NCT04549363 · ADVERSE EVENTS

Adverse events

Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin · Source last updated 2023-12-13

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 23 months.
Other-event reporting threshold: 0%

Impression cytology or superficial keratectomy procedure (ICSK) population included participants from all-treated population who had a tissue sample collected using IC or SK procedure, whether or not the specimen is evaluable.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Participants Allocated to Undergo Impression Cytology Procedure A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.	0 / 6	0 / 6	0 / 6
Participants Allocated to Undergo Superficial Keratectomy Procedure A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.	0 / 3	0 / 3	0 / 3

Group identifiers: EG000: Participants Allocated to Undergo Impression Cytology Procedure · EG001: Participants Allocated to Undergo Superficial Keratectomy Procedure

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
id
EG000
other Num Affected
0
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Participants Allocated to Undergo Impression Cytology Procedure
deaths Num Affected
0
deaths Num At Risk
3
description
A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
id
EG001
other Num Affected
0
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Participants Allocated to Undergo Superficial Keratectomy Procedure

frequency Threshold

time Frame

All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 23 months.

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Preserved source evidence · Not medical advice