Trial Outcomes & Findings for Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE) (NCT NCT02392351)

Last Updated: 2021-02-11

Results Overview

Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Through 8 weeks

Results posted on

2021-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Renal Denervation Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Overall Study STARTED	34	17
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	34	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography	Total n=51 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 10.1 • n=5 Participants	58.2 years STANDARD_DEVIATION 9.8 • n=7 Participants	58.4 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	4 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=5 Participants	14 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black, of African Heritage	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	17 participants n=7 Participants	51 participants n=5 Participants
Left Renal Artery	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants
Left Renal Accessory Artery	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Right Renal Artery	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants
Right Renal Accessory Artery	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Max Renal Artery Diameter	6.3 mm STANDARD_DEVIATION 1.3 • n=5 Participants	6.1 mm STANDARD_DEVIATION 1.2 • n=7 Participants	6.2 mm STANDARD_DEVIATION 1.3 • n=5 Participants
Reference Renal Artery Diameter	5.4 mm STANDARD_DEVIATION 1.2 • n=5 Participants	5.5 mm STANDARD_DEVIATION 1.1 • n=7 Participants	5.5 mm STANDARD_DEVIATION 1.1 • n=5 Participants
Renal Artery Length	42.0 mm STANDARD_DEVIATION 17.8 • n=5 Participants	46.3 mm STANDARD_DEVIATION 18.3 • n=7 Participants	43.6 mm STANDARD_DEVIATION 18.0 • n=5 Participants

PRIMARY outcome

Timeframe: Through 8 weeks

Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.

Outcome measures

Outcome measures
Measure	Renal Denervation n=32 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=15 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks	-5.3 mmHg Standard Deviation 10.1	-8.5 mmHg Standard Deviation 9.4

SECONDARY outcome

Timeframe: Through 6 months

Number of hospitalizations due to severe hypotension/syncope through 6 months.

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Number of Hospitalizations Due to Severe Hypotension/Syncope	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Number of renal artery dissection or perforation requiring intervention through 4 weeks.

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Renal Artery Dissection or Perforation Requiring Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Number of vascular complications through 4 weeks.

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Vascular Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Number of significant new renal artery stenosis events through 6 months.

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Significant New Renal Artery Stenosis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Number of subjects utilizing anti-hypertensive medications at 3 months.

Outcome measures

Outcome measures
Measure	Renal Denervation n=32 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Number of Subjects Utilizing Anti-hypertensive Medications	16 Participants	9 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.

Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline

Outcome measures

Outcome measures
Measure	Renal Denervation n=30 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=15 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months	-16.7 mmHg Standard Deviation 13.6	-9.5 mmHg Standard Deviation 11.4

SECONDARY outcome

Timeframe: 6 Months

Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.

Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.

Outcome measures

Outcome measures
Measure	Renal Denervation n=30 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=15 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months	-9.1 mmHg Standard Deviation 8.3	-5.5 mmHg Standard Deviation 8.2

SECONDARY outcome

Timeframe: 6 months

Number of subjects utilizing anti-hypertensive medications at 6 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=33 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Number of Subjects Utilizing Anti-hypertensive Medications	26 Participants	14 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.

Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=29 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=12 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure	-18.2 mmHg Standard Deviation 14.3	-14.3 mmHg Standard Deviation 8.4

SECONDARY outcome

Timeframe: 12 Months

Population: Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.

Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=29 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=12 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure	-11.0 mmHg Standard Deviation 9.8	-9.0 mmHg Standard Deviation 5.7

SECONDARY outcome

Timeframe: 24 Months

Number of all causes of death through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
All-Cause Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Number of renal failure events through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Number of Participants With Renal Failure	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Number of hypertensive crisis events through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Number of Participants With Hypertensive Crisis	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.

Mean Reduction in Average office-based systolic blood pressure through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=30 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=11 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Mean Reduction in Average Office-based Systolic Blood Pressure	-19.7 mmHg Standard Deviation 18.9	-25.7 mmHg Standard Deviation 21.2

SECONDARY outcome

Timeframe: 24 Months

Population: Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.

Mean Reduction in Office-based diastolic blood pressure through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=30 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=11 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Mean Reduction in Average Office-based Diastolic Blood Pressure	-9.5 mmHg Standard Deviation 10.3	-9.8 mmHg Standard Deviation 12.5

SECONDARY outcome

Timeframe: 24 Months

Population: Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.

Percent of subjects at target blood pressure through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=30 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=11 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Percent of Subjects at Target Blood Pressure	12 Participants	5 Participants

SECONDARY outcome

Timeframe: 24 Months

Number of subjects with congestive heart failure through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Congestive Heart Failure	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Number of subjects who experience myocardial infarction through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Myocardial Infarction	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Number of subjects experiencing stroke through 24 months

Outcome measures

Outcome measures
Measure	Renal Denervation n=34 Participants Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator	Masked Procedure n=17 Participants Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Stroke	0 Participants	0 Participants

Adverse Events

Treatment Group

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Masked Procedure - Control Group

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Manager

Boston Scientific

Phone: 970-294-4082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Group n=34 participants at risk Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System) Renal Denervation (Vessix): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator Through 6 Months	Masked Procedure - Control Group n=17 participants at risk Percutaneous renal angiography Renal Angiography: Percutaneous renal angiography
Vascular disorders Accelerated hypertension	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Vascular disorders Femoral artery occlusion	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Gastrointestinal disorders Diarrhoea	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Gastrointestinal disorders Inguinal hernia	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Eye disorders Cataract	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Psychiatric disorders Mental status changes	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Vascular disorders Hypertension	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Gastrointestinal disorders Hiatus hernia	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Infections and infestations Cellulitis	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Infections and infestations Diverticulitis	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Infections and infestations Osteomyelitis chronic	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Infections and infestations Pneumonia	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Injury, poisoning and procedural complications Intentional overdose	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Renal and urinary disorders Renal artery stenosis	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Renal and urinary disorders Renal failure acute	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Cardiac disorders Acute myocardial infarction	2.9% 1/34 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	0.00% 0/17 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Vascular disorders Deep vein thrombosis	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 1 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.
Vascular disorders Peripheral artery stenosis	0.00% 0/34 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.	5.9% 1/17 • Number of events 4 • Adverse events will be collected through 36 months from enrollment. Enrollment terminated. No endpoint analysis conducted.