NCT03277105 · ADVERSE EVENTS

Adverse events

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-04-29

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
Other-event reporting threshold: 5%

Safety population included all randomized participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Daratumumab IV Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.	89 / 258	216 / 258	130 / 258
Daratumumab SC Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.	83 / 260	217 / 260	126 / 260

Group identifiers: EG000: Daratumumab IV · EG001: Daratumumab SC

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 Version 21.1
stats
group Id
EG000
num Affected
4
num At Risk
258
group Id
EG001
num Affected
6
num At Risk
260
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
2
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
0
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Hyperviscosity Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
4
num At Risk
258
group Id
EG001
num Affected
3
num At Risk
260
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
0
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
0
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Atrioventricular Block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Atrioventricular Block Complete
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Cardiac Failure

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 Version 21.1
stats
group Id
EG000
num Affected
64
num At Risk
258
group Id
EG001
num Affected
71
num At Risk
260
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
10
num At Risk
258
group Id
EG001
num Affected
18
num At Risk
260
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
17
num At Risk
258
group Id
EG001
num Affected
21
num At Risk
260
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
34
num At Risk
258
group Id
EG001
num Affected
52
num At Risk
260
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
50
num At Risk
258
group Id
EG001
num Affected
49
num At Risk
260
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
22
num At Risk
258
group Id
EG001
num Affected
16
num At Risk
260
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
32
num At Risk
258
group Id
EG001
num Affected
41
num At Risk
260
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
31
num At Risk
258
group Id
EG001
num Affected
24
num At Risk
260
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
21
num At Risk
258
group Id
EG001
num Affected
16
num At Risk
260
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
17
num At Risk
258
group Id
EG001
num Affected
15
num At Risk
260
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
32
num At Risk
258
group Id
EG001
num Affected
15
num At Risk
260
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
26
num At Risk
258
group Id
EG001
num Affected
33
num At Risk
260
term
Fatigue

Complete source fields

description

Safety population included all randomized participants who received at least 1 dose of study drug.

event Groups

deaths Num Affected
130
deaths Num At Risk
258
description
Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
EG000
other Num Affected
216
other Num At Risk
258
serious Num Affected
89
serious Num At Risk
258
title
Daratumumab IV
deaths Num Affected
126
deaths Num At Risk
260
description
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
EG001
other Num Affected
217
other Num At Risk
260
serious Num Affected
83
serious Num At Risk
260
title
Daratumumab SC

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
64
num At Risk
258
group Id
EG001
num Affected
71
num At Risk
260
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
10
num At Risk
258
group Id
EG001
num Affected
18
num At Risk
260
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
17
num At Risk
258
group Id
EG001
num Affected
21
num At Risk
260
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
34
num At Risk
258
group Id
EG001
num Affected
52
num At Risk
260
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
50
num At Risk
258
group Id
EG001
num Affected
49
num At Risk
260
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
22
num At Risk
258
group Id
EG001
num Affected
16
num At Risk
260
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
32
num At Risk
258
group Id
EG001
num Affected
41
num At Risk
260
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
31
num At Risk
258
group Id
EG001
num Affected
24
num At Risk
260
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
21
num At Risk
258
group Id
EG001
num Affected
16
num At Risk
260
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
17
num At Risk
258
group Id
EG001
num Affected
15
num At Risk
260
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
32
num At Risk
258
group Id
EG001
num Affected
15
num At Risk
260
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
26
num At Risk
258
group Id
EG001
num Affected
33
num At Risk
260
term
Fatigue

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
4
num At Risk
258
group Id
EG001
num Affected
6
num At Risk
260
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
2
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
0
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Hyperviscosity Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
4
num At Risk
258
group Id
EG001
num Affected
3
num At Risk
260
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
0
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
0
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Atrioventricular Block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
0
num At Risk
260
term
Atrioventricular Block Complete
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 21.1
stats
group Id
EG000
num Affected
1
num At Risk
258
group Id
EG001
num Affected
1
num At Risk
260
term
Cardiac Failure

time Frame

Up to 3 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice