Trial Outcomes & Findings for SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System (NCT NCT02439775)
NCT ID: NCT02439775
Last Updated: 2025-11-14
Results Overview
The primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as a composite of the following events: All-cause mortality, End Stage Renal Disease (ESRD), Significant embolic event resulting in end-organ damage, Renal artery perforation requiring intervention, Renal artery dissection requiring intervention, Vascular complications, Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis \>70%, confirmed by angiography and as a determined by the angiographic core laboratory, through one-month post-randomization (6- months for new renal artery stenosis).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
337 participants
Primary outcome timeframe
From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
131
|
|
Overall Study
COMPLETED
|
115
|
73
|
|
Overall Study
NOT COMPLETED
|
91
|
58
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System
Baseline characteristics by cohort
| Measure |
Renal Denervation
n=206 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=131 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 Years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
54.6 Years
STANDARD_DEVIATION 9.4 • n=10 Participants
|
54.9 Years
STANDARD_DEVIATION 9.2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=10 Participants
|
28 Participants
n=10 Participants
|
67 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=10 Participants
|
103 Participants
n=10 Participants
|
270 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
27 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=10 Participants
|
25 Participants
n=10 Participants
|
60 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=10 Participants
|
48 Participants
n=10 Participants
|
119 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
81 Participants
n=10 Participants
|
48 Participants
n=10 Participants
|
129 Participants
n=20 Participants
|
|
Length of hypertension diagnosis
0-5 years
|
62 Participants
n=10 Participants
|
24 Participants
n=10 Participants
|
86 Participants
n=20 Participants
|
|
Length of hypertension diagnosis
6-10 years
|
37 Participants
n=10 Participants
|
27 Participants
n=10 Participants
|
64 Participants
n=20 Participants
|
|
Length of hypertension diagnosis
>10 years
|
107 Participants
n=10 Participants
|
80 Participants
n=10 Participants
|
187 Participants
n=20 Participants
|
|
Office Blood Pressure
Office Systolic Blood Pressure
|
163.0 mm Hg
STANDARD_DEVIATION 7.7 • n=10 Participants
|
163.1 mm Hg
STANDARD_DEVIATION 7.9 • n=10 Participants
|
163.05 mm Hg
STANDARD_DEVIATION 7.8 • n=20 Participants
|
|
Office Blood Pressure
Office Diastolic Blood Pressure
|
101.2 mm Hg
STANDARD_DEVIATION 7.0 • n=10 Participants
|
101.5 mm Hg
STANDARD_DEVIATION 7.3 • n=10 Participants
|
101.4 mm Hg
STANDARD_DEVIATION 7.2 • n=20 Participants
|
|
24- hour Ambulatory Blood Pressure
24- hour Ambulatory Systolic Blood Pressure
|
149.6 mm Hg
STANDARD_DEVIATION 7.0 • n=10 Participants
|
149.3 mm Hg
STANDARD_DEVIATION 7.0 • n=10 Participants
|
149.5 mm Hg
STANDARD_DEVIATION 7.0 • n=20 Participants
|
|
24- hour Ambulatory Blood Pressure
24-hour Ambulatory Diastolic Blood Pressure
|
96.6 mm Hg
STANDARD_DEVIATION 7.6 • n=10 Participants
|
95.7 mm Hg
STANDARD_DEVIATION 7.7 • n=10 Participants
|
96.2 mm Hg
STANDARD_DEVIATION 7.65 • n=20 Participants
|
PRIMARY outcome
Timeframe: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)Population: All randomized subjects are analyzed according to their randomized treatment.
The primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as a composite of the following events: All-cause mortality, End Stage Renal Disease (ESRD), Significant embolic event resulting in end-organ damage, Renal artery perforation requiring intervention, Renal artery dissection requiring intervention, Vascular complications, Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis \>70%, confirmed by angiography and as a determined by the angiographic core laboratory, through one-month post-randomization (6- months for new renal artery stenosis).
Outcome measures
| Measure |
Renal Denervation
n=206 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=131 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
No MAE
|
204 Participants
|
130 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Vascular Complication requiring intervention
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From baseline to 6 months post-procedurePopulation: All randomized subjects are analyzed according to their randomized treatment. Subjects who met the anti-hypertensive medication escape criteria (Office SBP\>180 or \<115 mmHg associated with symptoms of hypotension or safety concern requiring medication changes) are analyzed using Last Observation Carried Forward (LOCF) for their blood pressure measurements out to 6-months.
Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Outcome measures
| Measure |
Renal Denervation
n=192 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=116 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
|
-6.5 mm Hg
Standard Deviation 10.7
|
-4.5 mm Hg
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: From baseline to 6 months post-procedurePopulation: Valid readings at time of data collection
Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure
Outcome measures
| Measure |
Renal Denervation
n=199 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=126 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Change in Office Systolic Blood Pressure
|
-9.9 mmHg
Standard Deviation 13.9
|
-5.1 mmHg
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: From baseline to 6-month post-procedurePopulation: Prescribed daily medication reported
Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure
Outcome measures
| Measure |
Renal Denervation
n=206 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=131 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Antihypertensive Medication Usage and Changes to 6-months
Baseline
|
1.9 Number of Daily Medications
Standard Deviation .8
|
1.9 Number of Daily Medications
Standard Deviation 0.8
|
|
Antihypertensive Medication Usage and Changes to 6-months
6 Months
|
1.9 Number of Daily Medications
Standard Deviation 0.9
|
2.1 Number of Daily Medications
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: From baseline to 6 Months post-procedurePopulation: Prescribed medications reported
Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. Minimum value 0; No Maximum value
Outcome measures
| Measure |
Renal Denervation
n=206 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=131 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Antihypertensive Medication Burden to 6-months
Baseline
|
2.8 Medication Index 2 Score
Standard Deviation 2.5
|
3.0 Medication Index 2 Score
Standard Deviation 2.6
|
|
Antihypertensive Medication Burden to 6-months
6 Months
|
2.9 Medication Index 2 Score
Standard Deviation 2.7
|
3.5 Medication Index 2 Score
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline to 6-months post-procedurePopulation: Confirmed via Drug Testing Data at both Baseline (Screening Visit 2) and 6-months post-procedure
Patients who had medication changes based on Medication Index 2 drug testing data. Medication Index 2 score is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency.
Outcome measures
| Measure |
Renal Denervation
n=200 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=128 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Medication Changes
Increase
|
37 Participants
|
35 Participants
|
|
Medication Changes
No Change
|
131 Participants
|
80 Participants
|
|
Medication Changes
Decrease
|
32 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From baseline to 6 months post-procedurePopulation: Valid readings at time of data collection
Incidence of achieving target office systolic blood pressure (SBP\<140 mmHg) at 6 months post- procedure.
Outcome measures
| Measure |
Renal Denervation
n=199 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=126 Participants
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Incidence of Achieving Target Office Systolic Blood Pressure
|
39 Participants
|
8 Participants
|
Adverse Events
Renal Denervation
Serious events: 18 serious events
Other events: 129 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 15 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Renal Denervation
n=206 participants at risk
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=131 participants at risk
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Infections and infestations
Vestibular Neuronitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Viral Sepsis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Atrial Flutter
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Bradycardia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Endocrine disorders
Adrenal Mass
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Asthenia
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Chest Discomfort
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Pneumonia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pseudoaneurysm
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital Warts
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Surgical and medical procedures
Removal Of Foreign Body
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
General disorders
Chest Pain
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Simple Partial Seizures
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
Other adverse events
| Measure |
Renal Denervation
n=206 participants at risk
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
|
Sham Procedure
n=131 participants at risk
Renal angiography
Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Inguinal Mass
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.97%
2/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
1.9%
4/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
3/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.5%
3/206 • Adverse Events through 6 months
|
3.8%
5/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Dizziness
|
2.4%
5/206 • Adverse Events through 6 months
|
4.6%
6/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Headache
|
3.4%
7/206 • Adverse Events through 6 months
|
6.9%
9/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Nerve Compression
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Paraesthesia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Presyncope
|
1.5%
3/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Sciatic Nerve Neuropathy
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Syncope
|
0.49%
1/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Anxiety
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Depression
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Mental Disorder
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Neuropsychiatric Symptoms
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Poor Quality Sleep
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Renal Artery Dissection
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Renal Cyst
|
1.5%
3/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Reproductive system and breast disorders
Breast Mass
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Reproductive system and breast disorders
Scrotal Cyst
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
6/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough Variant Asthma
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.5%
3/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Swelling
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Transient Acantholytic Dermatosis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Surgical and medical procedures
Removal Of Foreign Body
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Vascular disorders
Arterial Spasm
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Vascular disorders
Haematoma
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Vascular disorders
Hypertension
|
1.5%
3/206 • Adverse Events through 6 months
|
4.6%
6/131 • Adverse Events through 6 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Vascular disorders
Hypertensive Urgency
|
1.5%
3/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Vascular disorders
Hypotension
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Vascular disorders
Iliac Artery Dissection
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Vascular disorders
Vasospasm
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital Warts
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Cardiac Hypertrophy
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Congenital, familial and genetic disorders
Liddle's Syndrome
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Stomach Mass
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
General disorders
Pain
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Ear Infection
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Aortic Bruit
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Exertional Headache
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Simple Partial Seizures
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.97%
2/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Food Poisoning
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.97%
2/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
General disorders
Adverse Drug Reaction
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Asthenia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Chest Discomfort
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Chest Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
3.1%
4/131 • Adverse Events through 6 months
|
|
General disorders
Cyst
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Drug Intolerance
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
General disorders
Fat Necrosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Fatigue
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Influenza Like Illness
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Oedema Peripheral
|
2.9%
6/206 • Adverse Events through 6 months
|
9.2%
12/131 • Adverse Events through 6 months
|
|
General disorders
Peripheral Swelling
|
1.5%
3/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
General disorders
Puncture Site Haematoma
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
General disorders
Pyrexia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
General disorders
Swelling
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
General disorders
Vessel Puncture Site Induration
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Hepatobiliary disorders
Hepatic Lesion
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Immune system disorders
Contrast Media Reaction
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Bacterial Vaginosis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Bronchitis
|
1.5%
3/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Bursitis Infective
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Cellulitis
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Conjunctivitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Conjunctivitis Viral
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Covid-19
|
2.4%
5/206 • Adverse Events through 6 months
|
2.3%
3/131 • Adverse Events through 6 months
|
|
Infections and infestations
Cystitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Eye Infection
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Folliculitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Fungal Foot Infection
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Groin Abscess
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Infectious Mononucleosis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Influenza
|
0.97%
2/206 • Adverse Events through 6 months
|
4.6%
6/131 • Adverse Events through 6 months
|
|
Infections and infestations
Localised Infection
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Ludwig Angina
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
3/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Oral Herpes
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Paronychia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Pneumonia
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Pulpitis Dental
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Respiratory Tract Infection
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Scrotal Abscess
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Sinusitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Tinea Cruris
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Tonsillitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Tooth Abscess
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Tooth Infection
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.49%
1/206 • Adverse Events through 6 months
|
2.3%
3/131 • Adverse Events through 6 months
|
|
Infections and infestations
Urethritis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Infections and infestations
Vestibular Neuronitis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Viral Sepsis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Exposure To Extreme Temperature
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Post Procedural Discomfort
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Stoma Prolapse
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Bruising
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
4.9%
10/206 • Adverse Events through 6 months
|
7.6%
10/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pain
|
2.4%
5/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pseudoaneurysm
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Thrombosis
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Blood Cholesterol Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Blood Creatinine Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
2.3%
3/131 • Adverse Events through 6 months
|
|
Investigations
Blood Glucose Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Blood Potassium Decreased
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Investigations
Blood Pressure Abnormal
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Blood Pressure Increased
|
2.9%
6/206 • Adverse Events through 6 months
|
3.1%
4/131 • Adverse Events through 6 months
|
|
Investigations
Blood Pressure Orthostatic Decreased
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Investigations
Blood Uric Acid Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Investigations
Heart Rate Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Hepatic Enzyme Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Lipids Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Liver Function Test Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Investigations
Oxygen Saturation Decreased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Pancreatic Enzymes Increased
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Renal Function Test Abnormal
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Investigations
Troponin T Increased
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Investigations
Weight Increased
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Gout
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.5%
3/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
12/206 • Adverse Events through 6 months
|
6.1%
8/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hypolipidaemia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.97%
2/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
4/206 • Adverse Events through 6 months
|
3.1%
4/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
12/206 • Adverse Events through 6 months
|
3.1%
4/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Facet Joint Syndrome
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Atrial Flutter
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Sinus Tachycardia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Tachycardia
|
0.97%
2/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Endocrine disorders
Adrenal Mass
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Endocrine disorders
Basedow's Disease
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Endocrine disorders
Primary Hyperaldosteronism
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Eye disorders
Conjunctivitis Allergic
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Eye disorders
Swelling Of Eyelid
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Eye disorders
Vision Blurred
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Eye disorders
Visual Impairment
|
0.49%
1/206 • Adverse Events through 6 months
|
0.00%
0/131 • Adverse Events through 6 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.5%
3/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Bradycardia
|
1.5%
3/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.97%
2/206 • Adverse Events through 6 months
|
1.5%
2/131 • Adverse Events through 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.49%
1/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/206 • Adverse Events through 6 months
|
0.76%
1/131 • Adverse Events through 6 months
|
Additional Information
Elishea Argent, Sr. Clinical Research Specialist
Medtronic
Phone: (763)505-9584
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place