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 @ 1:07 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT02877693
Description: * Adverse Device Effect (ADE)- An adverse event (AE) related to the use of a medical device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the medical device and any event resulting from the use error or from intentional misuse of the medical device. * Serious Adverse Device Effect - ADE that has resulted in any of the consequences characteristic of a Serious AE
Frequency Threshold: 0.5
Time Frame: Adverse events were collected from the time participants were enrolled, through the MRI scan Visit and the 1 month Post MRI Scan Visit follow-up, or the study completion (if subject withdrawn before the final follow-up).
Study: NCT02877693
Study Brief: A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Thoracic MRI Scan With 1.5 Tesla MRI Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit. 2 None 1 205 1 205 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breathlessness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Refractory cardiogenic shock, recurrent ventricular tachycardia, ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Serious Adverse Device Effect: Acute Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Loss of Capture SYSTEMATIC_ASSESSMENT Product Issues None View