.79 Months
Interval 2.5 to 16.6
|
2.79 Months
Interval 2.0 to 16.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: ITT Analysis Set. Only participants with data at both baseline and each post-baseline visit were included in the calculation of change from baseline.
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.
Outcome measures
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
|---|---|---|
|
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
Global Health Status/QOL: Week 12
|
-2.222 Score on a scale
Standard Deviation 16.9856
|
4.023 Score on a scale
Standard Deviation 16.2440
|
|
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
Global Health Status/QOL: Week 24
|
4.955 Score on a scale
Standard Deviation 15.1458
|
2.577 Score on a scale
Standard Deviation 17.3623
|
|
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
Physical Function: Week 12
|
-1.449 Score on a scale
Standard Deviation 13.2526
|
0.361 Score on a scale
Standard Deviation 13.8192
|
|
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
Physical Function: Week 24
|
0.270 Score on a scale
Standard Deviation 10.2553
|
0.412 Score on a scale
Standard Deviation 11.4186
|
|
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
Role Function: Week 12
|
1.812 Score on a scale
Standard Deviation 25.6347
|
2.730 Score on a scale
Standard Deviation 22.9412
|
|
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
Role Function: Week 24
|
-0.901 Score on a scale
Standard Deviation 21.1352
|
3.093 Score on a scale
Standard Deviation 17.4022
|
|
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
Fatigue: Week 12
|
2.657 Score on a scale
Standard Deviation 19.3424
|
-1.947 Score on a scale
Standard Deviation 19.5647
|
|
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
Fatigue: Week 24
|
-0.150 Score on a scale
Standard Deviation 15.0722
|
-2.291 Score on a scale
Standard Deviation 18.4911
|
|
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
Pain: Week 12
|
1.087 Score on a scale
Standard Deviation 21.1993
|
-1.580 Score on a scale
Standard Deviation 22.9448
|
|
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
Pain: Week 24
|
-1.351 Score on a scale
Standard Deviation 23.0332
|
-4.983 Score on a scale
Standard Deviation 16.3450
|
|
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
Nausea/Vomiting: Week 12
|
1.812 Score on a scale
Standard Deviation 7.2250
|
-0.855 Score on a scale
Standard Deviation 10.9085
|
|
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
Nausea/Vomiting: Week 24
|
0.450 Score on a scale
Standard Deviation 4.7895
|
-1.031 Score on a scale
Standard Deviation 8.9412
|
|
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
Diarrhea: Week 12
|
0.758 Score on a scale
Standard Deviation 25.4049
|
2.609 Score on a scale
Standard Deviation 19.3197
|
|
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
Diarrhea: Week 24
|
0.901 Score on a scale
Standard Deviation 16.6416
|
0.00 Score on a scale
Standard Deviation 20.4124
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: ITT Analysis Set; Only participants with data at both baseline and each post-baseline visit were included in the calculation of change from baseline.
The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Outcome measures
| Measure |
Obinutuzumab
n=72 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=145 Participants
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.
|
|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
Week 12
|
-0.3 Score on a scale
Standard Deviation 14.96
|
2.4 Score on a scale
Standard Deviation 16.71
|
|
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
Week 24
|
2.0 Score on a scale
Standard Deviation 14.17
|
3.1 Score on a scale
Standard Deviation 15.95
|
SECONDARY outcome
Timeframe: From first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.Population: The Safety Analysis Set includes all participants in the ITT Analysis Set who received any dose of any study drug
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug.
Outcome measures
| Measure |
Obinutuzumab
n=71 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=143 Participants
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.
|
|---|---|---|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
At Least One TEAE
|
65 Participants
|
137 Participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
At Least One SAE
|
22 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.Population: The PK Analysis Set included all zanubrutinib-treated participants with ≥1 post-baseline PK concentration (n=142). Concentrations were excluded per prespecified rules (missing/invalid times, pre-dose values, peak-trough switches, and outliers), resulting in 137 participants with reported PK parameters.
Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.
Outcome measures
| Measure |
Obinutuzumab
n=137 Participants
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.
|
Zanubrutinib + Obinutuzumab
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.
|
|---|---|---|
|
Area Under the Curve (AUCss) of Zanubrutinib at Steady State
|
2203.619021 nanogram·hour per milliliter (ng·h/mL)
Standard Deviation 1045.430371
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.Population: The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement.
Outcome measures
| Measure |
Obinutuzumab
n=142 Participants
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.
|
Zanubrutinib + Obinutuzumab
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.
|
|---|---|---|
|
Zanubrutinib Plasma Concentrations
Cycle 1 Day 1 (2h Postdose)
|
254.30 nanograms per milliliter (ng/ml)
Standard Deviation 181.783
|
—
|
|
Zanubrutinib Plasma Concentrations
Cycle 2 Day 1 (Predose)
|
22.29 nanograms per milliliter (ng/ml)
Standard Deviation 36.078
|
—
|
|
Zanubrutinib Plasma Concentrations
Cycle 2 Day 1 (2h Postdose)
|
198.37 nanograms per milliliter (ng/ml)
Standard Deviation 138.310
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.Population: The PK Analysis Set included all zanubrutinib-treated participants with ≥1 post-baseline PK concentration (n=142). Concentrations were excluded per prespecified rules (missing/invalid times, pre-dose values, peak-trough switches, and outliers), resulting in 137 participants with reported PK parameters. concentration measurement.
Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.
Outcome measures
| Measure |
Obinutuzumab
n=137 Participants
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.
|
Zanubrutinib + Obinutuzumab
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.
|
|---|---|---|
|
Minimum Observed Concentration (Cmin) of Zanubrutinib at Steady State
|
11.51 nanograms per milliliter (ng/ml)
Standard Deviation 9.72
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose)Population: The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement.
Outcome measures
| Measure |
Obinutuzumab
n=137 Participants
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.
|
Zanubrutinib + Obinutuzumab
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.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State
|
299.83 nanograms per milliliter (ng/ml)
Standard Deviation 134.12
|
—
|
POST_HOC outcome
Timeframe: From first dose to updated analysis data cutoff (25JUN2022) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up time was 20.21 months.Population: Participants in the ITT analysis set with a confirmed complete response (CR) or partial response (PR) per ICR assessment at the updated post-hoc analysis data cutoff (25 JUN 2022).
Per the Food and Drug Adminstrations's request, an additional analysis of DOR was conducted 12 months after the last participant was randomized. DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Obinutuzumab
n=33 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=100 Participants
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.
|
|---|---|---|
|
Duration of Response (DOR) as Determined by ICR
|
14.0 Months
Interval 9.2 to 25.1
|
NA Months
Interval 25.3 to
Not estimable due to insufficient number of participants with events
|
POST_HOC outcome
Timeframe: From first dose to updated analysis data cutoff (25JUN2022) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up time was 20.21 months.Population: Participants in the ITT analysis set with a confirmed complete response (CR) or partial response (PR) per investigator assessment at the updated post-hoc analysis data cutoff (25 JUN 2022).
Per the Food and Drug Adminstrations's request, an additional analysis of DOR was conducted 12 months after the last participant was randomized. DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Obinutuzumab
n=31 Participants
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.
|
Zanubrutinib + Obinutuzumab
n=99 Participants
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.
|
|---|---|---|
|
DOR as Determined by Investigator
|
8.8 Months
Interval 4.3 to
Not estimable due to insufficient number of participants with events
|
29.8 Months
Interval 20.4 to
Not estimable due to insufficient number of participants with events
|
Adverse Events
Obinutuzumab Monotherapy
Serious events: 22 serious events
Other events: 62 other events
Deaths: 33 deaths
Zanubrutinib Plus Obinutuzumab
Serious events: 75 serious events
Other events: 130 other events
Deaths: 51 deaths
Crossover Treatment
Serious events: 20 serious events
Other events: 32 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Obinutuzumab Monotherapy
n=71 participants at risk
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.
|
Zanubrutinib Plus Obinutuzumab
n=143 participants at risk
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.
|
Crossover Treatment
n=36 participants at risk
Participants in teh obinutuzumab monotherapy arm who experienced progressive disease or their disease did not respond to therapy after 12 months (confirmed by the independent central review) crossed over to receive zanubrutinib 160 mg twice a day orally in addition to obinutuzumab 1000 mg intravenously every 8 weeks for a maximum of 30 months or until disease progression at the investigator's discretion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Necrotic lymphadenopathy
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.1%
3/143 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Death
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Influenza like illness
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Swelling face
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
1.4%
1/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19
|
2.8%
2/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
9.1%
13/143 • Number of events 15 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
4.2%
3/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
7.0%
10/143 • Number of events 12 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
16.7%
6/36 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Complicated appendicitis
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
HCoV-OC43 infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Hepatitis E
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Myelitis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Nail infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
13.3%
19/143 • Number of events 25 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
13.9%
5/36 • Number of events 7 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pulmonary mucormycosis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Septic shock
|
1.4%
1/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Varicella
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Vascular access site infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Barotitis media
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Amylase increased
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Lipase increased
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Syncope
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
Other adverse events
| Measure |
Obinutuzumab Monotherapy
n=71 participants at risk
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.
|
Zanubrutinib Plus Obinutuzumab
n=143 participants at risk
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.
|
Crossover Treatment
n=36 participants at risk
Participants in teh obinutuzumab monotherapy arm who experienced progressive disease or their disease did not respond to therapy after 12 months (confirmed by the independent central review) crossed over to receive zanubrutinib 160 mg twice a day orally in addition to obinutuzumab 1000 mg intravenously every 8 weeks for a maximum of 30 months or until disease progression at the investigator's discretion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
6/71 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
15.4%
22/143 • Number of events 57 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.9%
12/71 • Number of events 22 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
15.4%
22/143 • Number of events 61 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
25.0%
9/36 • Number of events 20 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.9%
7/71 • Number of events 19 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
21.7%
31/143 • Number of events 99 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
11.1%
4/36 • Number of events 11 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Eye disorders
Cataract
|
4.2%
3/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
4/143 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.3%
8/71 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
7.7%
11/143 • Number of events 13 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
8.5%
6/71 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
14.7%
21/143 • Number of events 28 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
13.9%
5/36 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
13/71 • Number of events 17 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
20.3%
29/143 • Number of events 44 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
16.7%
6/36 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
15.5%
11/71 • Number of events 14 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
9.8%
14/143 • Number of events 19 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
8/143 • Number of events 11 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
5/71 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
6.3%
9/143 • Number of events 17 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Asthenia
|
8.5%
6/71 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
12.6%
18/143 • Number of events 25 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest discomfort
|
4.2%
3/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chills
|
5.6%
4/71 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
4/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
15.5%
11/71 • Number of events 13 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
16.8%
24/143 • Number of events 31 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
5.6%
4/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
4/143 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
11.1%
4/36 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pain
|
4.2%
3/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Peripheral swelling
|
5.6%
4/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
16.9%
12/71 • Number of events 16 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
16.8%
24/143 • Number of events 38 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.9%
7/143 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19
|
9.9%
7/71 • Number of events 7 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
16.8%
24/143 • Number of events 29 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
25.0%
9/36 • Number of events 12 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Conjunctivitis
|
4.2%
3/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Gastroenteritis
|
4.2%
3/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.4%
12/143 • Number of events 17 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Influenza
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/143 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.1%
3/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
4.2%
3/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 7 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
9.1%
13/143 • Number of events 17 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
5.6%
4/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
14.7%
21/143 • Number of events 26 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Rhinitis
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.2%
6/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
4/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
11.2%
16/143 • Number of events 23 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
4/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
15/143 • Number of events 20 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
9.1%
13/143 • Number of events 19 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
19.4%
7/36 • Number of events 9 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
3/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.9%
7/143 • Number of events 7 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.9%
7/71 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
4/143 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
4/143 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
1/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.2%
6/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
1/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.2%
6/143 • Number of events 9 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
1.4%
1/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 19 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
11.3%
8/71 • Number of events 20 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
16.8%
24/143 • Number of events 79 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
15.5%
11/71 • Number of events 30 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
18.9%
27/143 • Number of events 77 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
22.2%
8/36 • Number of events 16 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.9%
7/143 • Number of events 11 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
5.6%
4/71 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
12.6%
18/143 • Number of events 78 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
4/71 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.2%
3/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
3/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
9.1%
13/143 • Number of events 17 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.8%
2/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
8/143 • Number of events 9 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
5/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.2%
6/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
4/71 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
11.2%
16/143 • Number of events 18 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.0%
5/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.9%
7/143 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
4/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.2%
6/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
5.6%
4/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
4/143 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Headache
|
2.8%
2/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.2%
6/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
4.2%
3/71 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
1.4%
2/143 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Psychiatric disorders
Insomnia
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
7.0%
10/143 • Number of events 11 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.7%
9/71 • Number of events 9 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
17.5%
25/143 • Number of events 29 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.3%
8/71 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
11.9%
17/143 • Number of events 19 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
11.1%
4/36 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.9%
7/143 • Number of events 13 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.70%
1/143 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
2/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.2%
3/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
4/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.4%
1/71 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
5/143 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/36 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/71 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
6.3%
9/143 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 3 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.9%
7/71 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
7.0%
10/143 • Number of events 12 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
3/36 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
4/71 • Number of events 4 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
5.6%
8/143 • Number of events 10 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Haematoma
|
2.8%
2/71 • Number of events 2 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.2%
6/143 • Number of events 6 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
5.6%
4/71 • Number of events 5 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
4.9%
7/143 • Number of events 8 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
2.8%
1/36 • Number of events 1 • All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER