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: 2026-07-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
337 participants
Primary outcome timeframe
From baseline to 6 months post-procedure
Results posted on
2026-07-30
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
|
206
|
131
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number of subjects with evaluable data
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
|
|---|---|---|---|
|
Length of hypertension diagnosis
6-10 years
|
37 Participants
n=206 Participants
|
27 Participants
n=131 Participants
|
64 Participants
n=337 Participants
|
|
Length of hypertension diagnosis
>10 years
|
107 Participants
n=206 Participants
|
80 Participants
n=131 Participants
|
187 Participants
n=337 Participants
|
|
Age, Continuous
|
55.2 Years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
54.6 Years
STANDARD_DEVIATION 9.4 • n=131 Participants
|
54.9 Years
STANDARD_DEVIATION 9.2 • n=337 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=206 Participants
|
28 Participants
n=131 Participants
|
67 Participants
n=337 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=206 Participants
|
103 Participants
n=131 Participants
|
270 Participants
n=337 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=206 Participants
|
0 Participants
n=131 Participants
|
0 Participants
n=337 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=206 Participants
|
10 Participants
n=131 Participants
|
27 Participants
n=337 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=206 Participants
|
0 Participants
n=131 Participants
|
0 Participants
n=337 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=206 Participants
|
25 Participants
n=131 Participants
|
60 Participants
n=337 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=206 Participants
|
48 Participants
n=131 Participants
|
119 Participants
n=337 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=206 Participants
|
0 Participants
n=131 Participants
|
2 Participants
n=337 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
81 Participants
n=206 Participants
|
48 Participants
n=131 Participants
|
129 Participants
n=337 Participants
|
|
Length of hypertension diagnosis
0-5 years
|
62 Participants
n=206 Participants
|
24 Participants
n=131 Participants
|
86 Participants
n=337 Participants
|
|
Office Blood Pressure
Office Systolic Blood Pressure
|
163.0 mm Hg
STANDARD_DEVIATION 7.7 • n=206 Participants
|
163.1 mm Hg
STANDARD_DEVIATION 7.9 • n=131 Participants
|
163.05 mm Hg
STANDARD_DEVIATION 7.8 • n=337 Participants
|
|
Office Blood Pressure
Office Diastolic Blood Pressure
|
101.2 mm Hg
STANDARD_DEVIATION 7.0 • n=206 Participants
|
101.5 mm Hg
STANDARD_DEVIATION 7.3 • n=131 Participants
|
101.4 mm Hg
STANDARD_DEVIATION 7.2 • n=337 Participants
|
|
24- hour Ambulatory Blood Pressure
24- hour Ambulatory Systolic Blood Pressure
|
149.6 mm Hg
STANDARD_DEVIATION 7.0 • n=206 Participants • Number of subjects with evaluable data
|
149.3 mm Hg
STANDARD_DEVIATION 7.0 • n=130 Participants • Number of subjects with evaluable data
|
149.5 mm Hg
STANDARD_DEVIATION 7.0 • n=336 Participants • Number of subjects with evaluable data
|
|
24- hour Ambulatory Blood Pressure
24-hour Ambulatory Diastolic Blood Pressure
|
96.6 mm Hg
STANDARD_DEVIATION 7.6 • n=206 Participants • Number of subjects with evaluable data
|
95.7 mm Hg
STANDARD_DEVIATION 7.7 • n=130 Participants • Number of subjects with evaluable data
|
96.2 mm Hg
STANDARD_DEVIATION 7.65 • n=336 Participants • Number of subjects with evaluable data
|
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
|
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 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 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
|
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 to 6-months
|
-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
|
1.91 Number of Daily Medications
Standard Deviation 0.83
|
1.94 Number of Daily Medications
Standard Deviation 0.82
|
|
Antihypertensive Medication Usage and Changes to 6-months
6 Months
|
1.96 Number of Daily Medications
Standard Deviation 0.88
|
2.08 Number of Daily Medications
Standard Deviation 0.88
|
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
|
2.75 Medication Index 2 Score
Standard Deviation 2.42
|
3.04 Medication Index 2 Score
Standard Deviation 2.67
|
|
Antihypertensive Medication Burden to 6-months
6 Months
|
2.99 Medication Index 2 Score
Standard Deviation 2.74
|
3.55 Medication Index 2 Score
Standard Deviation 3.27
|
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: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
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
13.9
|
8 Participants
13.2
|
SECONDARY outcome
Timeframe: From Baseline to 12 months post procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in systolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Outcome measures
| Measure |
Renal Denervation
n=182 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=69 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 ABPM 12 Months
|
-9.6 mmHg
Standard Deviation 12.2
|
-9.1 mmHg
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: From baseline to 24 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in systolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Outcome measures
| Measure |
Renal Denervation
n=176 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=33 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 ABPM 24-months
|
-12.1 mmHg
Standard Deviation 15.3
|
-7.0 mmHg
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in systolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Outcome measures
| Measure |
Renal Denervation
n=155 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=30 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 ABPM 36-months
|
-14.0 mmHg
Standard Deviation 14.0
|
-10.7 mmHg
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: From Baseline to 12 months post procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in office systolic blood pressure from baseline (screening visit 2) to 12 months.
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=71 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 to 12-months
|
-14.3 mmHg
Standard Deviation 16.1
|
-11.6 mmHg
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: From baseline to 24 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in office systolic blood pressure from baseline (screening visit 2) to 24 months.
Outcome measures
| Measure |
Renal Denervation
n=187 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=35 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 to 24-months
|
-17.4 mmHg
Standard Deviation 16.1
|
-9.0 mmHg
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in office systolic blood pressure from baseline (screening visit 2) to 36 months.
Outcome measures
| Measure |
Renal Denervation
n=175 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=32 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 to 36-months
|
-18.5 mmHg
Standard Deviation 17.8
|
-18.7 mmHg
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: From Baseline to 12 months post procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in diastolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Outcome measures
| Measure |
Renal Denervation
n=182 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=69 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 Diastolic Blood Pressure as Measured by 24-hour ABPM 12-months
|
-6.8 mmHg
Standard Deviation 8.5
|
-6.4 mmHg
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: From baseline to 24 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in diastolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Outcome measures
| Measure |
Renal Denervation
n=176 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=33 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 Diastolic Blood Pressure as Measured by 24-hour ABPM 24-months
|
-8.6 mmHg
Standard Deviation 10.4
|
-5.3 mmHg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in diastolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Outcome measures
| Measure |
Renal Denervation
n=155 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=30 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 Diastolic Blood Pressure as Measured by 24-hour ABPM 36-months
|
-10.1 mmHg
Standard Deviation 8.8
|
-6.7 mmHg
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: From baseline to 12 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in office diastolic blood pressure from baseline (screening visit 2) to 12 months.
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=71 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 Diastolic Blood Pressure 12 Months
|
-7.4 mmHg
Standard Deviation 10.4
|
-7.0 mmHg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: From baseline to 24 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in office diastolic blood pressure from baseline (screening visit 2) to 24 months.
Outcome measures
| Measure |
Renal Denervation
n=187 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=35 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 Diastolic Blood Pressure 24 Months
|
-9.2 mmHg
Standard Deviation 10.4
|
-4.8 mmHg
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in office diastolic blood pressure from baseline (screening visit 2) to 36 months.
Outcome measures
| Measure |
Renal Denervation
n=175 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=32 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 Diastolic Blood Pressure 36 Months
|
-9.2 mmHg
Standard Deviation 10.7
|
-11.4 mmHg
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: From baseline to 12 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start
Incidence of Achieving Target Office Systolic Blood Pressure (SBP \<140 mmHg)
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=71 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.
|
|---|---|---|
|
Number of Participants Achieving Target Office Systolic Blood Pressure 12 Months
|
58 Participants
16.1
|
14 Participants
15.3
|
SECONDARY outcome
Timeframe: From baseline to 24 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start
Incidence of Achieving Target Office Systolic Blood Pressure (SBP \<140 mmHg).
Outcome measures
| Measure |
Renal Denervation
n=187 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=35 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.
|
|---|---|---|
|
Number of Participants Achieving Target Office Systolic Blood Pressure 24 Months
|
66 Participants
16.1
|
6 Participants
19.4
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start
Incidence of Achieving Target Office Systolic Blood Pressure (SBP \<140 mmHg)
Outcome measures
| Measure |
Renal Denervation
n=175 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=32 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.
|
|---|---|---|
|
Number of Participants Achieving Target Office Systolic Blood Pressure. 36 Months
|
82 Participants
17.8
|
14 Participants
16.7
|
SECONDARY outcome
Timeframe: From Baseline to 36-months post procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With All Cause Mortality
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 36-months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
End-stage Renal Disease (ESRD) - defined as two or more eGFR measurements \<15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following: * Volume management refractory to diuretics * Hyperkalemia unmanageable by diet and diuretics * Acidosis bicarbonate \<18 unmanageable with HCO3 supplements * Symptoms of uremia, nausea, vomiting
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With End-Stage Renal Disease (ESRD)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With Significant Embolic Event Resulting in End-organ Damage
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 36 month post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal artery perforation requiring intervention
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With Renal Artery Perforation Requiring Intervention
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Number of Participants with Renal artery dissection requiring intervention
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With Renal Artery Dissection Requiring Intervention
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With Vascular Complications
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With Hospitalization for Hypertensive Crisis Not Related to Confirmed Non-adherence With Medications and/or the Protocol.
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With New Renal Artery Stenosis > 70%, Confirmed by Angiography and as Determined by the Angiographic Core Laboratory
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=172 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=32 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.
|
|---|---|---|
|
Number of Participants With ≥ 40% Decline in eGFR
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=172 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=32 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.
|
|---|---|---|
|
Number of Participants With Increase in Serum Creatinine >50% From Screening Visit 2 (Baseline)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With New Myocardial Infarct
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With New Stroke
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With Renal Artery Re-intervention
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure
Outcome measures
| Measure |
Renal Denervation
n=184 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=113 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.
|
|---|---|---|
|
Number of Participants With Major Bleeding According to TIMI Definition
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to 6 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in diastolic blood pressure from baseline (screening visit 2) to 6 months 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 Diastolic Blood Pressure as Measured by 24-hour (ABPM) 6-months
|
-4.4 mmHg
Standard Deviation 7.3
|
-3.4 mmHg
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: From baseline to 6 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Change in office diastolic 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 Diastolic Blood Pressure to 6-months
|
-5.2 mmHg
Standard Deviation 8.8
|
-3.3 mmHg
Standard Deviation 8.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 36 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
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. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison)
Outcome measures
| Measure |
Renal Denervation
n=179 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=36 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 36-months
|
5.73 Medication Index 2 Score
Standard Deviation 5.28
|
9.70 Medication Index 2 Score
Standard Deviation 14.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 24 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
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. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison)
Outcome measures
| Measure |
Renal Denervation
n=194 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=59 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 24-months
|
5.21 Medication Index 2 Score
Standard Deviation 4.94
|
6.32 Medication Index 2 Score
Standard Deviation 5.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 months post-procedurePopulation: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
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. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison)
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=74 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 12-Months
|
4.06 Medication Index 2 Score
Standard Deviation 3.34
|
5.34 Medication Index 2 Score
Standard Deviation 4.74
|
Adverse Events
Renal Denervation
Serious events: 51 serious events
Other events: 148 other events
Deaths: 2 deaths
Sham Procedure
Serious events: 26 serious events
Other events: 96 other events
Deaths: 1 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.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.4%
5/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Atrial Flutter
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Bradycardia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Endocrine disorders
Adrenal Mass
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Asthenia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Chest Discomfort
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Pneumonia
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Vestibular Neuronitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pseudoaneurysm
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
2.3%
3/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital Warts
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Headache
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Surgical and medical procedures
Removal Of Foreign Body
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Chest Pain
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Hypertension
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Simple Partial Seizures
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Syncope
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Peripheral Venous Disease
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Ureteric Stenosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Impairment
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Artery Fibromuscular Dysplasia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Putamen Haemorrhage
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Presyncope
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Diplegia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Renal Cell Carcinoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Stage I
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear Cell Renal Cell Carcinoma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Obesity
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Csf Volume Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Stoma Prolapse
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Urinary Tract Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Sinusitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Sepsis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Post Procedural Pneumonia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Orchitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Influenza
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Epididymitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Cystitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Cellulitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Vascular Stent Thrombosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Vascular Stent Stenosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Sudden Cardiac Death
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Cardiac Arrest
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Angina Pectoris
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Acute Right Ventricular Failure
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Sars-Cov-2 Sepsis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Covid-19
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Atrial Flutter
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Bradycardia
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Tachycardia
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Endocrine disorders
Adrenal Mass
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Endocrine disorders
Graves' Disease
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Endocrine disorders
Primary Hyperaldosteronism
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Eye disorders
Swelling Of Eyelid
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Eye disorders
Visual Impairment
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Colitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Constipation
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Diarrhea
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Gastritis
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Toothache
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Adverse Drug Reaction
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Asthenia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Chest Discomfort
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Chest Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.1%
4/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Cyst
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Drug Intolerance
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Fatigue
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.1%
4/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Oedema Peripheral
|
4.4%
9/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
10.7%
14/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Peripheral Swelling
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Puncture Site Haematoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Pyrexia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Swelling
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Induration
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Hepatic Lesion
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Immune system disorders
Contrast Media Reaction
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Bacterial Vaginosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Bronchitis
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Bursitis Infective
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Cellulitis
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Conjunctivitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Conjunctivitis Viral
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Covid-19
|
4.4%
9/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.8%
5/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Cystitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Eye Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Folliculitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Fungal Foot Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Groin Abscess
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Infectious Mononucleosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Influenza
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
5.3%
7/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Localised Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Ludwig Angina
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Oral Herpes
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Paronychia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Pneumonia
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Pulpitis Dental
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Scrotal Abscess
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Sinusitis
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Tinea Cruris
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Tonsillitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Tooth Abscess
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Tooth Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.1%
4/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Urethritis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Urinary Tract Infection
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
2.3%
3/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Vestibular Neuronitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
2.3%
3/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Exposure To Extreme Temperature
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Post Procedural Discomfort
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Stoma Prolapse
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Immunisation Reaction
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Bruising
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
4.9%
10/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
7.6%
10/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pain
|
2.4%
5/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pseudoaneurysm
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Thrombosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Cholesterol Increased
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Creatinine Increased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.1%
4/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Glucose Increased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Potassium Decreased
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Pressure Abnormal
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Pressure Increased
|
3.4%
7/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.8%
5/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Pressure Orthostatic Decreased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Uric Acid Increased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Oxygen Saturation Decreased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Heart Rate Increased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Hepatic Enzyme Increased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Lipids Increased
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Liver Function Test Increased
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Pancreatic Enzymes Increased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Renal Function Test Abnormal
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Troponin T Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Weight Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Gout
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.3%
13/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
6.1%
8/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hypolipidaemia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
5/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
4.6%
6/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
11/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.8%
5/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Facet Joint Syndrome
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Inguinal Mass
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.4%
5/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
3.8%
5/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Dizziness
|
2.9%
6/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
5.3%
7/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Headache
|
3.9%
8/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
7.6%
10/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Migraine
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Nerve Compression
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Paraesthesia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Presyncope
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Sciatic Nerve Neuropathy
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Syncope
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
1.5%
2/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Anxiety
|
1.9%
4/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Depression
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Mental Disorder
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Neuropsychiatric Symptoms
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Poor Quality Sleep
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Artery Dissection
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Cyst
|
3.4%
7/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Breast Mass
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Scrotal Cyst
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
5/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Cough Variant Asthma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Skin Swelling
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Transient Acantholytic Dermatosis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Surgical and medical procedures
Removal Of Foreign Body
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Arterial Spasm
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Haematoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Hypertension
|
3.4%
7/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
4.6%
6/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Hypertensive Crisis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Hypertensive Urgency
|
1.5%
3/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Hypotension
|
0.97%
2/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Iliac Artery Dissection
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Vasospasm
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital Warts
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Cardiac Hypertrophy
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Congenital, familial and genetic disorders
Liddle's Syndrome
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Stomach Mass
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
General disorders
Pain
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Aortic Bruit
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Bell's Palsy
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Exertional Headache
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Simple Partial Seizures
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Peripheral Venous Disease
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Hypotensive Crisis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Flushing
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Vascular disorders
Blood Pressure Inadequately Controlled
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Mass
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Vulvovaginal Discomfort
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Reproductive system and breast disorders
Testicular Retraction
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Haemorrhage
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Disorder
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Artery Fibromuscular Dysplasia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Renal Aneurysm
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Pollakiuria
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Psychiatric disorders
Burnout Syndrome
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Nervous system disorders
Neurological Symptom
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Renal Cell Carcinoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma In Situ
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Stage I
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear Cell Renal Cell Carcinoma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Posture Abnormal
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Electrocardiogram Change
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Necrosis
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Genital Infection
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Immune system disorders
Seasonal Allergy
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Hepatobiliary disorders
Non-Alcoholic Fatty Liver
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Intestinal Mass
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Gastrointestinal disorders
Coeliac Artery Aneurysm
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Eye disorders
Photopsia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.76%
1/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Congenital, familial and genetic disorders
Type V Hyperlipidaemia
|
0.00%
0/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Nodal Rhythm
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
|
Infections and infestations
Sars-Cov-2 Sepsis
|
0.49%
1/206 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
0.00%
0/131 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits.
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
|
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