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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:16 AM
NCT ID: NCT01568034
Description: None
Frequency Threshold: 0
Time Frame: 10 months
Study: NCT01568034
Study Brief: A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
25 mg BIA 9-1067 25 mg BIA 9-1067 ESL, Eslicarbazepine None None 0 10 5 10 View
50 mg BIA 9-1067 50 mg BIA 9-1067 ESL, Eslicarbazepine None None 0 10 6 10 View
100 mg BIA 9-1067 100 mg BIA 9-1067 ESL, Eslicarbazepine None None 0 10 7 10 View
Placebo Placebo ESL, Eslicarbazepine None None 0 9 3 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
EOSINOPHIL PERCENTAGE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.0) View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (13.0) View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
SUPRAVENTRICULAR EXTRASYSTOLES SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.0) View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
PALLOR SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.0) View
RESPIRATORY INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (13.0) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.0) View
HALLUCINATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.0) View
BLOOD PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
LIGHTHEADEDNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (13.0) View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.0) View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.0) View