NCT02841033 · ADVERSE EVENTS

Adverse events

Daratumumab for the Treatment of Patients With AL Amyloidosis · Source last updated 2021-05-07

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: First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Other-event reporting threshold: 5%

Adverse events were assessed at every study treatment visit.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Daratumumab Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.	11 / 22	22 / 22	4 / 22

Group identifiers: EG000: Daratumumab

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
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
CK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Gastrointestinal hemorrhage - melena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
5
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hematuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Lung infection

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
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
4
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
6
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
5
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
10
term
Endocrine disorder - other, specify: TSH elevated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
2
term
Hypothyroidism

Complete source fields

description

Adverse events were assessed at every study treatment visit.

event Groups

deaths Num Affected
4
deaths Num At Risk
22
description
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
id
EG000
other Num Affected
22
other Num At Risk
22
serious Num Affected
11
serious Num At Risk
22
title
Daratumumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
4
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
6
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
5
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
10
term
Endocrine disorder - other, specify: TSH elevated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
2
term
Hypothyroidism

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
22
num Events
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
CK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Gastrointestinal hemorrhage - melena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
5
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Hematuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
3
term
Lung infection

time Frame

First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.

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Preserved source evidence · Not medical advice