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 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT00621751
Description: None
Frequency Threshold: 5
Time Frame: 42 days plus additional 30 days.
Study: NCT00621751
Study Brief: Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Carbamazepine Carbamazepine 800 mg daily Carbamazepine: 800 mg daily 0 None 6 35 29 35 View
Placebo Placebo Placebo: Placebo 0 None 1 35 19 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood & lymphatic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
General disorders & administration conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Lab Investigations SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Nervous system SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac disprders SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Lab results SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Metabolic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Nervous system SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
General disorders & administration conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Psychiatric SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View