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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT03209050
Description: Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.
Frequency Threshold: 0
Time Frame: 4 weeks or 30 days
Study: NCT03209050
Study Brief: Evaluation of the Surfacer System Approach to Central Venous Access
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Central Venous Access Placement Central venous access placement Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter 0 None 4 30 1 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders Hypotension View
unintended embolization NON_SYSTEMATIC_ASSESSMENT Vascular disorders embolization View
bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders bleeding View
Bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders bleeding View
Hemodynamic Instability NON_SYSTEMATIC_ASSESSMENT Vascular disorders hemodynamic unstable View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
allergic reaction NON_SYSTEMATIC_ASSESSMENT Infections and infestations allergic reaction View