Trial Outcomes & Findings for A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (NCT NCT00970632)
NCT ID: NCT00970632
Last Updated: 2012-03-12
Results Overview
The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
COMPLETED
PHASE3
511 participants
Baseline, 12 weeks
2012-03-12
Participant Flow
Period 1: Screening and 4-week washout of benign prostatic hyperplasia (BPH), overactive bladder (OAB), and/or erectile dysfunction (ED) treatments. Period 2: 4-week, single-blind, placebo lead-in to assess compliance and establish baseline levels. Period 3: Randomization to treatment (placebo, tadalafil 5 mg, or tamsulosin 0.4 mg for 12 weeks).
Participant milestones
| Measure |
Placebo
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
172
|
171
|
168
|
|
Overall Study
COMPLETED
|
148
|
156
|
150
|
|
Overall Study
NOT COMPLETED
|
24
|
15
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
2
|
|
Overall Study
Protocol Violation
|
8
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
4
|
|
Overall Study
Entry criteria not met
|
0
|
2
|
2
|
|
Overall Study
Sponsor decision
|
1
|
0
|
1
|
Baseline Characteristics
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Placebo
n=172 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=171 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=168 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Erectile Dysfunction (ED) Severity
Severe
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
23 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Age Continuous
|
63.7 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 8.08 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 8.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
511 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
372 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
France
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
56 participants
n=5 Participants
|
50 participants
n=7 Participants
|
56 participants
n=5 Participants
|
162 participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
18 participants
n=5 Participants
|
26 participants
n=7 Participants
|
15 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
38 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
10 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
28.1 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.09 • n=5 Participants
|
27.1 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.03 • n=7 Participants
|
27.9 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.73 • n=5 Participants
|
27.7 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.96 • n=4 Participants
|
|
Lower Urinary Tract Symptom (LUTS) Severity
Moderate (IPSS <20)
|
118 participants
n=5 Participants
|
123 participants
n=7 Participants
|
119 participants
n=5 Participants
|
360 participants
n=4 Participants
|
|
Lower Urinary Tract Symptom (LUTS) Severity
Severe (IPSS ≥20)
|
54 participants
n=5 Participants
|
48 participants
n=7 Participants
|
49 participants
n=5 Participants
|
151 participants
n=4 Participants
|
|
Peak Urine Flow Rate (Qmax) Category
<10 mL/sec
|
79 participants
n=5 Participants
|
92 participants
n=7 Participants
|
105 participants
n=5 Participants
|
276 participants
n=4 Participants
|
|
Peak Urine Flow Rate (Qmax) Category
10-15 mL/sec
|
69 participants
n=5 Participants
|
63 participants
n=7 Participants
|
53 participants
n=5 Participants
|
185 participants
n=4 Participants
|
|
Erectile Dysfunction (ED) Duration
<1 year
|
15 participants
n=5 Participants
|
28 participants
n=7 Participants
|
29 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Peak Urine Flow Rate (Qmax) Category
>15 mL/sec
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
7 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Postvoid Residual Volume (PVR)
|
50.9 milliliter (mL)
STANDARD_DEVIATION 51.14 • n=5 Participants
|
54.6 milliliter (mL)
STANDARD_DEVIATION 52.29 • n=7 Participants
|
59.8 milliliter (mL)
STANDARD_DEVIATION 57.99 • n=5 Participants
|
55.1 milliliter (mL)
STANDARD_DEVIATION 53.88 • n=4 Participants
|
|
Prostate Specific Antigen (PSA)
|
2.0 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 1.69 • n=5 Participants
|
2.1 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 1.83 • n=7 Participants
|
1.9 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 1.57 • n=5 Participants
|
2.0 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 1.70 • n=4 Participants
|
|
Erectile Dysfunction (ED)
Yes
|
120 participants
n=5 Participants
|
121 participants
n=7 Participants
|
116 participants
n=5 Participants
|
357 participants
n=4 Participants
|
|
Erectile Dysfunction (ED)
No
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
52 participants
n=5 Participants
|
154 participants
n=4 Participants
|
|
Erectile Dysfunction (ED) Severity
Mild
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
33 participants
n=5 Participants
|
107 participants
n=4 Participants
|
|
Erectile Dysfunction (ED) Severity
Moderate
|
64 participants
n=5 Participants
|
65 participants
n=7 Participants
|
60 participants
n=5 Participants
|
189 participants
n=4 Participants
|
|
Erectile Dysfunction (ED) Duration
≥1 year
|
105 participants
n=5 Participants
|
93 participants
n=7 Participants
|
87 participants
n=5 Participants
|
285 participants
n=4 Participants
|
|
Sexually Active with a Female Partner
Yes
|
145 participants
n=5 Participants
|
143 participants
n=7 Participants
|
139 participants
n=5 Participants
|
427 participants
n=4 Participants
|
|
Sexually Active with a Female Partner
No
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
29 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Expect to Remain Sexually Active
Yes
|
145 participants
n=5 Participants
|
142 participants
n=7 Participants
|
139 participants
n=5 Participants
|
426 participants
n=4 Participants
|
|
Expect to Remain Sexually Active
No
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=171 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=165 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks
|
-4.2 units on a scale
Standard Error 0.5
|
-6.3 units on a scale
Standard Error 0.5
|
-5.7 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=166 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=167 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=159 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks
|
-3.3 units on a scale
Standard Error 0.4
|
-5.5 units on a scale
Standard Error 0.4
|
-5.7 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=171 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=165 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks
|
-1.6 units on a scale
Standard Error 0.2
|
-2.2 units on a scale
Standard Error 0.2
|
-2.2 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=171 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=165 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.
|
-2.6 units on a scale
Standard Error 0.3
|
-4.1 units on a scale
Standard Error 0.3
|
-3.5 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=171 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=165 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks
|
-0.3 units on a scale
Standard Error 0.1
|
-0.5 units on a scale
Standard Error 0.1
|
-0.5 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=171 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=165 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks
|
-1.0 units on a scale
Standard Error 0.1
|
-1.3 units on a scale
Standard Error 0.1
|
-1.1 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, 1 weekPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=162 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=152 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week
|
-2.5 units on a scale
Standard Error 0.4
|
-4.0 units on a scale
Standard Error 0.4
|
-4.0 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=166 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=167 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=159 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks
|
-0.4 units on a scale
Standard Error 0.2
|
-1.2 units on a scale
Standard Error 0.2
|
-1.3 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.
BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=167 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=168 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=160 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks
|
-0.9 units on a scale
Standard Error 0.2
|
-1.7 units on a scale
Standard Error 0.2
|
-1.5 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data.
The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant's symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=160 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=157 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
Very much worse
|
2 participants
|
0 participants
|
0 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
Much worse
|
2 participants
|
1 participants
|
0 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
A little worse
|
4 participants
|
6 participants
|
8 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
No change
|
51 participants
|
28 participants
|
36 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
A little better
|
53 participants
|
52 participants
|
55 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
Much better
|
36 participants
|
56 participants
|
48 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
Very much better
|
11 participants
|
17 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data.
The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant's symptoms based on a 7-point scale. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".
Outcome measures
| Measure |
Placebo
n=160 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=163 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=157 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
Very much worse
|
1 participants
|
0 participants
|
0 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
Much worse
|
2 participants
|
2 participants
|
1 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
A little worse
|
6 participants
|
5 participants
|
7 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
No change
|
51 participants
|
32 participants
|
40 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
A little better
|
57 participants
|
58 participants
|
65 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
Much better
|
34 participants
|
50 participants
|
38 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
Very much better
|
9 participants
|
16 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline measurement.
The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.
Outcome measures
| Measure |
Placebo
n=158 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=163 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=156 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall
|
28.9 units on a scale
Standard Deviation 17.50
|
22.2 units on a scale
Standard Deviation 17.74
|
28.9 units on a scale
Standard Deviation 16.49
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all randomized sexually active participants with erectile dysfunction who started study medication, and had baseline and at least 1 post-baseline measurement.
IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Outcome measures
| Measure |
Placebo
n=100 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=103 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=93 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks
|
2.1 units on a scale
Standard Error 0.8
|
6.0 units on a scale
Standard Error 0.8
|
1.7 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).
Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=156 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=144 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks
|
0.3 milliliters per second (mL/sec)
Standard Deviation 4.84 • Interval -1.5 to 3.1
|
1.6 milliliters per second (mL/sec)
Standard Deviation 5.49 • Interval -0.7 to 5.2
|
1.6 milliliters per second (mL/sec)
Standard Deviation 4.06 • Interval -0.6 to 4.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).
Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was \>=125 mL.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=156 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=145 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks
|
0.10 milliliters per second (mL/sec)
Standard Deviation 2.72 • Interval -0.9 to 1.8
|
1.25 milliliters per second (mL/sec)
Standard Deviation 3.24 • Interval -0.3 to 3.25
|
0.70 milliliters per second (mL/sec)
Standard Deviation 3.03 • Interval -0.4 to 2.5
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).
V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=156 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=145 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks
|
0.0 milliliter (mL)
Standard Deviation 110.92 • Interval -61.0 to 69.0
|
11.0 milliliter (mL)
Standard Deviation 101.45 • Interval -64.0 to 70.5
|
16.0 milliliter (mL)
Standard Deviation 109.30 • Interval -38.0 to 79.0
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).
PVR was the amount of urine remaining in the bladder after void completion.
