Trial Outcomes & Findings for Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia (NCT NCT01789840)

NCT ID: NCT01789840

Last Updated: 2021-11-11

Results Overview

The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-11-11

Participant Flow

Participant milestones

Measure	Prostate Artery Emoblization (PAE) Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) Transurethral Resection of the Prostate (TURP) TURP
Overall Study STARTED	52	7
Overall Study COMPLETED	52	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Deviation recorded for Qmax not performed on 1 subject at baseline

Baseline characteristics by cohort

Measure	Prostate Artery Emoblization (PAE) n=52 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=7 Participants Transurethral Resection of the Prostate (TURP) TURP	Total n=59 Participants Total of all reporting groups
Age, Continuous	65.2 years STANDARD_DEVIATION 6.73 • n=52 Participants	62.9 years STANDARD_DEVIATION 76.74 • n=7 Participants	64.9 years STANDARD_DEVIATION 6.72 • n=59 Participants
Sex: Female, Male Female	0 Participants n=52 Participants	0 Participants n=7 Participants	0 Participants n=59 Participants
Sex: Female, Male Male	52 Participants n=52 Participants	7 Participants n=7 Participants	59 Participants n=59 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=52 Participants	2 Participants n=7 Participants	14 Participants n=59 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=52 Participants	5 Participants n=7 Participants	45 Participants n=59 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants	0 Participants n=7 Participants	0 Participants n=59 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=52 Participants	0 Participants n=7 Participants	0 Participants n=59 Participants
Race (NIH/OMB) Asian	3 Participants n=52 Participants	0 Participants n=7 Participants	3 Participants n=59 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=52 Participants	0 Participants n=7 Participants	1 Participants n=59 Participants
Race (NIH/OMB) Black or African American	1 Participants n=52 Participants	0 Participants n=7 Participants	1 Participants n=59 Participants
Race (NIH/OMB) White	47 Participants n=52 Participants	7 Participants n=7 Participants	54 Participants n=59 Participants
Race (NIH/OMB) More than one race	0 Participants n=52 Participants	0 Participants n=7 Participants	0 Participants n=59 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants	0 Participants n=7 Participants	0 Participants n=59 Participants
International Prostate Symptom Score (IPSS)	22.2 units on a scale STANDARD_DEVIATION 5.25 • n=52 Participants	24.6 units on a scale STANDARD_DEVIATION 5.59 • n=7 Participants	22.4 units on a scale STANDARD_DEVIATION 5.30 • n=59 Participants
Peak Urine Flow Rate (Qmax reported as mL/s)	6.6 mL/s STANDARD_DEVIATION 4.03 • n=51 Participants • Deviation recorded for Qmax not performed on 1 subject at baseline	8.1 mL/s STANDARD_DEVIATION 3.98 • n=7 Participants • Deviation recorded for Qmax not performed on 1 subject at baseline	6.7 mL/s STANDARD_DEVIATION 4.02 • n=58 Participants • Deviation recorded for Qmax not performed on 1 subject at baseline
