Trial Outcomes & Findings for A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS). (NCT NCT02431754)
NCT ID: NCT02431754
Last Updated: 2017-07-02
Results Overview
TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
171 participants
Primary outcome timeframe
Week 20
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Tadalafil/Placebo
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered once daily orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
Placebo administered orally QD for 8 weeks in one of two treatment periods.
5 mg tadalafil administered orally QD for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Period 1 (8 Weeks)
STARTED
|
85
|
86
|
|
Period 1 (8 Weeks)
Received at Least One Dose of Study Drug
|
85
|
86
|
|
Period 1 (8 Weeks)
COMPLETED
|
79
|
82
|
|
Period 1 (8 Weeks)
NOT COMPLETED
|
6
|
4
|
|
Wash-out Period (4 Weeks)
STARTED
|
79
|
82
|
|
Wash-out Period (4 Weeks)
COMPLETED
|
75
|
82
|
|
Wash-out Period (4 Weeks)
NOT COMPLETED
|
4
|
0
|
|
Period 2 (8 Weeks)
STARTED
|
75
|
82
|
|
Period 2 (8 Weeks)
COMPLETED
|
74
|
78
|
|
Period 2 (8 Weeks)
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).
Baseline characteristics by cohort
| Measure |
Tadalafil/Placebo
n=85 Participants
5 milligrams (mg) tadalafil administered QD orally for 8 weeks in one of two treatment periods.
Placebo administered once daily orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=86 Participants
Placebo administered once daily orally for 8 weeks in one of two treatment periods.
5 mg tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 6.0 • 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
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
Japan
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Current Smoking Habit
Yes
|
14 participants
n=5 Participants
|
20 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Current Smoking Habit
No
|
71 participants
n=5 Participants
|
66 participants
n=7 Participants
|
137 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 20Population: All randomized participants who received at least one dose of study drug and completed the TPQ.
TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.
Outcome measures
| Measure |
Tadalafil/Placebo
n=75 Participants
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=82 Participants
Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)
Prefer therapy tadalafil + a1 blocker
|
44.0 percentage of participants
|
68.3 percentage of participants
|
|
Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)
Prefer therapy placebo + a1 blocker
|
56.0 percentage of participants
|
31.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
Tadalafil/Placebo
n=157 Participants
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=156 Participants
Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score
|
-2.5 units on a scale
Standard Deviation 5.1
|
-1.8 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline,Week 8Population: All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.
IPSS Storage (Irritative) subscore was the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
Tadalafil/Placebo
n=157 Participants
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=156 Participants
Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Change From Baseline on the IPSS Storage (Irritative) Subscore
|
-0.6 units on a scale
Standard Deviation 2.1
|
-0.5 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.
IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
Tadalafil/Placebo
n=157 Participants
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=156 Participants
Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Change From Baseline on the IPSS Voiding (Obstructive) Subscore
|
-2.0 units on a scale
Standard Deviation 3.6
|
-1.3 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.
IPSS QoL assess 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 ranging from 0 to 6 with higher numerical score representing worse Quality of Life from BPH symptom.
Outcome measures
| Measure |
Tadalafil/Placebo
n=157 Participants
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=156 Participants
Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Change From Baseline on the IPSS Quality of Life Score (IPSS QoL )
|
-0.4 units on a scale
Standard Deviation 1.1
|
-0.4 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I measurement.
The PGI I is a participant rated instrument that measures the improvement or worsening of the subject's symptoms based on a 7 point scale. A score of "1" indicates that the subject feels his symptoms are "very much better." A score of "4" indicates that the subjects feels "no change" in his symptoms and a score of "7" indicates that the subject feels his symptoms are "very much worse." The percentage of participants who reported a PGI-I score of 1 to 3 are presented in the table below.
Outcome measures
| Measure |
Tadalafil/Placebo
n=167 Participants
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=161 Participants
Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Percentage of Participants With Global Impression of Improvement (PGI-I)
|
61.1 percentage of participants
|
53.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I (DRAQ) measurement.
PGI-I (Drug Attributes Questionnaire \[DRAQ\]) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms.The DRAQ includes the following urinary symptoms: 1. Difficulty to void; 2. Frequent nighttime voiding; 3. Feeling of incomplete emptying; 4. Frequent daytime voiding; 5. Urinary urgency; 6. Taking a long time to urinate; 7. Need abdominal pressure to void; 8. Dribbling, leakage, and/or accidents. Each urinary symptom in the DRAQ will be evaluated by a participant using the PGI-I (discrete variables with seven categories) at the end of each treatment period, compared with how the symptom was before the participant's began taking medication in this study. The percentage of participants who reported a PGI-I (Drug Attributes Questionnaire) score of 1 to 3 are presented in the table below.
Outcome measures
| Measure |
Tadalafil/Placebo
n=167 Participants
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo/Tadalafil
n=161 Participants
Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Difficulty to void -
|
44.9 percentage of participants
|
37.9 percentage of participants
|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Frequent nighttime voiding
|
48.5 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Feeling of incomplete emptying
|
48.5 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Frequent daytime voiding
|
42.5 percentage of participants
|
37.9 percentage of participants
|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Urinary urgency
|
37.1 percentage of participants
|
31.7 percentage of participants
|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Taking a long time to urinate
|
42.5 percentage of participants
|
32.9 percentage of participants
|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Need abdominal pressure to void
|
33.5 percentage of participants
|
33.5 percentage of participants
|
|
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Dribbling, leakage, and/or accidents
|
26.9 percentage of participants
|
27.3 percentage of participants
|
Adverse Events
Tadalafil
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tadalafil
n=167 participants at risk
5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
Placebo
n=161 participants at risk
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
3/167 • Number of events 3
|
0.00%
0/161
|
|
Eye disorders
Conjunctival haemorrhage
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.4%
4/167 • Number of events 4
|
0.00%
0/161
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Colitis
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/167
|
1.2%
2/161 • Number of events 2
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
2/167 • Number of events 2
|
0.00%
0/161
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Nausea
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
Periodontal disease
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
General disorders
Chest discomfort
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Infections and infestations
Bronchitis
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
Impetigo
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
13/167 • Number of events 13
|
8.1%
13/161 • Number of events 13
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
Tinea cruris
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Infections and infestations
Tinea pedis
|
0.60%
1/167 • Number of events 1
|
0.62%
1/161 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
2/167 • Number of events 2
|
2.5%
4/161 • Number of events 4
|
|
Investigations
Blood pressure increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Investigations
Blood uric acid increased
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Investigations
Residual urine volume increased
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
3/167 • Number of events 3
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Nervous system disorders
Dizziness postural
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Nervous system disorders
Headache
|
1.2%
2/167 • Number of events 2
|
0.00%
0/161
|
|
Nervous system disorders
Hypoaesthesia
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Nervous system disorders
Neuropathy peripheral
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Renal and urinary disorders
Micturition urgency
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Renal and urinary disorders
Urinary retention
|
0.60%
1/167 • Number of events 1
|
0.62%
1/161 • Number of events 1
|
|
Reproductive system and breast disorders
Erection increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Reproductive system and breast disorders
Prostatitis
|
1.2%
2/167 • Number of events 2
|
0.00%
0/161
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Vascular disorders
Flushing
|
0.00%
0/167
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
|
Vascular disorders
Internal haemorrhage
|
0.60%
1/167 • Number of events 1
|
0.00%
0/161
|
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