Trial Outcomes & Findings for Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (NCT NCT00384930)
NCT ID: NCT00384930
Last Updated: 2009-09-02
Results Overview
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1058 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2009-09-02
Participant Flow
Prior to randomization, participants had a 1-4 week Screening/Wash-out Period, followed by a 4 week Placebo Run-In Period. 1813 participants were screened with 755 screen failures, and 1058 participants randomized. The two participants who did not receive study drug were not included in the baseline demographics table.
Participant milestones
| Measure |
Placebo
placebo tablet by mouth once a day for twelve weeks
|
2.5 mg Tadalafil
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
|
5 mg Tadalafil
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
212
|
209
|
212
|
216
|
209
|
|
Overall Study
Received Double-Blind Study Drug
|
211
|
208
|
212
|
216
|
209
|
|
Overall Study
COMPLETED
|
185
|
182
|
182
|
175
|
162
|
|
Overall Study
NOT COMPLETED
|
27
|
27
|
30
|
41
|
47
|
Reasons for withdrawal
| Measure |
Placebo
placebo tablet by mouth once a day for twelve weeks
|
2.5 mg Tadalafil
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
|
5 mg Tadalafil
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
12
|
11
|
14
|
|
Overall Study
Entry Criteria Not Met
|
2
|
6
|
7
|
8
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
0
|
4
|
6
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
6
|
4
|
|
Overall Study
Sponsor Decision
|
3
|
4
|
0
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
7
|
6
|
16
|
|
Overall Study
Didn't Receive Double-Blind Study Drug
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Placebo
n=211 Participants
placebo tablet by mouth once a day for twelve weeks
|
2.5 mg Tadalafil
n=208 Participants
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
|
5 mg Tadalafil
n=212 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=216 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=209 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
Total
n=1056 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
61.75 years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
62.03 years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
61.95 years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
62.22 years
STANDARD_DEVIATION 7.20 • n=4 Participants
|
62.55 years
STANDARD_DEVIATION 8.09 • n=21 Participants
|
62.10 years
STANDARD_DEVIATION 7.91 • n=10 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
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
209 Participants
n=21 Participants
|
1056 Participants
n=10 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
4 participants
n=21 Participants
|
24 participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
13 participants
n=4 Participants
|
6 participants
n=21 Participants
|
45 participants
n=10 Participants
|
|
Region of Enrollment
France
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
9 participants
n=5 Participants
|
15 participants
n=4 Participants
|
11 participants
n=21 Participants
|
60 participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=5 Participants
|
35 participants
n=7 Participants
|
39 participants
n=5 Participants
|
28 participants
n=4 Participants
|
33 participants
n=21 Participants
|
164 participants
n=10 Participants
|
|
Region of Enrollment
Greece
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
11 participants
n=4 Participants
|
10 participants
n=21 Participants
|
50 participants
n=10 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
48 participants
n=10 Participants
|
|
Region of Enrollment
Mexico
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
19 participants
n=4 Participants
|
19 participants
n=21 Participants
|
90 participants
n=10 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
17 participants
n=10 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
20 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
112 participants
n=7 Participants
|
109 participants
n=5 Participants
|
106 participants
n=4 Participants
|
108 participants
n=21 Participants
|
540 participants
n=10 Participants
|
|
Baseline (Visit 3) Lower Urinary Tract Symptoms (LUTS) Severity
Moderate (<20 units on a scale: IPSS)
|
137 participants
n=5 Participants
|
139 participants
n=7 Participants
|
141 participants
n=5 Participants
|
143 participants
n=4 Participants
|
141 participants
n=21 Participants
|
701 participants
n=10 Participants
|
|
Baseline (Visit 3) Lower Urinary Tract Symptoms (LUTS) Severity
Severe (>=20 units on a scale: IPSS)
|
74 participants
n=5 Participants
|
69 participants
n=7 Participants
|
71 participants
n=5 Participants
|
72 participants
n=4 Participants
|
68 participants
n=21 Participants
|
354 participants
n=10 Participants
|
|
Baseline (Visit 3) Lower Urinary Tract Symptoms (LUTS) Severity
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
< 6 months
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
6 months to 1 year
|
44 participants
n=5 Participants
|
27 participants
n=7 Participants
|
37 participants
n=5 Participants
|
27 participants
n=4 Participants
|
39 participants
n=21 Participants
|
174 participants
n=10 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
1 year to 3 years
|
62 participants
n=5 Participants
|
64 participants
n=7 Participants
|
63 participants
n=5 Participants
|
81 participants
n=4 Participants
|
70 participants
n=21 Participants
|
340 participants
n=10 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
> 3 years
|
105 participants
n=5 Participants
|
117 participants
n=7 Participants
|
112 participants
n=5 Participants
|
107 participants
n=4 Participants
|
100 participants
n=21 Participants
|
541 participants
n=10 Participants
|
|
Erectile Dysfunction
Yes
|
142 participants
n=5 Participants
|
135 participants
n=7 Participants
|
144 participants
n=5 Participants
|
150 participants
n=4 Participants
|
145 participants
n=21 Participants
|
716 participants
n=10 Participants
|
|
Erectile Dysfunction
No
|
67 participants
n=5 Participants
|
71 participants
n=7 Participants
|
68 participants
n=5 Participants
|
64 participants
n=4 Participants
|
61 participants
n=21 Participants
|
331 participants
n=10 Participants
|
|
Erectile Dysfunction
Unknown
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
8 participants
n=10 Participants
|
|
Erectile Dysfunction
Not Collected
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Previous Therapy for Benign Prostatic Hyperplasia (BPH)
No
|
153 participants
n=5 Participants
|
139 participants
n=7 Participants
|
158 participants
n=5 Participants
|
160 participants
n=4 Participants
|
152 participants
n=21 Participants
|
762 participants
n=10 Participants
|
|
Previous Therapy for Benign Prostatic Hyperplasia (BPH)
Yes
|
58 participants
n=5 Participants
|
69 participants
n=7 Participants
|
54 participants
n=5 Participants
|
56 participants
n=4 Participants
|
57 participants
n=21 Participants
|
294 participants
n=10 Participants
|
|
Race/Ethnicity
African
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
23 participants
n=10 Participants
|
|
Race/Ethnicity
Caucasian
|
179 participants
n=5 Participants
|
184 participants
n=7 Participants
|
179 participants
n=5 Participants
|
186 participants
n=4 Participants
|
176 participants
n=21 Participants
|
904 participants
n=10 Participants
|
|
Race/Ethnicity
East Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Race/Ethnicity
Hispanic
|
29 participants
n=5 Participants
|
20 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
25 participants
n=21 Participants
|
123 participants
n=10 Participants
|
|
Race/Ethnicity
West Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
4 participants
n=10 Participants
|
|
Severity of Erectile Dysfunction (ED)
Mild
|
38 participants
n=5 Participants
|
42 participants
n=7 Participants
|
41 participants
n=5 Participants
|
56 participants
n=4 Participants
|
40 participants
n=21 Participants
|
217 participants
n=10 Participants
|
|
Severity of Erectile Dysfunction (ED)
Moderate
|
82 participants
n=5 Participants
|
75 participants
n=7 Participants
|
82 participants
n=5 Participants
|
72 participants
n=4 Participants
|
79 participants
n=21 Participants
|
390 participants
n=10 Participants
|
|
Severity of Erectile Dysfunction (ED)
Severe
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
21 participants
n=5 Participants
|
22 participants
n=4 Participants
|
26 participants
n=21 Participants
|
109 participants
n=10 Participants
|
|
Sexually Active
No
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
33 participants
n=5 Participants
|
42 participants
n=4 Participants
|
48 participants
n=21 Participants
|
205 participants
n=10 Participants
|
|
Sexually Active
Yes
|
169 participants
n=5 Participants
