Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 6:35 PM
Ignite Modification Date: 2025-12-25 @ 4:05 PM
NCT ID: NCT02407457
Description: None
Frequency Threshold: 0
Time Frame: AEs are collected through 5 year follow-up visit.
Study: NCT02407457
Study Brief: Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AFX EVAR AAA Graft System Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. 64 None 150 376 167 235 View
FDA Approved EVAR AAA Graft Systems Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems 50 None 136 358 162 220 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aneurysm Rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Device SYSTEMATIC_ASSESSMENT Vascular disorders None View
GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Malignancies SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Miscellaneous SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Device SYSTEMATIC_ASSESSMENT Vascular disorders None View
GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
miscellaneous SYSTEMATIC_ASSESSMENT General disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urogenital SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Malignancies SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View