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 @ 12:03 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT03885661
Description: Adverse events were reported during scheduled visits during and after the 12 week treatment period.
Frequency Threshold: 0
Time Frame: 12 weeks after subjects received their first daily dose of study drug or usual care.
Study: NCT03885661
Study Brief: Vascepa to Accelerate Lipoprotein Uptake and Elimination
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Icosapent Ethyl Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background Icosapent Ethyl 1000 MG \[Vascepa\]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate. 0 None 0 12 8 12 View
Usual Care Statin background 0 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation; Dyspepsia; Nausea; Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache; Migrane; Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dermatitis; Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sinusitis; Itchy Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Limb discomfort; Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View