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: 2025-12-26 @ 5:18 PM
Ignite Modification Date: 2025-12-26 @ 5:18 PM
NCT ID: NCT03573206
Description: Access-site related adverse events included
Frequency Threshold: 0
Time Frame: 30 days (± 10 days)
Study: NCT03573206
Study Brief: AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Arm Cardiva Medical Mid-Bore VVCS for venous femoral access site closure Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case. 0 None 3 168 9 168 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Access site closure-related serious adverse events, excluding major and minor complications NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Access site closure-related serious adverse events, including minor complications NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Access site closure-related serious adverse events, including minor complications NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Access site-related tissue tract oozing - prolonged* NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Access site hematoma ≤ 6 cm NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bruising at the access site* NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pain at the access site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Access site venous re-bleeding after initial hemostasis confirmed for 5 minutes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View