Trial Outcomes & Findings for A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM) (NCT NCT03053440)

NCT ID: NCT03053440

Last Updated: 2024-10-26

Results Overview

Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

201 participants

Primary outcome timeframe

Up to approximately 2 years and 7 months

Results posted on

2024-10-26

Participant Flow

A total of 201 participants were randomized to Arm A and Arm B in 12 countries in Australia, Europe, United Kingdom and United States.

The screening period consisted of Days -35 to -1.

Participant milestones

Participant milestones
Measure
Arm A: Ibrutinib
Participants diagnosed with Waldenström's Macroglobulinemia (WM) with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
Participants diagnosed with WM with mutated MYD88 gene received 160 milligrams (mg) zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Overall Study
STARTED
99
102
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
99
102

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm A: Ibrutinib
Participants diagnosed with Waldenström's Macroglobulinemia (WM) with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
Participants diagnosed with WM with mutated MYD88 gene received 160 milligrams (mg) zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Overall Study
Sponsor's Decision to End the Study
20
13
Overall Study
Death
18
14
Overall Study
Withdrawal by Subject
9
8
Overall Study
Lost to Follow-up
1
0
Overall Study
Enrolled in Long-term Extension Study
48
66
Overall Study
Physician Decision
2
1
Overall Study
Participant Randomized but died before dosing
1
0

Baseline Characteristics

A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Total
n=201 Participants
Total of all reporting groups
Age, Continuous
69.9 years
STANDARD_DEVIATION 8.58 • n=5 Participants
69.2 years
STANDARD_DEVIATION 10.26 • n=7 Participants
69.5 years
STANDARD_DEVIATION 9.46 • n=5 Participants
Sex: Female, Male
Female
34 Participants
n=5 Participants
33 Participants
n=7 Participants
67 Participants
n=5 Participants
Sex: Female, Male
Male
65 Participants
n=5 Participants
69 Participants
n=7 Participants
134 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
91 Participants
n=5 Participants
82 Participants
n=7 Participants
173 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
16 Participants
n=7 Participants
20 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
94 Participants
n=5 Participants
88 Participants
n=7 Participants
182 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
n=5 Participants
10 Participants
n=7 Participants
15 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 2 years and 7 months

Population: Intent To Treat (ITT) Analysis Set

Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC)
19.2 Percentage of Participants
Interval 12.0 to 28.3
28.4 Percentage of Participants
Interval 19.9 to 38.2

SECONDARY outcome

Timeframe: Up to approximately 2 years and 7 months

Population: ITT Analysis Set

MRR defined as the percentage of participants achieving a best response of response of CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) defined as ≥50% reduction of serum IgM from baseline.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC
77.8 Percentage of Participants
Interval 68.3 to 85.5
77.5 Percentage of Participants
Interval 68.1 to 85.1

SECONDARY outcome

Timeframe: Up to approximately 2 years and 7 months

Population: ITT Analysis Set

DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as ≥50% reduction of serum IgM from baseline.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Duration of Response (DOR) as Assessed by IRC
NA Months
Interval 8.0 to
NA = Not estimable due to insufficient number of events
NA Months
NA = Not estimable due to insufficient number of events

SECONDARY outcome

Timeframe: 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)

Population: ITT Analysis Set

Estimated percentage of participants who were event-free based on Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
DOR as Assessed by IRC: Event -Free Rate
12 Months
87.9 Percentage of Participants
Interval 77.0 to 93.8
94.4 Percentage of Participants
Interval 85.8 to 97.9
DOR as Assessed by IRC: Event -Free Rate
18 Months
87.9 Percentage of Participants
Interval 77.0 to 93.8
85.2 Percentage of Participants
Interval 71.7 to 92.6

SECONDARY outcome

Timeframe: Up to approximately 5 years and 5 months

Population: ITT Analysis Set

Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator
25.3 Percentage of Participants
Interval 17.1 to 35.0
38.2 Percentage of Participants
Interval 28.8 to 48.4

SECONDARY outcome

Timeframe: Up to approximately 5 years and 5 months

Population: ITT Analysis Set

DOR is defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
DOR as Assessed by the Investigator
NA Months
Interval 53.5 to
NA = Not estimable due to insufficient number of events
NA Months
NA = Not estimable due to insufficient number of events

