Trial Outcomes & Findings for A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer (NCT NCT02499497)
NCT ID: NCT02499497
Last Updated: 2021-09-28
Results Overview
The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
12 weeks from baseline
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
The participants will receive 1 mg LY2452473 daily for 12-weeks.
N-\[(2S)-7-cyano-1,2,3,4-tetrahydro-4-(2-pyridinylmethyl)cyclopent\[b\]indol-2-yl\]-,1-methylester (LY2452473): LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
28
|
36
|
14
|
|
Overall Study
COMPLETED
|
32
|
22
|
35
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=28 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=14 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 6.1 • n=36 Participants
|
67.1 years
STANDARD_DEVIATION 7.87 • n=28 Participants
|
67.4 years
STANDARD_DEVIATION 8.6 • n=36 Participants
|
69.6 years
STANDARD_DEVIATION 7.1 • n=14 Participants
|
67.5 years
STANDARD_DEVIATION 7.5 • n=114 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=36 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=36 Participants
|
28 Participants
n=28 Participants
|
36 Participants
n=36 Participants
|
14 Participants
n=14 Participants
|
114 Participants
n=114 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
36 Participants
n=36 Participants
|
28 Participants
n=28 Participants
|
36 Participants
n=36 Participants
|
14 Participants
n=14 Participants
|
114 Participants
n=114 Participants
|
|
Weight
|
84.9 kg
STANDARD_DEVIATION 12.7 • n=36 Participants
|
92.7 kg
STANDARD_DEVIATION 10.7 • n=28 Participants
|
89.7 kg
STANDARD_DEVIATION 15.4 • n=36 Participants
|
86.7 kg
STANDARD_DEVIATION 12.5 • n=14 Participants
|
88.5 kg
STANDARD_DEVIATION 13.4 • n=114 Participants
|
|
Body Mass Index (BMI)
|
27.9 kg/m^2
STANDARD_DEVIATION 3.8 • n=36 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 3.89 • n=28 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=36 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=14 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 4.1 • n=114 Participants
|
|
Short Physical Performance Battery (SPPB) score
|
11.4 units on a scale
STANDARD_DEVIATION 1.15 • n=36 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 1.21 • n=28 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 1.42 • n=36 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 1.07 • n=14 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 1.24 • n=114 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=23 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=35 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)
|
0.04 units on a scale
Standard Error 0.19
|
0.45 units on a scale
Standard Error 0.26
|
-0.02 units on a scale
Standard Error 0.22
|
0.12 units on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=12 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in All Domains of International Index of Erectile Function (IIEF)
Erectile Function
|
2.34 units on a scale
Standard Error 1.02
|
0.92 units on a scale
Standard Error 0.48
|
-0.50 units on a scale
Standard Error 0.94
|
3.38 units on a scale
Standard Error 2.83
|
|
Change in All Domains of International Index of Erectile Function (IIEF)
Intercourse satisfaction
|
0.97 units on a scale
Standard Error 0.50
|
0.42 units on a scale
Standard Error 0.25
|
-0.22 units on a scale
Standard Error 0.39
|
0.92 units on a scale
Standard Error 1.59
|
|
Change in All Domains of International Index of Erectile Function (IIEF)
Orgasmic function
|
0.12 units on a scale
Standard Error 0.48
|
0.17 units on a scale
Standard Error 0.32
|
-0.53 units on a scale
Standard Error 0.57
|
0.75 units on a scale
Standard Error 0.85
|
|
Change in All Domains of International Index of Erectile Function (IIEF)
Sexual desire
|
0.30 units on a scale
Standard Error 0.22
|
0.46 units on a scale
Standard Error 0.38
|
-0.19 units on a scale
Standard Error 0.25
|
0.83 units on a scale
Standard Error 0.61
|
|
Change in All Domains of International Index of Erectile Function (IIEF)
Overall satisfaction
|
1.13 units on a scale
Standard Error 0.34
|
0.79 units on a scale
Standard Error 0.32
|
0.31 units on a scale
Standard Error 0.33
|
0.25 units on a scale
Standard Error 0.70
|
|
Change in All Domains of International Index of Erectile Function (IIEF)
Composite IIEF
|
4.79 units on a scale
Standard Error 1.96
|
2.73 units on a scale
Standard Error 1.28
|
-1.22 units on a scale
Standard Error 1.90
|
6.14 units on a scale
Standard Error 5.90
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The Sexual Activity, Interest, and Desire Scale (SAID) is an 8-item questionnaire that evaluates 3 response domains, including sexual thinking, sexual arousal, and sexual activity. The score was linearly transformed to a 0 to 100 scale for each item. The average score ranges 0-100. The higher the score, the better the sexual function.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=12 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Sexual Activity, Interest, and Desire Scale (SAID)
