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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT02041702
Description: 1. In the Serious Adverse Event Section, only SADE are reported. 2. In the Other (Not Including Serious) Adverse Events Section, only ADE are reported. 3. In the All-Cause Mortality Section, there are 4 deaths reported. All of them happened prior to cardiac MRI scan and were not related to study procedures.
Frequency Threshold: 0
Time Frame: Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected.
Study: NCT02041702
Study Brief: Accent Cardiac MRI Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cardiac MRI Scan Group Non-diagnostic cardiac MRI scan 4 None 6 140 1 140 View
Control Group No non-diagnostic cardiac MRI scan 0 None 6 143 1 143 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylaxis, Anaphylactoid SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dressler's Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Righ Atrial Lead Dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right Ventricular Lead Dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
System Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ventricular Tachycardia Requiring Emergent Direct Current Cardioversion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Non-St Elevation Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Drug Allergy SYSTEMATIC_ASSESSMENT General disorders None View
Intracranial Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
New Onset Paroxysmal Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Retracted Right Atrial Lead SYSTEMATIC_ASSESSMENT General disorders None View