NCT07084896 · ADVERSE EVENTS

Adverse events

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM · Source last updated 2026-05-06

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 253 weeks.
Other-event reporting threshold: 5%

Safety set included all participants who received at least 1 dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.	8 / 10	10 / 10	7 / 10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.	2 / 4	4 / 4	2 / 4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.	3 / 10	10 / 10	3 / 10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.	2 / 10	10 / 10	2 / 10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.	0 / 1	0 / 1	0 / 1
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.	16 / 34	27 / 34	13 / 34
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.	13 / 37	34 / 37	11 / 37

Group identifiers: EG000: DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat · EG001: DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat · EG002: DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID · EG003: DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID · EG004: DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID · EG005: CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat · EG006: CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W

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 v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Retroperitoneal haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Hyperthermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Localised oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Multiple organ dysfunction syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Oedema peripheral

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 v28.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
4
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
5
num At Risk
34
num Events
10
group Id
EG006
num Affected
9
num At Risk
37
num Events
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
3
num At Risk
37
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
5
group Id
EG001
num Affected
3
num At Risk
4
num Events
4
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
3
num At Risk
10
num Events
3
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
10
num At Risk
34
num Events
19
group Id
EG006
num Affected
10
num At Risk
37
num Events
11
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Blepharitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
5
num At Risk
37
num Events
8
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Cataract nuclear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Cataract subcapsular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Conjunctivochalasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Corneal cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
10
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Corneal epithelial microcysts

Complete source fields

description

event Groups

deaths Num Affected
7
deaths Num At Risk
10
description
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
EG000
other Num Affected
10
other Num At Risk
10
serious Num Affected
8
serious Num At Risk
10
title
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
deaths Num Affected
2
deaths Num At Risk
4
description
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
deaths Num Affected
3
deaths Num At Risk
10
description
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
EG002
other Num Affected
10
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
deaths Num Affected
2
deaths Num At Risk
10
description
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
2
serious Num At Risk
10
title
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
deaths Num Affected
0
deaths Num At Risk
1
description
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
EG004
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
deaths Num Affected
13
deaths Num At Risk
34
description
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
EG005
other Num Affected
27
other Num At Risk
34
serious Num Affected
16
serious Num At Risk
34
title
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
deaths Num Affected
11
deaths Num At Risk
37
description
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
EG006
other Num Affected
34
other Num At Risk
37
serious Num Affected
13
serious Num At Risk
37
title
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
4
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
5
num At Risk
34
num Events
10
group Id
EG006
num Affected
9
num At Risk
37
num Events
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
3
num At Risk
37
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
5
group Id
EG001
num Affected
3
num At Risk
4
num Events
4
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
3
num At Risk
10
num Events
3
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
10
num At Risk
34
num Events
19
group Id
EG006
num Affected
10
num At Risk
37
num Events
11
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Blepharitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
5
num At Risk
37
num Events
8
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Cataract nuclear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Cataract subcapsular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Conjunctivochalasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Corneal cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
10
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Corneal epithelial microcysts

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Retroperitoneal haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
1
num At Risk
37
num Events
1
term
Hyperthermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Localised oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
1
num At Risk
34
num Events
1
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Multiple organ dysfunction syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
34
num Events
0
group Id
EG006
num Affected
0
num At Risk
37
num Events
0
term
Oedema peripheral

time Frame

All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 253 weeks.

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Preserved source evidence · Not medical advice