Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:14 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT02285166
Description: In this survey, only the data of mortality and cardiovascular side effects with Omega-3 fatty acid ethyl esters 2 g (see Other Adverse Event\[AE\]s table below) were planned to be collected and report. That is, due to observational study, the other AEs data such as serious AEs, non-cardiovascular AEs were not planned to be collected and reported. Reported data were only mortality and side effects data in the population of treatment with Omega-3 fatty acid ethyl esters 2 g.
Frequency Threshold: 0.01
Time Frame: Up to 36 months
Study: NCT02285166
Study Brief: Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Omega-3 Fatty Acid Ethyl Esters 2 g The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care. Reported groups were combined in this section because group assignment (groups with or without intervention of omega-3 fatty acid ethyl esters) was conducted after completion of data collection (collection of Case Report Form) in this observational study and collection of data for each group during this study was not planned on the protocol of this study. 74 None 0 0 25 6867 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 23.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 23.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 23.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 23.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 23.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 23.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Ver. 23.0 View