Trial Outcomes & Findings for A Study in Men With Benign Prostatic Hyperplasia (NCT NCT01097707)
NCT ID: NCT01097707
Last Updated: 2019-04-08
Results Overview
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) with an IPSS Total Score range of 0-35 points. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
414 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2019-04-08
Participant Flow
Participant milestones
| Measure |
1 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
Placebo
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
80
|
82
|
84
|
85
|
|
Overall Study
COMPLETED
|
39
|
37
|
37
|
40
|
35
|
|
Overall Study
NOT COMPLETED
|
44
|
43
|
45
|
44
|
50
|
Reasons for withdrawal
| Measure |
1 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
LY500307: Administered orally, daily for 24 weeks
|
Placebo
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Abnormal Lab/Electrocardiogram Result
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
4
|
2
|
3
|
1
|
3
|
|
Overall Study
Entry Criteria Not Met
|
2
|
1
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
0
|
3
|
|
Overall Study
Protocol Violation
|
2
|
2
|
3
|
2
|
2
|
|
Overall Study
Sponsor Decision
|
31
|
31
|
34
|
35
|
36
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
1
|
4
|
3
|
|
Overall Study
Reason unknown
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study in Men With Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
1 mg LY500307
n=83 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=80 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=82 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=84 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=85 Participants
Placebo: Administered orally, daily for 24 weeks
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.97 years
STANDARD_DEVIATION 7.55 • n=5 Participants
|
67.67 years
STANDARD_DEVIATION 7.34 • n=7 Participants
|
67.21 years
STANDARD_DEVIATION 7.10 • n=5 Participants
|
63.18 years
STANDARD_DEVIATION 7.34 • n=4 Participants
|
64.11 years
STANDARD_DEVIATION 7.92 • n=21 Participants
|
65.80 years
STANDARD_DEVIATION 7.64 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
414 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
402 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
394 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
209 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Region of Enrollment
Greece
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline IPSS total score measurement.
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) with an IPSS Total Score range of 0-35 points. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
1 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=47 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=50 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=45 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
|
-1.34 units on a scale
Standard Deviation 6.56
|
-2.61 units on a scale
Standard Deviation 7.00
|
-3.68 units on a scale
Standard Deviation 6.69
|
-4.38 units on a scale
Standard Deviation 5.68
|
-3.44 units on a scale
Standard Deviation 6.82
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline TPV measurement.
The TPV measurement (milliliters) by transrectal ultrasound (TRUS) is an established diagnostic test for men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Outcome measures
| Measure |
1 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=46 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=49 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=44 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)
|
1.6 percentage change in TPV
Standard Deviation 22.7
|
-4.5 percentage change in TPV
Standard Deviation 15.6
|
-6.7 percentage change in TPV
Standard Deviation 17.2
|
1.3 percentage change in TPV
Standard Deviation 20.6
|
-6.6 percentage change in TPV
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline Qmax measurement.
Qmax is defined as the peak urine flow rate measured using standard calibrated uroflowmeter.
Outcome measures
| Measure |
1 mg LY500307
n=40 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=36 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=41 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=38 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=37 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)
|
0.76 milliliters/second (mL/sec)
Standard Deviation 3.60
|
1.53 milliliters/second (mL/sec)
Standard Deviation 4.47
|
0.87 milliliters/second (mL/sec)
Standard Deviation 2.95
|
0.11 milliliters/second (mL/sec)
Standard Deviation 3.51
|
1.32 milliliters/second (mL/sec)
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline IPSS-QoL measurement.
IPSS QoL assesses participant's 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.
Outcome measures
| Measure |
1 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=48 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=50 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=45 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)
|
-0.27 units on a scale
Standard Deviation 1.25
|
-0.75 units on a scale
Standard Deviation 1.28
|
-0.60 units on a scale
Standard Deviation 1.18
|
-0.82 units on a scale
Standard Deviation 1.21
|
-0.71 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline IPSS subscores measurement.
IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with a total subscore of the 3 questions for irritative subscore ranging 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 a total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Nocturia Subscore is IPSS Question 7, which assesses how many times over the last month a participant gets up to urinate from the time they went to bed at night until the time they got up in the morning. Scores range from 0=None; 1=1 time; 2= 2 times; 3=3 times; 4=4 times; 5=5 or more times.
Outcome measures
| Measure |
1 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=44 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=48 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=50 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=45 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores
IPSS storage subscore
|
-0.73 units on a scale
Standard Deviation 3.49
|
-0.82 units on a scale
Standard Deviation 3.66
|
-1.64 units on a scale
Standard Deviation 3.19
|
-1.86 units on a scale
Standard Deviation 2.92
|
-1.47 units on a scale
Standard Deviation 3.35
|
|
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores
IPSS voiding subscore
|
-0.61 units on a scale
Standard Deviation 3.69
|
-1.80 units on a scale
Standard Deviation 4.81
|
-2.04 units on a scale
Standard Deviation 4.09
|
-2.52 units on a scale
Standard Deviation 3.72
|
-1.98 units on a scale
Standard Deviation 4.34
|
|
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores
IPSS Nocturia subscore
|
-0.23 units on a scale
Standard Deviation 1.34
|
-0.16 units on a scale
Standard Deviation 1.49
|
-0.54 units on a scale
Standard Deviation 1.20
|
-0.54 units on a scale
Standard Deviation 1.58
|
-0.47 units on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline PSA measurement.
The units of PSA measurement are nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
1 mg LY500307
n=55 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=59 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=59 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=65 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=56 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)
|
18.81 percentage change in PSA
Standard Deviation 47.00
|
6.62 percentage change in PSA
Standard Deviation 31.55
|
14.34 percentage change in PSA
Standard Deviation 36.30
|
5.66 percentage change in PSA
Standard Deviation 27.32
|
8.65 percentage change in PSA
Standard Deviation 50.67
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline fasting total testosterone measurement.
Outcome measures
| Measure |
1 mg LY500307
n=54 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=57 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=59 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=63 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=57 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone
|
-12.5 nanogram/deciliter (ng/dL)
Standard Deviation 166.4
|
-1.3 nanogram/deciliter (ng/dL)
Standard Deviation 129.6
|
-24.9 nanogram/deciliter (ng/dL)
Standard Deviation 112.2
|
24.6 nanogram/deciliter (ng/dL)
Standard Deviation 136.7
|
-14.6 nanogram/deciliter (ng/dL)
Standard Deviation 122.7
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants who had baseline and one post-baseline lipid measurement.
The lipid profile consisted of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.
Outcome measures
| Measure |
1 mg LY500307
n=55 Participants
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=59 Participants
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=60 Participants
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=65 Participants
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=58 Participants
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to 24-Week Endpoint in Lipid Profile
Triglyceride
|
3.91 milligram/deciliter (mg/dL)
Standard Deviation 103.66
|
-0.71 milligram/deciliter (mg/dL)
Standard Deviation 45.84
|
6.61 milligram/deciliter (mg/dL)
Standard Deviation 62.33
|
-2.15 milligram/deciliter (mg/dL)
Standard Deviation 66.69
|
2.23 milligram/deciliter (mg/dL)
Standard Deviation 62.99
|
|
Change From Baseline to 24-Week Endpoint in Lipid Profile
LDL-C
|
-0.4 milligram/deciliter (mg/dL)
Standard Deviation 22.5
|
-1.8 milligram/deciliter (mg/dL)
Standard Deviation 20.3
|
-1.1 milligram/deciliter (mg/dL)
Standard Deviation 27.3
|
-12.6 milligram/deciliter (mg/dL)
Standard Deviation 87.7
|
3.6 milligram/deciliter (mg/dL)
Standard Deviation 21.9
|
|
Change From Baseline to 24-Week Endpoint in Lipid Profile
HDL-C
|
-0.98 milligram/deciliter (mg/dL)
Standard Deviation 5.93
|
1.11 milligram/deciliter (mg/dL)
Standard Deviation 6.83
|
0.42 milligram/deciliter (mg/dL)
Standard Deviation 9.31
|
1.23 milligram/deciliter (mg/dL)
Standard Deviation 7.13
|
0.16 milligram/deciliter (mg/dL)
Standard Deviation 7.63
|
Adverse Events
1 mg LY500307
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
3 mg LY500307
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
10 mg LY500307
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
25 mg LY500307
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg LY500307
n=83 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=80 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=82 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=84 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=85 participants at risk
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Infections and infestations
Abscess neck
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Infections and infestations
Cellulitis
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Infections and infestations
Perirectal abscess
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Investigations
Residual urine volume increased
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
Other adverse events
| Measure |
1 mg LY500307
n=83 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
3 mg LY500307
n=80 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
10 mg LY500307
n=82 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
25 mg LY500307
n=84 participants at risk
LY500307: Administered orally, daily for 24 weeks
|
Placebo
n=85 participants at risk
Placebo: Administered orally, daily for 24 weeks
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/83
|
0.00%
0/80
|
2.4%
2/82 • Number of events 2
|
0.00%
0/84
|
0.00%
0/85
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Eye disorders
Eye inflammation
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Eye disorders
Eye irritation
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Eye disorders
Vision blurred
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/83 • Number of events 1
|
2.5%
2/80 • Number of events 2
|
0.00%
0/82
|
0.00%
0/84
|
2.4%
2/85 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
2.4%
2/85 • Number of events 2
|
|
Gastrointestinal disorders
Colonic polyp
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
1.2%
1/85 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/83 • Number of events 1
|
3.8%
3/80 • Number of events 3
|
2.4%
2/82 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
2.4%
2/85 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
3/83 • Number of events 3
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
4/83 • Number of events 4
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
2.4%
2/85 • Number of events 2
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 3
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
2.4%
2/85 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/83 • Number of events 2
|
1.2%
1/80 • Number of events 1
|
2.4%
2/82 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
2.4%
2/85 • Number of events 2
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
2.4%
2/85 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
2.4%
2/84 • Number of events 2
|
0.00%
0/85
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/83 • Number of events 1
|
2.5%
2/80 • Number of events 2
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Asthenia
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Chest pain
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
General disorders
Fatigue
|
1.2%
1/83 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
3.7%
3/82 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
|
General disorders
Feeling abnormal
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Influenza like illness
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Oedema peripheral
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/83
|
2.5%
2/80 • Number of events 2
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Pyrexia
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Therapeutic response unexpected
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Thirst
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Infections and infestations
Ear infection
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
2.4%
2/85 • Number of events 2
|
|
Infections and infestations
Eye infection
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Infected dermal cyst
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Infections and infestations
Influenza
|
0.00%
0/83
|
2.5%
2/80 • Number of events 2
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
4.9%
4/82 • Number of events 5
|
6.0%
5/84 • Number of events 6
|
7.1%
6/85 • Number of events 6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.2%
1/83 • Number of events 2
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
1.2%
1/83 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Infections and infestations
Tooth infection
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
2/83 • Number of events 2
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
1.2%
1/84 • Number of events 2
|
1.2%
1/85 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 2
|
1.2%
1/85 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Injury, poisoning and procedural complications
Deafness traumatic
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Investigations
Blood glucose increased
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Investigations
Blood luteinising hormone decreased
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Investigations
Blood pressure decreased
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.00%
0/83
|
2.5%
2/80 • Number of events 2
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Investigations
Blood urine present
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Investigations
Prostatic specific antigen increased
|
2.4%
2/83 • Number of events 2
|
3.8%
3/80 • Number of events 3
|
1.2%
1/82 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
0.00%
0/85
|
|
Investigations
Protein urine
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Investigations
Qrs axis abnormal
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Investigations
Semen analysis abnormal
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Investigations
Weight decreased
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
3.5%
3/85 • Number of events 3
|
|
Investigations
Weight increased
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Investigations
White blood cells urine
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
1.2%
1/85 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/83
|
2.5%
2/80 • Number of events 2
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/83
|
1.2%
1/80 • Number of events 2
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Nervous system disorders
Dizziness
|
3.6%
3/83 • Number of events 3
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
1.2%
1/84 • Number of events 2
|
3.5%
3/85 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Nervous system disorders
Headache
|
0.00%
0/83
|
2.5%
2/80 • Number of events 4
|
1.2%
1/82 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
2.4%
2/85 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Nervous system disorders
Lethargy
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Nervous system disorders
Sciatica
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
2.4%
2/84 • Number of events 2
|
1.2%
1/85 • Number of events 1
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Renal and urinary disorders
Calculus urethral
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
2.4%
2/84 • Number of events 2
|
1.2%
1/85 • Number of events 1
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Micturition urgency
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/83 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Renal and urinary disorders
Nocturia
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Pollakiuria
|
2.4%
2/83 • Number of events 2
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/83
|
1.2%
1/80 • Number of events 2
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Epididymal tenderness
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
2.4%
2/84 • Number of events 2
|
2.4%
2/85 • Number of events 2
|
|
Reproductive system and breast disorders
Genital rash
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Retrograde ejaculation
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
4/83 • Number of events 4
|
6.2%
5/80 • Number of events 5
|
1.2%
1/82 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
2.4%
2/85 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 4
|
0.00%
0/84
|
0.00%
0/85
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 2
|
0.00%
0/85
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
2.4%
2/84 • Number of events 3
|
0.00%
0/85
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/83
|
2.5%
2/80 • Number of events 2
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.4%
2/83 • Number of events 2
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/83
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Vascular disorders
Haematoma
|
0.00%
0/83
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Vascular disorders
Hot flush
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Vascular disorders
Hypertension
|
1.2%
1/83 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Vascular disorders
Hypotension
|
1.2%
1/83 • Number of events 1
|
0.00%
0/80
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/85
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/83
|
0.00%
0/80
|
1.2%
1/82 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
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