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 @ 5:23 PM
Ignite Modification Date: 2025-12-25 @ 2:58 PM
NCT ID: NCT01174550
Description: Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.
Frequency Threshold: 0
Time Frame: Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.
Study: NCT01174550
Study Brief: PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Functional Diagnostic Tests Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram Stress Echocardiogram: Use of standard equipment for usual-care testing Nuclear Stress Test: Use of standard equipment for usual-care testing Exercise Electrocardiogram: Use of standard equipment for usual-care testing None None 161 5007 16 5007 View
Anatomic Diagnostic Test Coronary Angiography Coronary Angiography: Use of standard equipment for usual-care testing None None 168 4996 37 4996 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death- Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Major Bleeding SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unstable Angina Hospitalization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death - Non cardiovascular known cause SYSTEMATIC_ASSESSMENT General disorders None View
Death - unknown cause SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Exercise Induced Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stress Induced Symptoms Related to Functional Testing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospital Admission Not In The Primary Endpoint SYSTEMATIC_ASSESSMENT General disorders None View
Any Event Potentially Related to Vasodilators SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mild Contrast Reaction (rash or hives) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hemodynamic Instability SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Extravasion of Contrast Into Surrounding Tissue SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View