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: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT02682420
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were reported from index procedure through the study follow-up period. Data is reported through 6 months.
Study: NCT02682420
Study Brief: everlinQ endoAVF Post Market Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
endoAVF everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created. 3 None 24 100 7 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bruising/Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Compartment Syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Closure Device Embolization SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Numbness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View