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 @ 1:21 AM
Ignite Modification Date: 2025-12-25 @ 11:30 PM
NCT ID: NCT04770493
Description: Participants are specifically queried each week regarding any adverse events since their last study appointment.
Frequency Threshold: 5
Time Frame: 9-week treatment period
Study: NCT04770493
Study Brief: Enhancing the Effects of Alcohol Treatment With Lamotrigine
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 (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Lamotrigine: Participants will be randomized to lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks. A comparator group will receive placebo (sugar pills). 0 None 0 23 21 23 View
Placebo Identical matching placebo capsules Placebo: Matching placebo (sugar pill) 0 None 0 21 20 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Loss of Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
Body Aches SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
Contact Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Sweating SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Impaired Memory SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Insomnia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Irregular Menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Soar Throat SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Vomiting SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View