Trial Outcomes & Findings for LIFE-BTK Randomized Controlled Trial (NCT NCT04227899)
NCT ID: NCT04227899
Last Updated: 2025-12-30
Results Overview
This endpoint was to evaluate the effectiveness of the Esprit BTK System in maintaining patency (CD-TLR and binary restenosis), and at preventing catastrophic limb events such as total vessel occlusion or major amputation. Composite of Limb Salvage and Primary Patency included freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
261 participants
Primary outcome timeframe
At 1 year
Results posted on
2025-12-30
Participant Flow
A total of 261 subjects from 50 sites were registered in the RCT population of the study including 88 in the PTA group and 173 in the Esprit BTK group up to 1-year follow-up, between August 18, 2020, and September 14, 2022.
Participant milestones
| Measure |
Esprit BTK
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
88
|
|
Overall Study
COMPLETED
|
153
|
78
|
|
Overall Study
NOT COMPLETED
|
20
|
10
|
Reasons for withdrawal
| Measure |
Esprit BTK
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Death
|
12
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
LIFE-BTK Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Esprit BTK
n=173 Participants
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
n=88 Participants
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 9.9 • n=174 Participants
|
71.1 years
STANDARD_DEVIATION 10.4 • n=166 Participants
|
72.6 years
STANDARD_DEVIATION 10.1 • n=167 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=174 Participants
|
27 Participants
n=166 Participants
|
83 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=174 Participants
|
61 Participants
n=166 Participants
|
178 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=174 Participants
|
12 Participants
n=166 Participants
|
43 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
132 Participants
n=174 Participants
|
70 Participants
n=166 Participants
|
202 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=174 Participants
|
6 Participants
n=166 Participants
|
16 Participants
n=167 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=174 Participants
|
11 Participants
n=166 Participants
|
47 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=174 Participants
|
11 Participants
n=166 Participants
|
32 Participants
n=167 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=174 Participants
|
56 Participants
n=166 Participants
|
153 Participants
n=167 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=174 Participants
|
7 Participants
n=166 Participants
|
25 Participants
n=167 Participants
|
|
Hypertension
|
163 Participants
n=174 Participants
|
80 Participants
n=166 Participants
|
243 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: At 1 yearPopulation: Analysis excluded subjects who terminated from the study prior to the lower limit (337 days) of the 1-year primary efficacy endpoint follow-up window without any components of the primary endpoint, and subjects with no known endpoint event and who did not have analyzable duplex ultrasound or angiography for the 1-year imaging assessment.
This endpoint was to evaluate the effectiveness of the Esprit BTK System in maintaining patency (CD-TLR and binary restenosis), and at preventing catastrophic limb events such as total vessel occlusion or major amputation. Composite of Limb Salvage and Primary Patency included freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
Outcome measures
| Measure |
Esprit BTK
n=149 Participants
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
n=71 Participants
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
Primary Efficacy Endpoint: Number of Participants With Composite of Limb Salvage and Primary Patency
|
111 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: At 30 days (for POD) and 6 months (for MALE)Population: Analysis excluded subjects who terminated from the study prior to the lower limit (152 days) of the 6-month primary safety endpoint follow-up window without any components of the primary endpoint.
The primary safety endpoint assessed the safety of the devices used for treatment of below the knee lesions. It included freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death). MALE includes above-ankle amputation in the index limb, major re-intervention on the index limb at 6 months and POD includes perioperative (30-day) mortality.
Outcome measures
| Measure |
Esprit BTK
n=160 Participants
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
n=85 Participants
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
Primary Safety Endpoint: Freedom From Major Adverse Limb Event + Peri-Operative Death Rate (MALE + POD)
|
155 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: At 1 yearPopulation: Analysis excluded subjects who terminated from the study prior to the lower limit (337 days) of the 1-year primary efficacy endpoint follow-up window without any components of the primary endpoint, and subjects with no known endpoint event and who did not have analyzable duplex ultrasound or angiography for the 1-year imaging assessment.
This endpoint was added to better evaluate the device performance as binary restenosis was used as a marker for disease progression over time.
