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 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:55 AM
NCT ID: NCT02966002
Description: None
Frequency Threshold: 0
Time Frame: 8 weeks
Study: NCT02966002
Study Brief: Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention: Aspirin 650 mg. Twice a day for 8 weeks Aspirin 0 None 0 5 1 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloody Bowel Movement NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View