NCT02076009 · ADVERSE EVENTS

Adverse events

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-05-01

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: From randomization up to 30 days after last dose of study treatment (up to 87.5 months)
Other-event reporting threshold: 5%

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

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).	148 / 281	268 / 281	Not reported / Not reported
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).	205 / 283	278 / 283	Not reported / Not reported

Group identifiers: EG000: Lenalidomide, Low-dose Dexamethasone (Rd) · EG001: Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)

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
2
num At Risk
281
group Id
EG001
num Affected
5
num At Risk
283
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
1
num At Risk
281
group Id
EG001
num Affected
0
num At Risk
283
term
Bone marrow failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
4
num At Risk
281
group Id
EG001
num Affected
13
num At Risk
283
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
1
num At Risk
281
group Id
EG001
num Affected
0
num At Risk
283
term
Hyperviscosity syndrome
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
281
group Id
EG001
num Affected
0
num At Risk
283
term
Lymphadenopathy
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
281
group Id
EG001
num Affected
3
num At Risk
283
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
281
group Id
EG001
num Affected
0
num At Risk
283
term
Sideroblastic 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
1
num At Risk
281
group Id
EG001
num Affected
3
num At Risk
283
term
Thrombocytopenia
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
281
group Id
EG001
num Affected
0
num At Risk
283
term
Thrombotic thrombocytopenic purpura
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
281
group Id
EG001
num Affected
1
num At Risk
283
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
4
num At Risk
281
group Id
EG001
num Affected
2
num At Risk
283
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
1
num At Risk
281
group Id
EG001
num Affected
2
num At Risk
283
term
Angina pectoris

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
117
num At Risk
281
group Id
EG001
num Affected
118
num At Risk
283
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
23
num At Risk
281
group Id
EG001
num Affected
29
num At Risk
283
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
17
num At Risk
281
group Id
EG001
num Affected
20
num At Risk
283
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
136
num At Risk
281
group Id
EG001
num Affected
185
num At Risk
283
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
90
num At Risk
281
group Id
EG001
num Affected
92
num At Risk
283
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
9
num At Risk
281
group Id
EG001
num Affected
17
num At Risk
283
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
281
group Id
EG001
num Affected
16
num At Risk
283
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
35
num At Risk
281
group Id
EG001
num Affected
59
num At Risk
283
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
17
num At Risk
281
group Id
EG001
num Affected
28
num At Risk
283
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
16
num At Risk
281
group Id
EG001
num Affected
30
num At Risk
283
term
Abdominal pain
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
281
group Id
EG001
num Affected
29
num At Risk
283
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
77
num At Risk
281
group Id
EG001
num Affected
94
num At Risk
283
term
Constipation

Complete source fields

description

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

event Groups

description
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
id
EG000
other Num Affected
268
other Num At Risk
281
serious Num Affected
148
serious Num At Risk
281
title
Lenalidomide, Low-dose Dexamethasone (Rd)
description
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
id
EG001
other Num Affected
278
other Num At Risk
283
serious Num Affected
205
serious Num At Risk
283
title
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)

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
117
num At Risk
281
group Id
EG001
num Affected
118
num At Risk
283
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
23
num At Risk
281
group Id
EG001
num Affected
29
num At Risk
283
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
17
num At Risk
281
group Id
EG001
num Affected
20
num At Risk
283
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
136
num At Risk
281
group Id
EG001
num Affected
185
num At Risk
283
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
90
num At Risk
281
group Id
EG001
num Affected
92
num At Risk
283
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
9
num At Risk
281
group Id
EG001
num Affected
17
num At Risk
283
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
281
group Id
EG001
num Affected
16
num At Risk
283
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
35
num At Risk
281
group Id
EG001
num Affected
59
num At Risk
283
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
17
num At Risk
281
group Id
EG001
num Affected
28
num At Risk
283
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
16
num At Risk
281
group Id
EG001
num Affected
30
num At Risk
283
term
Abdominal pain
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
281
group Id
EG001
num Affected
29
num At Risk
283
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
77
num At Risk
281
group Id
EG001
num Affected
94
num At Risk
283
term
Constipation

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
2
num At Risk
281
group Id
EG001
num Affected
5
num At Risk
283
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
1
num At Risk
281
group Id
EG001
num Affected
0
num At Risk
283
term
Bone marrow failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
4
num At Risk
281
group Id
EG001
num Affected
13
num At Risk
283
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
1
num At Risk
281
group Id
EG001
num Affected
0
num At Risk
283
term
Hyperviscosity syndrome
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
281
group Id
EG001
num Affected
0
num At Risk
283
term
Lymphadenopathy
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
281
group Id
EG001
num Affected
3
num At Risk
283
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
281
group Id
EG001
num Affected
0
num At Risk
283
term
Sideroblastic 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
1
num At Risk
281
group Id
EG001
num Affected
3
num At Risk
283
term
Thrombocytopenia
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
281
group Id
EG001
num Affected
0
num At Risk
283
term
Thrombotic thrombocytopenic purpura
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
281
group Id
EG001
num Affected
1
num At Risk
283
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
4
num At Risk
281
group Id
EG001
num Affected
2
num At Risk
283
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
1
num At Risk
281
group Id
EG001
num Affected
2
num At Risk
283
term
Angina pectoris

time Frame

From randomization up to 30 days after last dose of study treatment (up to 87.5 months)

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Preserved source evidence · Not medical advice