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 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
NCT ID:
NCT01238835
Description:
All adverse events are site reported
Frequency Threshold:
5
Time Frame:
5 Years
Study:
NCT01238835
Study Brief:
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TAVR-TA | Transcatheter valve replacement with transapical access SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach | 124 | None | 201 | 218 | 212 | 218 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Annular Dissection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Infection / Inflammation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Renal Insufficency not requiring Dialysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| Renal Insufficiency / Failure requiring Temporary Dialysis (< or = 30d) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| Access Related Complication - Thoracic | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Access Related Complication - Ventricle | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Arrhythmia Supraventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Arrhythmia Ventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Bleeding - Not Trauma Not Procedure | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Bleeding - Procedure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Bleeding - Trauma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | View |
| Coagulopathy / Hematological Disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| Conduction Defects w/o Permanent Pacemaker | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Conduction Defects with Permanent Pacemaker | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Decubitus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| Delivery System Malfunction | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (23.0) | View |
| Drug Reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Gastro-Intestinal Event | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Hemodynamic Collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Metabolic Disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| Mitral Regurg. ( 3+ or 4+) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Mitral Valve Compromise | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Multiple Organ Failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Neurological Event Minor - Not Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Neurological Event Severe - Not Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Non-Struct Valve Dysf. (Not PVL) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Orthopedic Event | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Perivalvular Leak (1+ or 2+) | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (23.0) | View |
| Perivalvular Leak (3+ or 4+) | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (23.0) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Renal Failure requiring Permanent Dialysis (>30d) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| Respiratory Comp / Failure not requ. Resp Assistance | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Respiratory Comp / Failure requ. Resp Assistance | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Stroke - Embolic / Ischemic Origin | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Stroke - Unknown Origin | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Struct Valve Deterioration (SVD) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Sudden Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Thoracic Wound Comp. | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Thrombus | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Transitory Psychotic Syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| Valve Embolization | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Vascular Event (Not Access-Related) | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Ventricular / Myocardial Injury / Perforation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Vision Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arrhythmia Supraventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Bleeding - Procedure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Coagulopathy / Hematological Disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| Conduction Defects w/o Permanent Pacemaker | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Gastro-Intestinal Event | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| Infection / Inflammation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Metabolic Disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| Neurological Event Minor - Not Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Orthopedic Event | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| Peripheral Edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Renal Insufficency not requiring Dialysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| Respiratory Comp / Failure not requ. Resp Assistance | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Transitory Psychotic Syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |