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: 2025-12-24 @ 6:27 PM
Ignite Modification Date: 2025-12-25 @ 3:57 PM
NCT ID: NCT00452868
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00452868
Study Brief: Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Donepezil None None None 3 11 11 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
ataxia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Incontinence, urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Personality/behavioral SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Neurology SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Head/headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Occular/Visual SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Fever (in the absence of neutropenia) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Speech Impairment SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Mood Alteration: Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Pain: Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Back SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hemorrhag, pulmonary/upper respiratory: nose SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Extrapyramidal/involuntary movement/restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Incontenence, anal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Muscle weakness, generalized: whole body SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain: Muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain: Extremity-limb SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Infection with unknown ANC: Bronchus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with unknown ANC: Nerv-peripheral SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with unknown ANC: Urinary tract NOS SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Muscle weakness, generalid or specfic ara (not due to neuropathy): Left sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Neuropathy: cranial: CN VIII Hearing and balance SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View