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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT04523168
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
Study: NCT04523168
Study Brief: Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chronic Refractory Angina Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it. 0 None 2 30 16 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wire related perforations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting/Nausea/Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT General disorders None View
Fever/chills/diarrhea SYSTEMATIC_ASSESSMENT General disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
General joint pain SYSTEMATIC_ASSESSMENT General disorders None View
Lightheaded/dizzy/sycope SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bruising SYSTEMATIC_ASSESSMENT General disorders None View
Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Irregular heart rate SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View