Trial Outcomes & Findings for Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia (NCT NCT00861757)
NCT ID: NCT00861757
Last Updated: 2011-06-28
Results Overview
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
612 participants
Primary outcome timeframe
baseline, 12 weeks
Results posted on
2011-06-28
Participant Flow
Participant milestones
| Measure |
Placebo
Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
|
2.5 mg Tadalafil
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
5.0 mg Tadalafil
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
0.2 mg Tamsulosin
Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
154
|
151
|
155
|
152
|
|
Overall Study
COMPLETED
|
145
|
136
|
137
|
143
|
|
Overall Study
NOT COMPLETED
|
9
|
15
|
18
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
|
2.5 mg Tadalafil
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
5.0 mg Tadalafil
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
0.2 mg Tamsulosin
Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
7
|
2
|
|
Overall Study
Entry Criteria Not Met
|
1
|
2
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
5
|
2
|
Baseline Characteristics
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Placebo
n=154 Participants
Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
5.0 mg Tadalafil
n=155 Participants
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
|
Total
n=612 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
63.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
63.1 years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
612 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
154 participants
n=5 Participants
|
151 participants
n=7 Participants
|
155 participants
n=5 Participants
|
152 participants
n=4 Participants
|
612 participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
21 participants
n=5 Participants
|
22 participants
n=4 Participants
|
90 participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
86 participants
n=5 Participants
|
84 participants
n=7 Participants
|
87 participants
n=5 Participants
|
85 participants
n=4 Participants
|
342 participants
n=21 Participants
|
|
Region of Enrollment
Korea, Republic of
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
47 participants
n=5 Participants
|
45 participants
n=4 Participants
|
180 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
24.3 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 2.9 • n=5 Participants
|
23.9 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 2.8 • n=7 Participants
|
24.2 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 2.8 • n=5 Participants
|
24.4 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 2.9 • n=4 Participants
|
24.2 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 2.8 • n=21 Participants
|
|
Current Tobacco Use
Yes
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
36 participants
n=5 Participants
|
23 participants
n=4 Participants
|
116 participants
n=21 Participants
|
|
Current Tobacco Use
No
|
127 participants
n=5 Participants
|
121 participants
n=7 Participants
|
119 participants
n=5 Participants
|
129 participants
n=4 Participants
|
496 participants
n=21 Participants
|
|
Current Alcohol Use
Yes
|
78 participants
n=5 Participants
|
81 participants
n=7 Participants
|
84 participants
n=5 Participants
|
83 participants
n=4 Participants
|
326 participants
n=21 Participants
|
|
Current Alcohol Use
No
|
76 participants
n=5 Participants
|
70 participants
n=7 Participants
|
71 participants
n=5 Participants
|
69 participants
n=4 Participants
|
286 participants
n=21 Participants
|
|
Benign Prostatic Hyperplasia (BPH) Severity
Moderate (IPSS<20)
|
102 participants
n=5 Participants
|
102 participants
n=7 Participants
|
102 participants
n=5 Participants
|
102 participants
n=4 Participants
|
408 participants
n=21 Participants
|
|
Benign Prostatic Hyperplasia (BPH) Severity
Severe (IPSS>=20)
|
52 participants
n=5 Participants
|
49 participants
n=7 Participants
|
53 participants
n=5 Participants
|
50 participants
n=4 Participants
|
204 participants
n=21 Participants
|
|
Duration of BPH
|
3.7 Years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
3.7 Years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
3.5 Years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
3.7 Years
STANDARD_DEVIATION 3.2 • n=4 Participants
|
3.7 Years
STANDARD_DEVIATION 3.2 • n=21 Participants
|
|
Patient Global Impressions of Severity Scale (PGI-S)
Normal
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Patient Global Impressions of Severity Scale (PGI-S)
Mild
|
45 participants
n=5 Participants
|
41 participants
n=7 Participants
|
43 participants
n=5 Participants
|
39 participants
n=4 Participants
|
168 participants
n=21 Participants
|
|
Patient Global Impressions of Severity Scale (PGI-S)
Moderate
|
92 participants
n=5 Participants
|
92 participants
n=7 Participants
|
100 participants
n=5 Participants
|
93 participants
n=4 Participants
|
377 participants
n=21 Participants
|
|
Patient Global Impressions of Severity Scale (PGI-S)
Severe
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
12 participants
n=5 Participants
|
20 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
Clinical Global Impressions of Severity Scale (CGI-S)
Normal
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Clinical Global Impressions of Severity Scale (CGI-S)
Mild
|
42 participants
n=5 Participants
|
36 participants
n=7 Participants
|
33 participants
n=5 Participants
|
35 participants
n=4 Participants
|
146 participants
n=21 Participants
|
|
Clinical Global Impressions of Severity Scale (CGI-S)
Moderate
|
97 participants
n=5 Participants
|
87 participants
n=7 Participants
|
95 participants
n=5 Participants
|
92 participants
n=4 Participants
|
371 participants
n=21 Participants
|
|
Clinical Global Impressions of Severity Scale (CGI-S)
Severe
|
14 participants
n=5 Participants
|
28 participants
n=7 Participants
|
27 participants
n=5 Participants
|
25 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Previous Alpha-Blocker Therapy
Yes
|
83 participants
n=5 Participants
|
83 participants
n=7 Participants
|
82 participants
n=5 Participants
|
87 participants
n=4 Participants
|
335 participants
n=21 Participants
|
|
Previous Alpha-Blocker Therapy
No
|
71 participants
n=5 Participants
|
68 participants
n=7 Participants
|
73 participants
n=5 Participants
|
65 participants
n=4 Participants
|
277 participants
n=21 Participants
|
|
Previous BPH Therapy
Yes
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
36 participants
n=5 Participants
|
27 participants
n=4 Participants
|
119 participants
n=21 Participants
|
|
Previous BPH Therapy
No
|
126 participants
n=5 Participants
|
123 participants
n=7 Participants
|
119 participants
n=5 Participants
|
125 participants
n=4 Participants
|
493 participants
n=21 Participants
|
|
Postvoid Residual Volume (PVR)
|
41.9 milliliters (mL)
STANDARD_DEVIATION 47.7 • n=5 Participants
|
37.7 milliliters (mL)
STANDARD_DEVIATION 40.3 • n=7 Participants
|
38.4 milliliters (mL)
STANDARD_DEVIATION 51.2 • n=5 Participants
|
32.7 milliliters (mL)
STANDARD_DEVIATION 37.1 • n=4 Participants
|
37.7 milliliters (mL)
STANDARD_DEVIATION 44.5 • n=21 Participants
|
|
Prostate Volume
|
35.1 mL
STANDARD_DEVIATION 14.0 • n=5 Participants
|
35.3 mL
STANDARD_DEVIATION 16.1 • n=7 Participants
|
34.8 mL
STANDARD_DEVIATION 13.7 • n=5 Participants
|
33.9 mL
STANDARD_DEVIATION 11.1 • n=4 Participants
|
34.8 mL
STANDARD_DEVIATION 13.8 • n=21 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=154 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
|
-3.0 Units on a scale
Standard Error 0.4
|
-4.8 Units on a scale
Standard Error 0.4
|
-4.7 Units on a scale
Standard Error 0.4
|
-5.5 Units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=154 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])
Voiding (Obstructive) Score (N = 154,151,155,152)
|
-1.9 units on a scale
Standard Error 0.3
|
-3.3 units on a scale
Standard Error 0.3
|
-3.0 units on a scale
Standard Error 0.3
|
-3.8 units on a scale
Standard Error 0.3
|
|
Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])
Storage (Irritative) Score (N = 154,151,155,152)
|
-1.1 units on a scale
Standard Error 0.2
|
-1.5 units on a scale
Standard Error 0.2
|
-1.7 units on a scale
Standard Error 0.2
|
-1.7 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=154 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks
|
-0.5 units on a scale
Standard Error 0.1
|
-0.8 units on a scale
Standard Error 0.1
|
-0.8 units on a scale
Standard Error 0.1
|
-1.1 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.
Outcome measures
| Measure |
Placebo
n=152 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=147 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=153 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=150 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks
|
-0.8 units on a scale
Standard Error 0.2
|
-1.1 units on a scale
Standard Error 0.2
|
-1.0 units on a scale
Standard Error 0.2
|
-1.6 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
Qmax: defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using standard calibrated flowmeter). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.
Outcome measures
| Measure |
Placebo
n=147 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=145 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=148 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=148 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks
|
2.1 milliliter per second (mL/sec)
Standard Error 0.4
|
1.6 milliliter per second (mL/sec)
Standard Error 0.4
|
1.3 milliliter per second (mL/sec)
Standard Error 0.4
|
2.1 milliliter per second (mL/sec)
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=155 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) at Week 12
Very Much Worse
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12
Much Worse
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12
A Little Worse
|
12 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12
No Change
|
45 Participants
|
26 Participants
|
23 Participants
|
25 Participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12
A Little Better
|
54 Participants
|
62 Participants
|
74 Participants
|
58 Participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12
Much Better
|
32 Participants
|
44 Participants
|
40 Participants
|
53 Participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12
Very Much Better
|
4 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=155 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12
No Change
|
44 participants
|
21 participants
|
29 participants
|
19 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12
Very Much Better
|
7 participants
|
11 participants
|
10 participants
|
12 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12
Very Much Worse
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12
Much Worse
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12
A Little Worse
|
8 participants
|
4 participants
|
3 participants
|
3 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12
A Little Better
|
60 participants
|
67 participants
|
62 participants
|
68 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12
Much Better
|
30 participants
|
39 participants
|
48 participants
|
47 participants
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
Nanograms of PSA per milliliter (ng/mL) of blood.
Outcome measures
| Measure |
Placebo
n=152 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=148 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=153 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=150 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks
|
-0.03 microgram/Liter
Standard Deviation 0.55
|
0.04 microgram/Liter
Standard Deviation 0.54
|
0.13 microgram/Liter
Standard Deviation 0.59
|
-0.06 microgram/Liter
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.
Outcome measures
| Measure |
Placebo
n=152 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=153 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
|
-1.20 milliliter (mL)
Standard Deviation 45.35
|
-0.09 milliliter (mL)
Standard Deviation 45.21
|
-2.90 milliliter (mL)
Standard Deviation 48.84
|
-5.67 milliliter (mL)
Standard Deviation 34.38
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=154 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Blood Pressure (Sitting) at 12 Weeks
Systolic Blood Pressure
|
0.9 mm Hg
Standard Deviation 10.9
|
-2.3 mm Hg
Standard Deviation 11.0
|
-0.5 mm Hg
Standard Deviation 12.4
|
0.2 mm Hg
Standard Deviation 12.2
|
|
Change From Baseline in Blood Pressure (Sitting) at 12 Weeks
Diastolic Blood Pressure
|
-0.3 mm Hg
Standard Deviation 8.6
|
-2.5 mm Hg
Standard Deviation 7.8
|
-1.4 mm Hg
Standard Deviation 8.1
|
-0.6 mm Hg
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All efficacy analyses were performed on an intent-to-treat (ITT) basis. The primary analysis population for efficacy was the Full Analysis Set (FAS) which included all subjects who were randomized and started study medication.
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=154 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Blood Pressure (Standing) at 12 Weeks
Systolic Blood Pressure
|
0.8 mm Hg
Standard Deviation 11.8
|
-2.9 mm Hg
Standard Deviation 12.3
|
0.6 mm Hg
Standard Deviation 11.6
|
-0.9 mm Hg
Standard Deviation 13.7
|
|
Change From Baseline in Blood Pressure (Standing) at 12 Weeks
Diastolic Blood Pressure
|
0.4 mm Hg
Standard Deviation 8.1
|
-2.3 mm Hg
Standard Deviation 8.0
|
-1.7 mm Hg
Standard Deviation 8.2
|
-1.0 mm Hg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.
Outcome measures
| Measure |
Placebo
n=154 Participants
Drug: Placebo PO, QD (30min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
5 mg Tadalafil
n=154 Participants
Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 Participants
Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks
|
-0.3 beats per minute (bpm)
Standard Deviation 8.9
|
0.7 beats per minute (bpm)
Standard Deviation 8.3
|
0.6 beats per minute (bpm)
Standard Deviation 8.3
|
0.6 beats per minute (bpm)
Standard Deviation 7.8
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
2.5 mg Tadalafil
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
5.0 mg Tadalafil
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
0.2 mg Tamsulosin
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=154 participants at risk
Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 participants at risk
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
5.0 mg Tadalafil
n=155 participants at risk
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 participants at risk
Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Vascular disorders
Hypertension
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
Other adverse events
| Measure |
Placebo
n=154 participants at risk
Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
|
2.5 mg Tadalafil
n=151 participants at risk
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
5.0 mg Tadalafil
n=155 participants at risk
Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
|
0.2 mg Tamsulosin
n=152 participants at risk
Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.65%
1/154 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Eye disorders
Glaucoma
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/154
|
1.3%
2/151 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/154
|
0.00%
0/151
|
1.3%
2/155 • Number of events 2
|
0.00%
0/152
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Gastrointestinal disorders
Gastritis
|
0.65%
1/154 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/154
|
0.00%
0/151
|
1.9%
3/155 • Number of events 3
|
0.00%
0/152
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
General disorders
Chest pain
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
1.3%
2/152 • Number of events 2
|
|
General disorders
Fatigue
|
0.65%
1/154 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Thirst
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.9%
3/154 • Number of events 3
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Bronchitis
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Cellulitis
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Infection
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Influenza
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
3/154 • Number of events 3
|
2.0%
3/151 • Number of events 3
|
1.3%
2/155 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Oral herpes
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Pneumonia
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Tinea infection
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
1.3%
2/152 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.65%
1/154 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 3
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
1.3%
2/152 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Investigations
Blood creatine phosphokinase increased
|
1.3%
2/154 • Number of events 2
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Investigations
Blood pressure increased
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Investigations
Blood uric acid increased
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
2/154 • Number of events 2
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Glucose urine present
|
0.65%
1/154 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Prostatic specific antigen increased
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
1.3%
2/155 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Transaminases abnormal
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Investigations
White blood cell count increased
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/154
|
1.3%
2/151 • Number of events 2
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
1/154 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
2.6%
4/155 • Number of events 4
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.65%
1/154 • Number of events 1
|
1.3%
2/151 • Number of events 2
|
0.00%
0/155
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/154
|
0.00%
0/151
|
1.3%
2/155 • Number of events 2
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/154
|
2.0%
3/151 • Number of events 4
|
3.9%
6/155 • Number of events 7
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Nervous system disorders
Dizziness
|
0.00%
0/154
|
2.0%
3/151 • Number of events 3
|
0.00%
0/155
|
1.3%
2/152 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.65%
1/154 • Number of events 1
|
2.0%
3/151 • Number of events 4
|
1.9%
3/155 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/154
|
1.3%
2/151 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.65%
1/154 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
1/154 • Number of events 1
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.00%
0/152
|
|
Surgical and medical procedures
Colon polypectomy
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/154
|
0.00%
0/151
|
0.65%
1/155 • Number of events 1
|
0.00%
0/152
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/154
|
0.00%
0/151
|
1.3%
2/155 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/154
|
0.66%
1/151 • Number of events 1
|
0.00%
0/155
|
0.66%
1/152 • Number of events 1
|
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