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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT00440518
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00440518
Study Brief: A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart None None 3 72 30 72 View
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart None None 2 72 36 72 View
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart None None 2 74 33 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery dissection NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Gallbladder disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Knee operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View