|
-0.67 units on a scale
Standard Error 2.36
|
4.25 units on a scale
Standard Error 2.85
|
-3.00 units on a scale
Standard Error 3.27
|
-1.50 units on a scale
Standard Error 4.67
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Derogatis Index of Sexual Function Male II (DISF-M-II) is a 25-item questionnaire that provides an estimate of perceived quality of sexual activities in 5 response domains: sexual desire/drive (range 0-33), sexual arousal (range 0-33), sexual activity (range 0-35), orgasm (range 0-26), and sexual satisfaction/partner relationship (range 0-25). The total possible score (sum of 5 domains) range of 0 to 152 with higher scores representing better function.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=23 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=12 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Sexual Desire
|
-0.88 units on a scale
Standard Error 0.89
|
0.87 units on a scale
Standard Error 1.63
|
-0.81 units on a scale
Standard Error 0.97
|
1.08 units on a scale
Standard Error 2.21
|
|
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Sexual Arousal
|
0.45 units on a scale
Standard Error 0.62
|
0.83 units on a scale
Standard Error 0.74
|
0.00 units on a scale
Standard Error 0.74
|
0.67 units on a scale
Standard Error 0.94
|
|
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Sexual Activity
|
-0.33 units on a scale
Standard Error 0.65
|
0.96 units on a scale
Standard Error 0.81
|
0.53 units on a scale
Standard Error 0.67
|
0.67 units on a scale
Standard Error 0.83
|
|
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Orgasm
|
0.55 units on a scale
Standard Error 0.82
|
0.57 units on a scale
Standard Error 0.84
|
-0.31 units on a scale
Standard Error 0.77
|
0.75 units on a scale
Standard Error 2.07
|
|
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Sexual Satisfaction
|
0.27 units on a scale
Standard Error 0.69
|
1.22 units on a scale
Standard Error 1.18
|
0.22 units on a scale
Standard Error 0.91
|
1.42 units on a scale
Standard Error 1.69
|
|
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Composite DISF-M-II
|
0.06 units on a scale
Standard Error 2.70
|
4.43 units on a scale
Standard Error 3.91
|
-0.36 units on a scale
Standard Error 3.26
|
4.58 units on a scale
Standard Error 5.98
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Men's Sexual Health Questionnaire (MSHQ), a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). Erection, Ejaculation and Satisfaction domains were measured and the higher score representing better sexual function and satisfaction.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
Erection
|
0.80 units on a scale
Standard Error 0.36
|
0.80 units on a scale
Standard Error 0.52
|
-0.65 units on a scale
Standard Error 0.48
|
1.30 units on a scale
Standard Error 0.45
|
|
Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
Ejaculation
|
1.34 units on a scale
Standard Error 1.15
|
2.38 units on a scale
Standard Error 1.72
|
-1.46 units on a scale
Standard Error 1.16
|
-1.55 units on a scale
Standard Error 3.26
|
|
Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
Satisfaction
|
1.03 units on a scale
Standard Error 0.58
|
0.98 units on a scale
Standard Error 0.85
|
-0.40 units on a scale
Standard Error 0.84
|
1.27 units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Expanded Prostate Cancer Index Composite (EPIC) is a 50-item, comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Of its four domains, the sexual domain (range 0-100) and hormonal domain (range 0-100) were utilized. The response for each item is standardized to a 0 to 100 scale. Higher score yields better quality of life.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)
Sexual function
|
1.86 units on a scale
Standard Error 2.14
|
3.68 units on a scale
Standard Error 3.04
|
0.08 units on a scale
Standard Error 2.52
|
5.77 units on a scale
Standard Error 3.90
|
|
Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)
Hormonal function
|
1.24 units on a scale
Standard Error 1.06
|
0.44 units on a scale
Standard Error 2.04
|
0.52 units on a scale
Standard Error 1.22
|
6.25 units on a scale
Standard Error 5.79
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
|
0.31 units on a scale
Standard Error 1.30
|
2.29 units on a scale
Standard Error 1.36
|
-0.36 units on a scale
Standard Error 1.28
|
0.26 units on a scale
Standard Error 1.47
