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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:58 PM
NCT ID: NCT03204695
Description: The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Frequency Threshold: 0
Time Frame: From baseline up to 45 days
Study: NCT03204695
Study Brief: WAVECREST Post Market Clinical Follow-Up (PMCF) 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
Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA. 2 None 6 24 6 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19 View
Cardiac aneurysm NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19 View
Cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19 View
Mitral valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19 View
Device embolization NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19 View
Multiple organ dysfunction syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19 View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19 View
Pneumococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19 View
Arterial injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 19 View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 19 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 19 View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19 View
Obstructive airways disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 19 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 19 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19 View