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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:24 AM
NCT ID: NCT02839902
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: Up to Week 8
Study: NCT02839902
Study Brief: Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAK-085 4 g A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose. 0 None 0 24 2 24 View
Control Group Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. 0 None 0 29 0 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 20.0 View