Trial Outcomes & Findings for Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia (NCT NCT00284518)
NCT ID: NCT00284518
Last Updated: 2012-12-17
Results Overview
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
380 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2012-12-17
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A 300 U
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
97
|
94
|
95
|
94
|
|
Overall Study
COMPLETED
|
71
|
66
|
67
|
61
|
|
Overall Study
NOT COMPLETED
|
26
|
28
|
28
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A 300 U
n=97 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=94 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=95 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=94 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
45 to 65 Years
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
|
Age, Customized
>65 Years
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
380 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=89 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=91 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=94 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=92 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
Baseline
|
21.3 Score on a scale
Standard Deviation 6.03
|
20.2 Score on a scale
Standard Deviation 5.80
|
21.5 Score on a scale
Standard Deviation 5.42
|
20.7 Score on a scale
Standard Deviation 5.44
|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
Change from baseline at Week 12 (N=86,89,93,90)
|
-5.6 Score on a scale
Standard Deviation 7.73
|
-6.3 Score on a scale
Standard Deviation 7.13
|
-6.6 Score on a scale
Standard Deviation 6.87
|
-5.5 Score on a scale
Standard Deviation 6.33
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=89 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=91 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=94 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=92 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
Baseline
|
21.3 Score on a scale
Standard Deviation 6.03
|
20.2 Score on a scale
Standard Deviation 5.80
|
21.5 Score on a scale
Standard Deviation 5.42
|
20.7 Score on a scale
Standard Deviation 5.44
|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
Change from baseline at Week 72 (N=64,61,66,58)
|
-5.0 Score on a scale
Standard Deviation 6.50
|
-4.1 Score on a scale
Standard Deviation 6.40
|
-4.7 Score on a scale
Standard Deviation 7.15
|
-4.3 Score on a scale
Standard Deviation 7.15
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 72Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=95 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=89 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=93 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=91 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in Peak Urine Flow Rate
Baseline
|
10.4 milliliters (mL)/second
Standard Deviation 2.70
|
10.6 milliliters (mL)/second
Standard Deviation 2.83
|
9.6 milliliters (mL)/second
Standard Deviation 2.57
|
10.1 milliliters (mL)/second
Standard Deviation 2.82
|
|
Change From Baseline in Peak Urine Flow Rate
Change from baseline to Week 12 (N=81,80,86,77)
|
1.8 milliliters (mL)/second
Standard Deviation 4.65
|
2.0 milliliters (mL)/second
Standard Deviation 4.98
|
2.7 milliliters (mL)/second
Standard Deviation 5.21
|
2.8 milliliters (mL)/second
Standard Deviation 4.74
|
|
Change From Baseline in Peak Urine Flow Rate
Change from baseline to Week 72 (N=59,56,64,53)
|
2.0 milliliters (mL)/second
Standard Deviation 4.67
|
2.4 milliliters (mL)/second
Standard Deviation 5.18
|
2.0 milliliters (mL)/second
Standard Deviation 4.07
|
2.3 milliliters (mL)/second
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 72Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=96 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=91 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=92 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=91 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in Total Prostate Volume
Baseline
|
48.78 milliliter (mL)
Standard Deviation 16.800
|
48.40 milliliter (mL)
Standard Deviation 16.325
|
47.54 milliliter (mL)
Standard Deviation 16.917
|
47.23 milliliter (mL)
Standard Deviation 14.867
|
|
Change From Baseline in Total Prostate Volume
Change from baseline at Week 12 (N=86,84,88,82)
|
-3.40 milliliter (mL)
Standard Deviation 10.046
|
-3.65 milliliter (mL)
Standard Deviation 9.255
|
-3.54 milliliter (mL)
Standard Deviation 9.823
|
-4.59 milliliter (mL)
Standard Deviation 8.392
|
|
Change From Baseline in Total Prostate Volume
Change from baseline at Week 72 (N=65,60,67,57)
|
-3.58 milliliter (mL)
Standard Deviation 9.773
|
-2.82 milliliter (mL)
Standard Deviation 11.194
|
-1.77 milliliter (mL)
Standard Deviation 10.714
|
-2.69 milliliter (mL)
Standard Deviation 10.875
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 72Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=94 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=89 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=90 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=87 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in Transitional Zone Prostate Volume
Baseline
|
20.78 milliliters (mL)
Standard Deviation 14.657
|
21.75 milliliters (mL)
Standard Deviation 12.931
|
21.00 milliliters (mL)
Standard Deviation 14.188
|
20.73 milliliters (mL)
Standard Deviation 13.210
|
|
Change From Baseline in Transitional Zone Prostate Volume
Change from baseline at Week 12 (N=83,82,86,79)
|
-0.23 milliliters (mL)
Standard Deviation 6.516
|
-0.76 milliliters (mL)
Standard Deviation 8.085
|
-0.02 milliliters (mL)
Standard Deviation 8.445
|
-0.27 milliliters (mL)
Standard Deviation 6.551
|
|
Change From Baseline in Transitional Zone Prostate Volume
Change from baseline at Week 72 (N=64,59,65,55)
|
0.19 milliliters (mL)
Standard Deviation 7.655
|
-0.94 milliliters (mL)
Standard Deviation 8.119
|
-0.35 milliliters (mL)
Standard Deviation 8.808
|
-1.35 milliliters (mL)
Standard Deviation 6.801
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 12, Week 72Population: Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.
Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=92 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=89 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=89 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=91 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in Post-Void Residual
Change from baseline at Week 2 (N=76,82,80,78)
|
5.4 milliliters (mL)
Standard Deviation 64.06
|
10.9 milliliters (mL)
Standard Deviation 88.62
|
-1.4 milliliters (mL)
Standard Deviation 65.01
|
1.6 milliliters (mL)
Standard Deviation 61.03
|
|
Change From Baseline in Post-Void Residual
Baseline
|
73.0 milliliters (mL)
Standard Deviation 57.07
|
69.7 milliliters (mL)
Standard Deviation 54.93
|
66.1 milliliters (mL)
Standard Deviation 55.59
|
64.3 milliliters (mL)
Standard Deviation 51.89
|
|
Change From Baseline in Post-Void Residual
Change from baseline at Week 12 (N=88,84,89,82)
|
7.5 milliliters (mL)
Standard Deviation 78.18
|
9.0 milliliters (mL)
Standard Deviation 81.23
|
-1.4 milliliters (mL)
Standard Deviation 62.82
|
3.2 milliliters (mL)
Standard Deviation 57.92
|
|
Change From Baseline in Post-Void Residual
Change from baseline at Week 72 (N=66,60,65,60)
|
10.9 milliliters (mL)
Standard Deviation 73.27
|
-12.4 milliliters (mL)
Standard Deviation 54.31
|
14.0 milliliters (mL)
Standard Deviation 75.97
|
6.0 milliliters (mL)
Standard Deviation 69.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 72Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=86 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=79 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=84 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=87 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Baseline
|
15.4 Score on a scale
Standard Deviation 10.20
|
14.6 Score on a scale
Standard Deviation 10.7
|
17.2 Score on a scale
Standard Deviation 10.19
|
16.7 Score on a scale
Standard Deviation 10.29
|
|
Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Change from baseline at Week 12 (N=80,72,83,79)
|
0.1 Score on a scale
Standard Deviation 6.66
|
-0.2 Score on a scale
Standard Deviation 5.54
|
-0.9 Score on a scale
Standard Deviation 6.93
|
1.3 Score on a scale
Standard Deviation 7.86
|
|
Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Change from baseline at Week 72 (N=61,54,61,58)
|
0.8 Score on a scale
Standard Deviation 7.17
|
0.5 Score on a scale
Standard Deviation 4.56
|
-1.5 Score on a scale
Standard Deviation 7.34
|
-0.9 Score on a scale
Standard Deviation 7.95
|
POST_HOC outcome
Timeframe: Baseline, Week 12Population: Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.
The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A 300 U
n=44 Participants
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=35 Participants
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=52 Participants
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=43 Participants
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers
Baseline
|
21.3 Score on a scale
Standard Deviation 6.20
|
19.6 Score on a scale
Standard Deviation 6.15
|
21.9 Score on a scale
Standard Deviation 5.65
|
20.4 Score on a scale
Standard Deviation 5.32
|
|
Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers
Change from baseline at Week 12 (N=44,35,52,42)
|
-5.1 Score on a scale
Standard Deviation 7.76
|
-6.6 Score on a scale
Standard Deviation 5.91
|
-5.4 Score on a scale
Standard Deviation 5.17
|
-3.5 Score on a scale
Standard Deviation 6.12
|
Adverse Events
Botulinum Toxin Type A 300 U
Serious events: 9 serious events
Other events: 41 other events
Deaths: 0 deaths
Botulinum Toxin Type A 200 U
Serious events: 16 serious events
Other events: 46 other events
Deaths: 0 deaths
Botulinum Toxin Type A 100 U
Serious events: 10 serious events
Other events: 53 other events
Deaths: 0 deaths
Placebo (Normal Saline)
Serious events: 11 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A 300 U
n=94 participants at risk
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=93 participants at risk
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=94 participants at risk
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=92 participants at risk
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.1%
2/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Eye disorders
Retinal artery thrombosis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
General disorders
Accidental death
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Infections and infestations
Bacterial prostatitis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Investigations
Prostatic specific antigen increased
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Calculus bladder
|
2.1%
2/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
0.00%
0/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
Other adverse events
| Measure |
Botulinum Toxin Type A 300 U
n=94 participants at risk
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 200 U
n=93 participants at risk
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum Toxin Type A 100 U
n=94 participants at risk
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Placebo (Normal Saline)
n=92 participants at risk
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
6.4%
6/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
1.1%
1/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
4.3%
4/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.3%
3/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
5/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
6.5%
6/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.3%
5/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.4%
5/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Investigations
Prostatic specific antigen increase
|
5.3%
5/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.4%
5/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.2%
3/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.4%
5/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.4%
5/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.1%
2/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.3%
3/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Renal cyst
|
7.4%
7/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
7.4%
7/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.3%
3/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Haematuria
|
4.3%
4/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
7.5%
7/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
8.5%
8/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
8.7%
8/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Urinary retention
|
2.1%
2/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.3%
5/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.3%
3/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Dysuria
|
2.1%
2/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.4%
5/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
4.3%
4/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.3%
3/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Micturition urgency
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.2%
3/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.3%
5/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
6.5%
6/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Renal and urinary disorders
Pollakiuria
|
1.1%
1/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.1%
2/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.4%
5/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Reproductive system and breast disorders
Haematospermia
|
2.1%
2/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
6.5%
6/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
5.3%
5/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
7.6%
7/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
|
Vascular disorders
Hypertension
|
5.3%
5/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
2.2%
2/93
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
3.2%
3/94
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
4.3%
4/92
Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER