Trial Outcomes & Findings for A Study of Tadalafil After Radical Prostatectomy (NCT NCT01026818)
NCT ID: NCT01026818
Last Updated: 2014-01-14
Results Overview
Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
583 participants
Primary outcome timeframe
Month 10.5
Results posted on
2014-01-14
Participant Flow
The study consisted of a 6-week screening period including the time of bilateral nerve-sparing radical prostatectomy (BNSRP) surgery, a 9-month, randomized Double-Blind (DB), Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label (OL) Period.
Participant milestones
| Measure |
Screen - BNSRP
BNSRP surgery during Screening Period.
|
Tadalafil 5 mg OaD
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|---|
|
Screening Period
STARTED
|
583
|
0
|
0
|
0
|
|
Screening Period
COMPLETED
|
423
|
0
|
0
|
0
|
|
Screening Period
NOT COMPLETED
|
160
|
0
|
0
|
0
|
|
DB Treatment Period (Month 0 - 9)
STARTED
|
0
|
139
|
143
|
141
|
|
DB Treatment Period (Month 0 - 9)
Received at Least 1 Dose of Study Drug
|
0
|
139
|
143
|
141
|
|
DB Treatment Period (Month 0 - 9)
COMPLETED
|
0
|
114
|
122
|
115
|
|
DB Treatment Period (Month 0 - 9)
NOT COMPLETED
|
0
|
25
|
21
|
26
|
|
Drug-Free Washout Period (Month 9-10.5)
STARTED
|
0
|
114
|
122
|
115
|
|
Drug-Free Washout Period (Month 9-10.5)
COMPLETED
|
0
|
105
|
117
|
108
|
|
Drug-Free Washout Period (Month 9-10.5)
NOT COMPLETED
|
0
|
9
|
5
|
7
|
|
OL Period (Month 10.5 - 13.5)
STARTED
|
0
|
105
|
117
|
108
|
|
OL Period (Month 10.5 - 13.5)
COMPLETED
|
0
|
98
|
112
|
105
|
|
OL Period (Month 10.5 - 13.5)
NOT COMPLETED
|
0
|
7
|
5
|
3
|
Reasons for withdrawal
| Measure |
Screen - BNSRP
BNSRP surgery during Screening Period.
|
Tadalafil 5 mg OaD
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|---|
|
Screening Period
Entry Criteria Not Met
|
105
|
0
|
0
|
0
|
|
Screening Period
Withdrawal by Subject
|
49
|
0
|
0
|
0
|
|
Screening Period
Protocol Deviation
|
3
|
0
|
0
|
0
|
|
Screening Period
Adverse Event
|
2
|
0
|
0
|
0
|
|
Screening Period
Physician Decision
|
1
|
0
|
0
|
0
|
|
DB Treatment Period (Month 0 - 9)
Adverse Event
|
0
|
10
|
6
|
4
|
|
DB Treatment Period (Month 0 - 9)
Withdrawal by Subject
|
0
|
7
|
3
|
3
|
|
DB Treatment Period (Month 0 - 9)
Lack of Efficacy
|
0
|
3
|
2
|
6
|
|
DB Treatment Period (Month 0 - 9)
Lost to Follow-up
|
0
|
3
|
0
|
4
|
|
DB Treatment Period (Month 0 - 9)
Entry Criteria Not Met
|
0
|
2
|
9
|
7
|
|
DB Treatment Period (Month 0 - 9)
Protocol Deviation
|
0
|
0
|
1
|
2
|
|
Drug-Free Washout Period (Month 9-10.5)
Entry Criteria Not Met
|
0
|
2
|
1
|
2
|
|
Drug-Free Washout Period (Month 9-10.5)
Lack of Efficacy
|
0
|
2
|
1
|
2
|
|
Drug-Free Washout Period (Month 9-10.5)
Adverse Event
|
0
|
1
|
0
|
0
|
|
Drug-Free Washout Period (Month 9-10.5)
Lost to Follow-up
|
0
|
1
|
0
|
2
|
|
Drug-Free Washout Period (Month 9-10.5)
Physician Decision
|
0
|
1
|
1
|
0
|
|
Drug-Free Washout Period (Month 9-10.5)
Sponsor Decision
|
0
|
1
|
0
|
0
|
|
Drug-Free Washout Period (Month 9-10.5)
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Drug-Free Washout Period (Month 9-10.5)
Death
|
0
|
0
|
0
|
1
|
|
OL Period (Month 10.5 - 13.5)
Entry Criteria Not Met
|
0
|
2
|
0
|
0
|
|
OL Period (Month 10.5 - 13.5)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
OL Period (Month 10.5 - 13.5)
Lost to Follow-up
|
0
|
1
|
2
|
1
|
|
OL Period (Month 10.5 - 13.5)
Protocol Deviation
|
0
|
1
|
3
|
1
|
|
OL Period (Month 10.5 - 13.5)
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
Baseline Characteristics
A Study of Tadalafil After Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=143 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 5.07 • n=99 Participants
|
57.5 years
STANDARD_DEVIATION 5.91 • n=107 Participants
|
57.6 years
STANDARD_DEVIATION 5.69 • n=206 Participants
|
57.9 years
STANDARD_DEVIATION 5.58 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
423 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
137 participants
n=99 Participants
|
141 participants
n=107 Participants
|
138 participants
n=206 Participants
|
416 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Region of Enrollment
France
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
13 participants
n=206 Participants
|
38 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
12 participants
n=206 Participants
|
38 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=99 Participants
|
9 participants
n=107 Participants
|
8 participants
n=206 Participants
|
24 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
8 participants
n=206 Participants
|
27 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
38 participants
n=99 Participants
|
39 participants
n=107 Participants
|
39 participants
n=206 Participants
|
116 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=99 Participants
|
25 participants
n=107 Participants
|
27 participants
n=206 Participants
|
78 participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
25 participants
n=99 Participants
|
24 participants
n=107 Participants
|
24 participants
n=206 Participants
|
73 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Month 10.5Population: All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5.
Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire
|
20.9 percentage of participants
|
16.9 percentage of participants
|
19.1 percentage of participants
|
SECONDARY outcome
Timeframe: Month 9 and Month 13.5Population: All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5.
Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain
Month 9
|
25.2 percentage of participants
|
19.7 percentage of participants
|
14.2 percentage of participants
|
|
Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain
Month 13.5
|
32.4 percentage of participants
|
33.1 percentage of participants
|
27.0 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization (Baseline), Months 9 and 10.5 and 13.5Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5.
Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score
Month 10.5
|
6.24 units on a scale
Interval 4.22 to 8.25
|
5.76 units on a scale
Interval 3.78 to 7.73
|
5.98 units on a scale
Interval 3.92 to 8.03
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score
Month 13.5
|
10.60 units on a scale
Interval 8.39 to 12.8
|
9.78 units on a scale
Interval 7.63 to 11.92
|
8.97 units on a scale
Interval 6.74 to 11.21
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score
Month 9
|
7.73 units on a scale
Interval 5.73 to 9.73
|
6.53 units on a scale
Interval 4.56 to 8.5
|
4.93 units on a scale
Interval 2.88 to 6.98
|
SECONDARY outcome
Timeframe: Randomization (Baseline), Months 9 and 10.5 and 13.5Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5.
Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Orgasmic function - Month 9
|
2.76 units on a scale
Interval 1.98 to 3.55
|
2.48 units on a scale
Interval 1.7 to 3.26
|
2.39 units on a scale
Interval 1.59 to 3.19
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Orgasmic function - Month 10.5
|
2.94 units on a scale
Interval 2.13 to 3.76
|
2.48 units on a scale
Interval 1.68 to 3.28
|
2.48 units on a scale
Interval 1.66 to 3.31
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Sexual desire - Month 9
|
0.65 units on a scale
Interval 0.18 to 1.12
|
0.65 units on a scale
Interval 0.18 to 1.11
|
0.63 units on a scale
Interval 0.15 to 1.11
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Intercourse satisfaction - Month 13.5
|
4.70 units on a scale
Interval 3.65 to 5.75
|
4.08 units on a scale
Interval 3.05 to 5.1
|
4.14 units on a scale
Interval 3.08 to 5.2
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Overall satisfaction - Month 9
|
0.97 units on a scale
Interval 0.38 to 1.56
|
0.93 units on a scale
Interval 0.35 to 1.51
|
0.78 units on a scale
Interval 0.18 to 1.38
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Orgasmic function - Month 13.5
|
3.57 units on a scale
Interval 2.75 to 4.39
|
2.90 units on a scale
Interval 2.1 to 3.7
|
3.42 units on a scale
Interval 2.59 to 4.25
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Sexual desire - Month 10.5
|
0.61 units on a scale
Interval 0.14 to 1.07
|
0.65 units on a scale
Interval 0.2 to 1.11
|
0.55 units on a scale
Interval 0.08 to 1.01
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Overall satisfaction - Month 10.5
|
0.64 units on a scale
Interval 0.05 to 1.23
|
0.48 units on a scale
Interval -0.1 to 1.06
|
0.72 units on a scale
Interval 0.12 to 1.32
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Overall satisfaction - Month 13.5
|
1.50 units on a scale
Interval 0.87 to 2.13
|
1.57 units on a scale
Interval 0.96 to 2.19
|
1.52 units on a scale
Interval 0.88 to 2.15
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Sexual desire - Month 13.5
|
1.04 units on a scale
Interval 0.56 to 1.52
|
0.89 units on a scale
Interval 0.42 to 1.35
|
0.95 units on a scale
Interval 0.46 to 1.43
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Intercourse satisfaction - Month 9
|
3.89 units on a scale
Interval 2.9 to 4.88
|
3.50 units on a scale
Interval 2.52 to 4.48
|
2.96 units on a scale
Interval 1.95 to 3.96
|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Intercourse satisfaction - Month 10.5
|
3.21 units on a scale
Interval 2.19 to 4.22
|
2.81 units on a scale
Interval 1.81 to 3.81
|
2.72 units on a scale
Interval 1.69 to 3.75
|
SECONDARY outcome
Timeframe: Months 9 and 13.5Population: All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5.
The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score
Month 9
|
2.21 units on a scale
95% Confidence Interval 0.11 • Interval 2.0 to 2.42
|
2.11 units on a scale
Interval 1.92 to 2.3
|
1.88 units on a scale
Interval 1.67 to 2.09
|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score
Month 13.5
|
2.54 units on a scale
Interval 2.31 to 2.77
|
2.38 units on a scale
Interval 2.17 to 2.59
|
2.25 units on a scale
Interval 2.03 to 2.48
|
SECONDARY outcome
Timeframe: Randomization (Baseline), Months 9 and 13.5Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5.
The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score
Sexual relationship - Month 9
|
4.78 units on a scale
Interval 2.87 to 6.68
|
3.50 units on a scale
Interval 1.61 to 5.38
|
3.02 units on a scale
Interval 1.09 to 4.95
|
|
Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score
Sexual relationship - Month 13.5
|
6.90 units on a scale
Interval 4.79 to 9.0
|
6.68 units on a scale
Interval 4.62 to 8.74
|
6.72 units on a scale
Interval 4.62 to 8.83
|
|
Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score
Self-esteem - Month 9
|
0.78 units on a scale
Interval -0.31 to 1.87
|
0.79 units on a scale
Interval -0.29 to 1.87
|
0.51 units on a scale
Interval -0.61 to 1.62
|
|
Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score
Self-esteem - Month 13.5
|
1.67 units on a scale
Interval 0.54 to 2.81
|
1.72 units on a scale
Interval 0.61 to 2.83
|
1.62 units on a scale
Interval 0.47 to 2.77
|
SECONDARY outcome
Timeframe: Month 9Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9.
GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=114 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=122 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=115 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
Very much better
|
9 participants
|
10 participants
|
4 participants
|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
Much better
|
12 participants
|
22 participants
|
9 participants
|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
A little better
|
33 participants
|
32 participants
|
22 participants
|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
No change
|
31 participants
|
28 participants
|
48 participants
|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
A little worse
|
4 participants
|
5 participants
|
3 participants
|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
Much worse
|
6 participants
|
8 participants
|
6 participants
|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
Very much worse
|
8 participants
|
11 participants
|
14 participants
|
|
Global Assessment Questions (GAQ) Question 1 at Month 9
Missing
|
11 participants
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Month 13.5Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5.
GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=100 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=114 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=106 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
A little Better
|
28 participants
|
27 participants
|
28 participants
|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
No Change
|
19 participants
|
23 participants
|
26 participants
|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
Very much better
|
13 participants
|
19 participants
|
16 participants
|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
Much better
|
24 participants
|
25 participants
|
18 participants
|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
A little worse
|
4 participants
|
4 participants
|
2 participants
|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
Much worse
|
3 participants
|
3 participants
|
5 participants
|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
Very much worse
|
5 participants
|
6 participants
|
6 participants
|
|
Global Assessment Question (GAQ) Question 1 at Month 13.5
Missing
|
4 participants
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Month 9Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9.
GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=114 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=122 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=115 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Global Assessment Question (GAQ) Question 2 at Month 9
Very much better
|
7 participants
|
7 participants
|
3 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 9
Much better
|
12 participants
|
25 participants
|
11 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 9
A little better
|
30 participants
|
26 participants
|
18 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 9
No change
|
31 participants
|
27 participants
|
49 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 9
A little worse
|
8 participants
|
10 participants
|
4 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 9
Much worse
|
7 participants
|
10 participants
|
10 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 9
Very much worse
|
9 participants
|
9 participants
|
11 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 9
Missing
|
10 participants
|
8 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Month 13.5Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5.
GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=100 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=114 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=106 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
Very much better
|
9 participants
|
20 participants
|
14 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
Much better
|
29 participants
|
23 participants
|
21 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
A little better
|
20 participants
|
26 participants
|
24 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
No change
|
25 participants
|
24 participants
|
26 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
A little worse
|
4 participants
|
5 participants
|
5 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
Much worse
|
4 participants
|
3 participants
|
7 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
Very much worse
|
5 participants
|
6 participants
|
4 participants
|
|
Global Assessment Question (GAQ) Question 2 at Month 13.5
Missing
|
4 participants
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All randomized participants who received at least 1 dose of study drug and had REF assessed at baseline.
The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Residual Erectile Function (REF) at Baseline
REF = 0
|
61 participants
|
62 participants
|
64 participants
|
|
Residual Erectile Function (REF) at Baseline
REF = 1
|
46 participants
|
48 participants
|
47 participants
|
|
Residual Erectile Function (REF) at Baseline
REF = 2
|
18 participants
|
17 participants
|
17 participants
|
|
Residual Erectile Function (REF) at Baseline
REF = 3
|
12 participants
|
11 participants
|
13 participants
|
|
Residual Erectile Function (REF) at Baseline
REF = 4
|
0 participants
|
2 participants
|
0 participants
|
|
Residual Erectile Function (REF) at Baseline
Missing
|
2 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Month 2Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 2.
The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Residual Erectile Function (REF) at Month 2
REF = 0
|
28 participants
|
27 participants
|
38 participants
|
|
Residual Erectile Function (REF) at Month 2
REF = 1
|
38 participants
|
51 participants
|
53 participants
|
|
Residual Erectile Function (REF) at Month 2
REF = 2
|
26 participants
|
28 participants
|
19 participants
|
|
Residual Erectile Function (REF) at Month 2
REF = 3
|
25 participants
|
23 participants
|
15 participants
|
|
Residual Erectile Function (REF) at Month 2
REF = 4
|
9 participants
|
5 participants
|
5 participants
|
|
Residual Erectile Function (REF) at Month 2
Missing
|
13 participants
|
8 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Month 5Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 5.
The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=123 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=128 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=123 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Residual Erectile Function (REF) at Month 5
REF = 0
|
12 participants
|
21 participants
|
27 participants
|
|
Residual Erectile Function (REF) at Month 5
REF = 1
|
37 participants
|
39 participants
|
35 participants
|
|
Residual Erectile Function (REF) at Month 5
REF = 2
|
19 participants
|
21 participants
|
27 participants
|
|
Residual Erectile Function (REF) at Month 5
REF = 3
|
32 participants
|
34 participants
|
19 participants
|
|
Residual Erectile Function (REF) at Month 5
REF = 4
|
15 participants
|
6 participants
|
6 participants
|
|
Residual Erectile Function (REF) at Month 5
Missing
|
8 participants
|
7 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Month 9Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 9.
The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=114 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=122 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=115 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Residual Erectile Function (REF) at Month 9
REF = 0
|
11 participants
|
17 participants
|
23 participants
|
|
Residual Erectile Function (REF) at Month 9
REF = 1
|
25 participants
|
28 participants
|
35 participants
|
|
Residual Erectile Function (REF) at Month 9
REF = 2
|
22 participants
|
30 participants
|
23 participants
|
|
Residual Erectile Function (REF) at Month 9
REF = 3
|
23 participants
|
27 participants
|
18 participants
|
|
Residual Erectile Function (REF) at Month 9
REF = 4
|
20 participants
|
15 participants
|
10 participants
|
|
Residual Erectile Function (REF) at Month 9
Missing
|
13 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Month 10.5Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 10.5.
The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=105 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=117 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=108 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Residual Erectile Function (REF) at Month 10.5
REF = 0
|
13 participants
|
17 participants
|
22 participants
|
|
Residual Erectile Function (REF) at Month 10.5
REF = 1
|
29 participants
|
30 participants
|
29 participants
|
|
Residual Erectile Function (REF) at Month 10.5
REF = 2
|
25 participants
|
23 participants
|
19 participants
|
|
Residual Erectile Function (REF) at Month 10.5
REF = 3
|
22 participants
|
31 participants
|
22 participants
|
|
Residual Erectile Function (REF) at Month 10.5
REF = 4
|
12 participants
|
10 participants
|
14 participants
|
|
Residual Erectile Function (REF) at Month 10.5
Missing
|
4 participants
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Month 13.5Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 13.5.
The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=100 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=114 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=106 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Residual Erectile Function (REF) at Month 13.5
REF = 0
|
5 participants
|
8 participants
|
11 participants
|
|
Residual Erectile Function (REF) at Month 13.5
REF = 1
|
19 participants
|
20 participants
|
25 participants
|
|
Residual Erectile Function (REF) at Month 13.5
REF = 2
|
17 participants
|
20 participants
|
15 participants
|
|
Residual Erectile Function (REF) at Month 13.5
REF = 3
|
34 participants
|
34 participants
|
28 participants
|
|
Residual Erectile Function (REF) at Month 13.5
REF = 4
|
21 participants
|
28 participants
|
24 participants
|
|
Residual Erectile Function (REF) at Month 13.5
Missing
|
4 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Randomization (Baseline), Months 9 and 10.5 and 13.5Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEP questions answered at Months 9, 10.5 and 13.5.
Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q5 - Month 9
|
25.42 percentage of "yes" responses
Interval 18.29 to 32.55
|
17.73 percentage of "yes" responses
Interval 10.99 to 24.47
|
14.04 percentage of "yes" responses
Interval 7.09 to 20.99
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q4 - Month 10.5
|
16.94 percentage of "yes" responses
Interval 9.66 to 24.23
|
11.74 percentage of "yes" responses
Interval 4.84 to 18.64
|
18.88 percentage of "yes" responses
Interval 11.54 to 26.22
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q4 - Month 13.5
|
42.08 percentage of "yes" responses
Interval 32.99 to 51.18
|
35.62 percentage of "yes" responses
Interval 26.88 to 44.37
|
30.56 percentage of "yes" responses
Interval 21.48 to 39.65
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q1 - Month 9
|
67.41 percentage of "yes" responses
Interval 58.29 to 76.54
|
63.88 percentage of "yes" responses
Interval 55.32 to 72.44
|
52.54 percentage of "yes" responses
Interval 43.62 to 61.46
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q1 - Month 10.5
|
67.78 percentage of "yes" responses
Interval 58.05 to 77.5
|
64.24 percentage of "yes" responses
Interval 55.06 to 73.41
|
58.86 percentage of "yes" responses
Interval 49.15 to 68.58
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q1 - Month 13.5
|
86.16 percentage of "yes" responses
Interval 77.82 to 94.51
|
79.79 percentage of "yes" responses
Interval 71.93 to 87.65
|
75.27 percentage of "yes" responses
Interval 66.93 to 83.6
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q2 - Month 9
|
44.00 percentage of "yes" responses
Interval 35.22 to 52.78
|
34.29 percentage of "yes" responses
Interval 26.03 to 42.56
|
27.67 percentage of "yes" responses
Interval 19.11 to 36.23
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q2 - Month 10.5
|
40.81 percentage of "yes" responses
Interval 31.21 to 50.4
|
34.99 percentage of "yes" responses
Interval 25.91 to 44.08
|
36.26 percentage of "yes" responses
Interval 26.67 to 45.85
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q2 - Month 13.5
|
63.48 percentage of "yes" responses
Interval 53.87 to 73.09
|
56.07 percentage of "yes" responses
Interval 46.91 to 65.24
|
50.11 percentage of "yes" responses
Interval 40.56 to 59.67
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q3 - Month 9
|
33.67 percentage of "yes" responses
Interval 25.47 to 41.86
|
24.09 percentage of "yes" responses
Interval 16.36 to 31.82
|
21.61 percentage of "yes" responses
Interval 13.62 to 29.59
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q3 - Month 10.5
|
28.75 percentage of "yes" responses
Interval 19.92 to 37.57
|
23.01 percentage of "yes" responses
Interval 14.65 to 31.37
|
28.52 percentage of "yes" responses
Interval 19.68 to 37.36
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q3 - Month 13.5
|
52.41 percentage of "yes" responses
Interval 42.8 to 62.02
|
45.83 percentage of "yes" responses
Interval 36.63 to 55.04
|
40.75 percentage of "yes" responses
Interval 31.18 to 50.31
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q4 - Month 9
|
26.17 percentage of "yes" responses
Interval 18.93 to 33.4
|
18.15 percentage of "yes" responses
Interval 11.31 to 24.99
|
14.30 percentage of "yes" responses
Interval 7.25 to 21.35
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q5 - Month 10.5
|
16.26 percentage of "yes" responses
Interval 9.21 to 23.31
|
10.52 percentage of "yes" responses
Interval 3.85 to 17.19
|
19.11 percentage of "yes" responses
Interval 12.0 to 26.23
|
|
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Q5 - Month 13.5
|
40.81 percentage of "yes" responses
Interval 31.82 to 49.81
|
34.96 percentage of "yes" responses
Interval 26.31 to 43.62
|
29.38 percentage of "yes" responses
Interval 20.39 to 38.37
|
SECONDARY outcome
Timeframe: Randomization (Baseline), Month 10.5Population: All randomized participants who received at least 1 dose of study drug and had morning erection question answered at Baseline and Month 10.5.
The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of "yes" responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Change From Baseline in 'Yes' Answers to Morning Erections
|
8.92 percentage of "yes" response
Interval 1.45 to 16.39
|
12.16 percentage of "yes" response
Interval 5.16 to 19.16
|
14.04 percentage of "yes" response
Interval 6.74 to 21.35
|
SECONDARY outcome
Timeframe: Month 2Population: All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 2
Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Standardized Morning Erections Question (SMEQ) Score at Month 2
Missing
|
13 participants
|
9 participants
|
11 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 2
Yes, regularly
|
4 participants
|
7 participants
|
7 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 2
Less frequently than in the past
|
8 participants
|
15 participants
|
10 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 2
Only occasionally
|
41 participants
|
31 participants
|
26 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 2
Never
|
73 participants
|
80 participants
|
87 participants
|
SECONDARY outcome
Timeframe: Month 9Population: All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 9.
Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=114 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=122 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=115 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Standardized Morning Erections Question (SMEQ) Score at Month 9
Yes, regularly
|
7 participants
|
9 participants
|
7 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 9
Less frequently than in the past
|
21 participants
|
19 participants
|
9 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 9
Only occasionally
|
36 participants
|
26 participants
|
27 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 9
Never
|
39 participants
|
61 participants
|
65 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 9
Missing
|
11 participants
|
7 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Month 13.5Population: All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 13.5.
Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=100 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=114 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=106 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Standardized Morning Erections Question (SMEQ) Score at Month 13.5
Less frequently than in the past
|
22 participants
|
24 participants
|
18 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 13.5
Yes, regularly
|
13 participants
|
15 participants
|
13 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 13.5
Only occasionally
|
31 participants
|
30 participants
|
27 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 13.5
Never
|
32 participants
|
40 participants
|
42 participants
|
|
Standardized Morning Erections Question (SMEQ) Score at Month 13.5
Missing
|
2 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Randomization (Baseline), Months 9 and 13.5Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline EPIC-26 scores measurement at Month 9 and Month 13.5.
EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Urinary Incontinence - Month 9
|
34.08 units on a scale
Interval 29.31 to 38.86
|
31.12 units on a scale
Interval 26.74 to 35.51
|
30.59 units on a scale
Interval 25.85 to 35.33
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Urinary Irritative/Obstructive - Month 13.5
|
13.86 units on a scale
Interval 11.53 to 16.2
|
13.82 units on a scale
Interval 11.7 to 15.94
|
12.30 units on a scale
Interval 0.01 to 14.6
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Urinary Incontinence - Month 13.5
|
37.41 units on a scale
Interval 32.56 to 42.26
|
35.54 units on a scale
Interval 31.1 to 39.97
|
35.44 units on a scale
Interval 30.65 to 40.23
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Urinary Irritative/Obstructive - Month 9
|
13.83 units on a scale
Interval 11.54 to 16.12
|
13.28 units on a scale
Interval 11.19 to 15.37
|
12.26 units on a scale
Interval 10.01 to 14.51
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Bowel - Month 9
|
5.94 units on a scale
Interval 3.71 to 8.17
|
6.27 units on a scale
Interval 4.22 to 8.33
|
6.48 units on a scale
Interval 4.31 to 8.65
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Bowel - Month 13.5
|
6.87 units on a scale
Interval 4.67 to 9.08
|
6.49 units on a scale
Interval 4.46 to 8.52
|
6.78 units on a scale
Interval 4.61 to 8.94
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Sexual - Month 9
|
27.53 units on a scale
Interval 21.64 to 33.42
|
20.66 units on a scale
Interval 15.27 to 26.06
|
17.98 units on a scale
Interval 12.14 to 23.81
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Sexual - Month 13.5
|
36.55 units on a scale
Interval 30.03 to 43.06
|
32.58 units on a scale
Interval 26.6 to 38.56
|
33.37 units on a scale
Interval 26.95 to 39.79
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Hormonal - Month 9
|
1.72 units on a scale
Interval -0.81 to 4.26
|
2.72 units on a scale
Interval 0.36 to 5.08
|
-0.18 units on a scale
Interval -2.67 to 2.31
|
|
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Hormonal - Month 13.5
|
2.48 units on a scale
Interval 0.1 to 4.87
|
2.92 units on a scale
Interval 0.76 to 5.08
|
3.01 units on a scale
Interval 0.67 to 5.36
|
SECONDARY outcome
Timeframe: Randomization (Baseline), Month 9Population: All randomized participants who received at least 1 dose of study drug and had penile measurements at Baseline and Month 9.
Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.
Outcome measures
| Measure |
Tadalafil 5 mg OaD
n=139 Participants
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalafil 20 mg PRN
n=142 Participants
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo
n=141 Participants
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|
|
Change in Penile Length and Girth
Length
|
-1.53 millimeter (mm)
Interval -5.54 to 2.47
|
-7.26 millimeter (mm)
Interval -11.04 to -3.49
|
-5.73 millimeter (mm)
Interval -9.68 to -1.78
|
|
Change in Penile Length and Girth
Girth
|
0.03 millimeter (mm)
Interval -3.09 to 3.15
|
0.82 millimeter (mm)
Interval -2.11 to 3.75
|
-2.34 millimeter (mm)
Interval -5.43 to 0.75
|
Adverse Events
Screen - BNSRP
Serious events: 6 serious events
Other events: 114 other events
Deaths: 0 deaths
Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo (Double-Blind Period/Washout Period)
Serious events: 10 serious events
Other events: 40 other events
Deaths: 0 deaths
Tadalafil 5 mg OaD (Open-Label Period)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Tadalfil 20 mg PRN (Open-Label Period)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo (Open-Label Period)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Screen - BNSRP
n=583 participants at risk
Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.
|
Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)
n=139 participants at risk
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
|
Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)
n=143 participants at risk
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
|
Placebo (Double-Blind Period/Washout Period)
n=141 participants at risk
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
|
Tadalafil 5 mg OaD (Open-Label Period)
n=139 participants at risk
Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalfil 20 mg PRN (Open-Label Period)
n=143 participants at risk
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo (Open-Label Period)
n=141 participants at risk
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Vascular disorders
Lymphocele
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Constipation
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Hernia obstructive
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Pyrexia
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Erysipelas
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Urinary tract infection
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Nervous system disorders
Syncope
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Depression
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Renal impairment
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
Other adverse events
| Measure |
Screen - BNSRP
n=583 participants at risk
Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.
|
Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)
n=139 participants at risk
Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
|
Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)
n=143 participants at risk
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
|
Placebo (Double-Blind Period/Washout Period)
n=141 participants at risk
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
|
Tadalafil 5 mg OaD (Open-Label Period)
n=139 participants at risk
Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Tadalfil 20 mg PRN (Open-Label Period)
n=143 participants at risk
Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
Placebo (Open-Label Period)
n=141 participants at risk
Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.86%
5/583 • Number of events 5
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Cardiac disorders
Palpitations
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/583
|
1.4%
2/139 • Number of events 2
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Endocrine disorders
Hypoprolactinaemia
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Blepharitis
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Chalazion
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Conjunctivitis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Diplopia
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Eye pain
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Eyelid pain
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Eye disorders
Posterior capsule opacification
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Eye disorders
Vision blurred
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/583
|
0.00%
0/139
|
1.4%
2/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.69%
4/583 • Number of events 4
|
2.2%
3/139 • Number of events 3
|
1.4%
2/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
2.1%
3/143 • Number of events 3
|
0.00%
0/141
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Gastrointestinal disorders
Constipation
|
1.4%
8/583 • Number of events 8
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
6/583 • Number of events 6
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 2
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/583
|
3.6%
5/139 • Number of events 6
|
3.5%
5/143 • Number of events 5
|
0.71%
1/141 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Gastrointestinal disorders
Flatulence
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/583
|
0.00%
0/139
|
1.4%
2/143 • Number of events 2
|
0.71%
1/141 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.34%
2/583 • Number of events 2
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Nausea
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Gastrointestinal disorders
Vomiting
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Asthenia
|
0.51%
3/583 • Number of events 3
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Catheter site pain
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Chest pain
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Device occlusion
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Fatigue
|
0.51%
3/583 • Number of events 3
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
General disorders
Local swelling
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Oedema peripheral
|
0.00%
0/583
|
0.00%
0/139
|
1.4%
2/143 • Number of events 2
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
General disorders
Pyrexia
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Immune system disorders
Hypersensitivity
|
0.17%
1/583 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/583
|
2.9%
4/139 • Number of events 4
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Bronchitis
|
0.34%
2/583 • Number of events 2
|
2.2%
3/139 • Number of events 3
|
0.70%
1/143 • Number of events 1
|
1.4%
2/141 • Number of events 3
|
0.00%
0/139
|
0.00%
0/143
|
1.4%
2/141 • Number of events 2
|
|
Infections and infestations
Catheter site infection
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Cystitis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Eye infection
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Haematoma infection
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Influenza
|
0.00%
0/583
|
0.00%
0/139
|
1.4%
2/143 • Number of events 2
|
0.71%
1/141 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Nail infection
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Nasopharyngitis
|
0.34%
2/583 • Number of events 2
|
3.6%
5/139 • Number of events 5
|
3.5%
5/143 • Number of events 5
|
2.1%
3/141 • Number of events 3
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Infections and infestations
Oral herpes
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Orchitis
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/583
|
0.00%
0/139
|
1.4%
2/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Infections and infestations
Post procedural infection
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Rhinitis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Sinusitis
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Infections and infestations
Skin infection
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Staphylococcal infection
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Tooth infection
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Urethritis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Urinary tract infection
|
3.6%
21/583 • Number of events 23
|
2.2%
3/139 • Number of events 4
|
2.8%
4/143 • Number of events 4
|
1.4%
2/141 • Number of events 2
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Infections and infestations
Wound infection
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.17%
1/583 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
7/583 • Number of events 10
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Head injury
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Incision site blister
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.17%
1/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Incision site pain
|
1.0%
6/583 • Number of events 6
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Open wound
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Optic nerve injury
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.2%
13/583 • Number of events 14
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Testicular injury
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Arthroscopy
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood luteinising hormone decreased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood pressure increased
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood selenium decreased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood selenium increased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood testosterone decreased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Blood uric acid increased
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Oestradiol increased
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Urine output increased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Weight decreased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Investigations
Weight increased
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Metabolism and nutrition disorders
Gout
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Metabolism and nutrition disorders
Obesity
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.34%
2/583 • Number of events 2
|
0.72%
1/139 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
1.4%
2/141 • Number of events 2
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
1/583 • Number of events 1
|
3.6%
5/139 • Number of events 5
|
3.5%
5/143 • Number of events 5
|
2.1%
3/141 • Number of events 3
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.86%
5/583 • Number of events 5
|
3.6%
5/139 • Number of events 7
|
3.5%
5/143 • Number of events 7
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.34%
2/583 • Number of events 2
|
2.2%
3/139 • Number of events 3
|
2.8%
4/143 • Number of events 4
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Convulsion
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Dizziness
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Nervous system disorders
Headache
|
1.5%
9/583 • Number of events 10
|
3.6%
5/139 • Number of events 11
|
7.7%
11/143 • Number of events 16
|
4.3%
6/141 • Number of events 7
|
0.72%
1/139 • Number of events 2
|
1.4%
2/143 • Number of events 2
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Migraine
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Paraesthesia
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Nervous system disorders
Somnolence
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
2.1%
3/141 • Number of events 3
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Depression
|
0.00%
0/583
|
1.4%
2/139 • Number of events 2
|
1.4%
2/143 • Number of events 2
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Insomnia
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Libido decreased
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Mood altered
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Psychiatric disorders
Orgasm abnormal
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Bladder tamponade
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Haematuria
|
0.51%
3/583 • Number of events 3
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.51%
3/583 • Number of events 3
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Incontinence
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Renal colic
|
0.17%
1/583 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Renal pain
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.86%
5/583 • Number of events 5
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Urge incontinence
|
0.34%
2/583 • Number of events 2
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Urinary incontinence
|
5.8%
34/583 • Number of events 34
|
2.2%
3/139 • Number of events 3
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Renal and urinary disorders
Urinary retention
|
0.51%
3/583 • Number of events 3
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Epididymitis
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.34%
2/583 • Number of events 2
|
0.72%
1/139 • Number of events 2
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Penile curvature
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Perineal pain
|
0.69%
4/583 • Number of events 4
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Testicular pain
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
1.4%
2/141 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/583
|
0.00%
0/139
|
1.4%
2/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.17%
1/583 • Number of events 1
|
0.72%
1/139 • Number of events 3
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/583
|
1.4%
2/139 • Number of events 2
|
1.4%
2/143 • Number of events 2
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Surgical and medical procedures
Arthroscopic surgery
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Bladder catheterisation
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Circumcision
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Eyelid operation
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/583
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Surgical and medical procedures
Wart excision
|
0.00%
0/583
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Vascular disorders
Deep vein thrombosis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Vascular disorders
Flushing
|
0.34%
2/583 • Number of events 2
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Vascular disorders
Hot flush
|
0.17%
1/583 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Vascular disorders
Hypertension
|
0.34%
2/583 • Number of events 2
|
0.72%
1/139 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
0.71%
1/141 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
0.00%
0/141
|
|
Vascular disorders
Hypotension
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.72%
1/139 • Number of events 1
|
0.00%
0/143
|
0.00%
0/141
|
|
Vascular disorders
Lymphocele
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/583
|
0.00%
0/139
|
0.00%
0/143
|
0.71%
1/141 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
|
Vascular disorders
Thrombosis
|
0.17%
1/583 • Number of events 1
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
0.00%
0/139
|
0.00%
0/143
|
0.00%
0/141
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60