Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:58 AM
Ignite Modification Date: 2025-12-26 @ 1:39 AM
NCT ID: NCT03041233
Description: An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
Frequency Threshold: 0
Time Frame: Through 12 months
Study: NCT03041233
Study Brief: ABLATOR Brazil - Ablation Observational Study (Registry)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enrolled Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form. 5 None 30 833 1 833 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary congestion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pericardial Effusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bruise NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Car accident NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tamponade NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Perioperative infarction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sinus dysfunction/asystole after interruption of flutter NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemorrhagic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Prolonged Hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Prolonged hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Change in medical strategy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Suspected bacterial endocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hemothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Drowning NON_SYSTEMATIC_ASSESSMENT General disorders None View
Catheter Deformation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Death NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View