NCT00425477 · ADVERSE EVENTS

Adverse events

Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia · Source last updated 2018-10-05

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bexarotene + GM-CSF BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.	7 / 26	7 / 26	3 / 26

Group identifiers: EG000: Bexarotene + GM-CSF

Serious adverse events

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

organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
26
term
Neutropenic infection
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
26
term
Dyspnea
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
term
Atrial flutter
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
term
acute subdural hemmorrhage
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
term
sepsis

Other reported adverse events

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

organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
3
num At Risk
26
term
Elevated ALT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
term
Hypertriglyceridemia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
term
Muscle weakness

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
26
description
BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
id
EG000
other Num Affected
7
other Num At Risk
26
serious Num Affected
7
serious Num At Risk
26
title
Bexarotene + GM-CSF

frequency Threshold

other Events

organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
3
num At Risk
26
term
Elevated ALT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
term
Hypertriglyceridemia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
term
Muscle weakness

serious Events

organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
26
term
Neutropenic infection
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
26
term
Dyspnea
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
term
Atrial flutter
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
term
acute subdural hemmorrhage
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
term
sepsis

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Preserved source evidence · Not medical advice