Outcome measures
| Measure |
Esprit BTK
n=149 Participants
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
n=71 Participants
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
First Powered Secondary Endpoint: Binary Restenosis of the Target Lesion
|
35 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: At 1 yearPopulation: Analysis excluded subjects who terminated from the study prior to the lower limit (337 days) of the 1-year primary efficacy endpoint follow-up window without any components of the primary endpoint, and subjects with no known endpoint event and who did not have analyzable duplex ultrasound or angiography for the 1-year imaging assessment.
This endpoint was chosen as it was important to assess whether Esprit BTK System was efficacious at maintaining patency and preventing catastrophic limb events through 1 year.
Outcome measures
| Measure |
Esprit BTK
n=149 Participants
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
n=71 Participants
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
Second Powered Secondary Endpoint: Freedom From Above Ankle Amputation in Index Limb, 100% Total Occlusion of the Target Vessel, and CD-TLR.
|
124 Participants
|
49 Participants
|
Adverse Events
Esprit BTK
Serious events: 89 serious events
Other events: 105 other events
Deaths: 12 deaths
Percutaneous Transluminal Angioplasty (PTA)
Serious events: 45 serious events
Other events: 60 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Esprit BTK
n=173 participants at risk
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
n=88 participants at risk
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.2%
2/173 • 1 year
|
3.4%
3/88 • 1 year
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
CARDIAC FAILURE
|
2.3%
4/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
2.9%
5/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
CYANOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.3%
4/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
MELAENA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
General disorders
ASTHENIA
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
General disorders
CHEST PAIN
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
General disorders
DEATH
|
3.5%
6/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
General disorders
OEDEMA PERIPHERAL
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
General disorders
PYREXIA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
General disorders
ULCER
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
BRONCHITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
CELLULITIS
|
2.9%
5/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Infections and infestations
CORONA VIRUS INFECTION
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
DIABETIC FOOT INFECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
GANGRENE
|
2.3%
4/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Infections and infestations
IMPLANT SITE INFECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
INCISION SITE ABSCESS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
INCISION SITE INFECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
LOCALISED INFECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
OSTEOMYELITIS
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
OSTEOMYELITIS CHRONIC
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
PAROTITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
PNEUMONIA
|
1.7%
3/173 • 1 year
|
3.4%
3/88 • 1 year
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
SEPSIS
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
SEPTIC SHOCK
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
WOUND INFECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
ARTERIAL RESTENOSIS
|
5.2%
9/173 • 1 year
|
8.0%
7/88 • 1 year
|
|
Injury, poisoning and procedural complications
FALL
|
3.5%
6/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
SKIN WOUND
|
4.0%
7/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
8.7%
15/173 • 1 year
|
5.7%
5/88 • 1 year
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Investigations
ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Investigations
DEVICE FUNCTION TEST
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
COMPARTMENT SYNDROME
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.2%
9/173 • 1 year
|
4.5%
4/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
APHASIA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
CAROTID ARTERY DISEASE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
CONVULSION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
DIZZINESS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
MYELOPATHY
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
SYNCOPE
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Renal and urinary disorders
HAEMATURIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.3%
4/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
3.5%
6/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.5%
6/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA PAROXYSMAL NOCTURNAL
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
4.0%
7/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Surgical and medical procedures
CARDIAC PACEMAKER INSERTION
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Surgical and medical procedures
FOOT AMPUTATION
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Surgical and medical procedures
OSTEOTOMY
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Surgical and medical procedures
PERIPHERAL REVASCULARISATION
|
2.3%
4/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Surgical and medical procedures
TOE AMPUTATION
|
4.6%
8/173 • 1 year
|
4.5%
4/88 • 1 year
|
|
Surgical and medical procedures
VASCULAR STENT INSERTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE
|
4.0%
7/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Vascular disorders
ARTERIAL RUPTURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
ARTERIAL STENOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
EMBOLISM
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
HAEMATOMA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
HAEMORRHAGE
|
2.9%
5/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Vascular disorders
HYPERTENSION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
HYPOTENSION
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
PERIPHERAL ARTERY DISSECTION
|
0.00%
0/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Vascular disorders
PERIPHERAL EMBOLISM
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
THROMBOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
Other adverse events
| Measure |
Esprit BTK
n=173 participants at risk
