NCT03112174 · ADVERSE EVENTS

Adverse events

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) · Source last updated 2025-07-22

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: For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).
Other-event reporting threshold: 5%

All treated participants

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Safety Run-in: Increased TLS Risk at Baseline Participants with an increased risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.	15 / 15	15 / 15	8 / 15
Safety Run-in: Low TLS Risk at Baseline Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.	3 / 6	6 / 6	3 / 6
Randomization Phase: Ibrutinb + Venetoclax Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.	92 / 134	131 / 134	70 / 134
Randomization Phase: Ibrutinib + Placebo Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.	86 / 132	127 / 132	78 / 132
Treatment-naive Open-label Arm Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).	48 / 78	77 / 78	20 / 78

Group identifiers: EG000: Safety Run-in: Increased TLS Risk at Baseline · EG001: Safety Run-in: Low TLS Risk at Baseline · EG002: Randomization Phase: Ibrutinb + Venetoclax · EG003: Randomization Phase: Ibrutinib + Placebo · EG004: Treatment-naive Open-label Arm

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 26.1
stats
group Id
EG000
num Affected
2
num At Risk
15
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
6
num At Risk
134
num Events
7
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
FEBRILE BONE MARROW APLASIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
3
num At Risk
132
num Events
3
group Id
EG004
num Affected
2
num At Risk
78
num Events
3
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
1
num At Risk
132
num Events
1
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
2
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
134
num Events
5
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
2
term
SPONTANEOUS HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
134
num Events
10
group Id
EG003
num Affected
4
num At Risk
132
num Events
4
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
term
ARTERIOSCLEROSIS CORONARY ARTERY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
6
num At Risk
134
num Events
7
group Id
EG003
num Affected
3
num At Risk
132
num Events
4
group Id
EG004
num Affected
3
num At Risk
78
num Events
3
term
ATRIAL FIBRILLATION

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 26.1
stats
group Id
EG000
num Affected
4
num At Risk
15
num Events
20
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
27
num At Risk
134
num Events
40
group Id
EG003
num Affected
17
num At Risk
132
num Events
32
group Id
EG004
num Affected
17
num At Risk
78
num Events
27
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
3
num At Risk
15
num Events
4
group Id
EG001
num Affected
3
num At Risk
6
num Events
4
group Id
EG002
num Affected
12
num At Risk
134
num Events
17
group Id
EG003
num Affected
10
num At Risk
132
num Events
12
group Id
EG004
num Affected
17
num At Risk
78
num Events
25
term
INCREASED TENDENCY TO BRUISE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
12
num At Risk
134
num Events
53
group Id
EG003
num Affected
1
num At Risk
132
num Events
2
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
134
num Events
2
group Id
EG003
num Affected
4
num At Risk
132
num Events
4
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
7
num At Risk
15
num Events
33
group Id
EG001
num Affected
1
num At Risk
6
num Events
2
group Id
EG002
num Affected
46
num At Risk
134
num Events
207
group Id
EG003
num Affected
19
num At Risk
132
num Events
25
group Id
EG004
num Affected
26
num At Risk
78
num Events
67
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
SPLENOMEGALY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
134
num Events
3
group Id
EG003
num Affected
3
num At Risk
132
num Events
3
group Id
EG004
num Affected
1
num At Risk
78
num Events
2
term
SPONTANEOUS HAEMATOMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
4
num At Risk
15
num Events
6
group Id
EG001
num Affected
4
num At Risk
6
num Events
5
group Id
EG002
num Affected
22
num At Risk
134
num Events
74
group Id
EG003
num Affected
20
num At Risk
132
num Events
46
group Id
EG004
num Affected
8
num At Risk
78
num Events
23
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
12
num At Risk
134
num Events
14
group Id
EG003
num Affected
12
num At Risk
132
num Events
16
group Id
EG004
num Affected
10
num At Risk
78
num Events
10
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
134
num Events
4
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
BRADYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
5
num At Risk
134
num Events
8
group Id
EG003
num Affected
3
num At Risk
132
num Events
3
group Id
EG004
num Affected
7
num At Risk
78
num Events
10
term
PALPITATIONS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
134
num Events
2
group Id
EG003
num Affected
1
num At Risk
132
num Events
1
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
EAR PAIN

Complete source fields

description

All treated participants

event Groups

deaths Num Affected
8
deaths Num At Risk
15
description
Participants with an increased risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
id
EG000
other Num Affected
15
other Num At Risk
15
serious Num Affected
15
serious Num At Risk
15
title
Safety Run-in: Increased TLS Risk at Baseline
deaths Num Affected
3
deaths Num At Risk
6
description
Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Safety Run-in: Low TLS Risk at Baseline
deaths Num Affected
70
deaths Num At Risk
134
description
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
id
EG002
other Num Affected
131
other Num At Risk
134
serious Num Affected
92
serious Num At Risk
134
title
Randomization Phase: Ibrutinb + Venetoclax
deaths Num Affected
78
deaths Num At Risk
132
description
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
id
EG003
other Num Affected
127
other Num At Risk
132
serious Num Affected
86
serious Num At Risk
132
title
Randomization Phase: Ibrutinib + Placebo
deaths Num Affected
20
deaths Num At Risk
78
description
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
id
EG004
other Num Affected
77
other Num At Risk
78
serious Num Affected
48
serious Num At Risk
78
title
Treatment-naive Open-label Arm

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
4
num At Risk
15
num Events
20
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
27
num At Risk
134
num Events
40
group Id
EG003
num Affected
17
num At Risk
132
num Events
32
group Id
EG004
num Affected
17
num At Risk
78
num Events
27
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
3
num At Risk
15
num Events
4
group Id
EG001
num Affected
3
num At Risk
6
num Events
4
group Id
EG002
num Affected
12
num At Risk
134
num Events
17
group Id
EG003
num Affected
10
num At Risk
132
num Events
12
group Id
EG004
num Affected
17
num At Risk
78
num Events
25
term
INCREASED TENDENCY TO BRUISE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
12
num At Risk
134
num Events
53
group Id
EG003
num Affected
1
num At Risk
132
num Events
2
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
134
num Events
2
group Id
EG003
num Affected
4
num At Risk
132
num Events
4
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
7
num At Risk
15
num Events
33
group Id
EG001
num Affected
1
num At Risk
6
num Events
2
group Id
EG002
num Affected
46
num At Risk
134
num Events
207
group Id
EG003
num Affected
19
num At Risk
132
num Events
25
group Id
EG004
num Affected
26
num At Risk
78
num Events
67
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
SPLENOMEGALY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
134
num Events
3
group Id
EG003
num Affected
3
num At Risk
132
num Events
3
group Id
EG004
num Affected
1
num At Risk
78
num Events
2
term
SPONTANEOUS HAEMATOMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
4
num At Risk
15
num Events
6
group Id
EG001
num Affected
4
num At Risk
6
num Events
5
group Id
EG002
num Affected
22
num At Risk
134
num Events
74
group Id
EG003
num Affected
20
num At Risk
132
num Events
46
group Id
EG004
num Affected
8
num At Risk
78
num Events
23
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
12
num At Risk
134
num Events
14
group Id
EG003
num Affected
12
num At Risk
132
num Events
16
group Id
EG004
num Affected
10
num At Risk
78
num Events
10
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
134
num Events
4
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
BRADYCARDIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
5
num At Risk
134
num Events
8
group Id
EG003
num Affected
3
num At Risk
132
num Events
3
group Id
EG004
num Affected
7
num At Risk
78
num Events
10
term
PALPITATIONS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
134
num Events
2
group Id
EG003
num Affected
1
num At Risk
132
num Events
1
group Id
EG004
num Affected
2
num At Risk
78
num Events
2
term
EAR PAIN

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
15
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
6
num At Risk
134
num Events
7
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
FEBRILE BONE MARROW APLASIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
3
num At Risk
132
num Events
3
group Id
EG004
num Affected
2
num At Risk
78
num Events
3
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
1
num At Risk
132
num Events
1
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
2
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
134
num Events
5
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
2
term
SPONTANEOUS HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
4
num At Risk
134
num Events
10
group Id
EG003
num Affected
4
num At Risk
132
num Events
4
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
2
num At Risk
132
num Events
2
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
134
num Events
1
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
0
num At Risk
78
num Events
0
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
134
num Events
0
group Id
EG003
num Affected
0
num At Risk
132
num Events
0
group Id
EG004
num Affected
1
num At Risk
78
num Events
1
term
ARTERIOSCLEROSIS CORONARY ARTERY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
6
num At Risk
134
num Events
7
group Id
EG003
num Affected
3
num At Risk
132
num Events
4
group Id
EG004
num Affected
3
num At Risk
78
num Events
3
term
ATRIAL FIBRILLATION

time Frame

For an overall median duration of 69.6 months (Safety Run-in: Increased TLS Risk), 77.9 months (Safety Run-in: Low TLS Risk), 61.0 months (Randomization Phase: Ibrutinb + Venetoclax), 61.7 months (Randomization Phase: Ibrutinb + Placebo), 40.5 months (Treatment-naive Open-label Arm).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice