Trial Outcomes & Findings for A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms (NCT NCT01139762)
NCT ID: NCT01139762
Last Updated: 2013-02-27
Results Overview
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
696 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2013-02-27
Participant Flow
The study consisted of 3 periods: a 4-week washout period, a 4-week, single-blind, placebo lead-in period, and a 26-week double-blind randomized active treatment period. Participants who did not complete the washout and placebo lead-in period were considered screen failures.
Participant milestones
| Measure |
Screening-Washout and Placebo Lead-In
4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
|
Tadalafil
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
Placebo
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
|---|---|---|---|
|
Washout and Placebo Lead-In Period
STARTED
|
1070
|
0
|
0
|
|
Washout and Placebo Lead-In Period
COMPLETED
|
696
|
0
|
0
|
|
Washout and Placebo Lead-In Period
NOT COMPLETED
|
374
|
0
|
0
|
|
Double-Blind Randomized Active Treatment
STARTED
|
0
|
346
|
350
|
|
Double-Blind Randomized Active Treatment
Received at Least 1 Dose of Study Drug
|
0
|
345
|
350
|
|
Double-Blind Randomized Active Treatment
COMPLETED
|
0
|
306
|
286
|
|
Double-Blind Randomized Active Treatment
NOT COMPLETED
|
0
|
40
|
64
|
Reasons for withdrawal
| Measure |
Screening-Washout and Placebo Lead-In
4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
|
Tadalafil
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
Placebo
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
|---|---|---|---|
|
Washout and Placebo Lead-In Period
Entry Criteria Not Met
|
258
|
0
|
0
|
|
Washout and Placebo Lead-In Period
Adverse Event
|
1
|
0
|
0
|
|
Washout and Placebo Lead-In Period
Withdrawal by Subject
|
83
|
0
|
0
|
|
Washout and Placebo Lead-In Period
Physician Decision
|
12
|
0
|
0
|
|
Washout and Placebo Lead-In Period
Sponsor Decision
|
10
|
0
|
0
|
|
Washout and Placebo Lead-In Period
Lost to Follow-up
|
10
|
0
|
0
|
|
Double-Blind Randomized Active Treatment
Adverse Event
|
0
|
4
|
10
|
|
Double-Blind Randomized Active Treatment
Death
|
0
|
1
|
1
|
|
Double-Blind Randomized Active Treatment
Entry Criteria Not Met
|
0
|
14
|
17
|
|
Double-Blind Randomized Active Treatment
Protocol Violation
|
0
|
2
|
8
|
|
Double-Blind Randomized Active Treatment
Withdrawal by Subject
|
0
|
6
|
13
|
|
Double-Blind Randomized Active Treatment
Physician Decision
|
0
|
2
|
0
|
|
Double-Blind Randomized Active Treatment
Sponsor Decision
|
0
|
5
|
6
|
|
Double-Blind Randomized Active Treatment
Lack of Efficacy
|
0
|
3
|
5
|
|
Double-Blind Randomized Active Treatment
Lost to Follow-up
|
0
|
3
|
4
|
Baseline Characteristics
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
Baseline characteristics by cohort
| Measure |
Tadalafil
n=345 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=350 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Total
n=695 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.8 years
STANDARD_DEVIATION 7.50 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 7.85 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
345 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
695 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
302 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
606 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
298 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
594 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
46 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
32 participants
n=5 Participants
|
37 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
France
|
21 participants
n=5 Participants
|
9 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
33 participants
n=5 Participants
|
37 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
46 participants
n=5 Participants
|
41 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=5 Participants
|
16 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
32 participants
n=5 Participants
|
39 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Lower urinary tract symptoms (LUTS) severity
Moderate (IPSS<20)
|
238 participants
n=5 Participants
|
235 participants
n=7 Participants
|
473 participants
n=5 Participants
|
|
Lower urinary tract symptoms (LUTS) severity
Severe (IPSS≥20)
|
106 participants
n=5 Participants
|
114 participants
n=7 Participants
|
220 participants
n=5 Participants
|
|
Lower urinary tract symptoms (LUTS) severity
Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Peak urine flow rate
<10 milliliters/second (mL/sec)
|
154 participants
n=5 Participants
|
169 participants
n=7 Participants
|
323 participants
n=5 Participants
|
|
Peak urine flow rate
10-15 mL/sec
|
190 participants