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Hypogonadism Energy Diary (HED) is a 4-item questionnaire that intended to assess real-time energy levels. Score ranges 0 to100 with higher scores representing higher energy. each question uses an 11-point numerical rating scale (0-10) with 10 corresponding to full of energy or extreme tiredness. HED score was the average of the scores for these 4 items. Scores were linearly transformed to a 0 to 100 scale. Higher scores representing higher energy.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Hypogonadism Energy Diary (HED)
|
-0.45 units on a scale
Standard Error 2.78
|
2.71 units on a scale
Standard Error 2.82
|
2.64 units on a scale
Standard Error 3.42
|
1.73 units on a scale
Standard Error 5.07
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
International Prostate Symptom Score (IPSS) is a 8-item, extensively validated and widely used self-reported measure of lower urinary tract symptoms questionnaire. It includes Urinary Symptoms (item1-7, range 0-35) and Quality of Life Due to Urinary Symptoms (item 8, range 0-6). The higher the score, the severer of the urinary symptoms and worse quality of life due to symptoms.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in International Prostate Symptom Score (IPSS)
Urinary Symptoms
|
-0.30 units on a scale
Standard Error 0.59
|
-2.08 units on a scale
Standard Error 0.65
|
0.06 units on a scale
Standard Error 0.48
|
0.00 units on a scale
Standard Error 0.62
|
|
Change in International Prostate Symptom Score (IPSS)
Quality of Life Due to Urinary Symptoms
|
-0.13 units on a scale
Standard Error 0.13
|
-0.17 units on a scale
Standard Error 0.17
|
-0.03 units on a scale
Standard Error 0.18
|
-0.15 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (very slightly or not at all) to 5 (extremely). Score ranges 10-50 for both positive and negative affect. The higher scores represent higher levels of positive/negative affect.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Positive and Negative Affect Scale (PANAS)
Positive Affect
|
0.91 units on a scale
Standard Error 0.89
|
0.75 units on a scale
Standard Error 1.84
|
1.42 units on a scale
Standard Error 1.03
|
-0.77 units on a scale
Standard Error 0.89
|
|
Change in Positive and Negative Affect Scale (PANAS)
Negative Affect
|
-1.70 units on a scale
Standard Error 0.72
|
-1.38 units on a scale
Standard Error 0.58
|
0.42 units on a scale
Standard Error 0.58
|
-2.77 units on a scale
Standard Error 1.49
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Whole body, appendicular, and trunk lean mass were measured using dual energy X- ray absorptiometry (DXA), calibrated using a soft tissue phantom before each scan.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=34 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Body Mass Using DXA
Trunk Lean Mass
|
0.22 kg
Standard Error 0.12
|
0.20 kg
Standard Error 0.19
|
0.68 kg
Standard Error 0.19
|
0.88 kg
Standard Error 0.26
|
|
Change in Body Mass Using DXA
Appendicular Fat Mass
|
-0.06 kg
Standard Error 0.11
|
-0.19 kg
Standard Error 0.10
|
-0.36 kg
Standard Error 0.11
|
-0.13 kg
Standard Error 0.11
|
|
Change in Body Mass Using DXA
Trunk Fat Mass
|
-0.00 kg
Standard Error 0.14
|
-0.32 kg
Standard Error 0.18
|
-0.38 kg
Standard Error 0.16
|
-0.72 kg
Standard Error 0.19
|
|
Change in Body Mass Using DXA
Total Fat Mass
|
-0.05 kg
Standard Error 0.22
|
-0.52 kg
Standard Error 0.24
|
-0.75 kg
Standard Error 0.22
|
-0.86 kg
Standard Error 0.27
|
|
Change in Body Mass Using DXA
Appendicular Lean Mass
|
-0.04 kg
Standard Error 0.10
|
0.15 kg
Standard Error 0.13
|
0.80 kg
Standard Error 0.13
|
1.05 kg
Standard Error 0.23
|
|
Change in Body Mass Using DXA
Total Lean Mass
|
0.20 kg
Standard Error 0.16
|
0.33 kg
Standard Error 0.27
|
1.48 kg
Standard Error 0.28
|
1.92 kg
Standard Error 0.42
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=10 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=18 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=7 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Maximal Voluntary Muscle Strength
|
-12.6 N
Standard Error 55.0
|
108.1 N
Standard Error 56.8
|
48.1 N
Standard Error 29.4
|
103.5 N
Standard Error 37.1
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=20 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=31 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=10 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Gait Speed in 6-minute Walk
|
0.05 m/sec
Standard Error 0.02
|
0.07 m/sec
Standard Error 0.02
|
0.08 m/sec
Standard Error 0.02
|
0.05 m/sec
Standard Error 0.03
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. One test consisted of walking 50 meters as rapidly as possible without running (unloaded) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags(loaded). Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=21 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=32 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=11 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of 50 Meters Walk Tests- Unloaded /Loaded
