NCT02316106 · ADVERSE EVENTS

Adverse events

A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma · Source last updated 2026-04-23

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: All-Cause Mortality: From randomization (Day -5) up to 7.89 years; Serious Adverse Events and Other Adverse Events: From Cycle 1 Day 1 up to 7.89 years
Other-event reporting threshold: 5%

All Cause Mortality: All randomized participants; Serious Adverse Events and Other Adverse Events: Safety analysis set included participants who had received at least 1 administration of daratumumab (partial or complete).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (Long Intense) Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).	20 / 41	38 / 41	7 / 41
Arm B (Intermediate) Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).	14 / 41	41 / 41	5 / 41
Arm C (Short Intense) Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).	4 / 40	32 / 40	4 / 41

Group identifiers: EG000: Arm A (Long Intense) · EG001: Arm B (Intermediate) · EG002: Arm C (Short Intense)

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 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
1
num At Risk
40
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
1
num At Risk
40
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Atrioventricular Block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Pericardial Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Haematochezia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Ileus

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 25.1
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
5
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
2
num At Risk
40
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
2
num At Risk
41
group Id
EG002
num Affected
2
num At Risk
40
term
Ear Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
2
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Lacrimation Increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
3
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
5
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
4
num At Risk
41
group Id
EG002
num Affected
1
num At Risk
40
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
8
num At Risk
41
group Id
EG001
num Affected
6
num At Risk
41
group Id
EG002
num Affected
2
num At Risk
40
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
14
num At Risk
41
group Id
EG001
num Affected
13
num At Risk
41
group Id
EG002
num Affected
4
num At Risk
40
term
Diarrhoea

Complete source fields

description

event Groups

deaths Num Affected
7
deaths Num At Risk
41
description
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
id
EG000
other Num Affected
38
other Num At Risk
41
serious Num Affected
20
serious Num At Risk
41
title
Arm A (Long Intense)
deaths Num Affected
5
deaths Num At Risk
41
description
Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
id
EG001
other Num Affected
41
other Num At Risk
41
serious Num Affected
14
serious Num At Risk
41
title
Arm B (Intermediate)
deaths Num Affected
4
deaths Num At Risk
41
description
Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).
id
EG002
other Num Affected
32
other Num At Risk
40
serious Num Affected
4
serious Num At Risk
40
title
Arm C (Short Intense)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
5
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
2
num At Risk
40
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
2
num At Risk
41
group Id
EG002
num Affected
2
num At Risk
40
term
Ear Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
2
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Dry Eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Lacrimation Increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
3
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
5
num At Risk
41
group Id
EG002
num Affected
3
num At Risk
40
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
4
num At Risk
41
group Id
EG002
num Affected
1
num At Risk
40
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
8
num At Risk
41
group Id
EG001
num Affected
6
num At Risk
41
group Id
EG002
num Affected
2
num At Risk
40
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
14
num At Risk
41
group Id
EG001
num Affected
13
num At Risk
41
group Id
EG002
num Affected
4
num At Risk
40
term
Diarrhoea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
1
num At Risk
40
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
1
num At Risk
40
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Atrioventricular Block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Pericardial Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Haematochezia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
41
group Id
EG002
num Affected
0
num At Risk
40
term
Ileus

time Frame

All-Cause Mortality: From randomization (Day -5) up to 7.89 years; Serious Adverse Events and Other Adverse Events: From Cycle 1 Day 1 up to 7.89 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice