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 @ 4:30 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT01334918
Description: Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Study: NCT01334918
Study Brief: A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPECT Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection. None None 1 117 53 117 View
MDCT Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline. None None 0 116 59 116 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 11.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 11.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 11.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 11.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 11.1 View