NCT00038675 · ADVERSE EVENTS

Adverse events

Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate · Source last updated 2022-01-04

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 Event collection from first treatment through 30 days following last treatment, treatment may continue up to one year without disease progression.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Imatinib Mesylate Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.	13 / 125	0 / 125	10 / 125

Group identifiers: EG000: Imatinib Mesylate

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
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
10
num At Risk
125
num Events
10
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Hepatic Cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Herniated disc Surgery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
GI Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Second Malignancy (Basal Cell Carcinoma)

Other reported adverse events

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

Complete source fields

event Groups

deaths Num Affected
10
deaths Num At Risk
125
description
Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
id
EG000
other Num Affected
0
other Num At Risk
125
serious Num Affected
13
serious Num At Risk
125
title
Imatinib Mesylate

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
10
num At Risk
125
num Events
10
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Hepatic Cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Herniated disc Surgery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
GI Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
1
term
Second Malignancy (Basal Cell Carcinoma)

time Frame

Adverse Event collection from first treatment through 30 days following last treatment, treatment may continue up to one year without disease progression.

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Preserved source evidence · Not medical advice