Trial Outcomes & Findings for Embosphere® PROstate Post Market Study (NCT NCT03527589)
NCT ID: NCT03527589
Last Updated: 2023-12-18
Results Overview
The two time points used in the calculation were baseline and 12 months. The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints). From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores on a scale' is the unite of measure
Recruitment status
COMPLETED
Target enrollment
499 participants
Primary outcome timeframe
12 Months
Results posted on
2023-12-18
Participant Flow
Participant milestones
| Measure |
Treated With Embosphere Microspheres
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Overall Study
STARTED
|
499
|
|
Overall Study
COMPLETED
|
487
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Embosphere® PROstate Post Market Study
Baseline characteristics by cohort
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 8.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
487 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
283 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
332 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
147 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
127 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
122 participants
n=5 Participants
|
|
Region of Enrollment
France
|
135 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsThe two time points used in the calculation were baseline and 12 months. The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints). From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores on a scale' is the unite of measure
Outcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).
|
-11.1 scores on scale
Interval -11.9 to -10.2
|
SECONDARY outcome
Timeframe: 3, 24 MonthsThe time points used in the calculation were baseline, 3 months and 24 months. The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints). The same calculation was also done at 24 months. From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.
Outcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.
3 Months
|
-12.4 scores on scale
Interval -13.2 to -11.6
|
|
International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.
24 Months
|
-10.1 scores on scale
Interval -11.1 to -9.1
|
SECONDARY outcome
Timeframe: 3, 24 MonthsThe time points used in the calculation were baseline, 3 months and 24 months. The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints). The same calculation was also done at 24 months. From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.
Outcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index.
3 Months
|
-2.7 scores on scale
Interval -2.9 to -2.5
|
|
Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index.
24 Months
|
-2.4 scores on scale
Interval -2.6 to -2.2
|
SECONDARY outcome
Timeframe: 3, 12, 24 MonthsThe measure used to assess "device or procedure related adverse events post procedure" at three different time points (3, 12, 24 months) are frequencies and percentages. For each visit (or reporting time point), the event rate will be calculated as the number of subjects with certain event terms over the number of evaluable subjects. The evaluable subjects at each reporting time point include all subjects who are enrolled and 1. had an event within (on or before) the reporting cutoff days, or 2. had a follow-up at or after the lower limit of the reporting window, or 3. the withdrawal consent date/recorded lost-to-follow-up date at or after the lower limit of the reporting window.
Outcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
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Device or Procedure Related Adverse Events Post Procedure.
3 Months
|
0 Participants
|
|
Device or Procedure Related Adverse Events Post Procedure.
12 Months
|
0 Participants
|
|
Device or Procedure Related Adverse Events Post Procedure.
24 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 3, 12, 24 MonthsOutcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
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Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
3 Months
|
55 Participants
|
|
Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
12 Months
|
0 Participants
|
|
Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
24 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: Day of PAE ProcedureOutcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
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|---|---|
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Technical Success Defined as Successful Embolization of the Treated Prostate Gland.
|
432 Participants
|
SECONDARY outcome
Timeframe: 3, 12, 24 MonthsOutcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
3 Months
|
20 Participants
|
|
Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
12 Months
|
22 Participants
|
|
Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
24 Months
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsThe calculation was done using the 12 months mean Sexual Health Inventory for Men (SHIM) score minus the baseline mean SHIM score for paired data (e.g., available data on both baseline and 12 month timepoints). From the SHIM questionnaire, the total scores was used and range from 1 to 25 with higher scores representing better outcomes (no signs of erectile dysfunction) and lower scores representing worse outcomes (severe erectile dysfunction). There are a total of 5 questions on the scale and the scores from each question are summed to get a total score. A positive change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.
Outcome measures
| Measure |
Treated With Embosphere Microspheres
n=487 Participants
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM).
|
-0.1 scores on scale
Interval -0.8 to 0.6
|
Adverse Events
Treated With Embosphere Microspheres
Serious events: 10 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treated With Embosphere Microspheres
n=487 participants at risk
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Renal and urinary disorders
Acute renal failure
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Blood in urine
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
General disorders
Dizziness upon walking
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Cardiac disorders
Dyspnea and congestive heart failure
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
General disorders
Emergency admission with abdominal pain and vomiting
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Surgical and medical procedures
False aneurysm at point of puncture
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Vascular disorders
Hypertension
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Infections and infestations
Prostatitis
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Urinary retention
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Infections and infestations
Urinary tract infection and hypotension
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
Other adverse events
| Measure |
Treated With Embosphere Microspheres
n=487 participants at risk
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
Prostate artery embolization: Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
|
|---|---|
|
Gastrointestinal disorders
Abdominal spasm
|
1.0%
5/487 • Number of events 6 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Gastrointestinal disorders
Acute retention of urine
|
0.41%
2/487 • Number of events 2 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Gastrointestinal disorders
Blood in stool
|
0.62%
3/487 • Number of events 3 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Gastrointestinal disorders
Bowel incontinence
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Gastrointestinal disorders
Constipation
|
0.62%
3/487 • Number of events 3 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
General disorders
Fatigue
|
4.1%
20/487 • Number of events 20 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
General disorders
Fever
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Gastrointestinal disorders
Low Grade Fever
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Gastrointestinal disorders
Pain
|
0.62%
3/487 • Number of events 3 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Infections and infestations
Urinary tract infection
|
0.41%
2/487 • Number of events 2 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
0.82%
4/487 • Number of events 4 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Nervous system disorders
Burning sensation
|
0.41%
2/487 • Number of events 2 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Bladder inability to empty
|
0.82%
4/487 • Number of events 4 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Bladder spasm
|
1.2%
6/487 • Number of events 7 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Burning micturition
|
6.0%
29/487 • Number of events 30 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Contracted bladder
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Frequency urinary
|
2.5%
12/487 • Number of events 13 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Hematuria
|
2.9%
14/487 • Number of events 14 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Incontinence urinary
|
1.8%
9/487 • Number of events 10 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Painful urination
|
6.4%
31/487 • Number of events 32 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Unable to urinate
|
0.41%
2/487 • Number of events 2 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Urgency urination
|
2.1%
10/487 • Number of events 11 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Urinary catheterization
|
0.41%
2/487 • Number of events 2 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Urinary frequency
|
0.62%
3/487 • Number of events 3 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Renal and urinary disorders
Urinary retention
|
0.41%
2/487 • Number of events 2 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Reproductive system and breast disorders
Bloody semen
|
2.3%
11/487 • Number of events 11 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.7%
13/487 • Number of events 13 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Reproductive system and breast disorders
Penile pain
|
0.21%
1/487 • Number of events 2 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Reproductive system and breast disorders
Rectoprostatic fistula
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.21%
1/487 • Number of events 1 • 24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place