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 @ 3:32 PM
Ignite Modification Date: 2025-12-25 @ 1:46 PM
NCT ID: NCT04717492
Description: Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
Frequency Threshold: 0
Time Frame: 6-month followup
Study: NCT04717492
Study Brief: An Observational Study of Beta-Blocker Use in Patients With COPD and Acute MI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Not Discharged With Beta Blockers Participants discharged without a beta blocker prescription 11 None 29 73 14 73 View
Discharged With Beta Blockers Participants discharged with a beta blocker prescription 48 None 163 480 82 480 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nonfatal overall hospitalization or revascularization SYSTEMATIC_ASSESSMENT General disorders ICD-10 View
Nonfatal CVD hospitalization or revascularization SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Nonfatal COPD or respiratory hospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Antibiotics or steroids for COPD exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View