SECONDARY outcome

Timeframe: 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)

Population: ITT Analysis Set

Estimated percentage of participants who were event-free based on Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
DOR as Assessed by the Investigator: Event-Free Rate
24 Months
87.7 Percentage of Participants
Interval 77.8 to 93.4
89.7 Percentage of Participants
Interval 80.4 to 94.7
DOR as Assessed by the Investigator: Event-Free Rate
36 Months
77.5 Percentage of Participants
Interval 65.9 to 85.6
81.1 Percentage of Participants
Interval 70.1 to 88.4
DOR as Assessed by the Investigator: Event-Free Rate
48 Months
73.9 Percentage of Participants
Interval 61.6 to 82.8
81.1 Percentage of Participants
Interval 70.1 to 88.4

SECONDARY outcome

Timeframe: Up to approximately 2 years and 7 months

Population: ITT Analysis Set

PFS as assessed by the IRC, defined as time from randomization to the first documentation of progression (per modified International Workshop on Waldenström macroglobulinemia \[IWWM criteria\]) or death, whichever occurs first

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Progression Free Survival (PFS) as Assessed by the IRC
NA Months
NA = Not estimable due to insufficient number of events
NA Months
NA = Not estimable due to insufficient number of events

SECONDARY outcome

Timeframe: 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)

Population: ITT Analysis Set

Estimated percentage of participants who were event-free based on Kaplan-Meier method

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
PFS as Assessed by IRC: Event-Free Rate
12 Months
87.2 Percentage of Participants
Interval 78.6 to 92.5
89.7 Percentage of Participants
Interval 81.7 to 94.3
PFS as Assessed by IRC: Event-Free Rate
18 Months
83.8 Percentage of Participants
Interval 74.5 to 89.9
85.0 Percentage of Participants
Interval 75.2 to 91.2

SECONDARY outcome

Timeframe: Up to approximately 5 years and 5 months

Population: ITT Analysis Set

PFS as assessed by the Investigator, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
PFS as Assessed by the Investigator
NA Months
Interval 54.4 to
NA = Not estimable due ot insufficient number of events
NA Months
NA = Not estimable due ot insufficient number of events

SECONDARY outcome

Timeframe: 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)

Population: ITT Analysis Set

Percentage of participants who were event-free based on Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
PFS as Assessed by the Investigator: Event-Free Rate
24 Months
80.6 Percentage of Participants
Interval 70.9 to 87.3
88.5 Percentage of Participants
Interval 80.2 to 93.5
PFS as Assessed by the Investigator: Event-Free Rate
36 Months
74.8 Percentage of Participants
Interval 64.5 to 82.5
78.3 Percentage of Participants
Interval 68.4 to 85.5
PFS as Assessed by the Investigator: Event-Free Rate
48 Months
67.3 Percentage of Participants
Interval 56.3 to 76.1
78.3 Percentage of Participants
Interval 68.4 to 85.5

SECONDARY outcome

Timeframe: Up to approximately 5 years and 5 months

Population: ITT Analysis Set

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Percentage of Participants With Resolution of All Treatment-precipitating Symptoms
78.6 Percentage of Participants
79.2 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 5 years and 5 months

Population: ITT Analysis Set

Anti-Lymphoma Effect is defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by CT scan, at any time during the course of study treatment.

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=99 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=102 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Percentage of Participants With an Anti-Lymphoma Effect
84.2 Percentage of Participants
78.8 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 5 years and 5 months

Population: Safety Analysis Set includes all participants who received any dose of zanubrutinib or ibrutinib

Outcome measures

Outcome measures
Measure
Arm A: Ibrutinib
n=98 Participants
Participants diagnosed with WM with mutated MYD88 gene received 420 mg Ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=101 Participants
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with At Least 1 TEAE
98 Number of Participants
101 Number of Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
50 Number of Participants
59 Number of Participants

Adverse Events

Arm A: Ibrutinib

Serious events: 50 serious events
Other events: 96 other events
Deaths: 19 deaths

