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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT00987558
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00987558
Study Brief: Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin 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
Simvastatin Simvastatin 80 mg None None 0 30 3 30 View
Eslicarbazepine Acetate eslicarbazepine acetate 800 mg None None 0 30 23 30 View
Eslicarbazepine Acetate + Simvastatin Simvastatin 80 mg + eslicarbazepine acetate 800 mg None None 0 30 5 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Asthenia None General disorders None View
Fatigue None General disorders None View
Cystitis None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Joint sprain None Injury, poisoning and procedural complications None View
Transaminases increased None Investigations None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Lymphadenopathy None Blood and lymphatic system disorders None View
Disturbance in attention None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Dizziness postural None Nervous system disorders None View
Headache None Nervous system disorders None View
Nightmare None Psychiatric disorders None View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash erythematous None Skin and subcutaneous tissue disorders None View
Rash morbilliform None Skin and subcutaneous tissue disorders None View
Rash papular None Skin and subcutaneous tissue disorders None View
Urticaria None Skin and subcutaneous tissue disorders None View
Orthostatic hypotension None Vascular disorders None View