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 @ 9:10 PM
Ignite Modification Date: 2025-12-25 @ 7:00 PM
NCT ID: NCT02830204
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02830204
Study Brief: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) 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
Mitral Valve Replacement With SAPEIN3 Subjects with surgical Mitral Valve Replacement with SAPEIN3 using minimally invasive surgical technique. 9 None 20 25 24 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal Failure or Insufficieny NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Left Ventricular Outflow Tract (LVOT) Obstruction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemodynamic Instability NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Kidney Stone NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Paravalvular Leak NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemolysis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Respirator Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Septicemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Multi-System Organ failure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mitral Stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thromboembolism NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Right Carotid Injury NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Right Ventricular Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Endometrial Cancer NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bleeding NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Arrhythmia and/or Conduction System Injury NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid Hemmorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atrioventricular (A-V) Groove Disruption NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bleeding NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Arrhythmia and/or Conduction System Injury NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Plural Effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal Failure or Insufficiency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular Injury NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Seroma NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Plasma Free Hemoglobin and Haptoglobin Elevated NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Troponin Elevated NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alcohol Withdrawal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain - non cardiac NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lactate Dehydrogenase (LDH) Elevated NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Musculoskeletal Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Prosthetic Valvular Endocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View