Post Void Residual (PVR)	170.6 mL STANDARD_DEVIATION 156.27 • n=52 Participants	112.0 mL STANDARD_DEVIATION 165.35 • n=7 Participants	163.7 mL STANDARD_DEVIATION 157.06 • n=59 Participants
Detrusor Pressure (Pdet) (mmH2O)	88.3 mmH2O STANDARD_DEVIATION 71.25 • n=50 Participants • Protocol deviations recorded for Pdet not captured on 2 patients.	80.9 mmH2O STANDARD_DEVIATION 38.69 • n=7 Participants • Protocol deviations recorded for Pdet not captured on 2 patients.	87.4 mmH2O STANDARD_DEVIATION 67.99 • n=57 Participants • Protocol deviations recorded for Pdet not captured on 2 patients.
International Index of Erectile Function (IIEF) - Total Total IIEF	29.5 units on a scale STANDARD_DEVIATION 20.71 • n=52 Participants	48.6 units on a scale STANDARD_DEVIATION 24.73 • n=7 Participants	31.8 units on a scale STANDARD_DEVIATION 21.89 • n=59 Participants
International Index of Erectile Function (IIEF) - Total Erectile function sub-score	11.7 units on a scale STANDARD_DEVIATION 9.82 • n=52 Participants	20.1 units on a scale STANDARD_DEVIATION 10.99 • n=7 Participants	12.7 units on a scale STANDARD_DEVIATION 10.25 • n=59 Participants
International Index of Erectile Function (IIEF) - Total Orgasmic function sub-score	4.2 units on a scale STANDARD_DEVIATION 3.76 • n=52 Participants	5.7 units on a scale STANDARD_DEVIATION 4.11 • n=7 Participants	4.4 units on a scale STANDARD_DEVIATION 3.81 • n=59 Participants
International Index of Erectile Function (IIEF) - Total Sexual desire sub-score	5.1 units on a scale STANDARD_DEVIATION 2.47 • n=52 Participants	7.4 units on a scale STANDARD_DEVIATION 2.70 • n=7 Participants	5.4 units on a scale STANDARD_DEVIATION 2.59 • n=59 Participants
International Index of Erectile Function (IIEF) - Total Intercourse satisfaction sub-score	4.1 units on a scale STANDARD_DEVIATION 4.63 • n=52 Participants	8.0 units on a scale STANDARD_DEVIATION 6.08 • n=7 Participants	4.5 units on a scale STANDARD_DEVIATION 4.93 • n=59 Participants
International Index of Erectile Function (IIEF) - Total Overall satisfaction sub-score	4.5 units on a scale STANDARD_DEVIATION 2.79 • n=52 Participants	7.3 units on a scale STANDARD_DEVIATION 3.30 • n=7 Participants	4.8 units on a scale STANDARD_DEVIATION 2.97 • n=59 Participants
Prostate volume (g)	66.4 g STANDARD_DEVIATION 11.8 • n=52 Participants	65.9 g STANDARD_DEVIATION 14.71 • n=7 Participants	66.4 g STANDARD_DEVIATION 12.04 • n=59 Participants
Prostate Specific Antigen (PSA) (ng/mL)	3.9 ng/mL STANDARD_DEVIATION 2.71 • n=52 Participants	5.5 ng/mL STANDARD_DEVIATION 6.71 • n=7 Participants	4.1 ng/mL STANDARD_DEVIATION 3.37 • n=59 Participants
Free Prostate Specific Antigen (PSA)	22.5 percentage of Free PSA STANDARD_DEVIATION 8.99 • n=45 Participants • Free PSA was not collected at baseline on all subjects due to protocol deviation	21.8 percentage of Free PSA STANDARD_DEVIATION 9.65 • n=2 Participants • Free PSA was not collected at baseline on all subjects due to protocol deviation	22.4 percentage of Free PSA STANDARD_DEVIATION 8.91 • n=47 Participants • Free PSA was not collected at baseline on all subjects due to protocol deviation

PRIMARY outcome

Timeframe: 12 months

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months.

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=10 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=4 Participants Transurethral Resection of the Prostate (TURP) TURP
International Prostate Symptom Score (IPSS) - Total Score at 12 Months	10.7 total score on a scale Standard Deviation 8.8	4.3 total score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 1 month

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

The duration of hospitalization associated with the procedure will be calculated in hours. T

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=28 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=6 Participants Transurethral Resection of the Prostate (TURP) TURP
Duration of Hospitalization Post Procedure	23.1 hours Standard Deviation 9.4	32.2 hours Standard Deviation 10.2

SECONDARY outcome

Timeframe: 1 month

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

The duration of post procedure catheterization will be calculated in hours.

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=27 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=6 Participants Transurethral Resection of the Prostate (TURP) TURP
Duration of Post Procedure Catheterization	24.2 hours Standard Deviation 44.2	24.2 hours Standard Deviation 12.9

SECONDARY outcome

Timeframe: Through early termination of study (with less than 25% of subjects completing 12 month follow up)

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

Adverse events during the study were predominantly mild. There are over 4 times as many PAE patients as TURP, so the overall incidence rate of events is proportional to the size of the cohort represented. The most common events among patients who underwent embolization were transient dysuria, bladder spasm, hematuria, hematospermia, nausea and fever. The last 2 are typical of post embolic syndrome common to all embolization procedures. The most frequent adverse events for surgery patients were dysuria and hematuria. Events also include non-TEAEs.

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=28 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=6 Participants Transurethral Resection of the Prostate (TURP) TURP
Number of Adverse Events Per Patient Mild adverse events	3.78 events per patient	4.0 events per patient
Number of Adverse Events Per Patient Moderate adverse events	0.39 events per patient	0.5 events per patient
Number of Adverse Events Per Patient Severe adverse events	0.21 events per patient	0.17 events per patient

SECONDARY outcome

Timeframe: TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up

Population: De Novo classification from FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization for symptomatic benign prostatic hyperplasia received 2017. IDE supplement proposed the termination of study follow-up visits; FDA granted approval of termination 03Nov2017. Early termination resulted in small numbers analyzed w less than 25% reaching 12 month follow-up.

Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the case report form (CRF) which began prior to treatment will not be included in the summary tables but will be included in the AE data listings.

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=52 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=6 Participants Transurethral Resection of the Prostate (TURP) TURP
Number of Patients With Procedure Related Adverse Events Cardiac disorders	3 Participants	1 Participants
Number of Patients With Procedure Related Adverse Events Congenital, familial and genetic disorders	1 Participants	0 Participants
Number of Patients With Procedure Related Adverse Events Ear and labryinth disorders	3 Participants	0 Participants
Number of Patients With Procedure Related Adverse Events Endocrine disorders	1 Participants	0 Participants
Number of Patients With Procedure Related Adverse Events Gastrointestinal disorders	22 Participants	2 Participants
Number of Patients With Procedure Related Adverse Events General disorders and administration site conditions	11 Participants	0 Participants
Number of Patients With Procedure Related Adverse Events Infections and infestation	7 Participants	1 Participants
Number of Patients With Procedure Related Adverse Events Injury, poisoning and procedural complications	3 Participants	0 Participants
Number of Patients With Procedure Related Adverse Events Investigations	1 Participants	1 Participants
Number of Patients With Procedure Related Adverse Events Metabolism and nutrition disorders	2 Participants	0 Participants
Number of Patients With Procedure Related Adverse Events Musculoskeletal and connective tissue disorders	10 Participants	1 Participants
Number of Patients With Procedure Related Adverse Events Nervous system disorders	7 Participants	1 Participants
Number of Patients With Procedure Related Adverse Events Renal and urinary disorders	30 Participants	5 Participants
Number of Patients With Procedure Related Adverse Events Reproductive system and breast disorders	13 Participants	2 Participants
Number of Patients With Procedure Related Adverse Events Respiratory, thoracic and mediastinal disorders	4 Participants	2 Participants
Number of Patients With Procedure Related Adverse Events Skin and subcutaneous tissue disorders	3 Participants	2 Participants
Number of Patients With Procedure Related Adverse Events Surgical and medical procedures	1 Participants	0 Participants
Number of Patients With Procedure Related Adverse Events Vascular disorders	4 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 month follow up

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

Free PSA percentage summarized for both groups at 6 months follow up

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=17 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=3 Participants Transurethral Resection of the Prostate (TURP) TURP
Free Prostate Specific Antigen (PSA) at 6 Month Follow up	18.7 percentage Standard Deviation 8.7	26.0 percentage Standard Deviation 8.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month follow-up

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments was assessed at 1 month follow up. (Additional timepoints were not assessed due to early termination).

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=23 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=4 Participants Transurethral Resection of the Prostate (TURP) TURP
Peak Urine Flow Rate (Qmax) at 1 Month	12.1 mL/s Standard Deviation 10.2	14.0 mL/s Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

Erectile Function (Questions 1-5 & 15), score range 0-5, max score = 30 Orgasmic Function (Questions 9-10), score range 0-5, max score = 10 Sexual Desire (Questions 11-12), score range 1-5, max score = 10 Intercourse Satisfaction (Questions 6-8), score range 0-5, max score = 15 Overall Satisfaction (Questions 13-14), score range 1-5, max score = 10

SCORING for erectile dysfunction (Total of Q1-5 and Q15) is interpreted as follows:

1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction

For all subscales, higher scores = less dysfunction/dissatisfaction Total IIEF is out of 75

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=22 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=6 Participants Transurethral Resection of the Prostate (TURP) TURP
International Index of Erectile Function (IIEF) Total IIEF (Q1 to 15 out of 75 points total)	33.3 score on a scale Standard Deviation 24.4	61.7 score on a scale Standard Deviation 25.3
International Index of Erectile Function (IIEF) Erectile function (sub-score Q1-5, 15 out of total 30pts)	12.6 score on a scale Standard Deviation 11.4	25.3 score on a scale Standard Deviation 11.4
International Index of Erectile Function (IIEF) Orgasmic function sub-score Q9-10 out of 10 points total)	4.1 score on a scale Standard Deviation 4.0	7.3 score on a scale Standard Deviation 3.3
International Index of Erectile Function (IIEF) Sexual desire sub-score Q11-12 out of 10 points total	5.9 score on a scale Standard Deviation 2.4	8.7 score on a scale Standard Deviation 2.4
International Index of Erectile Function (IIEF) Intercourse satisfaction sub-score Q6-8 out of 15 points total	5.5 score on a scale Standard Deviation 5.8	11.7 score on a scale Standard Deviation 5.8
International Index of Erectile Function (IIEF) Overall satisfaction sub-score Q13-14 out of 10 points total	5.4 score on a scale Standard Deviation 3.1	8.7 score on a scale Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 month follow-up

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

The mean prostate volume as assessed by MRI is summarized at 3 month time point.

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=23 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=4 Participants Transurethral Resection of the Prostate (TURP) TURP
Mean Prostate Volume, as Determined by MRI	52.1 grams Standard Deviation 15.0	28.2 grams Standard Deviation 5.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month follow-up

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments is summarized for both treatment groups at 1 month time point.

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=23 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=4 Participants Transurethral Resection of the Prostate (TURP) TURP
Post-void Residual Urinary Volume (PVR)	106 mL Standard Deviation 136	7.5 mL Standard Deviation 9.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

Prostate specific antigen (PSA) will be summarized for both treatment groups for 6 month time point

Outcome measures

Measure	Prostate Artery Emoblization (PAE) n=19 Participants Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres	Transurethral Resection of the Prostate (TURP) n=4 Participants Transurethral Resection of the Prostate (TURP) TURP
Total Prostate Specific Antigen (PSA) at 6 Months	2.9 ng/mL Standard Deviation 2.0	2.1 ng/mL Standard Deviation 1.1

Adverse Events

Prostate Artery Embolization (PAE) Arm

Serious events: 6 serious events

Other events: 40 other events

Deaths: 0 deaths

Transurethral Resection of the Prostate (TURP) Arm

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prostate Artery Embolization (PAE) Arm n=52 participants at risk Denominator for percent calculations is 52 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE.	Transurethral Resection of the Prostate (TURP) Arm n=6 participants at risk Denominator for percent calculations is 6 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE.
Gastrointestinal disorders Impacted stool	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Chest pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Duodenal ulcer	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Dysuria	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Fever	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Infections and infestations Sepsis	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.

Other adverse events

Measure	Prostate Artery Embolization (PAE) Arm n=52 participants at risk Denominator for percent calculations is 52 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE.	Transurethral Resection of the Prostate (TURP) Arm n=6 participants at risk Denominator for percent calculations is 6 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE.
Infections and infestations Sepsis	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Infections and infestations Nasopharyngitis	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Cardiac disorders Arrhythmia	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Ear and labyrinth disorders Ear Pain	5.8% 3/52 • Number of events 3 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Catheter site inflammation	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Infections and infestations Bronchitis	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Injury, poisoning and procedural complications Bladder injury	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Nervous system disorders Burning sensation	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Bladder discomfort	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Ejaculation disorder	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Skin and subcutaneous tissue disorders Ecchymosis	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Vascular disorders Haematoma	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Cardiac disorders Bradycardia	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Cardiac disorders Myocardial infarction	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Cardiac disorders Supraventricular tachycardia	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Congenital, familial and genetic disorders Hydrocele	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Endocrine disorders Hypogonadism	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Abdominal pain lower	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Abdominal pain upper	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Abdominal rigidity	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Anorectal discomfort	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Constipation	5.8% 3/52 • Number of events 3 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Dental necrosis	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Duodenal ulcer	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Faecaloma	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Haematochezia	5.8% 3/52 • Number of events 3 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Haemorrhoids	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Hiatal hernia	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Nausea	15.4% 8/52 • Number of events 8 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Gastrointestinal disorders Vomiting	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Catheter site related reaction	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Chest pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Chills	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Facial pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Fatigue	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Local swelling	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Pyrexia	5.8% 3/52 • Number of events 3 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
General disorders Suprapubic pain	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Infections and infestations Cellulits	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Infections and infestations Localised infection	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Infections and infestations Urinary tract infection	7.7% 4/52 • Number of events 4 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Injury, poisoning and procedural complications Fall	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Injury, poisoning and procedural complications Procedural pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Investigations Blood urine present	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Investigations Urine leukocyte esterase positive	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Metabolism and nutrition disorders Hyperkalemia	1.9% 1/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Metabolism and nutrition disorders Gout	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Chest wall mass	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Groin pain	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Muscle spasms	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 1/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Nervous system disorders Dizziness	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Nervous system disorders Headache	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Nervous system disorders Presyncope	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Nervous system disorders Sciatica	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Nervous system disorders Sensory loss	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Bladder spasm	9.6% 5/52 • Number of events 5 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Dysuria	36.5% 19/52 • Number of events 23 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	50.0% 3/6 • Number of events 3 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Haematuria	13.5% 7/52 • Number of events 7 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	50.0% 3/6 • Number of events 3 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Incontinence	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Micturition	7.7% 4/52 • Number of events 4 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Pollakiuria	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Renal failure acute	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Terminal dribbling	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Urethral pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Urinary incontinence	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Urinary retention	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Renal and urinary disorders Urinary straining	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Epididymal cyst	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Haematospermia	7.7% 4/52 • Number of events 4 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Pelvic pain	9.6% 5/52 • Number of events 5 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Penile burning sensation	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Penile pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Perineal pain	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Prostatitis	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Retrograde ejaculation	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Testicular pain	1.9% 1/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Reproductive system and breast disorders Varicocele	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/52 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Skin and subcutaneous tissue disorders Skin discoloration	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	16.7% 1/6 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Skin and subcutaneous tissue disorders Arthroscopic surgery	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Vascular disorders Hypertension	3.8% 2/52 • Number of events 2 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Vascular disorders Hypotension	1.9% 1/52 • Number of events 1 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.	0.00% 0/6 • Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point. Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized \& never treated are not included. If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.

Additional Information

Casey Holland

Merit Medical

Phone: 1 (617) 842-0251

Email: casey.holland@merit.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place