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 @ 11:21 PM
Ignite Modification Date: 2025-12-25 @ 9:04 PM
NCT ID: NCT02418156
Description: None
Frequency Threshold: 3
Time Frame: One year
Study: NCT02418156
Study Brief: A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Observation of subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair. CorMatrix ECM for Vascular Repair: Standard femoral arterial interventional procedure using CorMatrix ECM for arterial repair. 2 None 14 38 0 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression and Suicide Attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Non Healing Lower Extremity Ulcer NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Right upper lobe adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Failed Vascular Interventions/Severe PAD NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Coag Neg Staph Bacteremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Post Operative Seroma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Critical Limb Ischemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Stroke-like symptoms NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter & atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bilaterial lower extremity pain and numbness NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
CVA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):