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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT00677235
Description: None
Frequency Threshold: 0
Time Frame: From Index Procedure through 24 months of follow-up.
Study: NCT00677235
Study Brief: Post-Approval Study for the FLAIR Endovascular Stent Graft
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FLAIR FLAIR Endovascular Stent Graft FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft None None 84 138 128 138 View
PTA Only Percutaneous Transluminal Angioplasty PTA: Treatment of stenoses with PTA only None None 87 132 127 132 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
hemotoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Significant arm or hand edema NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Stenosis requiring intervention NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Thrombotic occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Perforation NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Significant arm or hand edema NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Steal syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Stenosis requiring intervention NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Thrombotic occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Vessel rupture NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View