Trial Outcomes & Findings for TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR (NCT NCT03227757)
NCT ID: NCT03227757
Last Updated: 2024-11-06
Results Overview
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
At 30 days
Results posted on
2024-11-06
Participant Flow
A total of 98 subjects were enrolled and underwent Tricuspid Valve Repair System (TVRS) procedure.
Participant milestones
| Measure |
Tricuspid Valve Repair System
Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
|
|---|---|
|
Overall Study
STARTED
|
98
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
Tricuspid Valve Repair System
Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
|
|---|---|
|
Overall Study
Death
|
25
|
|
Overall Study
Withdrawal
|
10
|
|
Overall Study
Missed visits
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
The number of participants analyzed includes subjects who were available at that time of analysis
Baseline characteristics by cohort
| Measure |
Tricuspid Valve Repair System
n=98 Participants
Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
|
|---|---|
|
Age, Continuous
|
77.5 years
STANDARD_DEVIATION 8.1 • n=98 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=98 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
6 Participants
n=71 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown or Not Reported
|
65 Participants
n=71 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Region of Enrollment
United States
|
25 Participants
n=98 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=98 Participants
|
|
Region of Enrollment
Germany
|
45 Participants
n=98 Participants
|
|
Region of Enrollment
Italy
|
11 Participants
n=98 Participants
|
|
Region of Enrollment
Spain
|
8 Participants
n=98 Participants
|
|
Region of Enrollment
Switzerland
|
7 Participants
n=98 Participants
|
|
New York Heart Association (NYHA) class II or above
NYHA class I
|
0 Participants
n=96 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
New York Heart Association (NYHA) class II or above
NYHA class II
|
23 Participants
n=96 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
New York Heart Association (NYHA) class II or above
NYHA class III
|
69 Participants
n=96 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
New York Heart Association (NYHA) class II or above
NYHA class IV
|
4 Participants
n=96 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
PRIMARY outcome
Timeframe: At 30 daysPopulation: The first 85 enrolled subjects with an attempted TriClip™ procedure upon femoral vein puncture. Note: The sample size and power estimation specified in the clinical investigation protocol indicated that a total of 85 subjects provided sufficient power to evaluate the primary endpoints. This endpoint was assessed in 82 of the 85 subjects. The reason for the inability to assess the endpoint in 3 subjects was missing echocardiogram data and limited imaging quality at baseline (1) and 30 days (2).
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Outcome measures
| Measure |
Tricuspid Valve Repair System
n=82 Participants
Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
|
|---|---|
|
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
|
71 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: The first 85 enrolled subjects with an attempted TriClip™ procedure upon femoral vein puncture. Note: The sample size and power estimation specified in the clinical investigation protocol indicated that a total of 85 subjects provided sufficient power to evaluate the primary endpoints. One subject withdrew from the study prior to the early window of the 6-month visit, without any reported adverse events, and was therefore excluded from the analysis.
Major Adverse Event (MAE) is defined as a composite of: * Cardiovascular Mortality * Myocardial Infarction (MI) * Stroke * New onset renal failure * Endocarditis requiring surgery, and * Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure
Outcome measures
| Measure |
Tricuspid Valve Repair System
n=84 Participants
Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
|
|---|---|
|
Number of Participants With Composite of Major Adverse Event (MAE)
|
5 Participants
|
Adverse Events
Tricuspid Valve Repair System
Serious events: 68 serious events
Other events: 88 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Tricuspid Valve Repair System
n=98 participants at risk
Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.0%
1/98 • 3 years
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.0%
2/98 • 3 years
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
1.0%
1/98 • 3 years
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC DIATHESIS
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.1%
5/98 • 3 years
|
|
Cardiac disorders
Atrial flutter
|
5.1%
5/98 • 3 years
|
|
Cardiac disorders
CARDIAC ARREST
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
Cardiac failure
|
21.4%
21/98 • 3 years
|
|
Cardiac disorders
Cardiorenal syndrome
|
3.1%
3/98 • 3 years
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.0%
2/98 • 3 years
|
|
Cardiac disorders
Sick sinus syndrome
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
TACHYARRHYTHMIA
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
Tricuspid valve incompetence
|
3.1%
3/98 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/98 • 3 years
|
|
Eye disorders
Cataract
|
1.0%
1/98 • 3 years
|
|
Eye disorders
Glaucoma
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
2/98 • 3 years
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
1.0%
1/98 • 3 years
|
|
General disorders
ASTHENIA
|
1.0%
1/98 • 3 years
|
|
General disorders
Chest pain
|
2.0%
2/98 • 3 years
|
|
General disorders
DEVICE DEPLOYMENT ISSUE
|
1.0%
1/98 • 3 years
|
|
General disorders
DEVICE MALFUNCTION
|
2.0%
2/98 • 3 years
|
|
General disorders
Death
|
3.1%
3/98 • 3 years
|
|
General disorders
Multi-organ failure
|
2.0%
2/98 • 3 years
|
|
General disorders
POLYP
|
1.0%
1/98 • 3 years
|
|
General disorders
SUDDEN DEATH
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
Bronchopneumonia
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
CORONA VIRUS INFECTION
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
GASTROENTERITIS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
Gallbladder empyema
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
INFECTION
|
2.0%
2/98 • 3 years
|
|
Infections and infestations
PNEUMONIA VIRAL
|
2.0%
2/98 • 3 years
|
|
Infections and infestations
Pneumonia
|
8.2%
8/98 • 3 years
|
|
Infections and infestations
SEPSIS
|
3.1%
3/98 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
3.1%
3/98 • 3 years
|
|
Injury, poisoning and procedural complications
BRAIN CONTUSION
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
BURNS SECOND DEGREE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
FALL
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
2.0%
2/98 • 3 years
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.0%
1/98 • 3 years
|
|
Investigations
Blood sodium decreased
|
1.0%
1/98 • 3 years
|
|
Investigations
Haemoglobin decreased
|
2.0%
2/98 • 3 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.0%
1/98 • 3 years
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
1.0%
1/98 • 3 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.0%
2/98 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
2/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER RECURRENT
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELOPROLIFERATIVE DISORDER
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
2.0%
2/98 • 3 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
2.0%
2/98 • 3 years
|
|
Nervous system disorders
EPILEPSY
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
Syncope
|
2.0%
2/98 • 3 years
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/98 • 3 years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.0%
1/98 • 3 years
|
|
Renal and urinary disorders
Renal failure
|
12.2%
12/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
2.0%
2/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
2.0%
2/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
3/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
3/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.0%
1/98 • 3 years
|
|
Surgical and medical procedures
ARRHYTHMIA PROPHYLAXIS
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
Arteriovenous fistula
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
Deep vein thrombosis
|
3.1%
3/98 • 3 years
|
|
Vascular disorders
Femoral arterial stenosis
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
HAEMATOMA
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
Haemorrhage
|
19.4%
19/98 • 3 years
|
|
Vascular disorders
Hypertension
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
Hypertensive crisis
|
2.0%
2/98 • 3 years
|
|
Vascular disorders
Hypotension
|
2.0%
2/98 • 3 years
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
1.0%
1/98 • 3 years
|
Other adverse events
| Measure |
Tricuspid Valve Repair System
n=98 participants at risk
Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.1%
3/98 • 3 years
|
|
Blood and lymphatic system disorders
ANAEMIA MACROCYTIC
|
1.0%
1/98 • 3 years
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
1.0%
1/98 • 3 years
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
1.0%
1/98 • 3 years
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC DIATHESIS
|
1.0%
1/98 • 3 years
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
2.0%
2/98 • 3 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
5.1%
5/98 • 3 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
8.2%
8/98 • 3 years
|
|
Cardiac disorders
BRADYCARDIA
|
4.1%
4/98 • 3 years
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
CARDIAC ARREST
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
CARDIORENAL SYNDROME
|
