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 @ 1:08 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT00280293
Description: Adverse events were assessed by a weekly questionnaire at each appointment.
Frequency Threshold: 0
Time Frame: Adverse events were collected during the study between 2006 and 2010. Each participant was enrolled for 10 weeks. Adverse events were collected for the full 10 weeks, beginning after consent was signed.
Study: NCT00280293
Study Brief: Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lamotrigine Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted. None None 5 55 6 55 View
Placebo Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted. None None 4 57 4 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inpatient psychiatric admittance SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Inpatient admittance for blood transfusion SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Inpatient admittance for urinary tract blockage SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Inpatient admittance due to hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fall related injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Expression of violent thoughts/ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Admittance to psychiatric facility SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nosebleed SYSTEMATIC_ASSESSMENT Vascular disorders None View
Superficial Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cut related injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall related injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Abscessed Tooth SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View