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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03053440
Recruitment Status : Completed
First Posted : February 15, 2017
Results First Posted : June 9, 2023
Last Update Posted : June 9, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Waldenström's Macroglobulinemia
Interventions Drug: BGB-3111
Drug: Ibrutinib
Enrollment 201
Recruitment Details A total of 201 participants were randomized to Arm A and Arm B in 12 countries in Australia, Europe, United Kingdom and United States.
Pre-assignment Details The screening period consisted of Days -35 to -1.
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 99 102
Completed 0 0
Not Completed 99 102
Reason Not Completed
Sponsor's Decision to End the Study             20             13
Death             18             14
Withdrawal by Subject             9             8
Lost to Follow-up             1             0
Enrolled in Long-term Extension Study             48             66
Physician Decision             2             1
Participant Randomized but died before dosing             1             0
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 99 102 201
Hide Baseline Analysis Population Description
Intent to Treat (ITT) Analysis Set: Includes all randomized participants assigned to an arm.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 102 participants 201 participants
69.9  (8.58) 69.2  (10.26) 69.5  (9.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
Female
34
  34.3%
33
  32.4%
67
  33.3%
Male
65
  65.7%
69
  67.6%
134
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
Hispanic or Latino
4
   4.0%
4
   3.9%
8
   4.0%
Not Hispanic or Latino
91
  91.9%
82
  80.4%
173
  86.1%
Unknown or Not Reported
4
   4.0%
16
  15.7%
20
  10.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
4
   3.9%
4
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
94
  94.9%
88
  86.3%
182
  90.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   5.1%
10
   9.8%
15
   7.5%
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Up to approximately 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT) Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
19.2
(12.0 to 28.3)
28.4
(19.9 to 38.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Ibrutinib, Arm B: Zanubrutinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0921
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.2
Confidence Interval (2-Sided) 95%
-1.5 to 22.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC
Hide Description 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.
Time Frame Up to approximately 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
77.8
(68.3 to 85.5)
77.5
(68.1 to 85.1)
3.Secondary Outcome
Title Duration of Response (DOR) as Assessed by IRC
Hide Description 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.
Time Frame Up to approximately 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(8.0 to NA)
NA [1] 
(NA to NA)
[1]
NA = Not estimable due to insufficient number of events
4.Secondary Outcome
Title DOR as Assessed by IRC: Event -Free Rate
Hide Description Estimated percentage of participants who were event-free based on Kaplan-Meier method.
Time Frame 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
12 Months
87.9
(77.0 to 93.8)
94.4
(85.8 to 97.9)
18 Months
87.9
(77.0 to 93.8)
85.2
(71.7 to 92.6)
5.Secondary Outcome
Title Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator
Hide Description 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.
Time Frame Up to approximately 5 years and 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
25.3
(17.1 to 35.0)
38.2
(28.8 to 48.4)
6.Secondary Outcome
Title DOR as Assessed by the Investigator
Hide Description 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
Time Frame Up to approximately 5 years and 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(53.5 to NA)
NA [1] 
(NA to NA)
[1]
NA = Not estimable due to insufficient number of events
7.Secondary Outcome
Title DOR as Assessed by the Investigator: Event-Free Rate
Hide Description Estimated percentage of participants who were event-free based on Kaplan-Meier method.
Time Frame 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
24 Months
87.7
(77.8 to 93.4)
89.7
(80.4 to 94.7)
36 Months
77.5
(65.9 to 85.6)
81.1
(70.1 to 88.4)
48 Months
73.9
(61.6 to 82.8)
81.1
(70.1 to 88.4)
8.Secondary Outcome
Title Progression Free Survival (PFS) as Assessed by the IRC
Hide Description 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
Time Frame Up to approximately 2 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = Not estimable due to insufficient number of events
9.Secondary Outcome
Title PFS as Assessed by IRC: Event-Free Rate
Hide Description Estimated percentage of participants who were event-free based on Kaplan-Meier method
Time Frame 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
12 Months
87.2
(78.6 to 92.5)
89.7
(81.7 to 94.3)
18 Months
83.8
(74.5 to 89.9)
85.0
(75.2 to 91.2)
10.Secondary Outcome
Title PFS as Assessed by the Investigator
Hide Description 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.
