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 @ 3:48 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT00558792
Description: Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.
Frequency Threshold: 5
Time Frame: Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370.
Study: NCT00558792
Study Brief: Coronary MDCTA With Iopamidol Injection 370
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Isovue 370, 70 mL iopamidol injection 370, 70 mL None None 0 68 15 68 View
Isovue 370, 80 mL iopamidol injection 370, 80 mL None None 0 63 14 63 View
Isovue 370, 90 mL iopamidol injection 370, 90 mL None None 0 60 13 60 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDRA version 12.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 12.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 12.1 View