NCT03450057 · ADVERSE EVENTS

Adverse events

Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment · Source last updated 2024-03-29

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: 3 years.
Other-event reporting threshold: 0%

The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	11 / 38	32 / 38	17 / 38

Group identifiers: EG000: Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Peritonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
4
num At Risk
38
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Eastern Cooperative Oncology Group performance status worsened
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Hyperkalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Cerebrovascular accident
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Acute kidney injury

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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
11
num At Risk
38
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
External ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Abdominal pain

Complete source fields

description

event Groups

deaths Num Affected
17
deaths Num At Risk
38
description
Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
id
EG000
other Num Affected
32
other Num At Risk
38
serious Num Affected
11
serious Num At Risk
38
title
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
11
num At Risk
38
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
External ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Peritonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
4
num At Risk
38
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Eastern Cooperative Oncology Group performance status worsened
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Hyperkalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Cerebrovascular accident
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Acute kidney injury

time Frame

3 years.

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Preserved source evidence · Not medical advice