Time Frame Up to approximately 5 years and 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(54.4 to NA)
NA [1] 
(NA to NA)
[1]
NA = Not estimable due ot insufficient number of events
11.Secondary Outcome
Title PFS as Assessed by the Investigator: Event-Free Rate
Hide Description Percentage of participants who were event-free based on Kaplan-Meier method.
Time Frame 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
24 Months
80.6
(70.9 to 87.3)
88.5
(80.2 to 93.5)
36 Months
74.8
(64.5 to 82.5)
78.3
(68.4 to 85.5)
48 Months
67.3
(56.3 to 76.1)
78.3
(68.4 to 85.5)
12.Secondary Outcome
Title Percentage of Participants With Resolution of All Treatment-precipitating Symptoms
Hide Description [Not Specified]
Time Frame Up to approximately 5 years and 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Unit of Measure: Percentage of Participants
78.6 79.2
13.Secondary Outcome
Title Percentage of Participants With an Anti-Lymphoma Effect
Hide Description 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.
Time Frame Up to approximately 5 years and 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Unit of Measure: Percentage of Participants
84.2 78.8
14.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Up to approximately 5 years and 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set includes all participants who received any dose of zanubrutinib or ibrutinib
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 98 101
Measure Type: Number
Unit of Measure: Number of Participants
Participants with At Least 1 TEAE 98 101
Participants with SAEs 50 59
Time Frame up to approximately 5 years and 5 months
Adverse Event Reporting Description The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
 
Arm/Group Title Arm A: Ibrutinib Arm B: Zanubrutinib
Hide Arm/Group Description 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 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
All-Cause Mortality
Arm A: Ibrutinib Arm B: Zanubrutinib
Affected / at Risk (%) Affected / at Risk (%)
Total   19/99 (19.19%)      14/102 (13.73%)    
Hide Serious Adverse Events
Arm A: Ibrutinib Arm B: Zanubrutinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/98 (51.02%)      59/101 (58.42%)    
Blood and lymphatic system disorders     
Anaemia † 1  1/98 (1.02%)  1 2/101 (1.98%)  2
Febrile neutropenia † 1  0/98 (0.00%)  0 3/101 (2.97%)  4
Haemolytic anaemia † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Haemorrhagic disorder † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Hyperviscosity syndrome † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Neutropenia † 1  0/98 (0.00%)  0 3/101 (2.97%)  4
Thrombocytopenia † 1  0/98 (0.00%)  0 2/101 (1.98%)  2
Cardiac disorders     
Acute left ventricular failure † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Acute myocardial infarction † 1  3/98 (3.06%)  3 2/101 (1.98%)  3
Angina pectoris † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Aortic valve incompetence † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Aortic valve stenosis † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Atrial fibrillation † 1  5/98 (5.10%)  5 2/101 (1.98%)  2
Atrial flutter † 1  2/98 (2.04%)  3 0/101 (0.00%)  0
Atrioventricular block complete † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Atrioventricular block second degree † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Cardiac failure † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Cardiac failure acute † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Cardiac failure congestive † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Cardiac tamponade † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Cardiomegaly † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Coronary artery disease † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Mitral valve incompetence † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Pericardial haemorrhage † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Pericarditis † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Sinus node dysfunction † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Eye disorders     
