Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:10 PM
NCT ID: NCT01931956
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT01931956
Study Brief: Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant 42 None 49 59 39 59 View
Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. 7 None 7 7 4 7 View
High Risk Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. 379 None 542 628 503 628 View
Non-high Risk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. 96 None 208 271 225 271 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lead displacement SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Mitral stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Other rhythm disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Residual/Recurrent MR SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Syncope/Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
AV fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Peripheral Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Bruise/contusion/ecchymosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Retroperitoneal hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Transient Ischemic Attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
MV Surgery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
SLDA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Heart transplant SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Mitral valve injury SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
peripheral edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Supraventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Bradyarrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Emergent MV surgery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Hematologic-Shock SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Mesentric Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Hematologic - Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Atrial arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrial septal defect SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac : other SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
GI related - bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
GI related - infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
GI related - other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Generalized weakness/fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Metabolic/endocrine disorders : Other SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
device malfunction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
infection : Other SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Intracerebral hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Neurologic - other SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Mental disorders : Other SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Renal - infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal - other SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal - renal insufficiency/failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Bronchial/lung disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Chronic obstructive pulmonary diseas SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory - other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Bleeding complication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Blood pressure complication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Deep vein thrombosis (DVT) SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Embolization SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hemodynamic instability SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Injury SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Vascular - other SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Infection/bacteremia/septicemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Skin/mucosal/subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Hemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Heart Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Generalized Weakness/Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Mental Disorders SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Metabolic/Endocrine Disorders SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Infection/Bacteremia/Septicemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Atrial Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrial Septal Defect SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Bradyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Chest Pain/Angina SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Lead Displacement SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Left Ventricular Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Mitral Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Mitral Valve Injury SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Other Rhythm Disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Peripheral Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Residual/Recurrent MR SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
SLDA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Syncope/Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Connective Tissue Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Delirium SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal Insufficiency/Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Bronchial/Lung Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
AV fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Bleeding Complication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Blood Pressure Complication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
DVT SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hemodynamic Instability SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Heart block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Supraventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Surgery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Transient Ischemic Attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Intracerebral hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Incisional site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Skin/mucosal/subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Chronic Obstructive Pulmonary Disease (COPD) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Peripheral Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Bruise/contusion/ecchymosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Injury SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Thrombosis/Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Thrombus SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Retroperitoneal hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
MV surgery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View