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 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
NCT ID:
NCT01940120
Description:
None
Frequency Threshold:
5
Time Frame:
5 years
Study:
NCT01940120
Study Brief:
EVEREST II Pivotal Study High Risk Registry (HRR)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| High Risk Registry Arm | Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant. Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve | 25 | None | 69 | 78 | 77 | 78 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.0 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.0 | View |
| Hematologic - Other | 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 |
| Atrial arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Atrial septal defect | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Bradyarrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Cardiac disorders: Other | 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/Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Congestive heart failure | 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 |
| Lead displacement | 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 |
| Other rhythm disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Residual/Recurrent MR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Supraventricular arrhythmia | 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 |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Gastrointestinal disorders: Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| General disorders: Other | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Generalized weakness/Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Metabolic/Endocrine disorders | 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 11.0 | View |
| Nervous system disorders: Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Neurologic - Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Transient ischemic attack (TIA) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Renal Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.0 | View |
| Renal and urinary disorders: 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 |
| Chronic Obstructive Pulmonary Disease (COPD) | 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 edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Respiratory - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Respiratory Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Arteriovenous (AV) fistula | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.0 | View |
| Bleeding complication | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Deep vein thrombosis (DVT) | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Embolization | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Hemodynamic instability | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Vascular Injury | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Vascular disorders: Other | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.0 | View |
| Hemolysis | 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 10.0 | View |
| Atrial septal defect | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Bradyarrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Cardiac disorders: other | 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 |
| Myocardial ischemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Other rhythm disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Peripheral edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Residual/recurrent magnetic resonance (MR) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Syncope/Dizziness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| cardiomyopathy | 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 |
| Gastrointestinal disorders: Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| General disorders: Other | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Generalized weakness/Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Incisional site pain | 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 |
| Skin/Mucosal/Subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | View |
| Nervous system disorders: Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Transient ischemic attack (TIA) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Renal Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.0 | View |
| Renal and urinary disorders: 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 |
| 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 |
| Respiratory Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Respiratory, thoracic and mediastinal disorders: Other | 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 |
| Bruise/Contusion/Ecchymosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.0 | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Hemodynamic instability | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Vascular disorders: Other | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |