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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:32 AM
NCT ID: NCT00090402
Description: Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00090402
Study Brief: Fish Oil and Alpha Lipoic Acid in Treating 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 Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate None None 1 13 9 13 View
Fish Oil Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate. None None 1 13 5 13 View
Fish Oil Plus Lipoic Acid Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg). None None 0 13 7 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
Urinary Tract Infection (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders SNOMED CT View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Endocrine disorders SNOMED CT View
Falls SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
cold SYSTEMATIC_ASSESSMENT General disorders SNOMED CT View
loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View