Trial Outcomes & Findings for A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers (NCT NCT00848081)
NCT ID: NCT00848081
Last Updated: 2010-09-14
Results Overview
The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
318 participants
Primary outcome timeframe
Baseline through 12 Weeks
Results posted on
2010-09-14
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo by mouth once daily for 12 weeks
|
Tadalafil
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
158
|
|
Overall Study
COMPLETED
|
140
|
140
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Placebo by mouth once daily for 12 weeks
|
Tadalafil
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
7
|
|
Overall Study
Protocol Violation
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
Baseline Characteristics
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
Baseline characteristics by cohort
| Measure |
Placebo
n=160 Participants
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=158 Participants
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
67.35 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
67.41 years
STANDARD_DEVIATION 9.11 • n=7 Participants
|
67.38 years
STANDARD_DEVIATION 9.10 • 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
|
160 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
318 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
157 participants
n=5 Participants
|
148 participants
n=7 Participants
|
305 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12 WeeksPopulation: Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.
The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=158 Participants
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Number of Men With Treatment-emergent Dizziness
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline through 12 WeeksPopulation: All randomized subjects in the analysis population with non-missing data.
A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of \>= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of \>=10 mmHg from the supine to standing position;(3)increase in heart rate of \>= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.
Outcome measures
| Measure |
Placebo
n=158 Participants
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=156 Participants
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit
Positive Pre-Random. to Negative Post-Random.
|
22 Participants
|
15 Participants
|
|
Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit
Negative Pre-Random. to Positive Post-Random.
|
21 Participants
|
19 Participants
|
|
Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit
Positive Pre-Random. to Positive Post-Random.
|
14 Participants
|
16 Participants
|
|
Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit
Negative Pre-Random. to Negative Post-Random.
|
101 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data.
Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=156 Participants
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
International Prostate Symptom Score (IPSS) Change From Baseline
Baseline
|
13.3 units on a scale
Standard Deviation 6.57 • Interval -2.01 to 0.26
|
13.87 units on a scale
Standard Deviation 7.15 • Interval -2.01 to 0.26
|
|
International Prostate Symptom Score (IPSS) Change From Baseline
Change from Baseline
|
-1.49 units on a scale
Standard Deviation 5.29
|
-2.28 units on a scale
Standard Deviation 5.65
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: All randomized subjects who had non-missing baseline and endpoint data.
Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.
Outcome measures
| Measure |
Placebo
n=150 Participants
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=151 Participants
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Postvoid Residual Volume (PVR) Change From Baseline
Baseline values
|
70.7 milliliters
Standard Deviation 74.87
|
80.3 milliliters
Standard Deviation 80.78
|
|
Postvoid Residual Volume (PVR) Change From Baseline
Change from Baseline
|
-1.9 milliliters
Standard Deviation 82.86
|
-8.1 milliliters
Standard Deviation 88.5
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: All randomized subjects with non-missing data.
Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using standard calibrated flowmeter).
Outcome measures
| Measure |
Placebo
n=115 Participants
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=115 Participants
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Uroflowmetry (Qmax) Change From Baseline
Baseline
|
12.8 milliliters per second
Standard Deviation 5.88
|
11.8 milliliters per second
Standard Deviation 4.93
|
|
Uroflowmetry (Qmax) Change From Baseline
Change from Baseline
|
0.6 milliliters per second
Standard Deviation 4.03
|
0.6 milliliters per second
Standard Deviation 3.67
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 53 other events
Deaths: 0 deaths
Tadalafil
Serious events: 2 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=160 participants at risk
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=158 participants at risk
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Non-cardiac chest pain
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
Other adverse events
| Measure |
Placebo
n=160 participants at risk
Placebo by mouth once daily for 12 weeks
|
Tadalafil
n=158 participants at risk
Tadalafil 5 mg taken by mouth once daily for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Eye disorders
Conjunctivitis
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Eye disorders
Eye swelling
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Eye disorders
Vision blurred
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.3%
2/158 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Eye disorders
Visual acuity reduced
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
3.2%
5/158 • Number of events 5 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
5.1%
8/158 • Number of events 9 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
2.5%
4/158 • Number of events 4 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Gingival disorder
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.9%
3/158 • Number of events 4 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Asthenia
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Cyst
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Fatigue
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.9%
3/158 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Oedema peripheral
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Suprapubic pain
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
General disorders
Temperature intolerance
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Diverticulitis
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Ear infection
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.3%
2/158 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Herpes zoster
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Oral herpes
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Sinusitis
|
1.2%
2/160 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Tinea infection
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
3/160 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Blood uric acid increased
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Colonoscopy
|
1.9%
3/160 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Creatinine renal clearance decreased
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Electrocardiogram abnormal
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Heart rate increased
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Investigations
Oesophagogastroduodenoscopy
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
2.5%
4/158 • Number of events 4 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.3%
2/158 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Nervous system disorders
Dizziness
|
5.0%
8/160 • Number of events 10 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
6.3%
10/158 • Number of events 14 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Nervous system disorders
Dizziness postural
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Nervous system disorders
Headache
|
1.9%
3/160 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.3%
2/158 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Nervous system disorders
Syncope
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Psychiatric disorders
Anxiety
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Psychiatric disorders
Insomnia
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Renal and urinary disorders
Dysuria
|
0.62%
1/160 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Renal and urinary disorders
Nocturia
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Renal and urinary disorders
Pollakiuria
|
1.9%
3/160 • Number of events 4 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.2%
2/160 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.3%
2/158 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
3/160 • Number of events 3 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.3%
2/158 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
1.3%
2/158 • Number of events 2 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Surgical and medical procedures
Colon polypectomy
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Surgical and medical procedures
Skin lesion excision
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Surgical and medical procedures
Tooth extraction
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/160 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.63%
1/158 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.62%
1/160 • Number of events 1 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
0.00%
0/158 • Treatment Emergent Adverse Events were collected from randomization until the subject completed the study.
|
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