NCT05911321 · ADVERSE EVENTS

Adverse events

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM · Source last updated 2026-06-09

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: Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up.
Other-event reporting threshold: 0%

CTCAE version 5.0

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Experimental: Single Arm Subjects with relapsed or refractory multiple myeloma receiving the study treatment.	0 / 6	6 / 6	0 / 6

Group identifiers: EG000: Experimental: Single Arm

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.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Watering eyes
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Bloating
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
4
num At Risk
6
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Gastrointestinal disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Flu like symptoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Allergic reaction

Complete source fields

description

CTCAE version 5.0

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Experimental: Single Arm

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Watering eyes
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Bloating
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
4
num At Risk
6
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Gastrointestinal disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Flu like symptoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE v5
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Allergic reaction

time Frame

Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up.

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Preserved source evidence · Not medical advice