NCT02136134 · ADVERSE EVENTS

Adverse events

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-08-29

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 6 years 9 months
Other-event reporting threshold: 5%

Safety population included all randomized participants who had at least 1 administration of any of the study treatment (partial or complete).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bortezomib + Dexamethasone (Vd) Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.	81 / 237	217 / 237	Not reported / Not reported
Daratumumab + Bortezomib and Dexamethasone (DVd) Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.	134 / 243	238 / 243	Not reported / Not reported
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy Participants in Vd group, who met sponsor confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.	7 / 87	29 / 87	Not reported / Not reported

Group identifiers: EG000: Bortezomib + Dexamethasone (Vd) · EG001: Daratumumab + Bortezomib and Dexamethasone (DVd) · EG002: Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
9
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
6
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Angina unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
1
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Arrhythmia supraventricular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
6
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
1
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
1
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Cardiac failure congestive

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 24.0
stats
group Id
EG000
num Affected
75
num At Risk
237
group Id
EG001
num Affected
68
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
12
num At Risk
237
group Id
EG001
num Affected
23
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
9
num At Risk
237
group Id
EG001
num Affected
33
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
23
num At Risk
237
group Id
EG001
num Affected
47
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
105
num At Risk
237
group Id
EG001
num Affected
145
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
10
num At Risk
237
group Id
EG001
num Affected
14
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
7
num At Risk
237
group Id
EG001
num Affected
19
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
37
num At Risk
237
group Id
EG001
num Affected
56
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
53
num At Risk
237
group Id
EG001
num Affected
88
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
13
num At Risk
237
group Id
EG001
num Affected
9
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
27
num At Risk
237
group Id
EG001
num Affected
37
num At Risk
243
group Id
EG002
num Affected
2
num At Risk
87
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
9
num At Risk
237
group Id
EG001
num Affected
30
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Vomiting

Complete source fields

description

Safety population included all randomized participants who had at least 1 administration of any of the study treatment (partial or complete).

event Groups

description
Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
id
EG000
other Num Affected
217
other Num At Risk
237
serious Num Affected
81
serious Num At Risk
237
title
Bortezomib + Dexamethasone (Vd)
description
Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
id
EG001
other Num Affected
238
other Num At Risk
243
serious Num Affected
134
serious Num At Risk
243
title
Daratumumab + Bortezomib and Dexamethasone (DVd)
description
Participants in Vd group, who met sponsor confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
id
EG002
other Num Affected
29
other Num At Risk
87
serious Num Affected
7
serious Num At Risk
87
title
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
75
num At Risk
237
group Id
EG001
num Affected
68
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
12
num At Risk
237
group Id
EG001
num Affected
23
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
9
num At Risk
237
group Id
EG001
num Affected
33
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
23
num At Risk
237
group Id
EG001
num Affected
47
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
105
num At Risk
237
group Id
EG001
num Affected
145
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
10
num At Risk
237
group Id
EG001
num Affected
14
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
7
num At Risk
237
group Id
EG001
num Affected
19
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
37
num At Risk
237
group Id
EG001
num Affected
56
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
53
num At Risk
237
group Id
EG001
num Affected
88
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
13
num At Risk
237
group Id
EG001
num Affected
9
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
27
num At Risk
237
group Id
EG001
num Affected
37
num At Risk
243
group Id
EG002
num Affected
2
num At Risk
87
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
9
num At Risk
237
group Id
EG001
num Affected
30
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Vomiting

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
9
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
6
num At Risk
243
group Id
EG002
num Affected
1
num At Risk
87
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Angina unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
1
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Arrhythmia supraventricular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
6
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
1
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
237
group Id
EG001
num Affected
1
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
237
group Id
EG001
num Affected
2
num At Risk
243
group Id
EG002
num Affected
0
num At Risk
87
term
Cardiac failure congestive

time Frame

Up to 6 years 9 months

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Preserved source evidence · Not medical advice