NCT02755597 · ADVERSE EVENTS

Adverse events

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy · Source last updated 2023-08-22

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: All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days.
Other-event reporting threshold: 5%

All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Venetoclax + Bortezomib and Dexamethasone Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	115 / 193	191 / 193	81 / 194
Placebo + Bortezomib and Dexamethasone Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23	53 / 96	95 / 96	36 / 97

Group identifiers: EG000: Venetoclax + Bortezomib and Dexamethasone · EG001: Placebo + Bortezomib and Dexamethasone

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 25.0
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
5
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
6
num At Risk
193
num Events
6
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
ANGINA UNSTABLE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
6
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
CARDIOMYOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
CORONARY ARTERY DISEASE

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 25.0
stats
group Id
EG000
num Affected
48
num At Risk
193
num Events
73
group Id
EG001
num Affected
23
num At Risk
96
num Events
31
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
19
num At Risk
193
num Events
54
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
54
num At Risk
193
num Events
183
group Id
EG001
num Affected
9
num At Risk
96
num Events
16
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
53
num At Risk
193
num Events
120
group Id
EG001
num Affected
34
num At Risk
96
num Events
78
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
193
num Events
6
group Id
EG001
num Affected
6
num At Risk
96
num Events
6
term
PALPITATIONS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
24
num At Risk
193
num Events
33
group Id
EG001
num Affected
11
num At Risk
96
num Events
17
term
CATARACT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
8
num At Risk
193
num Events
9
group Id
EG001
num Affected
5
num At Risk
96
num Events
5
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
12
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
ABDOMINAL DISCOMFORT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
193
num Events
17
group Id
EG001
num Affected
3
num At Risk
96
num Events
3
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
23
num At Risk
193
num Events
38
group Id
EG001
num Affected
8
num At Risk
96
num Events
10
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
20
num At Risk
193
num Events
26
group Id
EG001
num Affected
7
num At Risk
96
num Events
9
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
68
num At Risk
193
num Events
89
group Id
EG001
num Affected
29
num At Risk
96
num Events
35
term
CONSTIPATION

Complete source fields

description

All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.

event Groups

deaths Num Affected
81
deaths Num At Risk
194
description
Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23
id
EG000
other Num Affected
191
other Num At Risk
193
serious Num Affected
115
serious Num At Risk
193
title
Venetoclax + Bortezomib and Dexamethasone
deaths Num Affected
36
deaths Num At Risk
97
description
Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
id
EG001
other Num Affected
95
other Num At Risk
96
serious Num Affected
53
serious Num At Risk
96
title
Placebo + Bortezomib and Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
48
num At Risk
193
num Events
73
group Id
EG001
num Affected
23
num At Risk
96
num Events
31
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
19
num At Risk
193
num Events
54
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
54
num At Risk
193
num Events
183
group Id
EG001
num Affected
9
num At Risk
96
num Events
16
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
53
num At Risk
193
num Events
120
group Id
EG001
num Affected
34
num At Risk
96
num Events
78
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
193
num Events
6
group Id
EG001
num Affected
6
num At Risk
96
num Events
6
term
PALPITATIONS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
24
num At Risk
193
num Events
33
group Id
EG001
num Affected
11
num At Risk
96
num Events
17
term
CATARACT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
8
num At Risk
193
num Events
9
group Id
EG001
num Affected
5
num At Risk
96
num Events
5
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
12
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
ABDOMINAL DISCOMFORT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
193
num Events
17
group Id
EG001
num Affected
3
num At Risk
96
num Events
3
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
23
num At Risk
193
num Events
38
group Id
EG001
num Affected
8
num At Risk
96
num Events
10
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
20
num At Risk
193
num Events
26
group Id
EG001
num Affected
7
num At Risk
96
num Events
9
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
68
num At Risk
193
num Events
89
group Id
EG001
num Affected
29
num At Risk
96
num Events
35
term
CONSTIPATION

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
5
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
6
num At Risk
193
num Events
6
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
ANGINA UNSTABLE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
6
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
96
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
CARDIOMYOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
96
num Events
1
term
CORONARY ARTERY DISEASE

time Frame

All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days.

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