n=5 Participants
|
180 participants
n=7 Participants
|
370 participants
n=5 Participants
|
|
Peak urine flow rate
>15 mL/sec
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Postvoid residual volume (PVR)
|
65.5 milliliters (mL)
STANDARD_DEVIATION 60.69 • n=5 Participants
|
62.6 milliliters (mL)
STANDARD_DEVIATION 59.57 • n=7 Participants
|
64.1 milliliters (mL)
STANDARD_DEVIATION 60.10 • n=5 Participants
|
|
Prostate Volume
|
48.2 milliliters (mL)
STANDARD_DEVIATION 19.43 • n=5 Participants
|
50.6 milliliters (mL)
STANDARD_DEVIATION 21.17 • n=7 Participants
|
49.4 milliliters (mL)
STANDARD_DEVIATION 20.35 • n=5 Participants
|
|
Prostate Specific Antigen (PSA)
|
2.3 nanograms/milliliter (ng/mL)
STANDARD_DEVIATION 2.02 • n=5 Participants
|
2.5 nanograms/milliliter (ng/mL)
STANDARD_DEVIATION 2.06 • n=7 Participants
|
2.4 nanograms/milliliter (ng/mL)
STANDARD_DEVIATION 2.04 • n=5 Participants
|
|
Erectile Dysfunction
Yes
|
227 participants
n=5 Participants
|
223 participants
n=7 Participants
|
450 participants
n=5 Participants
|
|
Erectile Dysfunction
No
|
118 participants
n=5 Participants
|
127 participants
n=7 Participants
|
245 participants
n=5 Participants
|
|
Sexual activity with female partner
Yes
|
305 participants
n=5 Participants
|
305 participants
n=7 Participants
|
610 participants
n=5 Participants
|
|
Sexual activity with female partner
No
|
40 participants
n=5 Participants
|
44 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Sexual activity with female partner
Not Applicable
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Height
|
173.5 centimeters (cm)
STANDARD_DEVIATION 7.90 • n=5 Participants
|
173.8 centimeters (cm)
STANDARD_DEVIATION 7.65 • n=7 Participants
|
173.7 centimeters (cm)
STANDARD_DEVIATION 7.77 • n=5 Participants
|
|
Weight
|
85.3 kilograms (kg)
STANDARD_DEVIATION 14.16 • n=5 Participants
|
85.6 kilograms (kg)
STANDARD_DEVIATION 14.16 • n=7 Participants
|
85.4 kilograms (kg)
STANDARD_DEVIATION 14.15 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.3 kilograms/square meter (kg/m²)
STANDARD_DEVIATION 4.00 • n=5 Participants
|
28.3 kilograms/square meter (kg/m²)
STANDARD_DEVIATION 3.80 • n=7 Participants
|
28.3 kilograms/square meter (kg/m²)
STANDARD_DEVIATION 3.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=345 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=350 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
|
-5.18 units on a scale
Standard Error 0.32
|
-3.76 units on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=345 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=350 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks
26 weeks
|
-5.51 units on a scale
Standard Error 0.33
|
-4.47 units on a scale
Standard Error 0.33
|
|
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks
4 weeks
|
-3.95 units on a scale
Standard Error 0.29
|
-2.29 units on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=345 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=350 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS storage (irritative) subscore - 26 weeks
|
-2.00 units on a scale
Standard Error 0.15
|
-1.66 units on a scale
Standard Error 0.15
|
|
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS voiding (obstructive) subscore - 4 weeks
|
-2.65 units on a scale
Standard Error 0.19
|
-1.47 units on a scale
Standard Error 0.19
|
|
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS voiding (obstructive) subscore - 12 weeks
|
-3.41 units on a scale
Standard Error 0.21
|
-2.37 units on a scale
Standard Error 0.21
|
|
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS voiding (obstructive) subscore - 26 weeks
|
-3.50 units on a scale
Standard Error 0.22
|
-2.77 units on a scale
Standard Error 0.22
|
|
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS storage (irritative) subscore - 4 weeks
|
-1.27 units on a scale
Standard Error 0.14
|
-0.76 units on a scale
Standard Error 0.14
|
|
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS storage (irritative) subscore - 12 weeks
|
-1.74 units on a scale
Standard Error 0.14
|
-1.34 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.
IPSS Quality of Life Index assesses participant response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=345 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=350 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
4 weeks
|
-0.63 units on a scale
Standard Error 0.07
|
-0.32 units on a scale
Standard Error 0.06
|
|
Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
12 weeks
|
-0.95 units on a scale
Standard Error 0.07
|
-0.76 units on a scale
Standard Error 0.07
|
|
Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
26 weeks
|
-1.10 units on a scale
Standard Error 0.08
|
-0.92 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.
Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=203 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=201 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
4 weeks
|
3.71 units on a scale
Standard Error 0.50
|
-1.14 units on a scale
Standard Error 0.51
|
|
Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
12 weeks
|
4.71 units on a scale
Standard Error 0.56
|
0.63 units on a scale
Standard Error 0.57
|
|
Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
26 weeks
|
4.71 units on a scale
Standard Error 0.57
|
-0.02 units on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.
Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=203 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=201 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
12 weeks
|
1.38 units on a scale
Standard Error 0.16
|
0.31 units on a scale
Standard Error 0.17
|
|
Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
4 weeks
|
0.91 units on a scale
Standard Error 0.15
|
-0.10 units on a scale
Standard Error 0.15
|
|
Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
26 weeks
|
1.61 units on a scale
Standard Error 0.17
|
0.40 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.
Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=203 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=201 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
12 weeks
|
1.68 units on a scale
Standard Error 0.26
|
0.08 units on a scale
Standard Error 0.27
|
|
Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
26 weeks
|
1.72 units on a scale
Standard Error 0.27
|
-0.26 units on a scale
Standard Error 0.28
|
|
Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
4 weeks
|
1.36 units on a scale
Standard Error 0.24
|
-0.46 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.
Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=203 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=201 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks
4 weeks
|
0.90 units on a scale
Standard Error 0.22
|
-0.63 units on a scale
Standard Error 0.23
|
|
Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks
12 weeks
|
1.08 units on a scale
Standard Error 0.23
|
0.18 units on a scale
Standard Error 0.24
|
|
Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks
26 weeks
|
0.89 units on a scale
Standard Error 0.24
|
-0.18 units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.
Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=203 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=201 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks
12 weeks
|
0.56 units on a scale
Standard Error 0.13
|
-0.23 units on a scale
Standard Error 0.13
|
|
Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks
26 weeks
|
0.71 units on a scale
Standard Error 0.13
|
-0.05 units on a scale
Standard Error 0.14
|
|
Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks
4 weeks
|
0.46 units on a scale
Standard Error 0.12
|
-0.47 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.
Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Tadalafil
n=309 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=288 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
1 = Very much better
|
21 participants
|
29 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
2 = Much better
|
124 participants
|
82 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
3 = Little better
|
102 participants
|
112 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
4 = No change
|
49 participants
|
52 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
5 = A little worse
|
10 participants
|
5 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
6 = Much worse
|
2 participants
|
7 participants
|
|
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
7 = Very much worse
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug and had TSS-BPH measurement at 26 weeks endpoint.
The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.
Outcome measures
| Measure |
Tadalafil
n=303 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=293 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks
|
2.0 units on a scale
Standard Deviation 0.63
|
2.1 units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug and had CGI-I measurement at 26 weeks endpoint.
Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Tadalafil
n=307 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=290 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
1 = Very much improved
|
23 participants
|
22 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
2 = Much improved
|
129 participants
|
97 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
3 = Minimally improved
|
98 participants
|
106 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
4 = No change
|
47 participants
|
48 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
5 = Minimally worse
|
5 participants
|
10 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
6 = Much worse
|
5 participants
|
6 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
7 = Very much worse
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline PVR measurement.
Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.
Outcome measures
| Measure |
Tadalafil
n=307 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=293 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks
|
-24.8 milliliters (mL)
Standard Deviation 73.08
|
-23.1 milliliters (mL)
Standard Deviation 66.15
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF Questions 3 and 4 measurement.
IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Outcome measures
| Measure |
Tadalafil
n=345 Participants
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
Placebo
n=350 Participants
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
Question 3 - 4 weeks
|
0.42 units on a scale
Standard Error 0.09
|
-0.32 units on a scale
Standard Error 0.09
|
|
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
Question 3 - 12 weeks
|
0.72 units on a scale
Standard Error 0.09
|
0.04 units on a scale
Standard Error 0.09
|
|
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
Question 3 - 26 weeks
|
0.68 units on a scale
Standard Error 0.10
|
-0.07 units on a scale
Standard Error 0.10
|
|
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
Question 4 - 4 weeks
|
0.49 units on a scale
Standard Error 0.09
|
-0.21 units on a scale
Standard Error 0.09
|
|
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
Question 4 - 12 weeks
|
0.74 units on a scale
Standard Error 0.09
|
0.13 units on a scale
Standard Error 0.09
|
|
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
Question 4 - 26 weeks
|
0.68 units on a scale
Standard Error 0.10
|
0.06 units on a scale
Standard Error 0.10
|
Adverse Events
Screening-Washout and Placebo Lead-In
Serious events: 1 serious events
Other events: 153 other events
Deaths: 0 deaths
Tadalafil
Serious events: 9 serious events
Other events: 105 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Screening-Washout and Placebo Lead-In
n=1070 participants at risk
4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
|
Tadalafil
n=345 participants at risk
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
Placebo
n=350 participants at risk
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
General disorders
Death
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
General disorders
Sudden death
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
Other adverse events
| Measure |
Screening-Washout and Placebo Lead-In
n=1070 participants at risk
4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
|
Tadalafil
n=345 participants at risk
5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
Placebo
n=350 participants at risk
Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Cardiac disorders
Atrial fibrillation
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1070
|
0.87%
3/345 • Number of events 3
|
0.00%
0/350
|
|
Cardiac disorders
Sinus bradycardia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Ear and labyrinth disorders
Tinnitus
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Eye disorders
Cataract
|
0.00%
0/1070
|
0.58%
2/345 • Number of events 3
|
0.00%
0/350
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/1070
|
0.00%
0/345
|
0.86%
3/350 • Number of events 3
|
|
Eye disorders
Eye irritation
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Eye disorders
Glaucoma
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Eye disorders
Vision blurred
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Gastrointestinal disorders
Abdominal pain
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.28%
3/1070 • Number of events 3
|
0.87%
3/345 • Number of events 3
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Cheilosis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Gastrointestinal disorders
Constipation
|
0.28%
3/1070 • Number of events 3
|
0.00%
0/345
|
0.86%
3/350 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.47%
5/1070 • Number of events 5
|
1.4%
5/345 • Number of events 5
|
1.7%
6/350 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Gastrointestinal disorders
Dyspepsia
|
0.65%
7/1070 • Number of events 9
|
2.3%
8/345 • Number of events 11
|
0.57%
2/350 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1070 • Number of events 1
|
0.58%
2/345 • Number of events 2
|
0.00%
0/350
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Gastrointestinal disorders
Nausea
|
0.09%
1/1070 • Number of events 1
|
0.58%
2/345 • Number of events 2
|
0.57%
2/350 • Number of events 2
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Gastrointestinal disorders
Toothache
|
0.19%
2/1070 • Number of events 2
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
General disorders
Asthenia
|
0.37%
4/1070 • Number of events 4
|
0.00%
0/345
|
0.00%
0/350
|
|
General disorders
Chest pain
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
General disorders
Fatigue
|
0.37%
4/1070 • Number of events 4
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
General disorders
Fibrosis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
General disorders
Irritability
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
General disorders
Oedema peripheral
|
0.00%
0/1070
|
0.00%
0/345
|
0.86%
3/350 • Number of events 3
|
|
General disorders
Pyrexia
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Infections and infestations
Abscess
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.28%
3/1070 • Number of events 3
|
0.00%
0/345
|
0.00%
0/350
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Ear infection
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Infections and infestations
Gastroenteritis
|
0.28%
3/1070 • Number of events 3
|
0.00%
0/345
|
0.57%
2/350 • Number of events 2
|
|
Infections and infestations
Hordeolum
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Infections and infestations
Infected dermal cyst
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Infections and infestations
Influenza
|
0.56%
6/1070 • Number of events 6
|
2.3%
8/345 • Number of events 8
|
2.3%
8/350 • Number of events 11
|
|
Infections and infestations
Laryngitis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
13/1070 • Number of events 14
|
1.4%
5/345 • Number of events 5
|
0.86%
3/350 • Number of events 3
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/1070
|
0.00%
0/345
|
0.57%
2/350 • Number of events 2
|
|
Infections and infestations
Oral herpes
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Infections and infestations
Orchitis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.47%
5/1070 • Number of events 5
|
0.00%
0/345
|
0.00%
0/350
|
|
Infections and infestations
Urethritis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.57%
2/350 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.19%
2/1070 • Number of events 2
|
0.00%
0/345
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Laceration
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Investigations
Blood alkaline phosphatase increased
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Blood creatine phosphokinase increased
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Blood uric acid increased
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Investigations
Gastric ph decreased
|
0.00%
0/1070
|
1.2%
4/345 • Number of events 4
|
0.29%
1/350 • Number of events 2
|
|
Investigations
Glomerular filtration rate decreased
|
0.19%
2/1070 • Number of events 2
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Glucose urine present
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Glycosylated haemoglobin increased
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Heart rate irregular
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Investigations
Oestradiol increased
|
1.1%
12/1070 • Number of events 12
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Investigations
Prostatic specific antigen increased
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Investigations
Semen volume decreased
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Investigations
White blood cell count increased
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Gout
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.28%
3/1070 • Number of events 3
|
0.00%
0/345
|
0.57%
2/350 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.19%
2/1070 • Number of events 2
|
0.00%
0/345
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.19%
2/1070 • Number of events 2
|
0.87%
3/345 • Number of events 3
|
0.57%
2/350 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
6/1070 • Number of events 6
|
4.3%
15/345 • Number of events 16
|
1.7%
6/350 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.57%
2/350 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 2
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.28%
3/1070 • Number of events 3
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.09%
1/1070 • Number of events 1
|
0.58%
2/345 • Number of events 2
|
0.86%
3/350 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.19%
2/1070 • Number of events 2
|
0.00%
0/345
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1070
|
0.58%
2/345 • Number of events 2
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
5/1070 • Number of events 5
|
1.4%
5/345 • Number of events 5
|
1.4%
5/350 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.57%
2/350 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral fibroma
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Nervous system disorders
Amnesia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Cognitive disorder
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Nervous system disorders
Dizziness
|
0.28%
3/1070 • Number of events 3
|
0.58%
2/345 • Number of events 2
|
0.57%
2/350 • Number of events 3
|
|
Nervous system disorders
Dizziness postural
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Nervous system disorders
Facial paresis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Nervous system disorders
Headache
|
1.1%
12/1070 • Number of events 13
|
3.5%
12/345 • Number of events 20
|
3.4%
12/350 • Number of events 15
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Mental impairment
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Radiculitis brachial
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Nervous system disorders
Sciatica
|
0.09%
1/1070 • Number of events 1
|
0.58%
2/345 • Number of events 2
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Psychiatric disorders
Anxiety
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Psychiatric disorders
Depression
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.09%
1/1070 • Number of events 1
|
0.58%
2/345 • Number of events 2
|
0.00%
0/350
|
|
Psychiatric disorders
Libido decreased
|
0.37%
4/1070 • Number of events 4
|
0.00%
0/345
|
1.1%
4/350 • Number of events 4
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Psychiatric disorders
Mood swings
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Psychiatric disorders
Nervousness
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Renal and urinary disorders
Azotaemia
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Renal and urinary disorders
Dysuria
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
1.4%
5/350 • Number of events 5
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1070
|
0.58%
2/345 • Number of events 2
|
0.86%
3/350 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
0.19%
2/1070 • Number of events 2
|
0.00%
0/345
|
0.00%
0/350
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Renal and urinary disorders
Urine flow decreased
|
0.19%
2/1070 • Number of events 2
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
1.4%
5/350 • Number of events 5
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Reproductive system and breast disorders
Prostatitis
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular pain
|
0.19%
2/1070 • Number of events 2
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.09%
1/1070 • Number of events 2
|
0.00%
0/345
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial wall thickening
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.28%
3/1070 • Number of events 3
|
0.87%
3/345 • Number of events 3
|
0.86%
3/350 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.57%
2/350 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1070
|
0.58%
2/345 • Number of events 2
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1070
|
0.58%
2/345 • Number of events 2
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1070
|
0.58%
2/345 • Number of events 2
|
0.00%
0/350
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.19%
2/1070 • Number of events 2
|
0.00%
0/345
|
0.00%
0/350
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.19%
2/1070 • Number of events 2
|
0.87%
3/345 • Number of events 3
|
0.57%
2/350 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.09%
1/1070 • Number of events 2
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.09%
1/1070 • Number of events 1
|
0.00%
0/345
|
0.00%
0/350
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 2
|
0.00%
0/350
|
|
Surgical and medical procedures
Dental operation
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Surgical and medical procedures
Toe operation
|
0.00%
0/1070
|
0.00%
0/345
|
0.29%
1/350 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.29%
1/350 • Number of events 1
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Vascular disorders
Flushing
|
0.09%
1/1070 • Number of events 1
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
|
Vascular disorders
Hypertension
|
0.19%
2/1070 • Number of events 2
|
1.2%
4/345 • Number of events 4
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1070
|
0.29%
1/345 • Number of events 1
|
0.00%
0/350
|
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