3.1%
3/98 • 3 years
|
|
Cardiac disorders
CHORDAE TENDINAE RUPTURE
|
2.0%
2/98 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
Cardiac failure
|
28.6%
28/98 • 3 years
|
|
Cardiac disorders
INTRACARDIAC THROMBUS
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
4.1%
4/98 • 3 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
3.1%
3/98 • 3 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
2.0%
2/98 • 3 years
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
TACHYARRHYTHMIA
|
1.0%
1/98 • 3 years
|
|
Cardiac disorders
TACHYCARDIA
|
2.0%
2/98 • 3 years
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
8.2%
8/98 • 3 years
|
|
Ear and labyrinth disorders
SUDDEN HEARING LOSS
|
1.0%
1/98 • 3 years
|
|
Ear and labyrinth disorders
TYMPANIC MEMBRANE PERFORATION
|
1.0%
1/98 • 3 years
|
|
Ear and labyrinth disorders
VERTIGO
|
2.0%
2/98 • 3 years
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
1.0%
1/98 • 3 years
|
|
Endocrine disorders
HYPERTHYROIDISM
|
1.0%
1/98 • 3 years
|
|
Eye disorders
CATARACT
|
1.0%
1/98 • 3 years
|
|
Eye disorders
GLAUCOMA
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
2.0%
2/98 • 3 years
|
|
Gastrointestinal disorders
GASTRITIS HAEMORRHAGIC
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
NAUSEA
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
OESOPHAGITIS ULCERATIVE
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
TOOTH DISORDER
|
1.0%
1/98 • 3 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
1.0%
1/98 • 3 years
|
|
General disorders
ASTHENIA
|
1.0%
1/98 • 3 years
|
|
General disorders
CATHETER SITE HAEMATOMA
|
1.0%
1/98 • 3 years
|
|
General disorders
CHEST PAIN
|
6.1%
6/98 • 3 years
|
|
General disorders
DEATH
|
3.1%
3/98 • 3 years
|
|
General disorders
DEVICE DEPLOYMENT ISSUE
|
4.1%
4/98 • 3 years
|
|
General disorders
DEVICE MALFUNCTION
|
2.0%
2/98 • 3 years
|
|
General disorders
FATIGUE
|
1.0%
1/98 • 3 years
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.0%
1/98 • 3 years
|
|
General disorders
IMPAIRED HEALING
|
1.0%
1/98 • 3 years
|
|
General disorders
MULTI-ORGAN FAILURE
|
2.0%
2/98 • 3 years
|
|
General disorders
OEDEMA
|
1.0%
1/98 • 3 years
|
|
General disorders
OEDEMA PERIPHERAL
|
2.0%
2/98 • 3 years
|
|
General disorders
PAIN
|
2.0%
2/98 • 3 years
|
|
General disorders
POLYP
|
2.0%
2/98 • 3 years
|
|
General disorders
PYREXIA
|
1.0%
1/98 • 3 years
|
|
General disorders
SUDDEN DEATH
|
1.0%
1/98 • 3 years
|
|
General disorders
THROMBOSIS IN DEVICE
|
1.0%
1/98 • 3 years
|
|
Hepatobiliary disorders
CHOLESTASIS
|
1.0%
1/98 • 3 years
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
1.0%
1/98 • 3 years
|
|
Hepatobiliary disorders
LIVER INJURY
|
1.0%
1/98 • 3 years
|
|
Immune system disorders
SEASONAL ALLERGY
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
BACTERIAL INFECTION
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
BRONCHITIS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
CANDIDIASIS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
CORNEAL INFECTION
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
CORONA VIRUS INFECTION
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
ERYSIPELAS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
GALLBLADDER EMPYEMA
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
GASTROENTERITIS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
HERPES ZOSTER
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
INFECTION
|
5.1%
5/98 • 3 years
|
|
Infections and infestations
INFLUENZA
|
2.0%
2/98 • 3 years
|
|
Infections and infestations
PHARYNGITIS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
PNEUMONIA
|
8.2%
8/98 • 3 years
|
|
Infections and infestations
PNEUMONIA VIRAL
|
2.0%
2/98 • 3 years
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
RHINITIS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
SEPSIS
|
3.1%
3/98 • 3 years
|
|
Infections and infestations
UROSEPSIS
|
1.0%
1/98 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
8.2%
8/98 • 3 years
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
BRAIN CONTUSION
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
BURNS SECOND DEGREE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
FALL
|
8.2%
8/98 • 3 years
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
2.0%
2/98 • 3 years
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
1.0%
1/98 • 3 years
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
1.0%
1/98 • 3 years
|
|
Investigations
ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC
|
1.0%
1/98 • 3 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
1.0%
1/98 • 3 years
|
|
Investigations
BLOOD PRESSURE INCREASED
|
1.0%
1/98 • 3 years
|
|
Investigations
BLOOD SODIUM DECREASED
|
1.0%
1/98 • 3 years
|
|
Investigations
CARDIOACTIVE DRUG LEVEL DECREASED
|
2.0%
2/98 • 3 years
|
|
Investigations
COAGULATION FACTOR DECREASED
|
1.0%
1/98 • 3 years
|
|
Investigations
HAEMOGLOBIN DECREASED
|
2.0%
2/98 • 3 years
|
|
Investigations
HEART RATE INCREASED
|
1.0%
1/98 • 3 years
|
|
Investigations
N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED
|
1.0%
1/98 • 3 years
|
|
Investigations
OCCULT BLOOD
|
1.0%
1/98 • 3 years
|
|
Investigations
OXYGEN SATURATION DECREASED
|
1.0%
1/98 • 3 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.0%
1/98 • 3 years
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
2.0%
2/98 • 3 years
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
1.0%
1/98 • 3 years
|
|
Metabolism and nutrition disorders
GOUT
|
1.0%
1/98 • 3 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.0%
1/98 • 3 years
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
4.1%
4/98 • 3 years
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
3.1%
3/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
LIMB DISCOMFORT
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.0%
2/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.0%
2/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
4.1%
4/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.0%
2/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
1.0%
1/98 • 3 years
|
|
Musculoskeletal and connective tissue disorders
TRIGGER FINGER
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADRENAL NEOPLASM
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER RECURRENT
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELOPROLIFERATIVE DISORDER
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
1.0%
1/98 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
2.0%
2/98 • 3 years
|
|
Nervous system disorders
ANOSMIA
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
2.0%
2/98 • 3 years
|
|
Nervous system disorders
CONVULSION
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
DIZZINESS
|
2.0%
2/98 • 3 years
|
|
Nervous system disorders
EPILEPSY
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
MYOCLONUS
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
PARAESTHESIA
|
2.0%
2/98 • 3 years
|
|
Nervous system disorders
POLYNEUROPATHY
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
SYNCOPE
|
3.1%
3/98 • 3 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
1.0%
1/98 • 3 years
|
|
Nervous system disorders
VOCAL CORD PARALYSIS
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
ANXIETY
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
ANXIETY DISORDER DUE TO A GENERAL MEDICAL CONDITION
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
DELIRIUM
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
DEPRESSION
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
INSOMNIA
|
1.0%
1/98 • 3 years
|
|
Psychiatric disorders
MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION
|
1.0%
1/98 • 3 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
21.4%
21/98 • 3 years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
2.0%
2/98 • 3 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.0%
1/98 • 3 years
|
|
Reproductive system and breast disorders
BREAST PAIN
|
1.0%
1/98 • 3 years
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
2.0%
2/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
2.0%
2/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
5.1%
5/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.2%
10/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPERVENTILATION
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOVENTILATION
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.0%
2/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
4.1%
4/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.0%
1/98 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
2.0%
2/98 • 3 years
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
1.0%
1/98 • 3 years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
1.0%
1/98 • 3 years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
1.0%
1/98 • 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.0%
1/98 • 3 years
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
1.0%
1/98 • 3 years
|
|
Surgical and medical procedures
ARRHYTHMIA PROPHYLAXIS
|
1.0%
1/98 • 3 years
|
|
Surgical and medical procedures
STOMACH DILATION PROCEDURE
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
ARTERIOVENOUS FISTULA
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
3.1%
3/98 • 3 years
|
|
Vascular disorders
EMBOLISM
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
FEMORAL ARTERIAL STENOSIS
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
HAEMATOMA
|
3.1%
3/98 • 3 years
|
|
Vascular disorders
HYPERTENSION
|
3.1%
3/98 • 3 years
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
2.0%
2/98 • 3 years
|
|
Vascular disorders
HYPOTENSION
|
5.1%
5/98 • 3 years
|
|
Vascular disorders
Haemorrhage
|
31.6%
31/98 • 3 years
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
1.0%
1/98 • 3 years
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
1.0%
1/98 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60