NCT00462605 · ADVERSE EVENTS

Adverse events

MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia · Source last updated 2017-07-18

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: 4%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria. entinostat: Given PO sargramostim: Given SC	19 / 24	6 / 24	Not reported / Not reported

Group identifiers: EG000: Arm I

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
5
num At Risk
24
term
Neutropenic infection
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
24
term
Bone Pain
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
Fatigue
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Pericardial effusion
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Weakness
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
anorexia
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
hypoxia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
vasovagal episode
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Joint pain
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
cough
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
pneumonitis

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
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
Muscle weakness
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
hyponatremia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
confusion
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Neutropenic infection
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Dyspnea
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
fatigue
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
back pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
hypocalcemia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
GI bleed

Complete source fields

event Groups

description
Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria. entinostat: Given PO sargramostim: Given SC
id
EG000
other Num Affected
6
other Num At Risk
24
serious Num Affected
19
serious Num At Risk
24
title
Arm I

frequency Threshold

other Events

organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
Muscle weakness
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
hyponatremia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
confusion
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Neutropenic infection
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Dyspnea
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
fatigue
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
back pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
hypocalcemia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
GI bleed

serious Events

organ System
Infections and infestations
stats
group Id
EG000
num Affected
5
num At Risk
24
term
Neutropenic infection
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
24
term
Bone Pain
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
Fatigue
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Pericardial effusion
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Weakness
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
anorexia
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
term
hypoxia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
vasovagal episode
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Joint pain
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
cough
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
term
pneumonitis

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Preserved source evidence · Not medical advice