Participants who receive Esprit BTK device will be included in this arm
Esprit BTK Device: Participants will receive Esprit BTK Device
|
Percutaneous Transluminal Angioplasty (PTA)
n=88 participants at risk
Participants who receive PTA treatment will be included in this arm
Percutaneous Transluminal Angioplasty (PTA) Device: Participants will receive PTA treatment
|
|---|---|---|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
WOUND INFECTION
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
ARTERIAL RESTENOSIS
|
2.9%
5/173 • 1 year
|
4.5%
4/88 • 1 year
|
|
Injury, poisoning and procedural complications
COMPRESSION FRACTURE
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
EYELID INJURY
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
FALL
|
1.7%
3/173 • 1 year
|
4.5%
4/88 • 1 year
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
INCISION SITE HAEMATOMA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
INCISION SITE HAEMORRHAGE
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
OPEN WOUND
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
PUBIS FRACTURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
SKIN WOUND
|
6.4%
11/173 • 1 year
|
8.0%
7/88 • 1 year
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Injury, poisoning and procedural complications
WOUND
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
5.8%
10/173 • 1 year
|
6.8%
6/88 • 1 year
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Investigations
CORONAVIRUS TEST POSITIVE
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
GOUT
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.3%
4/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.9%
5/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
LIMB DISCOMFORT
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.7%
3/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
NUCHAL RIGIDITY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.1%
21/173 • 1 year
|
17.0%
15/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ABDOMINAL NEOPLASM
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADRENAL ADENOMA
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
ATAXIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
CAROTID ARTERY DISEASE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
COMA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
DIZZINESS
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Nervous system disorders
POLYNEUROPATHY
|
1.2%
2/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
PRESYNCOPE
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Nervous system disorders
SCIATICA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Renal and urinary disorders
DYSURIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Renal and urinary disorders
PYURIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
2.9%
5/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.7%
3/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.58%
1/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
SCAB
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
SKIN SWELLING
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Surgical and medical procedures
AMNIOTIC MEMBRANE GRAFT
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Surgical and medical procedures
CARDIAC ABLATION
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Surgical and medical procedures
FOOT AMPUTATION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Surgical and medical procedures
INCISIONAL HERNIA REPAIR
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Surgical and medical procedures
PERIPHERAL REVASCULARISATION
|
0.00%
0/173 • 1 year
|
4.5%
4/88 • 1 year
|
|
Surgical and medical procedures
REMOVAL OF FOREIGN BODY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE
|
6.4%
11/173 • 1 year
|
3.4%
3/88 • 1 year
|
|
Vascular disorders
ARTERIAL RUPTURE
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
ARTERIAL STENOSIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
ARTERY DISSECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
HAEMATOMA
|
2.3%
4/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
HAEMORRHAGE
|
1.7%
3/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
HYPERTENSION
|
2.3%
4/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
HYPOTENSION
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
ILIAC ARTERY STENOSIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
0.00%
0/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
Vascular disorders
LABILE BLOOD PRESSURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
PERIPHERAL ARTERY DISSECTION
|
1.2%
2/173 • 1 year
|
3.4%
3/88 • 1 year
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Vascular disorders
VASOSPASM
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
TINEA VERSICOLOUR
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
ARRHYTHMIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.3%
4/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Ear and labyrinth disorders
EAR HAEMORRHAGE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Ear and labyrinth disorders
VERTIGO
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Eye disorders
CATARACT
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Eye disorders
VISION BLURRED
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.7%
3/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
General disorders
ASTHENIA
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
General disorders
CHEST PAIN
|
1.2%
2/173 • 1 year
|
4.5%
4/88 • 1 year
|
|
General disorders
CHILLS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
General disorders
FATIGUE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
General disorders
HYPOTHERMIA
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
General disorders
OEDEMA
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
General disorders
OEDEMA PERIPHERAL
|
2.9%
5/173 • 1 year
|
2.3%
2/88 • 1 year
|
|
General disorders
PYREXIA
|
1.2%
2/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
BRONCHITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
CELLULITIS
|
2.3%
4/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
CORONA VIRUS INFECTION
|
2.3%
4/173 • 1 year
|
4.5%
4/88 • 1 year
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/173 • 1 year
|
1.1%
1/88 • 1 year
|
|
Infections and infestations
GANGRENE
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
HERPES ZOSTER
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
OSTEOMYELITIS
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
PARONYCHIA
|
0.58%
1/173 • 1 year
|
0.00%
0/88 • 1 year
|
|
Infections and infestations
SEPSIS
|
0.58%
1/173 • 1 year
|
1.1%
1/88 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60