Trial Outcomes & Findings for BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease (NCT NCT02655887)

NCT ID: NCT02655887

Last Updated: 2021-02-04

Results Overview

Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis \> 50% as measured by Duplex Ultrasound (DUS). Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 170 participants
• Primary outcome timeframe: 12 months post-index procedure
• Results posted on: 2021-02-04

Participant Flow

The study was activated at 25 investigational sites in the U.S., Europe and Australia. First subject was enrolled June 15, 2016, and the last subject on May 1, 2017. Approximately 60% of subjects are in the U.S.

Three U.S. sites were activated, but did not consent subjects. A fourth site enrolled 1 subject who was lost to follow-up after discharge (site closed). Fifty-eight (58) screen failures reported and three (3) eligible subjects were not treated with the device. In total, 170 subjects were treated with VENOVO.

Participant milestones

Measure	VENOVO™ Venous Stent. Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Overall Study STARTED	170
Overall Study COMPLETED	156
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	VENOVO™ Venous Stent. Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Overall Study Lost to Follow-up	3
Overall Study Death	4
Overall Study Withdrawal by Subject	3
Overall Study Missed 12-month follow-up visit	4

Baseline Characteristics

BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

Baseline characteristics by cohort

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Age, Customized < 65 years	125 Participants n=5 Participants
Age, Customized ≥ 65 years	45 Participants n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	156 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Netherlands	8 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants
Region of Enrollment Ireland	4 Participants n=5 Participants
Region of Enrollment United Kingdom	8 Participants n=5 Participants
Region of Enrollment Australia	5 Participants n=5 Participants
Region of Enrollment Germany	34 Participants n=5 Participants
Region of Enrollment Spain	11 Participants n=5 Participants
Cardiovascular Disease Stroke	4 Participants n=5 Participants
Cardiovascular Disease Angina	5 Participants n=5 Participants
Cardiovascular Disease Hypertension	55 Participants n=5 Participants
Cardiovascular Disease Coronary Artery Disease (CAD)	15 Participants n=5 Participants
Cardiovascular Disease Myocardial Infarction (MI)	6 Participants n=5 Participants
Cardiovascular Disease Transient Ischemic Attack (TIA)	3 Participants n=5 Participants
Cardiovascular Disease Cardiomyopathy	3 Participants n=5 Participants
Cardiovascular Disease Vascular Heart Disease	2 Participants n=5 Participants
Cardiovascular Disease Deep Vein Thrombosis (DVT)	92 Participants n=5 Participants
Cardiovascular Disease May-Thurner Syndrome	102 Participants n=5 Participants
Cardiovascular Disease Venous Valve Disease	12 Participants n=5 Participants
Cardiovascular Disease Varicosis	133 Participants n=5 Participants
Cardiovascular Disease Dyslipidemia	47 Participants n=5 Participants
Cardiovascular Disease Peripheral Arterial Disease (PAD)	18 Participants n=5 Participants
Cardiovascular Disease Atrial Fibrillation (A-FIB)	6 Participants n=5 Participants
Cardiovascular Disease Arrhythmia (other than A-FIB)	8 Participants n=5 Participants
Renal Disease Chronic Kidney Disease	4 Participants n=5 Participants
Renal Disease Acute Renal Insufficiency	1 Participants n=5 Participants
Renal Disease Uremia	1 Participants n=5 Participants
Disease Category Post-Thrombotic Syndrome (PTS)	93 Participants n=5 Participants
Disease Category Non-Thrombotic Iliac Vein Lesions (NIVL)	77 Participants n=5 Participants
Number of Target Lesions 1	154 Participants n=5 Participants
Number of Target Lesions 2	16 Participants n=5 Participants
Number of Study Devices Used 1 Study Device	122 Participants n=5 Participants
Number of Study Devices Used 2 Study Devices	47 Participants n=5 Participants
Number of Study Devices Used 3 Study Devices	1 Participants n=5 Participants
Target Limb Right Leg	28 Participants n=5 Participants
Target Limb Left Leg	142 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-index procedure

Population: ITT subjects. 25 subjects were excluded from the denominator due to discontinuation or other reasons prior to 12 month follow-up visit.

Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis > 50% as measured by Duplex Ultrasound (DUS).

Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.

Outcome measures

Measure	VENOVO™ Venous Stent. n=145 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure	128 Participants

PRIMARY outcome

Timeframe: 30 days post-index procedure

Population: ITT subjects. Results adjudicated by CEC. MAEs that occurred prior to day 30 of each subject's follow-up were counted as failures toward primary safety (n= 11). Those subjects were considered not evaluable and not included in the denominator for the primary safety endpoint (total evaluable = 170 subjects).

Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb.

Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.

Outcome measures

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Number of Participants With Freedom From Major Adverse Events (MAEs)	159 Participants

SECONDARY outcome

Timeframe: Evaluation at 12 months post-index procedure

Population: Evaluable ITT subjects are included in this analysis.(n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

The Venous Clinical Severity Score (VCSS) system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration. and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 means absent, 1 means mild, 2 means moderate and 3 means severe. Total VCSS is the sum of all VCSS assessment scores from categories for a given time point. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for Intent-to-Treat (ITT) subjects. Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.

Outcome measures

Measure	VENOVO™ Venous Stent. n=155 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months	-1.7 Scores on a scale Interval -1.81 to -1.49

SECONDARY outcome

Timeframe: Evaluation at 12 months post-index procedure

Population: Evaluable ITT subjects were included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

The Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIC-20) is a 20-item questionnaire which provides a global index and an outline of 4 QoL dimensions - pain (4 items), physical (4 items), psychological (9 items) and social (4 items). Items are scored on a scale from 1 to 5. A low score corresponds to greater patient comfort. Total CIVIQ-20 score is the sum of all 20-item scores The score of each dimension was obtained by adding up the scores of each constituent item within that dimension. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for evaluable ITT subjects. Lower values represent a better outcome, that is, a better QoL than that experienced at baseline.

Outcome measures

Measure	VENOVO™ Venous Stent. n=153 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months	-15.7 Scores on a scale Interval -18.41 to -12.96

SECONDARY outcome

Timeframe: Evaluation through 30 day, 6 months and 12 months post index procedure

Population: Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinical classification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).For each category of Etiology, Anatomy, and Pathophysiology classifications, at each time point, frequency of each category is reported. Subsequent clinical study reports will present CEAP at 24 and 36-months follow-up. Changes from baseline measures to given time points are presented. Lower mean scores represent an improvement from baseline measure.

Outcome measures

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure 30 day post procedure	-1.1 Scores on a scale Standard Deviation 1.26
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure 6 months post procedure	-1.3 Scores on a scale Standard Deviation 1.34
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure 12 months post procedure	-1.5 Scores on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: At time of Index Procedure

Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator.

Outcome measures

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success	170 Participants

SECONDARY outcome

Timeframe: Less than 30 days post index procedure

Technical success is defined as no major adverse events experienced between index procedure and discharge

Outcome measures

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)	168 Participants

SECONDARY outcome

Timeframe: At the conclusion of index procedure

Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure.

Outcome measures

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)	170 Participants

SECONDARY outcome

Timeframe: Evaluation throrugh 30 day, 6 months and 12 months post index procedure

Population: (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion.

Outcome measures

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects) 30 day post procedure	164 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects) 6 months post procedure	161 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects) 12 months post procedure	151 Participants

SECONDARY outcome

Timeframe: Evaluation through 30 days, 6 months and 12 months post index procedure

Population: (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Freedom from Target Vessel Revascularization (TVR) is defined as the first revascularization procedure of the target vessel, as determined by an Independent Core Lab. Freedom from Target Lesion Revascularization (TLR) and Freedom from TVR results are the same through the 12 month analysis as all TLRs were also TVRs in this case.

Outcome measures

Measure	VENOVO™ Venous Stent. n=170 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects) 30 days post procedure	164 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects) 6 months post procedure	161 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects) 12 months post procedure	151 Participants

SECONDARY outcome

Timeframe: Evaluation at 12 months post-index procedure

Population: Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.

Outcome measures

Measure	VENOVO™ Venous Stent. n=137 Participants Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up No Device Stent Fracture at 12 months	137 Participants
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up Device Stent Fracture at 12 months	0 Participants

Adverse Events

VENOVO™ Venous Stent.

Serious events: 44 serious events

Other events: 63 other events

Deaths: 4 deaths

Serious adverse events

Measure	VENOVO™ Venous Stent. n=170 participants at risk Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Blood and lymphatic system disorders Haemorrhagic Anaemia	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Acute myocardial infarction	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Angina pectoris	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Angina unstable	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Cardiac failure congestive	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Coronary artery disease	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Eye disorders Retinal detachment	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Coeliac artery stenosis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Diverticular perforation	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Rectal haemorrhage	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Chest discomfort	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Death	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Device occlusion	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Local swelling	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Oedema peripheral	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Thrombosis in device	3.5% 6/170 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Vessel puncture site haematoma	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Vessel puncture site pain	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Immune system disorders Hypersensitivity	0.00% 0/170 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Arthritis bacterial	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Cellulitis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Clostridium difficile infection	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Erysipelas	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Pneumonia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Urinary tract infection	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Femoral neck fracture	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Laceration	0.00% 0/170 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Procedural pain	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Status epilepticus	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Psychiatric disorders Alcohol withdrawal syndrome	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Psychiatric disorders Panic attacks	0.00% 0/170 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Psychiatric disorders Psychotic disorder	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Heamaturia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Renal artery arteriosclerosis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Renal impairment	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Diabetic neuropathis ulcer	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Circulatory collapse	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Deep vein thrombosis	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Iliac vein occlusion	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Pelvic vein occlusion	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Peripheral arterial occlusive disease	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Peripheral artery thrombosis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Post-thrombotic syndrome	0.00% 0/170 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Venous insufficiency	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Venous stenosis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Umbilical hernia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Reproductive system and breast disorders Cystocele	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.

Other adverse events

Measure	VENOVO™ Venous Stent. n=170 participants at risk Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement
Blood and lymphatic system disorders Anaemia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Blood and lymphatic system disorders Leukopenia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Acute myocardial infarction	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Angina pectoris	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Coronary artery disease	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Myocardial infraction	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Cardiac disorders Palpitation	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Eye disorders Endocrine ophthalmopathy	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Abdominal pain	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Abdominal pain lower	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Abdominal tenderness	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Constipation	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Diverticulum	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Gingival bleeding	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Mouth haemorrhage	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Nausea	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Rectal polyp	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Toothache	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Gastrointestinal disorders Vomiting	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Adverse drug reaction	2.4% 4/170 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Fatigue	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Hernia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Induration	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Injection site discoloration	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Injection site discomfort	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Injection site haematoma	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Injection site induration	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Injury associated with device	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Local swelling	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Non-cardiac chest pain	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Oedema peripheral	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Thrombosis in device	2.4% 4/170 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Vessel puncture site haematoma	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Vessel puncture site haemorrhage	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Vessel puncture site pain	2.4% 4/170 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
General disorders Vessel puncture site swelling	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Immune system disorders Hypersensitivity	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Bronchitis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Clostridium difficile colitis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Lower respiratory tract infection	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Nasopharyngitis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Oesophageal candidiasis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Parotitis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Urinary tract infection	2.4% 4/170 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Vaginal infection	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Infections and infestations Viral infection	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Contusion	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Cystitis radiation	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Excoriation	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Laceration	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Limb injury	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Meniscus injury	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Muscle strain	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Nerve injury	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Post procedural discomfort	2.9% 5/170 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Procedural pain	6.5% 11/170 • Number of events 11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Injury, poisoning and procedural complications Upper limb fracture	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Investigations International normalised ratio increased	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Metabolism and nutrition disorders Hypokalaemia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 8/170 • Number of events 8 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Back pain	4.1% 7/170 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Bursitis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Limb discomfort	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Pain in extremity	3.5% 6/170 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Burning sensation	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Headache	2.4% 4/170 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Hypoaesthesia	2.4% 4/170 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Meralgia paraesthetica	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Paraesthesia	2.4% 4/170 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Sciatica	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Nervous system disorders Syncope	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Psychiatric disorders Mental status change	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Psychiatric disorders Panic attack	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Haematuria	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Nephrolithiasis	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Renal failure acute	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Urinary incontinence	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Renal and urinary disorders Urinary retention	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Reproductive system and breast disorders Menorrhagia	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Reproductive system and breast disorders Pelvic pain	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Reproductive system and breast disorders Vaginal haemorrhage	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Reproductive system and breast disorders Varicose veins pelvic	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Blister	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Dermal cyst	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Rash	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Rash generalized	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Rash macular	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Skin disorder	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Skin and subcutaneous tissue disorders Skin ulcer	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Deep vein thrombosis	1.8% 3/170 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Haematoma	1.2% 2/170 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Orthostatic hypotension	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Peripheral arterial occlusive disease	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Peripheral artery stenosis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Post thrombotic syndrome	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Thrombophlebitis superficial	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Varicose vein	4.1% 7/170 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Vasospasm	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Venous insufficiency	3.5% 6/170 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.
Vascular disorders Venous stenosis	0.59% 1/170 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included.

Additional Information

Megan Hill

Becton Dickinson (BPV)

Phone: 480-350-6468

Email: Megan.Hill@bd.com

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to PI publication of site results, sponsor requires publication of multi-centers results.
• Publication restrictions are in place

Restriction type: OTHER