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 @ 7:18 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT01408303
Description: A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
Frequency Threshold: 5
Time Frame: None
Study: NCT01408303
Study Brief: [E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Epanova, 2 g omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks None None 3 215 13 215 View
Epanova, 4 g omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks None None 1 216 36 216 View
Placebo placebo, 1 g capsule placebo : 4 x 1 g capsule daily for 6 weeks None None 3 215 5 215 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (version 14.1 View
coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (version14.1) View
diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (version14.1) View
osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (version14.1) View
bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (version14.1) View
intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (version 14.1 View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (version14.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (version14.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v. 14.1) View