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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT05101993
Description: Serious Adverse Events
Frequency Threshold: 0
Time Frame: 12-months or greater post-procedure, an average of 1.5 years
Study: NCT05101993
Study Brief: VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AtriClip Group AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure 0 None 76 155 0 155 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia Needing Medical Treatment (new onset) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bleeding Event SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
TIA or Neurological Deficit SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post operative ileus requiring decompressive colonoscopy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Interstitial Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Left foot partial 1st ray amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nausea and Abdominal Pain-Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke, Other (Cardioembolic) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke, Ischemic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Node Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sternal Dehiscence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vascular Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Conduction Disturbance SYSTEMATIC_ASSESSMENT Immune system disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infraction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atrial Fibrillation with Rapid Ventricular rate SYSTEMATIC_ASSESSMENT Cardiac disorders None View
AV block requiring permanent pacemaker (new onset) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tricuspid Valve Regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Excessive Bleeding r/t Procedure (req >2u Blood or intervention) SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):