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 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
NCT ID:
NCT01876420
Description:
All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Frequency Threshold:
0
Time Frame:
Up to 30 days.
Study:
NCT01876420
Study Brief:
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical 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 |
|---|---|---|---|---|---|---|---|---|
| All Attempted Implanted Subjects | Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand. | None | None | 40 | 60 | 60 | 60 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA 14.1 | View |
| Blood disorder | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA 14.1 | View |
| Supraventricular arrythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Pulmonary edema | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Decreased BP | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Gastrointestianl Ulcers and Perforation, Site Unspecified | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 14.1 | View |
| Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 14.1 | View |
| Lower Respiratory Tract And Lung Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 14.1 | View |
| Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 14.1 | View |
| Renal Failure and Impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA 14.1 | View |
| Dermatitis Ascribed to Specific Agent | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 14.1 | View |
| Complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 14.1 | View |
| Upper Respiratory Tract Signs and Symptoms | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA 14.1 | View |
| Cardiac Conduction Disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Ischemic Coronary Artery Disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| General Signs and Symptoms Nec | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemias Nec | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA 14.1 | View |
| Thrombocytopenias | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA 14.1 | View |
| Cardiac Conduction Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Cardiac Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Heart Failure Nec | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Ischemic Coronary Artery Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Rate and Rhythm Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Supraventricular Arrythmias | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 14.1 | View |
| Gastrointestinal Atonic And Hypomobility | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 14.1 | View |
| Nausea and Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 14.1 | View |
| Gastrointestinal Atonic And HypomobilitySigns and Symptoms Nec | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 14.1 | View |
| Febrile Disorders | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 14.1 | View |
| Inflammations | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 14.1 | View |
| Complication Associated with Device Nec | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedRA 14.1 | View |
| Infections Nec | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 14.1 | View |
| Urinary Tract Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 14.1 | View |
| Non-site specific Procedural Complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 14.1 | View |
| Headach Nec | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 14.1 | View |
| Neurological Signs And Symptoms Nec | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 14.1 | View |
| Mental Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA 14.1 | View |
| Renal Failure and Impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA 14.1 | View |
| Urinary Abnormalities | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA 14.1 | View |
| Coughing And Associated Symptoms | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA 14.1 | View |
| Pneumothorax And Pleural Effusions | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA 14.1 | View |
| Dermatitis And Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 14.1 | View |
| Subcutaneous Tissue Ulcerations | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 14.1 | View |
| Skin injuries And Mechanical Dermatoses | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 14.1 | View |
| Vascular Hypotensive Disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA 14.1 | View |
| Aortic Valvular Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Ventricular Arrythmias | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 14.1 | View |
| Non-site specific Injuries Nec | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 14.1 | View |
| General Nutrition Disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 14.1 | View |
| Depressive Disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA 14.1 | View |
| Vulvovaginal Disorder Nec | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedRA 14.1 | View |