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 @ 3:03 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT00477659
Description: Safety analysis set included all participants who received at least one dose of study medication.
Frequency Threshold: 0
Time Frame: All adverse events were collected from first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 12 weeks)
Study: NCT00477659
Study Brief: Neural Correlates In Mild Alzheimer's Disease
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 Hydrochloride Participants received donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks. 0 None 0 14 11 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Obsessive thoughts SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Feces discolored SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View