Unloaded
|
0.06 m/sec
Standard Error 0.03
|
0.12 m/sec
Standard Error 0.04
|
0.03 m/sec
Standard Error 0.02
|
0.07 m/sec
Standard Error 0.06
|
|
Change of 50 Meters Walk Tests- Unloaded /Loaded
Loaded
|
0.05 m/sec
Standard Error 0.03
|
0.13 m/sec
Standard Error 0.05
|
0.05 m/sec
Standard Error 0.04
|
0.09 m/sec
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: \[body weight (kilograms) \* distance (meters)/ (time/60)\] /6.12.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=21 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=32 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=11 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Power of Stair Climbing Tests- Unloaded/Loaded
Loaded
|
0.22 watts
Standard Error 24.89
|
-36.6 watts
Standard Error 24.9
|
-9.8 watts
Standard Error 21.5
|
59.4 watts
Standard Error 42.3
|
|
Change in Power of Stair Climbing Tests- Unloaded/Loaded
Unloaded
|
12.8 watts
Standard Error 26.1
|
19.7 watts
Standard Error 19.6
|
1.8 watts
Standard Error 15.6
|
51.7 watts
Standard Error 21.9
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Serum total testosterone levels during screening was measured in the Quest Diagnostics Laboratory, Chantilly, VA, using liquid chromatography tandem mass spectrometry (LC-MS/MS) method certified by the Hormone Standardization Program for Testosterone (HoST) of the Centers for Disease Control and Prevention, Atlanta, Georgia.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Serum Total Testosterone Level
|
-6.5 ng/dL
Standard Error 15.8
|
-83.5 ng/dL
Standard Error 21.3
|
-172.3 ng/dL
Standard Error 27.6
|
-185.2 ng/dL
Standard Error 46.0
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Free testosterone level for screening was measured using an equilibrium dialysis method.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=22 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=35 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Free Testosterone Level
|
0.19 pg/mL
Standard Error 0.15
|
0.59 pg/mL
Standard Error 0.18
|
1.43 pg/mL
Standard Error 0.20
|
1.62 pg/mL
Standard Error 0.41
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Serum SHBG level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 2.5 nmol/L, and coefficients of variation less than 10% in low, medium and high range
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=21 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=35 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Serum Sex Hormone-binding Globulin (SHBG) Level
|
0.6 nmol/L
Standard Error 1.0
|
-9.6 nmol/L
Standard Error 1.3
|
-21.7 nmol/L
Standard Error 2.1
|
-24.2 nmol/L
Standard Error 5.5
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Serum LH level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 0.1 U/L, and coefficients of variation less than 10% in low, medium and high range
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=22 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=35 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Serum Luteinizing Hormone (LH) Level
|
0.23 mIU/mL
Standard Error 0.27
|
0.11 mIU/mL
Standard Error 0.23
|
0.72 mIU/mL
Standard Error 1.27
|
-0.42 mIU/mL
Standard Error 0.47
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Estradiol level was measured by LC-MS/MS.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=22 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=35 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Estradiol Levels
|
-0.2 pg/mL
Standard Error 1.5
|
-1.1 pg/mL
Standard Error 1.1
|
-5.5 pg/mL
Standard Error 1.1
|
-7.9 pg/mL
Standard Error 2.1
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
White Blood Cell was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of White Blood Cell
|
-0.24 K/uL
Standard Error 0.15
|
0.30 K/uL
Standard Error 0.29
|
-0.21 K/uL
Standard Error 0.19
|
0.32 K/uL
Standard Error 0.20
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Red Blood Cell was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Red Blood Cell
|
-0.08 K/uL
Standard Error 0.04
|
-0.05 K/uL
Standard Error 0.05
|
0.03 K/uL
Standard Error 0.03
|
0.06 K/uL
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Hematocrit was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Hematocrit
|
-0.61 percentage of volume of red cells
Standard Error 0.33
|
-0.30 percentage of volume of red cells
Standard Error 0.51
|
0.44 percentage of volume of red cells
Standard Error 0.25
|
0.11 percentage of volume of red cells
Standard Error 0.89
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Hemoglobin was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Hemoglobin
|
-0.32 g/dL
Standard Error 0.11
|
-0.12 g/dL
Standard Error 0.16
|
0.09 g/dL
Standard Error 0.09
|
-0.01 g/dL
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Mean corpuscular volume was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Mean Corpuscular Volume (MCV)
