NCT04246047 · ADVERSE EVENTS

Adverse events

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2026-04-23

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, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 41 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Other-event reporting threshold: 5%

Safety population included all randomized participants who took at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	121 / 242	238 / 242	50 / 242
Daratumumab + Bor + Dex Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	90 / 246	239 / 246	77 / 246

Group identifiers: EG000: Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) · EG001: Daratumumab + Bor + Dex

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
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
27
num At Risk
242
num Events
27
group Id
EG001
num Affected
10
num At Risk
246
num Events
13
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
11
num At Risk
242
num Events
11
group Id
EG001
num Affected
10
num At Risk
246
num Events
10
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
8
num At Risk
242
num Events
8
group Id
EG001
num Affected
8
num At Risk
246
num Events
8
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
3
num At Risk
242
num Events
3
group Id
EG001
num Affected
4
num At Risk
246
num Events
4
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
1
num At Risk
242
num Events
1
group Id
EG001
num Affected
3
num At Risk
246
num Events
3
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
3
num At Risk
242
num Events
3
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
4
num At Risk
242
num Events
4
group Id
EG001
num Affected
0
num At Risk
246
num Events
0
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
2
num At Risk
242
num Events
2
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Clostridium difficile colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
2
num At Risk
242
num Events
2
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Staphylococcal sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
2
num At Risk
242
num Events
2
group Id
EG001
num Affected
0
num At Risk
246
num Events
0
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
1
num At Risk
242
num Events
1
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
0
num At Risk
242
num Events
0
group Id
EG001
num Affected
2
num At Risk
246
num Events
2
term
Large intestine infection

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 V(22)
stats
group Id
EG000
num Affected
167
num At Risk
242
num Events
501
group Id
EG001
num Affected
122
num At Risk
246
num Events
269
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
45
num At Risk
242
num Events
66
group Id
EG001
num Affected
64
num At Risk
246
num Events
110
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
34
num At Risk
242
num Events
83
group Id
EG001
num Affected
27
num At Risk
246
num Events
51
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
21
num At Risk
242
num Events
44
group Id
EG001
num Affected
23
num At Risk
246
num Events
38
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
14
num At Risk
242
num Events
42
group Id
EG001
num Affected
10
num At Risk
246
num Events
17
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
61
num At Risk
242
num Events
81
group Id
EG001
num Affected
51
num At Risk
246
num Events
68
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
50
num At Risk
242
num Events
59
group Id
EG001
num Affected
55
num At Risk
246
num Events
70
term
Neuropathy peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
21
num At Risk
242
num Events
24
group Id
EG001
num Affected
19
num At Risk
246
num Events
20
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
21
num At Risk
242
num Events
25
group Id
EG001
num Affected
18
num At Risk
246
num Events
20
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
15
num At Risk
242
num Events
17
group Id
EG001
num Affected
13
num At Risk
246
num Events
14
term
Polyneuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
14
num At Risk
242
num Events
16
group Id
EG001
num Affected
13
num At Risk
246
num Events
14
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
76
num At Risk
242
num Events
109
group Id
EG001
num Affected
77
num At Risk
246
num Events
119
term
Diarrhoea

Complete source fields

description

Safety population included all randomized participants who took at least 1 dose of study treatment.

event Groups

deaths Num Affected
50
deaths Num At Risk
242
description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
id
EG000
other Num Affected
238
other Num At Risk
242
serious Num Affected
121
serious Num At Risk
242
title
Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)
deaths Num Affected
77
deaths Num At Risk
246
description
Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
id
EG001
other Num Affected
239
other Num At Risk
246
serious Num Affected
90
serious Num At Risk
246
title
Daratumumab + Bor + Dex

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
167
num At Risk
242
num Events
501
group Id
EG001
num Affected
122
num At Risk
246
num Events
269
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
45
num At Risk
242
num Events
66
group Id
EG001
num Affected
64
num At Risk
246
num Events
110
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
34
num At Risk
242
num Events
83
group Id
EG001
num Affected
27
num At Risk
246
num Events
51
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
21
num At Risk
242
num Events
44
group Id
EG001
num Affected
23
num At Risk
246
num Events
38
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
14
num At Risk
242
num Events
42
group Id
EG001
num Affected
10
num At Risk
246
num Events
17
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
61
num At Risk
242
num Events
81
group Id
EG001
num Affected
51
num At Risk
246
num Events
68
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
50
num At Risk
242
num Events
59
group Id
EG001
num Affected
55
num At Risk
246
num Events
70
term
Neuropathy peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
21
num At Risk
242
num Events
24
group Id
EG001
num Affected
19
num At Risk
246
num Events
20
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
21
num At Risk
242
num Events
25
group Id
EG001
num Affected
18
num At Risk
246
num Events
20
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
15
num At Risk
242
num Events
17
group Id
EG001
num Affected
13
num At Risk
246
num Events
14
term
Polyneuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
14
num At Risk
242
num Events
16
group Id
EG001
num Affected
13
num At Risk
246
num Events
14
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
76
num At Risk
242
num Events
109
group Id
EG001
num Affected
77
num At Risk
246
num Events
119
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
27
num At Risk
242
num Events
27
group Id
EG001
num Affected
10
num At Risk
246
num Events
13
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
11
num At Risk
242
num Events
11
group Id
EG001
num Affected
10
num At Risk
246
num Events
10
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
8
num At Risk
242
num Events
8
group Id
EG001
num Affected
8
num At Risk
246
num Events
8
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
3
num At Risk
242
num Events
3
group Id
EG001
num Affected
4
num At Risk
246
num Events
4
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
1
num At Risk
242
num Events
1
group Id
EG001
num Affected
3
num At Risk
246
num Events
3
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
3
num At Risk
242
num Events
3
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
4
num At Risk
242
num Events
4
group Id
EG001
num Affected
0
num At Risk
246
num Events
0
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
2
num At Risk
242
num Events
2
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Clostridium difficile colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
2
num At Risk
242
num Events
2
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Staphylococcal sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
2
num At Risk
242
num Events
2
group Id
EG001
num Affected
0
num At Risk
246
num Events
0
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
1
num At Risk
242
num Events
1
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V(22)
stats
group Id
EG000
num Affected
0
num At Risk
242
num Events
0
group Id
EG001
num Affected
2
num At Risk
246
num Events
2
term
Large intestine infection

time Frame

All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 41 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.

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