Trial Outcomes & Findings for A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (NCT NCT03734016)
NCT ID: NCT03734016
Last Updated: 2025-03-30
Results Overview
ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment. Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.
COMPLETED
PHASE3
652 participants
From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
2025-03-30
Participant Flow
This study was conducted at 113 study centers in 15 countries (Australia, Belgium, China, the Czech Republic, France, Germany, Italy, the Netherlands, New Zealand, Poland, Spain, Sweden, Turkey, the United Kingdom, and the United States).
Participants were randomly assigned to one of two treatment groups. Randomization was stratified according to age (\< 65 versus ≥ 65 years), geographic region (China vs non-China), refractory status (yes or no), and chromosome 17p deletion or TP53 mutation status (present or absent).
Participant milestones
| Measure |
Zanubrutinib
Participants received 160 milligrams (mg) zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Overall Study
STARTED
|
327
|
325
|
|
Overall Study
Received Study Drug
|
324
|
324
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
327
|
325
|
Reasons for withdrawal
| Measure |
Zanubrutinib
Participants received 160 milligrams (mg) zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Overall Study
Sponsor Ended Study
|
225
|
200
|
|
Overall Study
Death
|
69
|
83
|
|
Overall Study
Withdrawal by Subject
|
21
|
27
|
|
Overall Study
Physician Decision
|
1
|
12
|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
|
Overall Study
Miscellaneous
|
5
|
1
|
Baseline Characteristics
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
126 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
251 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
201 Participants
n=93 Participants
|
200 Participants
n=4 Participants
|
401 Participants
n=27 Participants
|
|
Age, Continuous
|
67.0 years
n=93 Participants
|
68.0 years
n=4 Participants
|
67.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
207 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
213 Participants
n=93 Participants
|
232 Participants
n=4 Participants
|
445 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
309 Participants
n=93 Participants
|
298 Participants
n=4 Participants
|
607 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
47 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
261 Participants
n=93 Participants
|
265 Participants
n=4 Participants
|
526 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Geographic Region
Asia
|
49 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Geographic Region
Australia/New Zealand
|
28 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Geographic Region
Europe
|
198 Participants
n=93 Participants
|
191 Participants
n=4 Participants
|
389 Participants
n=27 Participants
|
|
Geographic Region
North America
|
52 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
|
Chromosome 17p Deletion (del[17p]) and TP53 Mutation Status
Del(17p) and/or TP53 mutation
|
75 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
150 Participants
n=27 Participants
|
|
Chromosome 17p Deletion (del[17p]) and TP53 Mutation Status
Neither Del(17p) nor TP53 mutation
|
251 Participants
n=93 Participants
|
250 Participants
n=4 Participants
|
501 Participants
n=27 Participants
|
|
Chromosome 17p Deletion (del[17p]) and TP53 Mutation Status
Missing
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: Intent To Treat (ITT) Analysis Set
ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment. Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Overall Response Rate (ORR) Assessed by the Investigator
|
83.5 percentage of participants
Interval 79.0 to 87.3
|
74.2 percentage of participants
Interval 69.0 to 78.8
|
PRIMARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: ITT Analysis Set
ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) assessed by a blinded independent review committee. Overall response was assessed by the IRC for the purpose of regulatory filing with the Food and Drug Administration (FDA). Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
ORR Assessed by the Independent Review Committee (IRC)
|
86.2 percentage of participants
Interval 82.0 to 89.8
|
75.7 percentage of participants
Interval 70.7 to 80.3
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: ITT Analysis Set
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Progression-free Survival (PFS) Assessed by the Investigator
|
NA months
Interval 34.3 to
Insufficient number of participants with events to estimate median and upper 95% confidence limit.
|
34.2 months
Interval 33.3 to
Insufficient number of participants with events to estimate upper 95% confidence limit.
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: Intent To Treat Analysis Set
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Progression-free Survival Assessed by the Independent Review Committee
|
NA months
Interval 34.3 to
Insufficient number of participants with events to estimate median and upper 95% confidence limit.
|
35.0 months
Interval 33.2 to 44.3
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: The Safety Analysis Set includes all participants who received any dose of study drug.
