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 @ 4:41 AM
Ignite Modification Date: 2025-12-26 @ 3:42 AM
NCT ID: NCT01591018
Description: Serious adverse events.
Frequency Threshold: 0
Time Frame: 30 Days
Study: NCT01591018
Study Brief: SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cardiac Surgery With Sonolysis cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring) sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement None None 42 60 0 60 View
Cardiac Surgery Without Sonolysis cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring) cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement None None 44 60 0 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
Infection of respiratory system SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders SNOMED CT View
Other infections SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders SNOMED CT View
Gastrointestinal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Other Events(If Any):