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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT00469456
Description: None
Frequency Threshold: 5
Time Frame: Occurring on or after the date of the first dose of double-blind study medication and within 30 days of the date of last dose of double-blind study medication.
Study: NCT00469456
Study Brief: Effect of Memantine on Functional Communication in Patients With 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
Placebo Matching placebo, oral administration, twice daily for 12 weeks None None 13 129 2 129 View
Memantine Memantine 20mg (10mg twice daily), oral administration for 12 weeks None None 4 135 7 135 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Atrioventricular Block First Degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Bile Duct Stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastrointeritis Yersinia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Squamous Cell Carcinoma of Skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Vestibular Disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cerebellar Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Hiatus Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View