Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT00045734
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT00045734
Study Brief: Imatinib Mesylate in Treating Patients With Recurrent Meningioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Imatinib Mesylate) Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies None None 0 22 10 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
CNS (intracranial) Hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
dehydrations NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
elevated serum glutamic pyruvic transaminase NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View