Outcome measures
| Measure |
Placebo
n=157 Participants
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
Tadalafil 5 mg
n=163 Participants
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=156 Participants
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
|
0.0 milliliter (mL)
Standard Deviation 56.48 • Interval -20.0 to 23.0
|
-1.0 milliliter (mL)
Standard Deviation 46.97 • Interval -28.0 to 18.0
|
-5.5 milliliter (mL)
Standard Deviation 59.21 • Interval -23.5 to 17.0
|
Adverse Events
Tadalafil 5 mg
Tamsulosin 0.4 mg
Placebo
Serious adverse events
| Measure |
Tadalafil 5 mg
n=171 participants at risk
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=168 participants at risk
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
Placebo
n=172 participants at risk
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Gastrointestinal disorders
Pancreatitis
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Nervous system disorders
Dizziness
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Nervous system disorders
Headache
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Vascular disorders
Flushing
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
Other adverse events
| Measure |
Tadalafil 5 mg
n=171 participants at risk
Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
|
Tamsulosin 0.4 mg
n=168 participants at risk
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
|
Placebo
n=172 participants at risk
Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Cardiac disorders
Palpitations
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/171
|
0.00%
0/168
|
1.2%
2/172 • Number of events 2
|
|
Eye disorders
Photopsia
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.58%
1/172 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/171 • Number of events 2
|
0.60%
1/168 • Number of events 1
|
1.2%
2/172 • Number of events 2
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Gastrointestinal disorders
Dry mouth
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
4/171 • Number of events 4
|
1.2%
2/168 • Number of events 2
|
0.00%
0/172
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
2/171 • Number of events 2
|
0.60%
1/168 • Number of events 1
|
0.58%
1/172 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
3/171 • Number of events 3
|
0.00%
0/168
|
0.00%
0/172
|
|
Gastrointestinal disorders
Haematochezia
|
0.58%
1/171 • Number of events 4
|
0.00%
0/168
|
0.00%
0/172
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Gastrointestinal disorders
Nausea
|
0.58%
1/171 • Number of events 1
|
0.60%
1/168 • Number of events 1
|
1.7%
3/172 • Number of events 3
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Gastrointestinal disorders
Toothache
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
General disorders
Chest pain
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
General disorders
Fatigue
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
1.2%
2/172 • Number of events 2
|
|
General disorders
Feeling cold
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
General disorders
Feeling hot
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
General disorders
Ill-defined disorder
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
General disorders
Influenza like illness
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
General disorders
Pyrexia
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Immune system disorders
Allergy to arthropod bite
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Infections and infestations
Furuncle
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Infections and infestations
Genital herpes
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Infections and infestations
Herpes zoster
|
0.58%
1/171 • Number of events 1
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Infections and infestations
Influenza
|
0.00%
0/171
|
1.2%
2/168 • Number of events 2
|
1.2%
2/172 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
5/171 • Number of events 5
|
1.8%
3/168 • Number of events 3
|
4.7%
8/172 • Number of events 8
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.58%
1/172 • Number of events 1
|
|
Infections and infestations
Rash pustular
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Investigations
Blood pressure increased
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Investigations
Semen volume decreased
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.58%
1/171 • Number of events 1
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
4/171 • Number of events 4
|
1.2%
2/168 • Number of events 2
|
0.58%
1/172 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.58%
1/171 • Number of events 1
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
2/171 • Number of events 3
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.58%
1/172 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
2/171 • Number of events 2
|
1.2%
2/168 • Number of events 2
|
1.2%
2/172 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
3/171 • Number of events 4
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous adenoma
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Nervous system disorders
Dizziness
|
2.3%
4/171 • Number of events 4
|
3.0%
5/168 • Number of events 5
|
1.7%
3/172 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Nervous system disorders
Headache
|
2.9%
5/171 • Number of events 5
|
3.6%
6/168 • Number of events 7
|
1.2%
2/172 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/171
|
0.00%
0/168
|
1.2%
2/172 • Number of events 2
|
|
Nervous system disorders
Lethargy
|
0.00%
0/171
|
0.60%
1/168 • Number of events 2
|
0.00%
0/172
|
|
Nervous system disorders
Paraesthesia
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Psychiatric disorders
Abnormal dreams
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Psychiatric disorders
Insomnia
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Renal and urinary disorders
Incontinence
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Renal and urinary disorders
Micturition urgency
|
0.58%
1/171 • Number of events 1
|
0.60%
1/168 • Number of events 4
|
0.00%
0/172
|
|
Renal and urinary disorders
Nocturia
|
0.58%
1/171 • Number of events 1
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Reproductive system and breast disorders
Haematospermia
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Reproductive system and breast disorders
Retrograde ejaculation
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
2/171 • Number of events 2
|
1.8%
3/168 • Number of events 3
|
0.58%
1/172 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/171 • Number of events 2
|
0.00%
0/168
|
0.00%
0/172
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
1.2%
2/172 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.58%
1/172 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.58%
1/171 • Number of events 1
|
1.2%
2/168 • Number of events 2
|
0.00%
0/172
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Surgical and medical procedures
Meniscus removal
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Vascular disorders
Flushing
|
1.8%
3/171 • Number of events 3
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
|
Vascular disorders
Hot flush
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.58%
1/171 • Number of events 1
|
0.00%
0/168
|
0.00%
0/172
|
|
Vascular disorders
Hypotension
|
0.00%
0/171
|
0.00%
0/168
|
0.58%
1/172 • Number of events 1
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/171
|
0.60%
1/168 • Number of events 1
|
0.00%
0/172
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60