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 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT01618669
Description: None
Frequency Threshold: 5
Time Frame: From the time of administration of regadenoson to within 24 hours of administration of regadenoson for each stress MPI.
Study: NCT01618669
Study Brief: A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using 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
Regadenoson After Peak Exercise: MPI 1 On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI. None None 5 575 277 575 View
Regadenoson After Peak Exercise: MPI 2 On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI. None None 2 544 274 544 View
Regadenoson Alone: MPI 1 On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI. None None 1 567 307 567 View
Regadenoson Alone: MPI 2 On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI. None None 1 548 290 548 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Anticoagulation drug level below therapeutic SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Hepatic enzyme abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View