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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT01154751
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT01154751
Study Brief: Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Device SUPERA Stent SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area None None 84 109 87 109 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospital readmittance SYSTEMATIC_ASSESSMENT General disorders Abbott categories View
Death SYSTEMATIC_ASSESSMENT General disorders Abbott categories View
Amputation SYSTEMATIC_ASSESSMENT General disorders Abbott categories View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Abbott categories View
Other SYSTEMATIC_ASSESSMENT General disorders Abbott categories View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospital readmittance SYSTEMATIC_ASSESSMENT General disorders Abbott categories View
Death SYSTEMATIC_ASSESSMENT General disorders Abbott categories View
Other SYSTEMATIC_ASSESSMENT General disorders Abbott categories View