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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:50 PM
NCT ID: NCT02279667
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02279667
Study Brief: Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BIA 2-093 16 mL Oral Suspension 50 mg/mL BIA 2-093, ESL, Eslicarbazepine acetate oral suspension 50 mg/mL None None 0 18 3 18 View
BIA 2-093 - Four 200 mg Tablets BIA 2-093, ESL, Eslicarbazepine acetate 200 mg tablets None None 0 18 1 18 View
BIA 2-093 One 800 mg Tablet BIA 2-093, ESL, Eslicarbazepine acetate 800 mg tablet None None 0 18 0 18 View
Follow-up Follow-up. None None 0 18 1 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (4.1) View
CPK increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (4.1) View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (4.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (4.1) View
Migraine type headaches SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (4.1) View
Localized erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (4.1) View
Facial flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (4.1) View