Diplopia † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Eye haemorrhage † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Gastrointestinal disorders     
Anal inflammation † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Colitis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Dysphagia † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Gastric haemorrhage † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Melaena † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Oral blood blister † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Pancreatic disorder † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Upper gastrointestinal haemorrhage † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Vomiting † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
General disorders     
Adverse drug reaction † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Death † 1  2/98 (2.04%)  2 0/101 (0.00%)  0
Drug withdrawal syndrome † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Oedema peripheral † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Pyrexia † 1  3/98 (3.06%)  3 4/101 (3.96%)  4
Hepatobiliary disorders     
Cholecystitis † 1  2/98 (2.04%)  2 0/101 (0.00%)  0
Drug-induced liver injury † 1  1/98 (1.02%)  1 1/101 (0.99%)  1
Immune system disorders     
Amyloidosis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Infections and infestations     
Arthritis bacterial † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Bacterial sepsis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Brain abscess † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
COVID-19 † 1  2/98 (2.04%)  2 1/101 (0.99%)  1
COVID-19 pneumonia † 1  2/98 (2.04%)  2 2/101 (1.98%)  2
Cellulitis † 1  2/98 (2.04%)  4 0/101 (0.00%)  0
Clostridium difficile infection † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Cryptococcal fungaemia † 1  0/98 (0.00%)  0 1/101 (0.99%)  2
Device related infection † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Diverticulitis † 1  0/98 (0.00%)  0 1/101 (0.99%)  6
Endocarditis bacterial † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Escherichia sepsis † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Gastroenteritis rotavirus † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Gastrointestinal infection † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Herpes zoster † 1  1/98 (1.02%)  1 1/101 (0.99%)  1
Influenza † 1  1/98 (1.02%)  1 3/101 (2.97%)  3
Lower respiratory tract infection † 1  0/98 (0.00%)  0 2/101 (1.98%)  3
Neurocryptococcosis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Neutropenic sepsis † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Osteomyelitis † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Paronychia † 1  1/98 (1.02%)  3 1/101 (0.99%)  1
Pneumonia † 1  14/98 (14.29%)  15 2/101 (1.98%)  4
Pneumonia viral † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Post procedural sepsis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Post-acute COVID-19 syndrome † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Postoperative abscess † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Pulmonary tuberculosis † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Pyelonephritis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Sepsis † 1  4/98 (4.08%)  4 3/101 (2.97%)  3
