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 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:47 AM
NCT ID: NCT01815502
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01815502
Study Brief: Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sildenafil Sildenafil will be given an one time dose 30 to 90 minutes prior to catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes.. Dobutamine: Patients will receive a dobutamine infusion during catheterization. 0 None 0 10 0 10 View
Sugar Pill Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes.. Dobutamine: Patients will receive a dobutamine infusion during catheterization. 0 None 0 10 0 10 View
Serious Events(If Any):

Serious Events

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

Other Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View