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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT01842035
Description: Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.
Frequency Threshold: 0
Time Frame: Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months
Study: NCT01842035
Study Brief: Heart Rate Response to Regadenoson and Sudden Cardiac Death
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Regadenoson Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline. \-------------------------------------------------------------------------------- regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline. 16 None 0 90 24 90 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
symptomatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
flushing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View