Septic shock † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Soft tissue infection † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Streptococcal bacteraemia † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Streptococcal endocarditis † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Streptococcal sepsis † 1  1/98 (1.02%)  1 1/101 (0.99%)  1
Upper respiratory tract infection † 1  2/98 (2.04%)  2 0/101 (0.00%)  0
Urinary tract infection † 1  2/98 (2.04%)  2 0/101 (0.00%)  0
Urinary tract infection bacterial † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Urosepsis † 1  1/98 (1.02%)  2 0/101 (0.00%)  0
Viral infection † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Wound infection staphylococcal † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Contusion † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Fall † 1  1/98 (1.02%)  1 2/101 (1.98%)  3
Femoral neck fracture † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Femur fracture † 1  1/98 (1.02%)  1 1/101 (0.99%)  1
Head injury † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Lumbar vertebral fracture † 1  1/98 (1.02%)  2 1/101 (0.99%)  1
Periorbital haematoma † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Post procedural complication † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Post procedural haemorrhage † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Spinal compression fracture † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Stress fracture † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Subdural haematoma † 1  1/98 (1.02%)  1 1/101 (0.99%)  1
Subdural haemorrhage † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Thoracic vertebral fracture † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Traumatic intracranial haemorrhage † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Investigations     
Interferon gamma release assay positive † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Metabolism and nutrition disorders     
Hypokalaemia † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Hyponatraemia † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Malnutrition † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Musculoskeletal and connective tissue disorders     
Neck pain † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Osteoarthritis † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Spinal stenosis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma † 1  0/98 (0.00%)  0 2/101 (1.98%)  2
Bladder transitional cell carcinoma † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Breast cancer † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Endometrial adenocarcinoma † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Lymphoma transformation † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Metastatic malignant melanoma † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Myelodysplastic syndrome † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Nodular melanoma † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Tumour haemorrhage † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Nervous system disorders     
Cerebrovascular accident † 1  1/98 (1.02%)  1 1/101 (0.99%)  1
Dizziness † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Headache † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Lethargy † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Loss of consciousness † 1  2/98 (2.04%)  2 0/101 (0.00%)  0
Subarachnoid haemorrhage † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Syncope † 1  3/98 (3.06%)  3 3/101 (2.97%)  3
Psychiatric disorders     
Anxiety † 1  1/98 (1.02%)  3 0/101 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury † 1  1/98 (1.02%)  1 1/101 (0.99%)  1