Arm B: Zanubrutinib

Serious events: 59 serious events
Other events: 99 other events
Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure
Arm A: Ibrutinib
n=98 participants at risk
Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=101 participants at risk
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Blood and lymphatic system disorders
Anaemia
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Haemolytic anaemia
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Haemorrhagic disorder
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Hyperviscosity syndrome
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Acute left ventricular failure
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Acute myocardial infarction
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Angina pectoris
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Aortic valve incompetence
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Aortic valve stenosis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Atrial fibrillation
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Atrial flutter
2.0%
2/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Atrioventricular block complete
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Atrioventricular block second degree
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Cardiac failure
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Cardiac failure acute
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Cardiac failure congestive
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Cardiac tamponade
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Cardiomegaly
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Coronary artery disease
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Mitral valve incompetence
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Pericardial haemorrhage
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Pericarditis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Sinus node dysfunction
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Diplopia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Eye haemorrhage
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Anal inflammation
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Colitis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Dysphagia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Gastric haemorrhage
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Melaena
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Oral blood blister
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Pancreatic disorder
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Vomiting
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Adverse drug reaction
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Death
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Drug withdrawal syndrome
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Oedema peripheral
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Pyrexia
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Hepatobiliary disorders
Cholecystitis
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Hepatobiliary disorders
Drug-induced liver injury
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Immune system disorders
Amyloidosis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Arthritis bacterial
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Bacterial sepsis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Brain abscess
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
COVID-19
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
COVID-19 pneumonia
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Cellulitis
2.0%
2/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Clostridium difficile infection
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Cryptococcal fungaemia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Device related infection
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Diverticulitis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Endocarditis bacterial
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Escherichia sepsis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Gastroenteritis rotavirus
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Gastrointestinal infection
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Herpes zoster
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Influenza
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Lower respiratory tract infection
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Neurocryptococcosis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Neutropenic sepsis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Osteomyelitis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Paronychia
1.0%
1/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Pneumonia
14.3%
14/98 • Number of events 15 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Pneumonia viral
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Post procedural sepsis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Post-acute COVID-19 syndrome
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Postoperative abscess
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Pulmonary tuberculosis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Pyelonephritis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Sepsis
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Septic shock
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Soft tissue infection
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Streptococcal bacteraemia
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Streptococcal endocarditis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Streptococcal sepsis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Upper respiratory tract infection
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Urinary tract infection
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Urinary tract infection bacterial
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Urosepsis
1.0%
1/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Viral infection
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Wound infection staphylococcal
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Ankle fracture
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Contusion
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Fall
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Femoral neck fracture
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Femur fracture
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Head injury
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
1.0%
1/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Periorbital haematoma
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Post procedural haemorrhage
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Stress fracture
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Subdural haematoma
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Subdural haemorrhage
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Investigations
Interferon gamma release assay positive
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Spinal stenosis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma transformation
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Cerebrovascular accident
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Dizziness
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Headache
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Lethargy
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Loss of consciousness
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Subarachnoid haemorrhage
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Syncope
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Psychiatric disorders
Anxiety
1.0%
1/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Acute kidney injury
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Chronic kidney disease
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Haematuria
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Urinary bladder haemorrhage
1.0%
1/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Reproductive system and breast disorders
Prostatitis
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Reproductive system and breast disorders
Vaginal prolapse
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.0%
2/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Vascular disorders
Peripheral vascular disorder
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.

Other adverse events

Other adverse events
Measure
Arm A: Ibrutinib
n=98 participants at risk
Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Arm B: Zanubrutinib
n=101 participants at risk
Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Skin and subcutaneous tissue disorders
Nail disorder
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Ecchymosis
4.1%
4/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Erythema
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Anaemia
22.4%
22/98 • Number of events 48 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
17.8%
18/101 • Number of events 57 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Increased tendency to bruise
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Lymphadenopathy
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Neutropenia
16.3%
16/98 • Number of events 51 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
28.7%
29/101 • Number of events 87 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Blood and lymphatic system disorders
Thrombocytopenia
16.3%
16/98 • Number of events 47 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
14.9%
15/101 • Number of events 61 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Angina pectoris
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Atrial fibrillation
18.4%
18/98 • Number of events 24 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
6.9%
7/101 • Number of events 8 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Atrial flutter
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Bradycardia
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Palpitations
10.2%
10/98 • Number of events 15 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 8 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Cardiac disorders
Sinus bradycardia
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Ear and labyrinth disorders
Tinnitus
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Ear and labyrinth disorders
Vertigo
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Cataract
6.1%
6/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Conjunctival haemorrhage
6.1%
6/98 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Dry eye
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Ocular hyperaemia
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Retinal haemorrhage
4.1%
4/98 • Number of events 8 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Eye disorders
Vision blurred
6.1%
6/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Abdominal discomfort
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Abdominal distension
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Abdominal pain
6.1%
6/98 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Abdominal pain upper
6.1%
6/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Constipation
12.2%
12/98 • Number of events 18 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
19.8%
20/101 • Number of events 25 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Diarrhoea
36.7%
36/98 • Number of events 62 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
22.8%
23/101 • Number of events 38 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Dry mouth
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Dyspepsia
7.1%
7/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Dysphagia
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Gastrooesophageal reflux disease
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Gingival bleeding
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Haemorrhoids
4.1%
4/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Inguinal hernia
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Mouth ulceration
5.1%
5/98 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Nausea
15.3%
15/98 • Number of events 22 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
18.8%
19/101 • Number of events 25 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Rectal haemorrhage
2.0%
2/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Stomatitis
5.1%
5/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Gastrointestinal disorders
Vomiting
15.3%
15/98 • Number of events 20 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
13.9%
14/101 • Number of events 27 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Asthenia
6.1%
6/98 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
8.9%
9/101 • Number of events 14 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Chest pain
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Chills
4.1%
4/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Drug withdrawal syndrome
2.0%
2/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Fatigue
19.4%
19/98 • Number of events 25 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
25.7%
26/101 • Number of events 49 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Gait disturbance
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Influenza like illness
5.1%
5/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Malaise
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Oedema peripheral
22.4%
22/98 • Number of events 38 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
18.8%
19/101 • Number of events 29 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Peripheral swelling
12.2%
12/98 • Number of events 12 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
General disorders
Pyrexia
12.2%
12/98 • Number of events 21 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
15.8%
16/101 • Number of events 30 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Immune system disorders
Seasonal allergy
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Bronchitis
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
COVID-19
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
8.9%
9/101 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Cellulitis
7.1%
7/98 • Number of events 18 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Conjunctivitis
7.1%
7/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Cystitis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Ear infection
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Folliculitis
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Furuncle
4.1%
4/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Gastroenteritis
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Herpes zoster
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Laryngitis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Localised infection
11.2%
11/98 • Number of events 15 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Lower respiratory tract infection
10.2%
10/98 • Number of events 15 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
7.9%
8/101 • Number of events 13 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Nail infection
6.1%
6/98 • Number of events 11 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Nasopharyngitis
9.2%
9/98 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
13.9%
14/101 • Number of events 21 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Onychomycosis
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Oral herpes
5.1%
5/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Paronychia
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Pneumonia
9.2%
9/98 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Respiratory tract infection
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
7.9%
8/101 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Rhinitis
7.1%
7/98 • Number of events 8 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
6.9%
7/101 • Number of events 12 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Sinusitis
10.2%
10/98 • Number of events 11 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Skin infection
7.1%
7/98 • Number of events 16 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Tooth infection
5.1%
5/98 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Upper respiratory tract infection
31.6%
31/98 • Number of events 55 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
32.7%
33/101 • Number of events 49 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Urinary tract infection
17.3%
17/98 • Number of events 38 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
15.8%
16/101 • Number of events 25 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Infections and infestations
Wound infection
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Contusion
