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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT04228302
Description: A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A treatment-related TEAE was defined as a TEAE considered related to the study drug.
Frequency Threshold: 0
Time Frame: 14 days
Study: NCT04228302
Study Brief: Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EC5026 0.5 mg Single 0.5 mg dose of oral EC5026 0 None 0 6 2 6 View
EC5026 2 mg Single 2 mg dose of oral EC5026 0 None 0 6 4 6 View
EC5026 8 mg Single 8 mg dose of oral EC5026 0 None 0 6 2 6 View
EC5026 16 mg Single 16 mg dose of oral EC5026 0 None 0 6 4 6 View
EC5026 24 mg Single 24 mg dose of oral EC5026 0 None 0 6 4 6 View
Placebo Single dose of matching oral placebo 0 None 0 10 3 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Medical device site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Trichomoniasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View