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 @ 12:30 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT02021461
Description: The study comprised a Screening Visit (not more than 1 month before the Study Day), a single Study Day (which could occur on the same day as the Screening Visit), and a follow-up telephone contact interview (that was to be performed between 1 and 4 days after the Study Day). Thus, individual study durations may have been between 2-6 days.
Frequency Threshold: 0
Time Frame: After the first tasting of study treatment until 1-4 days after tasting the IMP
Study: NCT02021461
Study Brief: Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eslicarbazepine Acetate Eslicarbazepine acetate (ESL) supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses. None None 1 38 0 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.1) View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.1) View
Other Events(If Any):