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 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:35 PM
NCT ID: NCT01726257
Description: None
Frequency Threshold: 0
Time Frame: All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
Study: NCT01726257
Study Brief: Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pivotal Cohort (ITT) The Intention to Treat Pivotal Cohort includes up to 150 subjects will be enrolled at a maximum of 30 sites in the US and the EU.This includes the statistically justified sample size of 132 plus an allowance for deviations from assumptions. 1 None 26 150 38 150 View
Roll-In Cohort One (1) roll-in subject may be enrolled per site, therefore a maximum of 30 enrolled in the study, to allow for Investigator(s) to receive additional training on the Nellix System. Any roll-in subjects will be screened, consented, treated and followed identically to the main study cohort.However, the roll-in cohort of this study will be evaluated separately. 0 None 5 29 7 29 View
Continued Access Cohort Up to 250 patients will be enrolled into the Extended Investigation based on an enrollment rate of 0.5 patients per site per month and an estimated 20 months from the close of enrollment in the Primary Investigation. Enrollment in Extended Investigation (continued access) phase will be limited to the 27 US sites only as the Nellix System is commercially available to the three participating European sites. 1 None 37 154 40 154 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding/Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bowel SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Malignancies SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Miscellaneous SYSTEMATIC_ASSESSMENT General disorders None View
Nellix Device SYSTEMATIC_ASSESSMENT Product Issues None View
Neurological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Surgical Site Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urogenital SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding/Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bowel SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Malignancies SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Miscellaneous SYSTEMATIC_ASSESSMENT General disorders None View
Nellix Device SYSTEMATIC_ASSESSMENT Product Issues None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Surgical Site Wound SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urogenital 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