NCT01611090 · ADVERSE EVENTS

Adverse events

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2020-03-03

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: From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years)
Other-event reporting threshold: 5%

Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ibrutinib+BR Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	198 / 287	268 / 287	74 / 287
Placebo+BR Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.	127 / 287	271 / 287	107 / 287
Crossover to Ibrutinib Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg \[3 \* 140 mg capsules\] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.	105 / 183	157 / 183	57 / 183

Group identifiers: EG000: Ibrutinib+BR · EG001: Placebo+BR · EG002: Crossover to 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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
3
num At Risk
287
group Id
EG001
num Affected
7
num At Risk
287
group Id
EG002
num Affected
2
num At Risk
183
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Aplasia Pure Red Cell
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
1
num At Risk
183
term
Aplastic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
5
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Autoimmune Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Bone Marrow Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
1
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Cytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
30
num At Risk
287
group Id
EG001
num Affected
22
num At Risk
287
group Id
EG002
num Affected
2
num At Risk
183
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
1
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
1
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Immune Thrombocytopenic Purpura
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
7
num At Risk
287
group Id
EG001
num Affected
6
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
2
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
4
num At Risk
287
group Id
EG001
num Affected
2
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Thrombocytopenia

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
73
num At Risk
287
group Id
EG001
num Affected
79
num At Risk
287
group Id
EG002
num Affected
33
num At Risk
183
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
15
num At Risk
287
group Id
EG001
num Affected
18
num At Risk
287
group Id
EG002
num Affected
2
num At Risk
183
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
170
num At Risk
287
group Id
EG001
num Affected
159
num At Risk
287
group Id
EG002
num Affected
40
num At Risk
183
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
90
num At Risk
287
group Id
EG001
num Affected
69
num At Risk
287
group Id
EG002
num Affected
24
num At Risk
183
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
23
num At Risk
287
group Id
EG001
num Affected
5
num At Risk
287
group Id
EG002
num Affected
19
num At Risk
183
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
20
num At Risk
287
group Id
EG001
num Affected
3
num At Risk
287
group Id
EG002
num Affected
8
num At Risk
183
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
15
num At Risk
287
group Id
EG001
num Affected
9
num At Risk
287
group Id
EG002
num Affected
6
num At Risk
183
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
19
num At Risk
287
group Id
EG001
num Affected
19
num At Risk
287
group Id
EG002
num Affected
3
num At Risk
183
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
39
num At Risk
287
group Id
EG001
num Affected
24
num At Risk
287
group Id
EG002
num Affected
3
num At Risk
183
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
23
num At Risk
287
group Id
EG001
num Affected
16
num At Risk
287
group Id
EG002
num Affected
11
num At Risk
183
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
61
num At Risk
287
group Id
EG001
num Affected
50
num At Risk
287
group Id
EG002
num Affected
15
num At Risk
183
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
115
num At Risk
287
group Id
EG001
num Affected
68
num At Risk
287
group Id
EG002
num Affected
47
num At Risk
183
term
Diarrhoea

Complete source fields

description

Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.

event Groups

deaths Num Affected
74
deaths Num At Risk
287
description
Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
268
other Num At Risk
287
serious Num Affected
198
serious Num At Risk
287
title
Ibrutinib+BR
deaths Num Affected
107
deaths Num At Risk
287
description
Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
id
EG001
other Num Affected
271
other Num At Risk
287
serious Num Affected
127
serious Num At Risk
287
title
Placebo+BR
deaths Num Affected
57
deaths Num At Risk
183
description
Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg \[3 \* 140 mg capsules\] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.
id
EG002
other Num Affected
157
other Num At Risk
183
serious Num Affected
105
serious Num At Risk
183
title
Crossover to Ibrutinib

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
73
num At Risk
287
group Id
EG001
num Affected
79
num At Risk
287
group Id
EG002
num Affected
33
num At Risk
183
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
15
num At Risk
287
group Id
EG001
num Affected
18
num At Risk
287
group Id
EG002
num Affected
2
num At Risk
183
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
170
num At Risk
287
group Id
EG001
num Affected
159
num At Risk
287
group Id
EG002
num Affected
40
num At Risk
183
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
90
num At Risk
287
group Id
EG001
num Affected
69
num At Risk
287
group Id
EG002
num Affected
24
num At Risk
183
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
23
num At Risk
287
group Id
EG001
num Affected
5
num At Risk
287
group Id
EG002
num Affected
19
num At Risk
183
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
20
num At Risk
287
group Id
EG001
num Affected
3
num At Risk
287
group Id
EG002
num Affected
8
num At Risk
183
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
15
num At Risk
287
group Id
EG001
num Affected
9
num At Risk
287
group Id
EG002
num Affected
6
num At Risk
183
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
19
num At Risk
287
group Id
EG001
num Affected
19
num At Risk
287
group Id
EG002
num Affected
3
num At Risk
183
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
39
num At Risk
287
group Id
EG001
num Affected
24
num At Risk
287
group Id
EG002
num Affected
3
num At Risk
183
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
23
num At Risk
287
group Id
EG001
num Affected
16
num At Risk
287
group Id
EG002
num Affected
11
num At Risk
183
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
61
num At Risk
287
group Id
EG001
num Affected
50
num At Risk
287
group Id
EG002
num Affected
15
num At Risk
183
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
115
num At Risk
287
group Id
EG001
num Affected
68
num At Risk
287
group Id
EG002
num Affected
47
num At Risk
183
term
Diarrhoea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
3
num At Risk
287
group Id
EG001
num Affected
7
num At Risk
287
group Id
EG002
num Affected
2
num At Risk
183
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Aplasia Pure Red Cell
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
1
num At Risk
183
term
Aplastic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
5
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Autoimmune Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Bone Marrow Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
1
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Cytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
30
num At Risk
287
group Id
EG001
num Affected
22
num At Risk
287
group Id
EG002
num Affected
2
num At Risk
183
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
1
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
287
group Id
EG001
num Affected
1
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Immune Thrombocytopenic Purpura
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
7
num At Risk
287
group Id
EG001
num Affected
6
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
2
num At Risk
287
group Id
EG001
num Affected
0
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
4
num At Risk
287
group Id
EG001
num Affected
2
num At Risk
287
group Id
EG002
num Affected
0
num At Risk
183
term
Thrombocytopenia

time Frame

From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years)

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