|
168 participants
n=7 Participants
|
179 participants
n=5 Participants
|
174 participants
n=4 Participants
|
161 participants
n=21 Participants
|
851 participants
n=10 Participants
|
|
Sexually Active and Erectile Dysfunction (ED)
Sexually Active with ED
|
115 participants
n=5 Participants
|
113 participants
n=7 Participants
|
117 participants
n=5 Participants
|
120 participants
n=4 Participants
|
116 participants
n=21 Participants
|
581 participants
n=10 Participants
|
|
Sexually Active and Erectile Dysfunction (ED)
Sexually Active without ED
|
54 participants
n=5 Participants
|
55 participants
n=7 Participants
|
62 participants
n=5 Participants
|
54 participants
n=4 Participants
|
45 participants
n=21 Participants
|
270 participants
n=10 Participants
|
|
Sexually Active and Erectile Dysfunction (ED)
Not Sexually Active with ED
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
25 participants
n=5 Participants
|
28 participants
n=4 Participants
|
28 participants
n=21 Participants
|
128 participants
n=10 Participants
|
|
Sexually Active and Erectile Dysfunction (ED)
Not Sexually Active without ED
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
18 participants
n=21 Participants
|
70 participants
n=10 Participants
|
|
Sexually Active and Erectile Dysfunction (ED)
Sexual Activity and/or ED Status is Unknown
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
7 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Outcome measures
| Measure |
Placebo
n=205 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=205 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis
Baseline
|
17.08 units on a scale
Standard Deviation 6.36
|
17.30 units on a scale
Standard Deviation 5.97
|
—
|
—
|
—
|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis
Change from Baseline
|
-2.25 units on a scale
Standard Deviation 6.17
|
-4.92 units on a scale
Standard Deviation 5.67
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Outcome measures
| Measure |
Placebo
n=205 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=201 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=205 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=207 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=199 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis
|
-2.23 units on a scale
Standard Error 0.49
|
-3.81 units on a scale
Standard Error 0.50
|
-4.83 units on a scale
Standard Error 0.49
|
-5.13 units on a scale
Standard Error 0.48
|
-5.17 units on a scale
Standard Error 0.50
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Outcome measures
| Measure |
Placebo
n=205 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=201 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=205 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=208 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=199 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore
Baseline
|
7.58 units on a scale
Standard Deviation 3.09
|
7.78 units on a scale
Standard Deviation 2.86
|
7.65 units on a scale
Standard Deviation 2.84
|
7.88 units on a scale
Standard Deviation 2.67
|
7.53 units on a scale
Standard Deviation 3.07
|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore
Change from Baseline
|
-0.99 units on a scale
Standard Deviation 2.92
|
-1.62 units on a scale
Standard Deviation 2.83
|
-1.91 units on a scale
Standard Deviation 2.64
|
-2.04 units on a scale
Standard Deviation 2.75
|
-2.05 units on a scale
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Outcome measures
| Measure |
Placebo
n=205 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=202 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=205 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=207 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=199 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Baseline
|
9.51 units on a scale
Standard Deviation 4.21
|
9.71 units on a scale
Standard Deviation 4.16
|
9.65 units on a scale
Standard Deviation 4.10
|
9.88 units on a scale
Standard Deviation 3.87
|
9.57 units on a scale
Standard Deviation 4.45
|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Change from Baseline
|
-1.27 units on a scale
Standard Deviation 4.00
|
-2.31 units on a scale
Standard Deviation 3.84
|
-3.00 units on a scale
Standard Deviation 3.87
|
-3.29 units on a scale
Standard Deviation 4.04
|
-3.17 units on a scale
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).
