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 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT01070069
Description: All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Frequency Threshold: 0
Time Frame: 1 Year
Study: NCT01070069
Study Brief: Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard EVAR (IntuiTrak) EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR None None 20 50 42 50 View
PEVAR (ProstarXL Closure) Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device None None 19 51 39 51 View
PEVAR (ProGlide Closure) Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device None None 13 50 44 50 View
PEVAR (Prostar XL Roll -In) PEVAR performed with the Prostar XL suture mediated closure system. None None 9 19 14 19 View
PEVAR (ProGlide Roll -In) PEVAR performed with the ProGlide suture mediated closure system. None None 6 22 20 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
General Disorder SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Blood and Lymph Disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Custom Coding View
Cardiac Disorder SYSTEMATIC_ASSESSMENT Cardiac disorders Custom Coding View
GI Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Infections and Infestations SYSTEMATIC_ASSESSMENT Infections and infestations Custom Coding View
Injury and Procedural Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Custom Coding View
Investigations SYSTEMATIC_ASSESSMENT Investigations Custom Coding View
Metabolism/Nutrition Disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Custom Coding View
Neoplasms SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders Custom Coding View
Renal and Urinary Disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom Coding View
Respiratory/Thoracic Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Custom Coding View
Vascular Disorders SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Surgical/Medical procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom Coding View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood and Lymph Disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Custom Coding View
Cardiac Disorders SYSTEMATIC_ASSESSMENT Cardiac disorders Custom Coding View
Eye Disorders SYSTEMATIC_ASSESSMENT Eye disorders Custom Coding View
GI Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
General Disorders SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Infections and Infestations SYSTEMATIC_ASSESSMENT Infections and infestations Custom Coding View
injury and Procedural Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Custom Coding View
Investigations SYSTEMATIC_ASSESSMENT Investigations Custom Coding View
Metabolism/Nutritional Disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Custom Coding View
Neoplasms SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders Custom Coding View
Psychiatric Disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders Custom Coding View
Renal and Urinary Disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom Coding View
Reproductive Disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Custom Coding View
Respiratory/Thoracic Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Custom Coding View
Skin Disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Custom Coding View
Surgical/Medical Procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom Coding View
Vascular Disorders SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom Coding View
Congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders Custom Coding View