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 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
NCT ID:
NCT01634269
Description:
None
Frequency Threshold:
0
Time Frame:
Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Study:
NCT01634269
Study Brief:
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
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 Subjects (As Treated Subjects) | This includes subjects from all access approaches, iliofemoral and direct aortic who were implanted with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. | None | None | 16 | 20 | 20 | 20 | View |
| Iliofemoral (As Treated Subjects) | The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients implanted with Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. | None | None | 13 | 16 | 16 | 16 | View |
| Direct Aortic (As Treated Subjects) | For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in overseas (EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. | None | None | 3 | 4 | 4 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aortic Valvular Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Cardiac Conduction Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Cardiac Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Heart Failures Nec | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Pericardial Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Supraventricular Arrhythmias | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Blindness (Excl Colour Blindness) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Cataract Conditions | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Non-Site Specific Gastrointestinal Haemorrhages | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Oesophageal Stenosis And Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Device Issues Nec | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Hepatic Fibrosis And Cirrhosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 14.1 | View |
| Hepatocellular Damage And Hepatitis Nec | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 14.1 | View |
| Cardiac Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Influenza Viral Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Lower Respiratory Tract And Lung Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Sepsis, Bacteraemia, Viraemia And Fungaemia Nec | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Staphylococcal Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Lower Limb Fractures And Dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Skull Fractures, Facial Bone Fractures And Dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Spinal Fractures And Dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Total Fluid Volume Decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Arthropathies Nec | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Breast And Nipple Neoplasms Malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Central Nervous System Haemorrhages And Cerebrovascular Accidents | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Breathing Abnormalities | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pneumothorax And Pleural Effusions Nec | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Aortic Necrosis And Vascular Insufficiency | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Lymphangiopathies | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Non-Site Specific Necrosis And Vascular Insufficiency Nec | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Peripheral Embolism And Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections Nec | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Influenza Viral Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Upper Respiratory Tract Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Urinary Tract Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Fractures And Dislocations Nec | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Non-Site Specific Injuries Nec | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Non-Site Specific Procedural Complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Skin Injuries Nec | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Spinal Fractures And Dislocations | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Carbohydrate Tolerance Analyses (Incl Diabetes) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Liver Function Analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Metabolism Tests Nec | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Mineral And Electrolyte Analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Platelet Analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Protein Analyses Nec | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Renal Function Analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Skeletal And Cardiac Muscle Analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Tissue Enzyme Analyses Nec | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Vascular Tests Nec (Incl Blood Pressure) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| White Blood Cell Analyses | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Hyperlipidaemias Nec | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Lipid Metabolism And Deposit Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Potassium Imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Protein Metabolism Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Joint Related Signs And Symptoms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Muscle Related Signs And Symptoms Nec | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Musculoskeletal And Connective Tissue Pain And Discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Musculoskeletal And Connective Tissue Signs And Symptoms Nec | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Rheumatoid Arthropathies | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Soft Tissue Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Central Nervous System Haemorrhages And Cerebrovascular Accidents | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Headaches Nec | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Memory Loss (Excl Dementia) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Neurological Signs And Symptoms Nec | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Structural Brain Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Confusion And Disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Disturbances In Initiating And Maintaining Sleep | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Urinary Abnormalities | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Breathing Abnormalities | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Coughing And Associated Symptoms | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Lower Respiratory Tract Inflammatory And Immunologic Conditions | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Nasal Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pneumothorax And Pleural Effusions Nec | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Dermatitis Ascribed To Specific Agent | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rashes, Eruptions And Exanthems Nec | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Skin Haemorrhages | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Blood Pressure Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Haemorrhages Nec | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Lymphangiopathies | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Lymphoedemas | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Peripheral Aneurysms And Dissections | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Anaemia Deficiencies | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Anaemias Nec | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Lymphatic System Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Cardiac Conduction Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Heart Failures Nec | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Rate And Rhythm Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Supraventricular Arrhythmias | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Ventricular Arrhythmias And Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Diarrhoea (Excl Infective) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gastrointestinal And Abdominal Pains (Excl Oral And Throat) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gastrointestinal Atonic And Hypomotility Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea And Vomiting Symptoms | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Administration Site Reactions Nec | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Complications Associated With Device Nec | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Device Physical Property And Chemical Issues | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Febrile Disorders | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Implant And Catheter Site Reactions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Inflammations | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Infusion Site Reactions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Oedema Nec | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Pain And Discomfort Nec | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Hepatic And Hepatobiliary Disorders Nec | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 14.1 | View |
| Hepatic Enzymes And Function Abnormalities | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 14.1 | View |
| Herpes Viral Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Vascular Hypotensive Disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |