NCT03734016 · ADVERSE EVENTS

Adverse events

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
Other-event reporting threshold: 3%

All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Zanubrutinib Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.	172 / 324	310 / 324	69 / 327
Ibrutinib Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.	196 / 324	314 / 324	83 / 325

Group identifiers: EG000: Zanubrutinib · EG001: Ibrutinib

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
324
num Events
8
group Id
EG001
num Affected
4
num At Risk
324
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
2
num At Risk
324
num Events
2
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
3
term
Hypoglobulinaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
2
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Lymphocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Splenic haematoma

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
53
num At Risk
324
num Events
82
group Id
EG001
num Affected
56
num At Risk
324
num Events
122
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
324
num Events
10
group Id
EG001
num Affected
11
num At Risk
324
num Events
13
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
81
num At Risk
324
num Events
195
group Id
EG001
num Affected
73
num At Risk
324
num Events
162
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
34
num At Risk
324
num Events
90
group Id
EG001
num Affected
35
num At Risk
324
num Events
92
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
22
num At Risk
324
num Events
27
group Id
EG001
num Affected
45
num At Risk
324
num Events
69
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
324
num Events
7
group Id
EG001
num Affected
10
num At Risk
324
num Events
10
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
13
num At Risk
324
num Events
19
group Id
EG001
num Affected
14
num At Risk
324
num Events
16
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
324
num Events
10
group Id
EG001
num Affected
12
num At Risk
324
num Events
15
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
11
num At Risk
324
num Events
11
group Id
EG001
num Affected
6
num At Risk
324
num Events
6
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
18
num At Risk
324
num Events
22
group Id
EG001
num Affected
10
num At Risk
324
num Events
10
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
20
num At Risk
324
num Events
32
group Id
EG001
num Affected
21
num At Risk
324
num Events
23
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
324
num Events
18
group Id
EG001
num Affected
7
num At Risk
324
num Events
7
term
Abdominal pain upper

Complete source fields

description

All-cause mortality is reported for all randomized participants. Adverse events are all reported for all participants who received any dose of study drug.

event Groups

deaths Num Affected
69
deaths Num At Risk
327
description
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
id
EG000
other Num Affected
310
other Num At Risk
324
serious Num Affected
172
serious Num At Risk
324
title
Zanubrutinib
deaths Num Affected
83
deaths Num At Risk
325
description
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
id
EG001
other Num Affected
314
other Num At Risk
324
serious Num Affected
196
serious Num At Risk
324
title
Ibrutinib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
53
num At Risk
324
num Events
82
group Id
EG001
num Affected
56
num At Risk
324
num Events
122
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
324
num Events
10
group Id
EG001
num Affected
11
num At Risk
324
num Events
13
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
81
num At Risk
324
num Events
195
group Id
EG001
num Affected
73
num At Risk
324
num Events
162
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
34
num At Risk
324
num Events
90
group Id
EG001
num Affected
35
num At Risk
324
num Events
92
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
22
num At Risk
324
num Events
27
group Id
EG001
num Affected
45
num At Risk
324
num Events
69
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
324
num Events
7
group Id
EG001
num Affected
10
num At Risk
324
num Events
10
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
13
num At Risk
324
num Events
19
group Id
EG001
num Affected
14
num At Risk
324
num Events
16
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
324
num Events
10
group Id
EG001
num Affected
12
num At Risk
324
num Events
15
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
11
num At Risk
324
num Events
11
group Id
EG001
num Affected
6
num At Risk
324
num Events
6
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
18
num At Risk
324
num Events
22
group Id
EG001
num Affected
10
num At Risk
324
num Events
10
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
20
num At Risk
324
num Events
32
group Id
EG001
num Affected
21
num At Risk
324
num Events
23
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
324
num Events
18
group Id
EG001
num Affected
7
num At Risk
324
num Events
7
term
Abdominal pain upper

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
324
num Events
8
group Id
EG001
num Affected
4
num At Risk
324
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
2
num At Risk
324
num Events
2
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
3
term
Hypoglobulinaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
324
num Events
0
group Id
EG001
num Affected
1
num At Risk
324
num Events
1
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
2
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Lymphocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
2
num At Risk
324
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
324
num Events
1
group Id
EG001
num Affected
0
num At Risk
324
num Events
0
term
Splenic haematoma

time Frame

All-cause mortality was collected through the end of study, maximum time on study was 60.5 months. Adverse events were collected up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.

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