Participants were considered as having an atrial fibrillation/flutter event if they had a treatment-emergent AE of either "atrial fibrillation" or "atrial flutter".
Outcome measures
| Measure |
Zanubrutinib
n=324 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=324 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Percentage of Participants With Atrial Fibrillation or Atrial Flutter
|
5.2 percentage of participants
Interval 3.1 to 8.3
|
13.3 percentage of participants
Interval 9.8 to 17.5
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: Participants in the ITT Analysis Set with an objective response assessed by the IRC
DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by independent central review. Median DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=282 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=246 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Duration of Response Assessed by the Independent Review Committee
|
NA months
Interval 31.3 to
Insufficient number of participants with events to estimate median and upper 95% confidence limit.
|
33.9 months
Interval 32.2 to 41.4
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: Participants in the ITT Analysis Set with an objective response as assessed by the investigator
DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by investigator assessment. Median DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=273 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=241 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Duration of Response (DOR) Assessed by the Investigator
|
NA months
Interval 31.3 to
Insufficient number of participants with events to estimate median and upper 95% confidence limit.
|
33.9 months
Interval 33.9 to
Insufficient number of participants with events to estimate upper 95% confidence limit.
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: ITT Analysis Set
Time to treatment failure is defined as the time from randomization to discontinuation of study drug due to any reason. Median time to treatment failure was estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Time to Treatment Failure
|
NA months
Insufficient number of participants with events to estimate median and 95% confidence interval.
|
NA months
Interval 34.4 to
Insufficient number of participants with events to estimate median and upper 95% confidence limit.
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: ITT Analysis Set
The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or a complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis assessed by the blinded IRC. Disease response was assessed per iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and per Lugano classification for participants with SLL.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Independent Review Committee
|
91.7 percentage of participants
Interval 88.2 to 94.5
|
83.1 percentage of participants
Interval 78.5 to 87.0
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: ITT Analysis Set
The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis as assessed by the investigator. Disease response was assessed according to the iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and in accordance with Lugano classification for participants with SLL. Partial response with lymphocytosis: blood lymphocytes decreased \< 50% or increased from baseline, and otherwise meeting criteria for PR.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Investigator
|
89.9 percentage of participants
Interval 86.1 to 93.0
|
82.5 percentage of participants
Interval 77.9 to 86.4
|
SECONDARY outcome
Timeframe: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).Population: ITT Analysis Set
Overall survival is defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=327 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=325 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Insufficient number of participants with events to estimate median and 95% confidence interval.
|
NA months
Insufficient number of participants with events to estimate median and 95% confidence interval.
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24 and 48Population: Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.
Outcome measures
| Measure |
Zanubrutinib
n=315 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=313 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores
GHS/QoL Scale at Week 24
|
8.18 score on a scale
Interval 6.25 to 10.12
|
5.18 score on a scale
Interval 3.2 to 7.17
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores
GHS/QoL Scale at Week 48
|
7.28 score on a scale
Interval 5.41 to 9.15
|
5.93 score on a scale
Interval 3.97 to 7.89
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores
Physical Functioning Scale at Week 24
|
6.55 score on a scale
Interval 4.96 to 8.15
|
4.73 score on a scale
Interval 3.08 to 6.38
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores
Physical Functioning Scale at Week 48
|
5.46 score on a scale
Interval 3.87 to 7.04
|
4.31 score on a scale
Interval 2.65 to 5.97
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores
Role Functioning Scale at Week 24
|
6.95 score on a scale
Interval 4.85 to 9.06
|
6.32 score on a scale
Interval 4.14 to 8.5
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning and Role Functioning Scores
Role Functioning Scale at Week 48
|
6.81 score on a scale
Interval 4.61 to 9.02
|
5.01 score on a scale
Interval 2.69 to 7.33
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24 and 48Population: Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores in symptom scales indicate better quality of life.
Outcome measures
| Measure |
Zanubrutinib
n=315 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=313 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Fatigue Symptom Scale at Week 48
|
-11.13 score on a scale
Interval -13.19 to -9.08
|
-10.78 score on a scale
Interval -12.93 to -8.63
|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Nausea and Vomiting Symptom Scale at Week 24
|
-1.21 score on a scale
Interval -2.03 to -0.38
|
-0.92 score on a scale
Interval -1.77 to -0.07
|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Fatigue Symptom Scale at Week 24
|
-12.54 score on a scale
Interval -14.47 to -10.6
|
-10.63 score on a scale
Interval -12.63 to -8.62
|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Nausea and Vomiting Symptom Scale at Week 48
|
-0.92 score on a scale
Interval -1.94 to 0.1
|
-0.40 score on a scale
Interval -1.47 to 0.66
|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Pain Symptom Scale at Week 24
|
-5.06 score on a scale
Interval -7.21 to -2.91
|
-3.63 score on a scale
Interval -5.85 to -1.42
|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Pain Symptom Scale at Week 48
|
-5.18 score on a scale
Interval -7.38 to -2.97
|
-2.75 score on a scale
Interval -5.06 to -0.44
|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Diarrhoea Symptom Scale at Week 24
|
-2.11 score on a scale
Interval -3.8 to -0.42
|
-0.52 score on a scale
Interval -2.27 to 1.22
|
|
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
Diarrhoea Symptom Scale at Week 48
|
-3.23 score on a scale
Interval -4.79 to -1.66
|
-1.38 score on a scale
Interval -3.03 to 0.27
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24 and 48Population: Participants in the ITT Analysis Set who completed the EQ-5D-5L VAS at Baseline; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point.
The EQ-5D-5L VAS measures 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 |
Zanubrutinib
n=315 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=315 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Change From Baseline in European Quality of Life 5-dimensions 5-levels Health Questionnaire (EQ-5D-5L) Visual Analog Scale (VAS)
Week 24
|
7.92 score on a scale
Standard Deviation 18.245
|
3.44 score on a scale
Standard Deviation 16.972
|
|
Change From Baseline in European Quality of Life 5-dimensions 5-levels Health Questionnaire (EQ-5D-5L) Visual Analog Scale (VAS)
Week 48
|
7.75 score on a scale
Standard Deviation 18.806
|
3.92 score on a scale
Standard Deviation 16.778
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.Population: The Safety Analysis Set includes all participants who received any dose of study drug.
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Resulted in a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgment
Outcome measures
| Measure |
Zanubrutinib
n=324 Participants
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=324 Participants
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Any TEAE
|
322 Participants
|
323 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Serious adverse events
|
172 Participants
|
196 Participants
|
Adverse Events
Zanubrutinib
Ibrutinib
Serious adverse events
| Measure |
Zanubrutinib
n=324 participants at risk
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=324 participants at risk
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia legionella
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia
|
7.4%
24/324 • Number of events 39 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
10.2%
33/324 • Number of events 47 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.62%
2/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.31%
1/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia fungal
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
5/324 • Number of events 8 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
1.2%
4/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Hypoglobulinaemia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Right ventricular failure
|
0.31%
1/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Eye disorders
Cataract
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Eye disorders
Dacryostenosis acquired
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Eye disorders
Keratitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Chest pain
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Death
|
1.2%
4/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Malaise
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Pyrexia
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
1.5%
5/324 • Number of events 6 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Arthritis bacterial
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
COVID-19
|
8.6%
28/324 • Number of events 35 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
6.2%
20/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
10.2%
33/324 • Number of events 44 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
6.8%
22/324 • Number of events 35 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Dacryocystitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Encephalitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Encephalomyelitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Enterococcal sepsis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Fungal abscess central nervous system
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Gastritis viral
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Haematoma infection
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Infection
|
0.31%
1/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Keratitis bacterial
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Keratitis fungal
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Large intestine infection
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Meningitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Meningitis aseptic
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Orchitis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Otitis externa
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia viral
|
0.31%
1/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Post procedural infection
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.2%
4/324 • Number of events 6 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Sporotrichosis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Tick-borne viral encephalitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
7/324 • Number of events 8 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 13 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
False positive investigation result
|
0.31%
1/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.62%
2/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Water intoxication
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.31%
1/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Atypical fibroxanthoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.93%
3/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chromophobe renal cell carcinoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer recurrent
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma of salivary gland
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the cervix
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral haemangioma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
4/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma metastatic
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.93%
3/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage II
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma malignant recurrent
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Headache
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Bladder dysplasia
|
0.31%
1/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.62%
2/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.31%
1/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary necrosis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 4 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/324 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.31%
1/324 • Number of events 1 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
Other adverse events
| Measure |
Zanubrutinib
n=324 participants at risk
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
Ibrutinib
n=324 participants at risk
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.4%
53/324 • Number of events 82 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
17.3%
56/324 • Number of events 122 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.9%
6/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 13 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
2.5%
8/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 15 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
81/324 • Number of events 195 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
22.5%
73/324 • Number of events 162 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.5%
34/324 • Number of events 90 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
10.8%
35/324 • Number of events 92 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
6.8%
22/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
13.9%
45/324 • Number of events 69 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
6/324 • Number of events 7 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Cardiac disorders
Palpitations
|
4.0%
13/324 • Number of events 19 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.3%
14/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
11/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
1.9%
6/324 • Number of events 6 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Eye disorders
Cataract
|
5.6%
18/324 • Number of events 22 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
20/324 • Number of events 32 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
6.5%
21/324 • Number of events 23 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
14/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.2%
7/324 • Number of events 7 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
24/324 • Number of events 30 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
8.3%
27/324 • Number of events 31 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
61/324 • Number of events 106 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
25.6%
83/324 • Number of events 158 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
25/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
7.1%
23/324 • Number of events 32 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.6%
15/324 • Number of events 22 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
5.2%
17/324 • Number of events 19 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Fatigue
|
11.1%
36/324 • Number of events 43 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
15.1%
49/324 • Number of events 57 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.5%
5/324 • Number of events 6 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.0%
29/324 • Number of events 47 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
9.9%
32/324 • Number of events 38 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
3.4%
11/324 • Number of events 17 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
3.1%
10/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
1.9%
6/324 • Number of events 9 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
22/324 • Number of events 25 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
9.0%
29/324 • Number of events 35 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Asthenia
|
6.5%
21/324 • Number of events 30 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.0%
13/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Chest pain
|
0.62%
2/324 • Number of events 2 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Influenza like illness
|
3.1%
10/324 • Number of events 28 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.2%
7/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Oedema peripheral
|
7.4%
24/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
7.4%
24/324 • Number of events 31 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Peripheral swelling
|
4.3%
14/324 • Number of events 15 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
8.0%
26/324 • Number of events 30 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
General disorders
Pyrexia
|
10.8%
35/324 • Number of events 44 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
11.4%
37/324 • Number of events 50 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
3.7%
12/324 • Number of events 13 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 13 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.9%
19/324 • Number of events 22 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
8.0%
26/324 • Number of events 34 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
COVID-19
|
37.3%
121/324 • Number of events 163 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
25.9%
84/324 • Number of events 105 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
4.0%
13/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.6%
15/324 • Number of events 20 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Cellulitis
|
3.7%
12/324 • Number of events 15 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.0%
13/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
2.2%
7/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.6%
15/324 • Number of events 20 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Ear infection
|
3.1%
10/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
1.2%
4/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
10/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
1.9%
6/324 • Number of events 6 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
3.4%
11/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.7%
12/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
20/324 • Number of events 26 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.9%
16/324 • Number of events 23 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Oral herpes
|
1.2%
4/324 • Number of events 9 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.0%
13/324 • Number of events 17 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Paronychia
|
1.5%
5/324 • Number of events 6 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
1.9%
6/324 • Number of events 8 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia
|
10.2%
33/324 • Number of events 47 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
11.4%
37/324 • Number of events 57 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
4.9%
16/324 • Number of events 20 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.2%
7/324 • Number of events 8 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Rhinitis
|
3.1%
10/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Sinusitis
|
6.2%
20/324 • Number of events 26 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.9%
16/324 • Number of events 19 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Skin infection
|
2.2%
7/324 • Number of events 8 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.0%
13/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
29.3%
95/324 • Number of events 155 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
19.8%
64/324 • Number of events 105 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
10.8%
