Not provided
Not provided
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Not provided
Not provided
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Not provided
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This study is being conducted to satisfy the post-CE approval requirement.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary cohort | Subjects requiring aortic or mitral valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosaic model 305, model 310, and ultra model 305 | Device | Aortic or mitral valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Deaths, Reinterventions, or Explants | Number of deaths, reinterventions, or explants related to the valve | 1-year post implant |
| Number of Deaths, Reinterventions, or Explants | Number of deaths, reinterventions, or explants related to the valve | 3-years post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Gradient (mmHg) | Measured by echocardiogram via Echo Core Lab | 1-year post implant |
| Peak Gradient (mmHg) | Measured by echocardiogram via Echo Core Lab |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects requiring aortic or mitral valve replacement of the native valve.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscan Saint Francis Health | Indianapolis | Indiana | 46237 | United States | ||
| ProMedica Toledo Hospital |
Not provided
122 subject were consented to participate. 22 were withdrawn from the study prior to study device implant.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aortic Valve Replacements | Subjects that received an aortic valve replacement |
| FG001 | Mitral Valve Replacements | Subjects that received a mitral valve replacement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis only include subjects implanted with a study valve
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aortic Valve Replacements | Subjects requiring aortic valve replacement |
| BG001 | Mitral Valve Replacements | Subjects requiring mitral valve replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline demographics only includes subjects implanted with a study valve. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Deaths, Reinterventions, or Explants | Number of deaths, reinterventions, or explants related to the valve | Posted | Count of Participants | Participants | 1-year post implant |
|
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aortic Valve Replacements | Subjects requiring aortic valve replacement | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Halverson, Clinical Research Director | Medtronic | 763-514-9756 | rs.CSHHAMMOCKPAS@medtronic.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2017 | Mar 31, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2017 | Mar 31, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1-year post implant |
| Effective Orifice Area (EOA) | Measured by echocardiogram via Echo Core Lab | 1-year post implant |
| Effective Orifice Area Index (EOAi) | EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area | 1-year post implant |
| Cardiac Output | Measured by echocardiogram via Echo Core Lab | 1-year post implant |
| Cardiac Index | Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area | 1-year post implant |
| Performance Index | The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size. | 1-year post implant |
| Transvalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | 1-year post implant |
| Paravalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | 1-year post implant |
| Total Regurgitation | Measured by echocardiogram via Echo Core Lab | 1-year post implant |
| New York Heart Association (NYHA) Classification | Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 1-year post implant |
| Mean Gradient | Measured by echocardiogram via Echo Core Lab | 3-years post implant |
| Peak Gradient | Measured by echocardiogram via Echo Core Lab | 3-years post implant |
| Effective Orifice Area (EOA) | Measured by echocardiogram via Echo Core Lab | 3-years post implant |
| Effective Orifice Area Index (EOAi) | EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area | 3-years post implant |
| Cardiac Output | Measure by echocardiogram via Echo Core Lab | 3-years post implant |
| Cardiac Index | Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area | 3-years post implant |
| Performance Index | The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size. | 3-years post implant |
| Transvalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | 3-years post implant |
| Paravalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | 3-years post implant |
| Total Regurgitation | Measured by echocardiogram via Echo Core Lab | 3-years post implant |
| New York Heart Association (NYHA) Classification | Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 3-years post implant |
| Toledo |
| Ohio |
| 43606 |
| United States |
| Saint Joseph Medical Center | Tacoma | Washington | 98405 | United States |
| Bellin Memorial Hospital | Green Bay | Wisconsin | 54301 | United States |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Deutsches Herzzentrum München Klinik an der TU München | München | 80636 | Germany |
| Institute of Cardiology in Warsaw | Warsaw | Poland |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Baseline demographics only include subjects implanted with a study valve | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Baseline demographics only include subjects implanted with a study valve | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline demographics only include subjects implanted with a study valve | Count of Participants | Participants | No |
|
| Region of Enrollment | Region of enrollment only includes subjects implanted with a study valve | Number | participants |
|
| Height | Baseline demographics only include subjects implanted with a study valve | Mean | Standard Deviation | cm |
|
| Weight | Baseline demographics only include subjects implanted with a study valve | Mean | Standard Deviation | kg |
|
| Body Surface Area | Baseline demographics only include subjects implanted with a study valve | Mean | Standard Deviation | m^2 |
|
| Body Mass Index | Baseline demographics only include subjects implanted with a study valve | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Secondary | Mean Gradient (mmHg) | Measured by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | mmHg | 1-year post implant |
|
|
|
| Secondary | Peak Gradient (mmHg) | Measured by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | mmHg | 1-year post implant |
|
|
|
| Secondary | Effective Orifice Area (EOA) | Measured by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | cm^2 | 1-year post implant |
|
|
|
| Secondary | Effective Orifice Area Index (EOAi) | EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area | Posted | Mean | Standard Deviation | cm^2/m^2 | 1-year post implant |
|
|
|
| Secondary | Cardiac Output | Measured by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | L/min | 1-year post implant |
|
|
|
| Secondary | Cardiac Index | Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area | Posted | Mean | Standard Deviation | L/min/m^2 | 1-year post implant |
|
|
|
| Secondary | Performance Index | The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size. | Posted | Mean | Standard Deviation | Units do not exist | 1-year post implant |
