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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT02209766
Description: None
Frequency Threshold: 0.166
Time Frame: AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
Study: NCT02209766
Study Brief: A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)
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 g D4884 Japanese None None None 0 6 2 6 View
4 g D4884 Japanese None None None 0 6 2 6 View
4 g D4884 Caucasian None None None 0 6 5 6 View
Placebo Japanese Single dose followed by once daily for 14 consecutive days None None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Feeling abnormal NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
ALT increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
AST increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View