35/324 • Number of events 68 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
9.6%
31/324 • Number of events 58 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
15.1%
49/324 • Number of events 62 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
11.7%
38/324 • Number of events 44 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
16/324 • Number of events 19 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
7.1%
23/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.7%
12/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
1.9%
6/324 • Number of events 6 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
12/324 • Number of events 20 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
6.2%
20/324 • Number of events 29 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
7/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.9%
16/324 • Number of events 23 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.5%
5/324 • Number of events 8 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 15 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
2.5%
8/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 20 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Blood creatinine increased
|
5.6%
18/324 • Number of events 36 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 21 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Blood pressure increased
|
1.9%
6/324 • Number of events 19 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.1%
10/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
8.0%
26/324 • Number of events 75 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
7.4%
24/324 • Number of events 69 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Platelet count decreased
|
3.4%
11/324 • Number of events 40 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
6.2%
20/324 • Number of events 47 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Investigations
Weight decreased
|
6.8%
22/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.3%
14/324 • Number of events 20 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.7%
12/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
6.8%
22/324 • Number of events 23 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
1.2%
4/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
13/324 • Number of events 21 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.5%
8/324 • Number of events 8 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.9%
16/324 • Number of events 37 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
6.8%
22/324 • Number of events 37 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
24/324 • Number of events 39 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
7.4%
24/324 • Number of events 39 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
10/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.5%
8/324 • Number of events 13 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
4.3%
14/324 • Number of events 15 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
54/324 • Number of events 69 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
19.4%
63/324 • Number of events 85 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
26/324 • Number of events 26 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
8.0%
26/324 • Number of events 30 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.1%
10/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
13/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
13.0%
42/324 • Number of events 51 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
11/324 • Number of events 13 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.3%
14/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
4/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
26/324 • Number of events 30 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
8.0%
26/324 • Number of events 30 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.4%
11/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
5.2%
17/324 • Number of events 40 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
4.3%
14/324 • Number of events 21 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.6%
15/324 • Number of events 23 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Dizziness
|
9.9%
32/324 • Number of events 39 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
8.0%
26/324 • Number of events 28 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Headache
|
9.0%
29/324 • Number of events 36 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
10.8%
35/324 • Number of events 46 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Nervous system disorders
Syncope
|
3.4%
11/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.5%
8/324 • Number of events 9 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.4%
11/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.3%
14/324 • Number of events 22 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
7.7%
25/324 • Number of events 27 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
8.0%
26/324 • Number of events 28 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
18/324 • Number of events 23 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.0%
13/324 • Number of events 20 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.2%
46/324 • Number of events 59 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
13.3%
43/324 • Number of events 55 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
16/324 • Number of events 19 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.0%
13/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
27/324 • Number of events 46 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
7.4%
24/324 • Number of events 45 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.7%
12/324 • Number of events 14 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.1%
10/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.2%
17/324 • Number of events 18 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
2.5%
8/324 • Number of events 16 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 15 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.5%
5/324 • Number of events 5 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
11/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.8%
9/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.9%
32/324 • Number of events 41 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
5.9%
19/324 • Number of events 19 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
24/324 • Number of events 32 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.8%
9/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.7%
38/324 • Number of events 69 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
13.6%
44/324 • Number of events 58 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.7%
12/324 • Number of events 15 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
2.2%
7/324 • Number of events 10 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
2.5%
8/324 • Number of events 12 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.7%
12/324 • Number of events 13 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Haematoma
|
5.2%
17/324 • Number of events 23 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
4.3%
14/324 • Number of events 17 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Hypertension
|
25.3%
82/324 • Number of events 154 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
22.8%
74/324 • Number of events 155 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.93%
3/324 • Number of events 3 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
3.4%
11/324 • Number of events 11 • All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.
|
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