NCT06655818 · ADVERSE EVENTS

Adverse events

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM · Source last updated 2025-03-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 153 weeks.
Other-event reporting threshold: 5%

Safety set included all participants who received at least 1 dose of any component of the combination therapy.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).	2 / 4	4 / 4	2 / 4

Group identifiers: EG000: 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab

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
General disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Hypercalcaemia

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 v25.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Foreign body sensation in eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
7
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
3
term
Neutrophil count decreased

Complete source fields

description

Safety set included all participants who received at least 1 dose of any component of the combination therapy.

event Groups

deaths Num Affected
2
deaths Num At Risk
4
description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Foreign body sensation in eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
7
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
3
term
Neutrophil count decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
Hypercalcaemia

time Frame

All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 153 weeks.

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Preserved source evidence · Not medical advice