Chronic kidney disease † 1  1/98 (1.02%)  1 1/101 (0.99%)  2
Haematuria † 1  2/98 (2.04%)  2 1/101 (0.99%)  1
Urinary bladder haemorrhage † 1  1/98 (1.02%)  2 0/101 (0.00%)  0
Reproductive system and breast disorders     
Prostatitis † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Vaginal prolapse † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Acute respiratory failure † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Haemothorax † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Interstitial lung disease † 1  0/98 (0.00%)  0 2/101 (1.98%)  2
Laryngeal oedema † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Pleural effusion † 1  2/98 (2.04%)  3 2/101 (1.98%)  6
Pneumonia aspiration † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Respiratory disorder † 1  1/98 (1.02%)  1 0/101 (0.00%)  0
Respiratory failure † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
Vascular disorders     
Peripheral vascular disorder † 1  0/98 (0.00%)  0 1/101 (0.99%)  1
1
Term from vocabulary, meddra 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Arm A: Ibrutinib Arm B: Zanubrutinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/98 (97.96%)      99/101 (98.02%)    
Blood and lymphatic system disorders     
Anaemia † 1  22/98 (22.45%)  48 18/101 (17.82%)  57
Increased tendency to bruise † 1  5/98 (5.10%)  6 3/101 (2.97%)  3
Lymphadenopathy † 1  1/98 (1.02%)  1 4/101 (3.96%)  4
Neutropenia † 1  16/98 (16.33%)  51 29/101 (28.71%)  87
Thrombocytopenia † 1  16/98 (16.33%)  47 15/101 (14.85%)  61
Cardiac disorders     
Angina pectoris † 1  4/98 (4.08%)  4 4/101 (3.96%)  4
Atrial fibrillation † 1  18/98 (18.37%)  24 7/101 (6.93%)  8
Atrial flutter † 1  4/98 (4.08%)  4 1/101 (0.99%)  1
Bradycardia † 1  3/98 (3.06%)  4 1/101 (0.99%)  1
Palpitations † 1  10/98 (10.20%)  15 6/101 (5.94%)  8
Sinus bradycardia † 1  3/98 (3.06%)  3 6/101 (5.94%)  6
Ear and labyrinth disorders     
Tinnitus † 1  3/98 (3.06%)  4 6/101 (5.94%)  6
Vertigo † 1  4/98 (4.08%)  4 3/101 (2.97%)  3
Eye disorders     
Cataract † 1  6/98 (6.12%)  7 3/101 (2.97%)  4
Conjunctival haemorrhage † 1  6/98 (6.12%)  10 5/101 (4.95%)  9
Dry eye † 1  3/98 (3.06%)  3 2/101 (1.98%)  2
Ocular hyperaemia † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Retinal haemorrhage † 1  4/98 (4.08%)  8 0/101 (0.00%)  0
Vision blurred † 1  6/98 (6.12%)  7 3/101 (2.97%)  3
Gastrointestinal disorders     
Abdominal discomfort † 1  5/98 (5.10%)  5 1/101 (0.99%)  1
Abdominal distension † 1  3/98 (3.06%)  3 2/101 (1.98%)  2
Abdominal pain † 1  6/98 (6.12%)  9 4/101 (3.96%)  5
Abdominal pain upper † 1  6/98 (6.12%)  7 4/101 (3.96%)  4
Constipation † 1  12/98 (12.24%)  18 20/101 (19.80%)  25
Diarrhoea † 1  36/98 (36.73%)  62 23/101 (22.77%)  38
Dry mouth † 1  4/98 (4.08%)  4 5/101 (4.95%)  5
Dyspepsia † 1  7/98 (7.14%)  7 6/101 (5.94%)  7
Dysphagia † 1  3/98 (3.06%)  4 3/101 (2.97%)  4
Gastrooesophageal reflux disease † 1  5/98 (5.10%)  5 4/101 (3.96%)  4
Gingival bleeding † 1  5/98 (5.10%)  6 2/101 (1.98%)  2
Haemorrhoids † 1  4/98 (4.08%)  5 2/101 (1.98%)  2
Inguinal hernia † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Mouth ulceration † 1  5/98 (5.10%)  9 2/101 (1.98%)  2
Nausea † 1  15/98 (15.31%)  22 19/101 (18.81%)  25
Rectal haemorrhage † 1  2/98 (2.04%)  3 5/101 (4.95%)  5
Stomatitis † 1  5/98 (5.10%)  7 4/101 (3.96%)  4
Vomiting † 1  15/98 (15.31%)  20 14/101 (13.86%)  27
General disorders     
Asthenia † 1  6/98 (6.12%)  9 9/101 (8.91%)  14
Chest pain † 1  5/98 (5.10%)  5 4/101 (3.96%)  4
Chills † 1  4/98 (4.08%)  5 3/101 (2.97%)  3
Drug withdrawal syndrome † 1  2/98 (2.04%)  3 4/101 (3.96%)  4
Fatigue † 1  19/98 (19.39%)  25 26/101 (25.74%)  49
Gait disturbance † 1  0/98 (0.00%)  0 4/101 (3.96%)  4
Influenza like illness † 1  5/98 (5.10%)  7 6/101 (5.94%)  9
Malaise † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Oedema peripheral † 1  22/98 (22.45%)  38 19/101 (18.81%)  29
Peripheral swelling † 1  12/98 (12.24%)  12 5/101 (4.95%)  6
Pyrexia † 1  12/98 (12.24%)  21 16/101 (15.84%)  30
Immune system disorders     
Seasonal allergy † 1  2/98 (2.04%)  2 4/101 (3.96%)  4
Infections and infestations     
Bronchitis † 1  4/98 (4.08%)  4 4/101 (3.96%)  4
COVID-19 † 1  5/98 (5.10%)  5 9/101 (8.91%)  10
Cellulitis † 1  7/98 (7.14%)  18 6/101 (5.94%)  10
Conjunctivitis † 1  7/98 (7.14%)  7 2/101 (1.98%)  3
Cystitis † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Ear infection † 1  3/98 (3.06%)  3 2/101 (1.98%)  2
Folliculitis † 1  5/98 (5.10%)  6 2/101 (1.98%)  2
Furuncle † 1  4/98 (4.08%)  7 0/101 (0.00%)  0
Gastroenteritis † 1  5/98 (5.10%)  6 6/101 (5.94%)  7
Herpes zoster † 1  4/98 (4.08%)  4 5/101 (4.95%)  5
Laryngitis † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Localised infection † 1  11/98 (11.22%)  15 2/101 (1.98%)  2
Lower respiratory tract infection † 1  10/98 (10.20%)  15 8/101 (7.92%)  13
Nail infection † 1  6/98 (6.12%)  11 0/101 (0.00%)  0
Nasopharyngitis † 1  9/98 (9.18%)  10 14/101 (13.86%)  21
Onychomycosis † 1  5/98 (5.10%)  5 1/101 (0.99%)  1
Oral herpes † 1  5/98 (5.10%)  7 1/101 (0.99%)  1
Paronychia † 1  3/98 (3.06%)  4 2/101 (1.98%)  2
Pneumonia † 1  9/98 (9.18%)  9 3/101 (2.97%)  3
Respiratory tract infection † 1  3/98 (3.06%)  4 8/101 (7.92%)  10
Rhinitis † 1  7/98 (7.14%)  8 7/101 (6.93%)  12
Sinusitis † 1  10/98 (10.20%)  11 6/101 (5.94%)  9
Skin infection † 1  7/98 (7.14%)  16 3/101 (2.97%)  4
Tooth infection † 1  5/98 (5.10%)  9 3/101 (2.97%)  3
Upper respiratory tract infection † 1  31/98 (31.63%)  55 33/101 (32.67%)  49
Urinary tract infection † 1  17/98 (17.35%)  38 16/101 (15.84%)  25
Wound infection † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion † 1  27/98 (27.55%)  59 19/101 (18.81%)  38
Fall † 1  10/98 (10.20%)  12 9/101 (8.91%)  17
Joint injury † 1  4/98 (4.08%)  5 1/101 (0.99%)  1
Limb injury † 1  5/98 (5.10%)  7 5/101 (4.95%)  5
Procedural pain † 1  0/98 (0.00%)  0 4/101 (3.96%)  5
Skin laceration † 1  8/98 (8.16%)  13 5/101 (4.95%)  5
Investigations     
Alanine aminotransferase increased † 1  3/98 (3.06%)  5 2/101 (1.98%)  2
Blood alkaline phosphatase increased † 1  4/98 (4.08%)  4 0/101 (0.00%)  0
Gamma-glutamyltransferase increased † 1  3/98 (3.06%)  6 2/101 (1.98%)  2
Neutrophil count decreased † 1  4/98 (4.08%)  9 8/101 (7.92%)  33
Metabolism and nutrition disorders     
Decreased appetite † 1  4/98 (4.08%)  6 4/101 (3.96%)  4
Gout † 1  5/98 (5.10%)  6 3/101 (2.97%)  3
Hyperglycaemia † 1  4/98 (4.08%)  10 3/101 (2.97%)  4
Hyperuricaemia † 1  9/98 (9.18%)  14 4/101 (3.96%)  7
Hypoalbuminaemia † 1  3/98 (3.06%)  5 1/101 (0.99%)  1
Hypokalaemia † 1  6/98 (6.12%)  6 3/101 (2.97%)  14
Hyponatraemia † 1  1/98 (1.02%)  1 4/101 (3.96%)  4
Iron deficiency † 1  7/98 (7.14%)  7 7/101 (6.93%)  8
Vitamin D deficiency † 1  2/98 (2.04%)  2 5/101 (4.95%)  5
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  24/98 (24.49%)  50 24/101 (23.76%)  42
Back pain † 1  18/98 (18.37%)  23 18/101 (17.82%)  31
Joint swelling † 1  4/98 (4.08%)  5 4/101 (3.96%)  5
Muscle spasms † 1  28/98 (28.57%)  43 12/101 (11.88%)  15
Muscular weakness † 1  1/98 (1.02%)  1 4/101 (3.96%)  4
Musculoskeletal chest pain † 1  3/98 (3.06%)  4 3/101 (2.97%)  4
Myalgia † 1  3/98 (3.06%)  4 7/101 (6.93%)  9
Neck pain † 1  6/98 (6.12%)  6 3/101 (2.97%)  3
Osteoarthritis † 1  3/98 (3.06%)  3 2/101 (1.98%)  2
Osteoporosis † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Pain in extremity † 1  10/98 (10.20%)  12 15/101 (14.85%)  21
Rotator cuff syndrome † 1  3/98 (3.06%)  3 3/101 (2.97%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma † 1  5/98 (5.10%)  5 4/101 (3.96%)  4