|
0.32 fL
Standard Error 0.30
|
0.44 fL
Standard Error 0.48
|
0.37 fL
Standard Error 0.31
|
-1.08 fL
Standard Error 0.84
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Red blood cell distribution width (RDW) was measured for safety monitoring. RDW was calculated with: standard deviation of the mean cell size divided by the mean corpuscular volume of the red cells multiplied by 100
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Red Blood Cell Distribution Width (RDW)
|
0.09 percentage of variation of red cells
Standard Error 0.14
|
-0.15 percentage of variation of red cells
Standard Error 0.22
|
0.18 percentage of variation of red cells
Standard Error 0.10
|
-0.44 percentage of variation of red cells
Standard Error 0.29
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Platelet count was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Platelet Count
|
0.67 K/uL
Standard Error 4.61
|
6.54 K/uL
Standard Error 5.13
|
13.5 K/uL
Standard Error 4.9
|
28.7 K/uL
Standard Error 4.1
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Aspartate aminotransferase was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Aspartate Aminotransferase (AST)
|
-1.24 U/L
Standard Error 0.67
|
-1.25 U/L
Standard Error 0.81
|
2.33 U/L
Standard Error 0.82
|
4.46 U/L
Standard Error 2.03
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Alanine aminotransferase was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Alanine Aminotransferase (ALT)
|
-1.36 U/L
Standard Error 0.89
|
-3.46 U/L
Standard Error 1.51
|
1.28 U/L
Standard Error 1.37
|
5.46 U/L
Standard Error 3.35
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Total Bilirubin was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Total Bilirubin
|
-0.13 mg/dL
Standard Error 0.03
|
-0.02 mg/dL
Standard Error 0.03
|
-0.16 mg/dL
Standard Error 0.05
|
-0.18 mg/dL
Standard Error 0.04
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Serum alkaline phosphatase was measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Serum Alkaline Phosphatase
|
-2.94 U/L
Standard Error 1.45
|
-2.83 U/L
Standard Error 1.55
|
-8.97 U/L
Standard Error 1.44
|
-14.1 U/L
Standard Error 3.2
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Plasma lipids were measured for safety monitoring.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=35 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change of Lipid Panel
HDL
|
-2.55 mg/dL
Standard Error 1.18
|
-4.38 mg/dL
Standard Error 1.21
|
-12.6 mg/dL
Standard Error 1.3
|
-14.6 mg/dL
Standard Error 3.0
|
|
Change of Lipid Panel
Total Cholesterol
|
-7.55 mg/dL
Standard Error 2.53
|
-15.1 mg/dL
Standard Error 5.8
|
-13.4 mg/dL
Standard Error 4.5
|
-14.9 mg/dL
Standard Error 7.9
|
|
Change of Lipid Panel
LDL
|
-6.00 mg/dL
Standard Error 2.10
|
-7.13 mg/dL
Standard Error 5.44
|
0.57 mg/dL
Standard Error 4.05
|
3.92 mg/dL
Standard Error 6.94
|
|
Change of Lipid Panel
Triglycerides
|
9.36 mg/dL
Standard Error 8.66
|
-23.5 mg/dL
Standard Error 7.4
|
-7.40 mg/dL
Standard Error 4.57
|
-31.7 mg/dL
Standard Error 24.5
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Glucose will be measured in a fasting serum sample at Quest Lab.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=24 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=13 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Fasting Glucose Levels
|
0.33 mg/dL
Standard Error 1.74
|
0.04 mg/dL
Standard Error 2.02
|
-2.78 mg/dL
Standard Error 1.44
|
-8.54 mg/dL
Standard Error 4.31
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Insulin will be measured using an immunoassay at Quest lab.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=11 Participants
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=16 Participants
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=3 Participants
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Change in Insulin
|
-0.17 uIU/mL
Standard Error 0.93
|
0.36 uIU/mL
Standard Error 1.52
|
-1.63 uIU/mL
Standard Error 0.68
|
-1.00 uIU/mL
Standard Error 0.50
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
LY2452473 Dose 1
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
LY2452473 Dose 2
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
LY2452473 Dose 3
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=28 participants at risk
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 participants at risk
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=14 participants at risk
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic ocular melanoma
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Renal and urinary disorders
Renal Cancer
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Placebo: The participants will receive pills containing no active drug daily for 12-weeks.
|
LY2452473 Dose 1
n=28 participants at risk
The participants will receive 1 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 2
n=36 participants at risk
The participants will receive 5 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
LY2452473 Dose 3
n=14 participants at risk
The participants will receive 15 mg LY2452473 daily for 12-weeks.
LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/36 • 12 weeks
|
7.1%
2/28 • Number of events 4 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
1/36 • Number of events 2 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • Number of events 2 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Dizziness
|
2.8%
1/36 • Number of events 3 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Endocrine disorders
Diabetes mellitus
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Endocrine disorders
Goitre
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Asthenopia
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Cataract
|
5.6%
2/36 • Number of events 3 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Diplopia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Iritis
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Lacrimation increased
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
3/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
2.8%
1/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
11.1%
4/36 • Number of events 5 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
General disorders
Decreased appetite
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
General disorders
Fatigue
|
13.9%
5/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
General disorders
Increased appetite
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
General disorders
Influenza like illness
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
General disorders
Night sweats
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.8%
1/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
General disorders
Pain
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
General disorders
Pyrexia
|
2.8%
1/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Immune system disorders
Hypersensitivity
|
2.8%
1/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Bronchitis
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Lyme Disease
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
5.6%
2/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
5.6%
2/36 • Number of events 3 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Infections and infestations
Skin infection
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
3/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.6%
2/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
2/36 • Number of events 3 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
21.4%
3/14 • Number of events 11 • 12 weeks
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • Number of events 3 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Hand injury
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Palate injury
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
7.1%
1/14 • Number of events 2 • 12 weeks
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • Number of events 3 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Investigations
Biopsy skin
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Investigations
Blood iron decreased
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Investigations
Breath sounds abnormal
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankle impingement
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
8.3%
3/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36 • 12 weeks
|
17.9%
5/28 • 12 weeks
|
5.6%
2/36 • Number of events 3 • 12 weeks
|
14.3%
2/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
1/36 • Number of events 2 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
7.1%
1/14 • Number of events 2 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
2/36 • Number of events 3 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
13.9%
5/36 • Number of events 8 • 12 weeks
|
14.3%
2/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer fatigue
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
2.8%
1/36 • Number of events 3 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • Number of events 2 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cyst
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cyst
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Nervous system disorders
Cognitive disorder
|
5.6%
2/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
3/36 • 12 weeks
|
14.3%
4/28 • 12 weeks
|
11.1%
4/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
1/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
3/36 • 12 weeks
|
17.9%
5/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
14.3%
2/14 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
13.9%
5/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
14.3%
2/14 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Abdominal pain
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • Number of events 2 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • Number of events 2 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
5.6%
2/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
7.1%
1/14 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.8%
1/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
5.6%
2/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Surgical and medical procedures
Cataract operation
|
2.8%
1/36 • Number of events 2 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
0.00%
0/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/36 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
2.8%
1/36 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
8.3%
3/36 • 12 weeks
|
7.1%
1/14 • 12 weeks
|
Additional Information
Dr. Shalender Bhasin, Principal Investigator
Brigham and Women's hospital
Phone: 617 525 9150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place