NCT03871829 · ADVERSE EVENTS

Adverse events

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab · Source last updated 2025-03-30

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 3 years and 7 months
Other-event reporting threshold: 5%

Serious and non-serious AEs were analyzed on safety population which included all participants who received at least 1 dose of study treatment; and all-cause mortality was analyzed on IIT set which included all participants who were randomized in the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: Carfilzomib+Dexamethasone (Kd) Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.	20 / 43	39 / 43	12 / 44
Arm B: Dara-SC in Combination With Kd (DKd) Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.	12 / 43	37 / 43	8 / 44

Group identifiers: EG000: Arm A: Carfilzomib+Dexamethasone (Kd) · EG001: Arm B: Dara-SC in Combination With Kd (DKd)

Serious 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
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
43
num Events
0
group Id
EG001
num Affected
1
num At Risk
43
num Events
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
43
num Events
0
group Id
EG001
num Affected
1
num At Risk
43
num Events
1
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
3
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
1
num At Risk
43
num Events
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Noninfective sialoadenitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
General physical health deterioration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
4
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Bacteraemia

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
MedDRA 24.0
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
37
group Id
EG001
num Affected
11
num At Risk
43
num Events
20
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
2
group Id
EG001
num Affected
4
num At Risk
43
num Events
5
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
8
num At Risk
43
num Events
14
group Id
EG001
num Affected
3
num At Risk
43
num Events
15
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
6
group Id
EG001
num Affected
8
num At Risk
43
num Events
18
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
8
num At Risk
43
num Events
32
group Id
EG001
num Affected
16
num At Risk
43
num Events
77
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
group Id
EG001
num Affected
3
num At Risk
43
num Events
3
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
5
group Id
EG001
num Affected
1
num At Risk
43
num Events
2
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
11
num At Risk
43
num Events
14
group Id
EG001
num Affected
4
num At Risk
43
num Events
8
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
7
group Id
EG001
num Affected
6
num At Risk
43
num Events
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
5
num At Risk
43
num Events
5
group Id
EG001
num Affected
5
num At Risk
43
num Events
9
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
6
num At Risk
43
num Events
8
group Id
EG001
num Affected
5
num At Risk
43
num Events
7
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
3
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Catheter site pain

Complete source fields

description

event Groups

deaths Num Affected
12
deaths Num At Risk
44
description
Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
id
EG000
other Num Affected
39
other Num At Risk
43
serious Num Affected
20
serious Num At Risk
43
title
Arm A: Carfilzomib+Dexamethasone (Kd)
deaths Num Affected
8
deaths Num At Risk
44
description
Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
id
EG001
other Num Affected
37
other Num At Risk
43
serious Num Affected
12
serious Num At Risk
43
title
Arm B: Dara-SC in Combination With Kd (DKd)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
37
group Id
EG001
num Affected
11
num At Risk
43
num Events
20
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
2
group Id
EG001
num Affected
4
num At Risk
43
num Events
5
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
8
num At Risk
43
num Events
14
group Id
EG001
num Affected
3
num At Risk
43
num Events
15
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
6
group Id
EG001
num Affected
8
num At Risk
43
num Events
18
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
8
num At Risk
43
num Events
32
group Id
EG001
num Affected
16
num At Risk
43
num Events
77
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
group Id
EG001
num Affected
3
num At Risk
43
num Events
3
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
5
group Id
EG001
num Affected
1
num At Risk
43
num Events
2
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
11
num At Risk
43
num Events
14
group Id
EG001
num Affected
4
num At Risk
43
num Events
8
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
7
group Id
EG001
num Affected
6
num At Risk
43
num Events
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
5
num At Risk
43
num Events
5
group Id
EG001
num Affected
5
num At Risk
43
num Events
9
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
6
num At Risk
43
num Events
8
group Id
EG001
num Affected
5
num At Risk
43
num Events
7
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
3
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Catheter site pain

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
43
num Events
0
group Id
EG001
num Affected
1
num At Risk
43
num Events
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
43
num Events
0
group Id
EG001
num Affected
1
num At Risk
43
num Events
1
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
3
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
1
num At Risk
43
num Events
1
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Noninfective sialoadenitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
General physical health deterioration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
4
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
group Id
EG001
num Affected
0
num At Risk
43
num Events
0
term
Bacteraemia

time Frame

Up to 3 years and 7 months

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Preserved source evidence · Not medical advice