NCT04115059 · ADVERSE EVENTS

Adverse events

Dasatinib In Waldenström Macroglobulinemia · Source last updated 2024-03-21

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: Adverse events were collected after dasatinib initiation, through 30 days after the last dose of dasatinib (e.g. 6 months). Participants were observed for overall survival for up to 2 years, or until withdrawal of consent or death.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dasatinib \-- After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. Dasatinib: Oral Study Drug(s): * Each study treatment cycle lasts 4 weeks during which time you will be taking the study drug one time per day. * This will continue for up to 24 cycles. Dasatinib: Oral, daily, dosing per protocol, once a day for cycle	2 / 3	3 / 3	1 / 3

Group identifiers: EG000: Dasatinib

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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Metapneumovirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
term
Arrhythmia

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 10.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Congestive heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Abdominal distention
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Mouth sores
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Fluid overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Leg edema

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
3
description
\-- After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. Dasatinib: Oral Study Drug(s): * Each study treatment cycle lasts 4 weeks during which time you will be taking the study drug one time per day. * This will continue for up to 24 cycles. Dasatinib: Oral, daily, dosing per protocol, once a day for cycle
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dasatinib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Congestive heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Abdominal distention
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Mouth sores
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Fluid overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Leg edema

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Metapneumovirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
term
Arrhythmia

time Frame

Adverse events were collected after dasatinib initiation, through 30 days after the last dose of dasatinib (e.g. 6 months). Participants were observed for overall survival for up to 2 years, or until withdrawal of consent or death.

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Preserved source evidence · Not medical advice