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 @ 5:14 PM
Ignite Modification Date: 2025-12-25 @ 2:52 PM
NCT ID: NCT05448950
Description: None
Frequency Threshold: 0
Time Frame: Adverse event information was collected over a 6 month follow up period, or up to the date of a terminal study event (e.g., death, AVG abandonment, subject withdrawal), up to 6 months.
Study: NCT05448950
Study Brief: Continued Access Study VIG Anastomotic Connector
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VIG Continued Access Patients referred for AVG implant were screened for study eligibility by a member of the research team. If all initial inclusion criteria were met and no exclusion criteria were present, the patient was informed of the study's purpose and invited to participate. Final enrollment eligibility was determined at the time of surgery, after the investigator confirmed the final inclusion criteria were met. Enrolled subjects were assigned a unique study subject identification number. Written informed consent was obtained from all enrolled patients prior to performing any study procedures. VIG Continued Access Study: Small skin incisions are made for tunneling the AVG under the skin in a standard manner. The VIG device is provided pre-loaded within a customized catheter-based delivery system for over-the-wire delivery. The VIG is inserted through an introducer sheath placed in the target vein so that the 'vessel end' of the VIG is deployed within the vein, and the 'graft end' extends out of the vein for manual insertion within the AVG. Delivery and deployment are performed under fluoroscopic guidance. The VIG is deployed first, connected to the AVG, then the AVG and VIG are flushed and clamped. The arterial anastomosis is then created using a standard suturing method. 2 None 5 12 4 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pneumonia, requiring hospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
infection of AVG SYSTEMATIC_ASSESSMENT Infections and infestations None View
abscess, tooth SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
pain SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
bruising following a fall SYSTEMATIC_ASSESSMENT General disorders None View
bleeding, minor SYSTEMATIC_ASSESSMENT General disorders None View
inflammation SYSTEMATIC_ASSESSMENT General disorders None View
cancer, skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View