Outcome measures
| Measure |
Placebo
n=205 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=201 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=205 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=208 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=199 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)
Baseline
|
2.36 units on a scale
Standard Deviation 1.10
|
2.37 units on a scale
Standard Deviation 1.31
|
2.36 units on a scale
Standard Deviation 1.91
|
2.36 units on a scale
Standard Deviation 1.15
|
2.20 units on a scale
Standard Deviation 1.23
|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)
Change from Baseline
|
-0.36 units on a scale
Standard Deviation 1.09
|
-0.43 units on a scale
Standard Deviation 1.33
|
-0.49 units on a scale
Standard Deviation 1.17
|
-0.43 units on a scale
Standard Deviation 1.28
|
-0.54 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Outcome measures
| Measure |
Placebo
n=205 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=202 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=205 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=206 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=199 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Baseline
|
3.57 units on a scale
Standard Deviation 1.19
|
3.69 units on a scale
Standard Deviation 1.19
|
3.54 units on a scale
Standard Deviation 1.30
|
3.55 units on a scale
Standard Deviation 1.23
|
3.59 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Change from Baseline
|
-0.56 units on a scale
Standard Deviation 1.20
|
-0.86 units on a scale
Standard Deviation 1.13
|
-0.92 units on a scale
Standard Deviation 1.30
|
-0.98 units on a scale
Standard Deviation 1.46
|
-0.97 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.
Outcome measures
| Measure |
Placebo
n=205 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=201 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=204 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=209 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=199 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)
Change from Baseline
|
-0.79 units on a scale
Standard Deviation 2.52
|
-0.83 units on a scale
Standard Deviation 2.66
|
-1.25 units on a scale
Standard Deviation 2.75
|
-1.31 units on a scale
Standard Deviation 2.79
|
-1.34 units on a scale
Standard Deviation 2.41
|
|
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)
Baseline
|
4.94 units on a scale
Standard Deviation 2.95
|
4.73 units on a scale
Standard Deviation 2.95
|
4.66 units on a scale
Standard Deviation 2.98
|
4.86 units on a scale
Standard Deviation 2.98
|
4.75 units on a scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.
Outcome measures
| Measure |
Placebo
n=199 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=194 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=201 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=200 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=186 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
|
109 participants
|
120 participants
|
139 participants
|
146 participants
|
138 participants
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.
Outcome measures
| Measure |
Placebo
n=198 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=201 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=202 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=201 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=190 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow
Baseline
|
10.31 milliliter per second
Standard Deviation 4.85
|
9.97 milliliter per second
Standard Deviation 4.09
|
10.37 milliliter per second
Standard Deviation 3.86
|
9.93 milliliter per second
Standard Deviation 3.77
|
9.82 milliliter per second
Standard Deviation 3.97
|
|
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow
Change from Baseline
|
1.23 milliliter per second
Standard Deviation 5.01
|
1.50 milliliter per second
Standard Deviation 4.56
|
1.61 milliliter per second
Standard Deviation 3.95
|
1.69 milliliter per second
Standard Deviation 4.46
|
2.15 milliliter per second
Standard Deviation 4.69
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward.
Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Outcome measures
| Measure |
Placebo
n=113 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=109 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
5 mg Tadalafil
n=113 Participants
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
n=113 Participants
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
n=109 Participants
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain
Baseline
|
17.26 units on a scale
Standard Deviation 7.95
|
17.42 units on a scale
Standard Deviation 8.30
|
15.29 units on a scale
Standard Deviation 8.13
|
17.22 units on a scale
Standard Deviation 8.43
|
16.28 units on a scale
Standard Deviation 8.05
|
|
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain
Change from Baseline
|
0.78 units on a scale
Standard Deviation 6.32
|
3.97 units on a scale
Standard Deviation 7.30
|
6.56 units on a scale
Standard Deviation 9.43
|
6.64 units on a scale
Standard Deviation 8.29
|
7.44 units on a scale
Standard Deviation 8.42
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
2.5 mg Tadalafil
Serious events: 3 serious events
Other events: 54 other events
Deaths: 0 deaths
5 mg Tadalafil
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
10 mg Tadalafil
Serious events: 2 serious events
Other events: 75 other events
Deaths: 0 deaths
20 mg Tadalafil
Serious events: 5 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
placebo tablet by mouth once a day for twelve weeks
|
2.5 mg Tadalafil
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
|
5 mg Tadalafil