Bladder transitional cell carcinoma † 1  3/98 (3.06%)  4 0/101 (0.00%)  0
Seborrhoeic keratosis † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Squamous cell carcinoma of skin † 1  5/98 (5.10%)  6 3/101 (2.97%)  3
Nervous system disorders     
Dizziness † 1  14/98 (14.29%)  16 15/101 (14.85%)  29
Headache † 1  15/98 (15.31%)  20 17/101 (16.83%)  20
Neuralgia † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Paraesthesia † 1  8/98 (8.16%)  10 4/101 (3.96%)  6
Peripheral sensory neuropathy † 1  5/98 (5.10%)  6 8/101 (7.92%)  10
Sciatica † 1  3/98 (3.06%)  4 1/101 (0.99%)  1
Syncope † 1  6/98 (6.12%)  7 3/101 (2.97%)  5
Psychiatric disorders     
Anxiety † 1  7/98 (7.14%)  7 5/101 (4.95%)  5
Depression † 1  4/98 (4.08%)  4 3/101 (2.97%)  4
Insomnia † 1  9/98 (9.18%)  10 3/101 (2.97%)  4
Renal and urinary disorders     
Acute kidney injury † 1  3/98 (3.06%)  4 1/101 (0.99%)  1
Dysuria † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Haematuria † 1  13/98 (13.27%)  17 11/101 (10.89%)  13
Pollakiuria † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Urinary retention † 1  0/98 (0.00%)  0 4/101 (3.96%)  6
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders     
Cough † 1  20/98 (20.41%)  29 20/101 (19.80%)  36
Dyspnoea † 1  9/98 (9.18%)  11 17/101 (16.83%)  22
Dyspnoea exertional † 1  3/98 (3.06%)  3 2/101 (1.98%)  2
Epistaxis † 1  21/98 (21.43%)  35 18/101 (17.82%)  21
Nasal congestion † 1  3/98 (3.06%)  6 2/101 (1.98%)  2
Oropharyngeal pain † 1  10/98 (10.20%)  11 4/101 (3.96%)  5
Pneumonitis † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Productive cough † 1  4/98 (4.08%)  4 6/101 (5.94%)  7
Rhinorrhoea † 1  5/98 (5.10%)  5 2/101 (1.98%)  2
Wheezing † 1  1/98 (1.02%)  1 4/101 (3.96%)  4
Skin and subcutaneous tissue disorders     
Actinic keratosis † 1  5/98 (5.10%)  6 3/101 (2.97%)  3
Dermatitis † 1  5/98 (5.10%)  6 1/101 (0.99%)  1
Dry skin † 1  7/98 (7.14%)  12 2/101 (1.98%)  5
Ecchymosis † 1  4/98 (4.08%)  6 1/101 (0.99%)  1
Erythema † 1  3/98 (3.06%)  3 5/101 (4.95%)  5
Nail disorder † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Onychoclasis † 1  10/98 (10.20%)  10 1/101 (0.99%)  1
Petechiae † 1  5/98 (5.10%)  6 7/101 (6.93%)  8
Pruritus † 1  6/98 (6.12%)  10 15/101 (14.85%)  20
Psoriasis † 1  3/98 (3.06%)  3 0/101 (0.00%)  0
Purpura † 1  6/98 (6.12%)  9 4/101 (3.96%)  4
Rash † 1  19/98 (19.39%)  25 19/101 (18.81%)  25
Rash erythematous † 1  1/98 (1.02%)  1 5/101 (4.95%)  6
Rash maculo-papular † 1  2/98 (2.04%)  2 4/101 (3.96%)  6
Rosacea † 1  5/98 (5.10%)  5 2/101 (1.98%)  2
Skin fissures † 1  3/98 (3.06%)  4 1/101 (0.99%)  2
Skin lesion † 1  3/98 (3.06%)  3 6/101 (5.94%)  9
Skin toxicity † 1  3/98 (3.06%)  3 1/101 (0.99%)  1
Skin ulcer † 1  4/98 (4.08%)  4 3/101 (2.97%)  3
Vascular disorders     
Haematoma † 1  9/98 (9.18%)  11 5/101 (4.95%)  7
Hypertension † 1  24/98 (24.49%)  46 16/101 (15.84%)  20
Hypotension † 1  2/98 (2.04%)  3 4/101 (3.96%)  4
1
Term from vocabulary, meddra 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: BeiGene
Phone: +1-877-828-5568
EMail: clinicaltrials@beigene.com
Publications of Results:
Tam CS, LeBlond V, Novotny W, Owen RG, Tedeschi A, Atwal S, Cohen A, Huang J, Buske C. A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenstrom macroglobulinemia. Future Oncol. 2018 Sep;14(22):2229-2237. doi: 10.2217/fon-2018-0163. Epub 2018 Jun 5.
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03053440    
Other Study ID Numbers: BGB-3111-302
2016-002980-33 ( EudraCT Number )
First Submitted: February 7, 2017
First Posted: February 15, 2017
Results First Submitted: March 29, 2023
Results First Posted: June 9, 2023
Last Update Posted: June 9, 2023