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 @ 7:37 PM
Ignite Modification Date: 2025-12-25 @ 5:17 PM
NCT ID: NCT00979303
Description: Adverse events were evaluated in all patients during the study, prior to discharge and in follow up at 1 month and 1 year after the procedure.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT00979303
Study Brief: Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group Control Patients - Undergo ablation procedures with radiation/fluoroscopy only 0 None 0 37 8 37 View
Study Group Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation. Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure. 0 None 0 37 6 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mechanical trauma to pathway SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Groin Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin abrasion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vasovagal syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View