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 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT01820559
Description: None
Frequency Threshold: 2
Time Frame: Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
Study: NCT01820559
Study Brief: Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ESL 800 mg eslicarbazepine acetate 800 mg ESL 800 mg : None None 1 135 67 135 View
ESL 1200 mg eslicarbazepine acetate 1200 mg ESL 1200 mg : None None 4 139 74 139 View
Placebo Placebo tablets Placebo : Tablets None None 1 136 46 136 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
STATUS MIGRAINOSUS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
ADJUSTMENT DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
VENTRICULAR ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Influenza SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Status migrainosus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (Unspecified) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View