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Cardiac disorders
Coronary artery stenosis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.47%
1/212 • Number of events 2
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Nervous system disorders
Cerebrovascular accident
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Renal colic
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Ureteric rupture
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Urinary retention
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Surgical and medical procedures
Indwelling catheter management
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Surgical and medical procedures
Ureteral catheterisation
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
Other adverse events
| Measure |
Placebo
placebo tablet by mouth once a day for twelve weeks
|
2.5 mg Tadalafil
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
|
5 mg Tadalafil
5 mg tadalafil tablet by mouth once a day for twelve weeks
|
10 mg Tadalafil
10 mg tadalafil tablet by mouth once a day for twelve weeks
|
20 mg Tadalafil
20 mg tadalafil tablet by mouth once a day for twelve weeks
|
|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Cardiac disorders
Left atrial dilatation
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 2
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Eye disorders
Eye irritation
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Eyelid irritation
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Glaucoma
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Panophthalmitis
|
0.47%
1/212 • Number of events 2
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Photopsia
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Retinal tear
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 2
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Vision blurred
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.94%
2/212 • Number of events 2
|
0.96%
2/209 • Number of events 3
|
0.94%
2/212 • Number of events 2
|
1.4%
3/216 • Number of events 3
|
0.00%
0/209
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
3/212 • Number of events 3
|
0.96%
2/209 • Number of events 2
|
2.8%
6/212 • Number of events 12
|
0.46%
1/216 • Number of events 1
|
2.4%
5/209 • Number of events 5
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/212
|
0.96%
2/209 • Number of events 3
|
4.7%
10/212 • Number of events 15
|
2.8%
6/216 • Number of events 6
|
4.8%
10/209 • Number of events 10
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
1.4%
3/216 • Number of events 3
|
0.96%
2/209 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/212
|
0.96%
2/209 • Number of events 2
|
0.94%
2/212 • Number of events 2
|
2.8%
6/216 • Number of events 6
|
1.4%
3/209 • Number of events 3
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.47%
1/212 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Nausea
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
1.4%
3/212 • Number of events 3
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Gastrointestinal disorders
Vomiting
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
1.4%
3/212 • Number of events 3
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
General disorders
Asthenia
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/212
|
0.00%
0/209
|
1.4%
3/212 • Number of events 3
|
0.00%
0/216
|
0.00%
0/209
|
|
General disorders
Fatigue
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
General disorders
Inflammation
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
General disorders
Influenza like illness
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
General disorders
Irritability
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
General disorders
Local swelling
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
General disorders
Oedema
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
General disorders
Oedema peripheral
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.93%
2/216 • Number of events 2
|
0.00%
0/209
|
|
General disorders
Pain
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.94%
2/212 • Number of events 2
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
General disorders
Pyrexia
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.94%
2/212 • Number of events 2
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
General disorders
Sensation of foreign body
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.96%
2/209 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 2
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.47%
1/212 • Number of events 1
|
1.4%
3/209 • Number of events 3
|
0.47%
1/212 • Number of events 1
|
2.3%
5/216 • Number of events 5
|
0.00%
0/209
|
|
Infections and infestations
Cystitis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Infections and infestations
Ear infection
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Infections and infestations
Folliculitis
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Infections and infestations
Fungal infection
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.93%
2/216 • Number of events 2
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.47%
1/212 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.96%
2/209 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.47%
1/212 • Number of events 1
|
1.9%
4/209 • Number of events 4
|
1.9%
4/212 • Number of events 4
|
0.46%
1/216 • Number of events 1
|
0.96%
2/209 • Number of events 2
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Infections and infestations
Lower respiratory tract infection
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Infections and infestations
Nasopharyngitis
|
0.94%
2/212 • Number of events 2
|
3.3%
7/209 • Number of events 8
|
1.9%
