NCT03652064 · ADVERSE EVENTS

Adverse events

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy · Source last updated 2026-06-02

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: Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months
Other-event reporting threshold: 5%

SAEs and other AEs: The safety analysis set included all participants who received at least 1 dose of any study treatment (partial or complete). All-cause mortality: all randomized analysis set 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: Bortezomib-lenalidomide-dexamethasone (VRd) Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.	131 / 195	191 / 195	59 / 198
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd) Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.	142 / 197	196 / 197	51 / 197

Group identifiers: EG000: Arm A: Bortezomib-lenalidomide-dexamethasone (VRd) · EG001: Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)

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 23.0
stats
group Id
EG000
num Affected
2
num At Risk
195
group Id
EG001
num Affected
6
num At Risk
197
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
4
num At Risk
195
group Id
EG001
num Affected
4
num At Risk
197
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
2
num At Risk
197
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
3
num At Risk
197
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
2
num At Risk
195
group Id
EG001
num Affected
4
num At Risk
197
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
0
num At Risk
197
term
Aortic Valve Incompetence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Aortic Valve Stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
0
num At Risk
197
term
Arrhythmia Supraventricular

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 23.0
stats
group Id
EG000
num Affected
62
num At Risk
195
group Id
EG001
num Affected
71
num At Risk
197
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
19
num At Risk
195
group Id
EG001
num Affected
28
num At Risk
197
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
34
num At Risk
195
group Id
EG001
num Affected
36
num At Risk
197
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
76
num At Risk
195
group Id
EG001
num Affected
108
num At Risk
197
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
66
num At Risk
195
group Id
EG001
num Affected
91
num At Risk
197
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
17
num At Risk
195
group Id
EG001
num Affected
12
num At Risk
197
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
4
num At Risk
195
group Id
EG001
num Affected
12
num At Risk
197
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
13
num At Risk
195
group Id
EG001
num Affected
16
num At Risk
197
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
50
num At Risk
195
group Id
EG001
num Affected
53
num At Risk
197
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
17
num At Risk
195
group Id
EG001
num Affected
9
num At Risk
197
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
19
num At Risk
195
group Id
EG001
num Affected
24
num At Risk
197
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
15
num At Risk
195
group Id
EG001
num Affected
8
num At Risk
197
term
Abdominal Distension

Complete source fields

description

event Groups

deaths Num Affected
59
deaths Num At Risk
198
description
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
id
EG000
other Num Affected
191
other Num At Risk
195
serious Num Affected
131
serious Num At Risk
195
title
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
deaths Num Affected
51
deaths Num At Risk
197
description
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
id
EG001
other Num Affected
196
other Num At Risk
197
serious Num Affected
142
serious Num At Risk
197
title
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
62
num At Risk
195
group Id
EG001
num Affected
71
num At Risk
197
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
19
num At Risk
195
group Id
EG001
num Affected
28
num At Risk
197
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
34
num At Risk
195
group Id
EG001
num Affected
36
num At Risk
197
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
76
num At Risk
195
group Id
EG001
num Affected
108
num At Risk
197
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
66
num At Risk
195
group Id
EG001
num Affected
91
num At Risk
197
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
17
num At Risk
195
group Id
EG001
num Affected
12
num At Risk
197
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
4
num At Risk
195
group Id
EG001
num Affected
12
num At Risk
197
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
13
num At Risk
195
group Id
EG001
num Affected
16
num At Risk
197
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
50
num At Risk
195
group Id
EG001
num Affected
53
num At Risk
197
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
17
num At Risk
195
group Id
EG001
num Affected
9
num At Risk
197
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
19
num At Risk
195
group Id
EG001
num Affected
24
num At Risk
197
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
15
num At Risk
195
group Id
EG001
num Affected
8
num At Risk
197
term
Abdominal Distension

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
2
num At Risk
195
group Id
EG001
num Affected
6
num At Risk
197
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
4
num At Risk
195
group Id
EG001
num Affected
4
num At Risk
197
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
2
num At Risk
197
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
3
num At Risk
197
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
2
num At Risk
195
group Id
EG001
num Affected
4
num At Risk
197
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
0
num At Risk
197
term
Aortic Valve Incompetence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Aortic Valve Stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
0
num At Risk
195
group Id
EG001
num Affected
1
num At Risk
197
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 23.0
stats
group Id
EG000
num Affected
1
num At Risk
195
group Id
EG001
num Affected
0
num At Risk
197
term
Arrhythmia Supraventricular

time Frame

Serious adverse events (SAE) and other adverse events (AEs): From start of treatment (Day 1) up to 30 days after the last dose of study treatment (up to 64.8 months); All-cause mortality: From screening (Day -28) up to 64.8 months

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Preserved source evidence · Not medical advice