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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT02057406
Description: None
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
Study: NCT02057406
Study Brief: Omega 3 for Treatment of Depression in Patients With Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2:1 EPA/DHA 400/200 EPA/DHA fish oil 2 grams 2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams 1 None 4 36 7 36 View
High EPA Almost pure EPA 2 grams High EPA 0 None 5 36 6 36 View
Placebo Matched placebo corn oil capsules Placebo 1 None 7 36 10 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertensive Urgency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heart Failure Exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain on Exertion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mild Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
None SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cataract Removal SYSTEMATIC_ASSESSMENT Eye disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bacterial Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute Pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Knee Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza A SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right Lower Back/Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nerve Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heart failure exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arm Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lumbar Burst Fracture, With Acute Exacerbation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View