27.6%
27/98 • Number of events 59 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
18.8%
19/101 • Number of events 38 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Fall
10.2%
10/98 • Number of events 12 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
8.9%
9/101 • Number of events 17 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Joint injury
4.1%
4/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Limb injury
5.1%
5/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Injury, poisoning and procedural complications
Skin laceration
8.2%
8/98 • Number of events 13 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Investigations
Alanine aminotransferase increased
3.1%
3/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Investigations
Blood alkaline phosphatase increased
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Investigations
Gamma-glutamyltransferase increased
3.1%
3/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Investigations
Neutrophil count decreased
4.1%
4/98 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
7.9%
8/101 • Number of events 33 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Decreased appetite
4.1%
4/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Gout
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Hyperglycaemia
4.1%
4/98 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Hyperuricaemia
9.2%
9/98 • Number of events 14 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Hypoalbuminaemia
3.1%
3/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Hypokalaemia
6.1%
6/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 14 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Hyponatraemia
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Iron deficiency
7.1%
7/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
6.9%
7/101 • Number of events 8 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Metabolism and nutrition disorders
Vitamin D deficiency
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Arthralgia
24.5%
24/98 • Number of events 50 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
23.8%
24/101 • Number of events 42 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Back pain
18.4%
18/98 • Number of events 23 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
17.8%
18/101 • Number of events 31 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Joint swelling
4.1%
4/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Muscle spasms
28.6%
28/98 • Number of events 43 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
11.9%
12/101 • Number of events 15 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Muscular weakness
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Myalgia
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
6.9%
7/101 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Neck pain
6.1%
6/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Osteoarthritis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Osteoporosis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Pain in extremity
10.2%
10/98 • Number of events 12 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
14.9%
15/101 • Number of events 21 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Dizziness
14.3%
14/98 • Number of events 16 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
14.9%
15/101 • Number of events 29 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Headache
15.3%
15/98 • Number of events 20 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
16.8%
17/101 • Number of events 20 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Neuralgia
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Paraesthesia
8.2%
8/98 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Peripheral sensory neuropathy
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
7.9%
8/101 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Sciatica
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Nervous system disorders
Syncope
6.1%
6/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Psychiatric disorders
Anxiety
7.1%
7/98 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Psychiatric disorders
Depression
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Psychiatric disorders
Insomnia
9.2%
9/98 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Acute kidney injury
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Dysuria
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Haematuria
13.3%
13/98 • Number of events 17 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
10.9%
11/101 • Number of events 13 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Pollakiuria
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Renal and urinary disorders
Urinary retention
0.00%
0/98 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Reproductive system and breast disorders
Benign prostatic hyperplasia
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Cough
20.4%
20/98 • Number of events 29 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
19.8%
20/101 • Number of events 36 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
9.2%
9/98 • Number of events 11 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
16.8%
17/101 • Number of events 22 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Epistaxis
21.4%
21/98 • Number of events 35 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
17.8%
18/101 • Number of events 21 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
3.1%
3/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
10.2%
10/98 • Number of events 11 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Productive cough
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders
Wheezing
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Actinic keratosis
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Dermatitis
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Dry skin
7.1%
7/98 • Number of events 12 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Onychoclasis
10.2%
10/98 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Petechiae
5.1%
5/98 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
6.9%
7/101 • Number of events 8 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Pruritus
6.1%
6/98 • Number of events 10 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
14.9%
15/101 • Number of events 20 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Psoriasis
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.00%
0/101 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Purpura
6.1%
6/98 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Rash
19.4%
19/98 • Number of events 25 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
18.8%
19/101 • Number of events 25 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Rash erythematous
1.0%
1/98 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Rash maculo-papular
2.0%
2/98 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 6 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Rosacea
5.1%
5/98 • Number of events 5 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
2.0%
2/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Skin fissures
3.1%
3/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 2 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Skin lesion
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.9%
6/101 • Number of events 9 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Skin toxicity
3.1%
3/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
0.99%
1/101 • Number of events 1 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Skin and subcutaneous tissue disorders
Skin ulcer
4.1%
4/98 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
3.0%
3/101 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Vascular disorders
Haematoma
9.2%
9/98 • Number of events 11 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
5.0%
5/101 • Number of events 7 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Vascular disorders
Hypertension
24.5%
24/98 • Number of events 46 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
15.8%
16/101 • Number of events 20 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
Vascular disorders
Hypotension
2.0%
2/98 • Number of events 3 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
4.0%
4/101 • Number of events 4 • up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

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