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 @ 2:15 PM
Ignite Modification Date: 2025-12-25 @ 12:53 PM
NCT ID: NCT00971295
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00971295
Study Brief: Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin + ESL Metformin HCl 850 mg, ESL 1200 mg Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days None None 0 20 9 20 View
Metformin Metformin HCl 850 mg None None 0 20 5 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythropapular rash None Skin and subcutaneous tissue disorders MedDRA 10.0 View
Constipation None General disorders MedDRA 10.0 View
Herpes labialis None Infections and infestations MedDRA 10.0 View
Right forearm ecchymosis None General disorders MedDRA 10.0 View
Recurrent vasovagal reaction None Nervous system disorders MedDRA 10.0 View
Bilateral popliteal erythromacular rash None Skin and subcutaneous tissue disorders MedDRA 10.0 View
Headache None Nervous system disorders MedDRA 10.0 View
Eczema aggravated None Skin and subcutaneous tissue disorders MedDRA 10.0 View
Acute gastroenteritis None Infections and infestations MedDRA 10.0 View
Eyelid hematoma None Injury, poisoning and procedural complications MedDRA 10.0 View
Vasovagal reaction None Nervous system disorders MedDRA 10.0 View
Nasal congestion None Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Anxiety None Psychiatric disorders MedDRA 10.0 View