4/212 • Number of events 6
|
0.93%
2/216 • Number of events 2
|
2.4%
5/209 • Number of events 5
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.93%
2/216 • Number of events 2
|
0.00%
0/209
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Infections and infestations
Rhinitis
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Infections and infestations
Sinusitis
|
0.47%
1/212 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Infections and infestations
Tracheitis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Infections and infestations
Upper respiratory tract infection
|
0.94%
2/212 • Number of events 2
|
0.00%
0/209
|
0.94%
2/212 • Number of events 2
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.4%
3/212 • Number of events 3
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/212
|
0.96%
2/209 • Number of events 2
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 2
|
0.00%
0/216
|
0.00%
0/209
|
|
Investigations
Arthroscopy
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Investigations
Cardiac murmur
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Investigations
Heart rate abnormal
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Investigations
Heart rate irregular
|
0.00%
0/212
|
0.48%
1/209 • Number of events 2
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Investigations
Hepatic enzyme increased
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Investigations
Weight increased
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/212
|
0.00%
0/209
|
1.4%
3/212 • Number of events 3
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.96%
2/209 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Metabolism and nutrition disorders
Obesity
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Metabolism and nutrition disorders
Podagra
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/212 • Number of events 1
|
1.4%
3/209 • Number of events 3
|
0.94%
2/212 • Number of events 3
|
4.6%
10/216 • Number of events 10
|
5.3%
11/209 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.93%
2/216 • Number of events 2
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/212
|
0.96%
2/209 • Number of events 2
|
0.00%
0/212
|
0.93%
2/216 • Number of events 2
|
2.4%
5/209 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.94%
2/212 • Number of events 2
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/212
|
1.4%
3/209 • Number of events 4
|
1.4%
3/212 • Number of events 3
|
2.8%
6/216 • Number of events 6
|
2.9%
6/209 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/212
|
1.4%
3/209 • Number of events 5
|
2.4%
5/212 • Number of events 5
|
0.93%
2/216 • Number of events 2
|
1.4%
3/209 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.47%
1/212 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.46%
1/216 • Number of events 1
|
1.4%
3/209 • Number of events 3
|
|
Nervous system disorders
Headache
|
2.8%
6/212 • Number of events 6
|
2.4%
5/209 • Number of events 5
|
2.8%
6/212 • Number of events 7
|
5.1%
11/216 • Number of events 11
|
3.3%
7/209 • Number of events 8
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Nervous system disorders
Lethargy
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Nervous system disorders
Nerve compression
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Nervous system disorders
Sciatica
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/212
|
0.96%
2/209 • Number of events 3
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Psychiatric disorders
Depression
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.94%
2/212 • Number of events 2
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Psychiatric disorders
Insomnia
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.93%
2/216 • Number of events 2
|
0.00%
0/209
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.46%
1/216 • Number of events 1
|
0.48%
1/209 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 2
|
0.00%
0/209
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Reproductive system and breast disorders
Painful erection
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.47%
1/212 • Number of events 1
|
1.4%
3/209 • Number of events 3
|
0.94%
2/212 • Number of events 2
|
0.93%
2/216 • Number of events 2
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.94%
2/212 • Number of events 2
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/212
|
0.96%
2/209 • Number of events 2
|
0.94%
2/212 • Number of events 2
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/212
|
0.00%
0/209
|
0.94%
2/212 • Number of events 2
|
0.93%
2/216 • Number of events 2
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.94%
2/212 • Number of events 2
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 4
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.96%
2/209 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.94%
2/212 • Number of events 2
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Surgical and medical procedures
Dental operation
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.48%
1/209 • Number of events 1
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/212
|
0.00%
0/209
|
0.00%
0/212
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Vascular disorders
Flushing
|
0.00%
0/212
|
0.48%
1/209 • Number of events 1
|
0.00%
0/212
|
0.00%
0/216
|
0.00%
0/209
|
|
Vascular disorders
Hot flush
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
|
Vascular disorders
Hypertension
|
0.47%
1/212 • Number of events 1
|
0.00%
0/209
|
1.9%
4/212 • Number of events 4
|
0.46%
1/216 • Number of events 1
|
0.00%
0/209
|
|
Vascular disorders
Hypotension
|
0.00%
0/212
|
0.00%
0/209
|
0.47%
1/212 • Number of events 1
|
0.00%
0/216
|
0.00%
0/209
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60