|
|
|
| Secondary | Transvalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | Posted | Count of Participants | Participants | 1-year post implant |
|
|
|
| Secondary | Paravalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | Posted | Count of Participants | Participants | 1-year post implant |
|
|
|
| Secondary | Total Regurgitation | Measured by echocardiogram via Echo Core Lab | Posted | Count of Participants | Participants | 1-year post implant |
|
|
|
| Secondary | New York Heart Association (NYHA) Classification | Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Posted | Count of Participants | Participants | 1-year post implant |
|
|
|
| Primary | Number of Deaths, Reinterventions, or Explants | Number of deaths, reinterventions, or explants related to the valve | Posted | Count of Participants | Participants | 3-years post implant |
|
|
|
| Secondary | Mean Gradient | Measured by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | mmHg | 3-years post implant |
|
|
|
| Secondary | Peak Gradient | Measured by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | mmHg | 3-years post implant |
|
|
|
| Secondary | Effective Orifice Area (EOA) | Measured by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | cm^2 | 3-years post implant |
|
|
|
| Secondary | Effective Orifice Area Index (EOAi) | EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area | Posted | Mean | Standard Deviation | cm^2/m^2 | 3-years post implant |
|
|
|
| Secondary | Cardiac Output | Measure by echocardiogram via Echo Core Lab | Posted | Mean | Standard Deviation | L/min | 3-years post implant |
|
|
|
| Secondary | Cardiac Index | Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area | Posted | Mean | Standard Deviation | L/min/m^2 | 3-years post implant |
|
|
|
| Secondary | Performance Index | The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size. | Posted | Mean | Standard Deviation | Units do not exist | 3-years post implant |
|
|
|
| Secondary | Transvalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | Posted | Count of Participants | Participants | 3-years post implant |
|
|
|
| Secondary | Paravalvular Regurgitation | Measured by echocardiogram via Echo Core Lab | Posted | Count of Participants | Participants | 3-years post implant |
|
|
|
| Secondary | Total Regurgitation | Measured by echocardiogram via Echo Core Lab | Posted | Count of Participants | Participants | 3-years post implant |
|
|
|
| Secondary | New York Heart Association (NYHA) Classification | Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Posted | Count of Participants | Participants | 3-years post implant |
|
|
|
| 89 |
| 55 |
| 89 |
| 52 |
| 89 |
| EG001 | Mitral Valve Replacements | Subjects requiring mitral valve replacement | 1 | 11 | 7 | 11 | 11 | 11 |
| Blood Loss Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arrhythmia Supraventricular | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial Rupture | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Failure Acute | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiogenic Shock | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Low Cardiac Output Syndrome | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pericardial Haemorrhage | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Right Ventricular Dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sinus Node Dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tricuspid Valve Incompetence | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ventricular Asystole | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Retinal Artery Occlusion | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal Compartment Syndrome | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Alcoholic Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oesophageal Stenosis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abscess Limb | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Endocarditis Enterococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Staphylococcal Abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Vein Perforation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Carotid Artery Restenosis | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Postpericardiotomy Syndrome | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural Pneumothorax | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Ulna Fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Human Metapneumovirus Test | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Compartment Syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Adenocarcinoma Of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Colon Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| End Stage Renal Disease | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary Bladder Haemorrhage | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Scrotal Oedema | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary Air Leakage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thoracic Cavity Drainage | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aortic Dissection | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aortic Stenosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Jugular Vein Thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Blood Loss Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrioventricular Block First Degree | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bundle Branch Block Left | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bundle Branch Block Right | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nodal Rhythm | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pericardial Rub | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Impaired Healing | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Physical Deconditioning | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Depression Postoperative | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Face Injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood Urea Nitrogen/Creatinine Ratio Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Index Decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Prothrombin Time Ratio Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vitamin B12 Deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary Air Leakage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary Vascular Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
The PI is restricted to publish results until the Sponsor has published the results.
| Mild |
|
| Moderate |
|
| Moderate to Severe |
|
| Severe |
|
| Not recorded/unable to assess |
|
| Mild |
|
| Moderate |
|
| Moderate to Severe |
|
| Severe |
|
| Not recorded/unable to assess |
|
| Mild |
|
| Moderate |
|
| Moderate to Severe |
|
| Severe |
|
| Not recorded/unable to assess |
|
| NYHA III |
|
| NYHA IV |
|
| Mild |
|
| Moderate |
|
| Moderate to Severe |
|
| Severe |
|
| Not recorded/unable to assess |
|
| Mild |
|
| Moderate |
|
| Moderate to Severe |
|
| Severe |
|
| Not recorded/Unable to assess |
|
| Mild |
|
| Moderate |
|
| Moderate to Severe |
|
| Severe |
|
| Not recorded/Unable to assess |
|
| NYHA III |
|
| NYHA IV |
|