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 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
NCT ID:
NCT05330468
Description:
None
Frequency Threshold:
0
Time Frame:
At one year
Study:
NCT05330468
Study Brief:
Regent China Post-Market Clinical Follow-up 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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Regent MHV | Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. Abbott Mechanical Heart Valve (MHV) Regent™: SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756) | 6 | None | 67 | 200 | 10 | 200 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (27.1) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Atrioventricular Block Complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Cardiac Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Cardiac Tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Cardiogenic Shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Cardiorenal Syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Low Cardiac Output Syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Ventricular Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Inguinal Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Impaired Healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Paravalvular Regurgitation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Fungal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Pneumonia Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Postoperative Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Foreign Body in Gastrointestinal Tract | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.1) | View |
| Coagulation Test Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| International Normalised Ratio Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Colon Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | View |
| Metastases to Liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.1) | View |
| Ischemic Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.1) | View |
| Calculus Urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.1) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.1) | View |
| Renal Cyst | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.1) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | View |
| Pneumothorax Spontaneous | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | View |
| Arterial Insufficiency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.1) | View |
| Hemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.1) | View |
| Vasculitis Necrotising | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Cardiac Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Ischaemic Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.1) | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.1) | View |
| Aortic Valve Incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |