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 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT03423602
Description: Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Frequency Threshold: 0
Time Frame: From Subject enrolment to study exit which was 3-months ± 1-month
Study: NCT03423602
Study Brief: Safety and Performance Study of Large Hole Vascular Closure Device FIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational Device To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system 1 None 21 75 5 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphocele SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arteriovenous fistula - access site SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac decompensation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Access site haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arrhythmia - AV Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Graft occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Septicaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Spinal anterior syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke - ischemic SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View