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: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT00530712
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00530712
Study Brief: Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EverFlex™ Peripheral Self-Expanding Stent System Subjects recieved the EverFlex Peripheral Self-Expanding Stent None None 99 287 229 287 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Access site complication - Hematoma None General disorders None View
Access site complication - Pseudoaneurysm None General disorders None View
Acute Stent Thrombosis None General disorders None View
Allergic reaction to contrast dye None General disorders None View
Allergic reaction to procedure meds None General disorders None View
Amputation of treated limb above metatarsal line None General disorders None View
Amputation of treated limb below metatarsal line None General disorders None View
Artery perforation None General disorders None View
Death None General disorders None View
Dissection None General disorders None View
GI bleeding None General disorders None View
Hypotension None General disorders None View
Other Respiratory Issues None General disorders None View
Other Vascular Disorders None General disorders None View
Percutaneous revascularization of target vessel None General disorders None View
Renal Failure None General disorders None View
Restenosis None General disorders None View
Stent misplacement None General disorders None View
Stent/Vessel thrombosis None General disorders None View
Stroke None General disorders None View
Other None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina None General disorders None View
Other Bleeding/lymphatic system disorders None General disorders None View
Other Cardiac Disorders None Cardiac disorders None View
Other Gastrointestinal Disorders None Gastrointestinal disorders None View
Other Infections None Infections and infestations None View
Other Musculoskeletal disorders None Musculoskeletal and connective tissue disorders None View
Other Vascular Disorders None Vascular disorders None View