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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT00440050
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00440050
Study Brief: DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of 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
Docosahexaenoic Acid (DHA) Dosing of 2 grams of DHA administered in a divided dose twice daily with food. None None 76 238 214 238 View
Placebo Dosing of 2 grams of placebo administered in a divided dose twice daily with food. None None 50 164 144 164 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
death SYSTEMATIC_ASSESSMENT General disorders None View
deep venous thrombosis/pulmonary embolus SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
other SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
dizziness SYSTEMATIC_ASSESSMENT General disorders None View
agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
other SYSTEMATIC_ASSESSMENT General disorders None View