Trial Outcomes & Findings for Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer (NCT NCT01615120)
NCT ID: NCT01615120
Last Updated: 2021-03-24
Results Overview
The percentage of subjects with a 50% decline from baseline in serum PSA (confirmed by a second serum PSA assessment 30 days later) by Day 90 (with follow up confirmation by Day 120)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
120 days
Results posted on
2021-03-24
Participant Flow
Participant milestones
| Measure |
GTx-758 125mg
one GTx-758 tablet orally administered daily
GTx-758 125 mg: One 125 mg tablet once a day
|
GTx-758 250 mg
two GTx-758 tablets orally administered daily
GTx-758 250 mg: two 125 mg tablets once daily
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
39
|
|
Overall Study
COMPLETED
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer
Baseline characteristics by cohort
| Measure |
GTx-758 125mg
n=38 Participants
one GTx-758 tablet orally administered daily
GTx-758 125 mg: One 125 mg tablet once a day
|
GTx-758 250 mg
n=39 Participants
two GTx-758 tablets orally administered daily
GTx-758 250 mg: two 125 mg tablets once daily
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
69 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
21 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=5 Participants
|
18 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 daysThe percentage of subjects with a 50% decline from baseline in serum PSA (confirmed by a second serum PSA assessment 30 days later) by Day 90 (with follow up confirmation by Day 120)
Outcome measures
| Measure |
GTx-758 125mg
n=38 Participants
one GTx-758 tablet orally administered daily
GTx-758 125 mg: One 125 mg tablet once a day
|
GTx-758 250 mg
n=39 Participants
two GTx-758 tablets orally administered daily
GTx-758 250 mg: two 125 mg tablets once daily
|
|---|---|---|
|
Decline in Serum PSA
|
4 participants
|
10 participants
|
Adverse Events
GTx-758 125mg
Serious events: 1 serious events
Other events: 31 other events
Deaths: 1 deaths
GTx-758 250 mg
Serious events: 10 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
GTx-758 125mg
n=38 participants at risk
one GTx-758 tablet orally administered daily
GTx-758 125 mg: One 125 mg tablet once a day
|
GTx-758 250 mg
n=39 participants at risk
two GTx-758 tablets orally administered daily
GTx-758 250 mg: two 125 mg tablets once daily
|
|---|---|---|
|
Renal and urinary disorders
Acute pyelonephritis
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
acute renal failure
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
pulmonary embolism
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
acute myocardial infarction
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
venous thrombosis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
pulmonary artery stenosis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
dehydration
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
paraplegia
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
Other adverse events
| Measure |
GTx-758 125mg
n=38 participants at risk
one GTx-758 tablet orally administered daily
GTx-758 125 mg: One 125 mg tablet once a day
|
GTx-758 250 mg
n=39 participants at risk
two GTx-758 tablets orally administered daily
GTx-758 250 mg: two 125 mg tablets once daily
|
|---|---|---|
|
Surgical and medical procedures
CATARACT OPERATION
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
10.5%
4/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
CIRCUMCISION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
COLECTOMY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Blood and lymphatic system disorders
anemia
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Blood and lymphatic system disorders
bruising
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Blood and lymphatic system disorders
leukocytosis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Blood and lymphatic system disorders
lymph node calcification
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
acute coronary syndrome
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
angina
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
AV block, first degree
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
bradycardia
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
bundle branch block, right
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
cardiac aneurysm
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
congestive heart failure
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
cardiomegaly
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
coronary artery disease
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
left ventricular hypertrophy
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
myocardial infarction
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Cardiac disorders
ventricular extrasystoles
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Congenital, familial and genetic disorders
adenomatous polyposis coli
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Congenital, familial and genetic disorders
asplenia
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Ear and labyrinth disorders
deafness, bilateral
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Ear and labyrinth disorders
deafness, neurosensory
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Ear and labyrinth disorders
tinnitus
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Ear and labyrinth disorders
vertigo
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Endocrine disorders
adrenal mass
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Endocrine disorders
goiter
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Endocrine disorders
hyperthyroidism
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Endocrine disorders
hypogonadism
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Endocrine disorders
hypothyroidism
|
10.5%
4/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Eye disorders
cataracts
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Eye disorders
glaucoma
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Eye disorders
lacrimation increased
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Eye disorders
visual impairment
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Eye disorders
strabismus
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
abdominal hernia
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
abdominal pain
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
anal fissure
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
barrett's oesophagus
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
constipation
|
15.8%
6/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
diverticulum
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
dysphagia
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
gastric ulcer
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
gastroesophageal reflux
|
21.1%
8/38 • From time of screening to end of study, up to 4 years
|
20.5%
8/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
haematochezia
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
hemorrhoids
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
hiatus hernia
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
inguinal hernia
|
10.5%
4/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
intestinal cyst
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
irritable bowl syndrome
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
74.4%
29/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
large intestine polyp
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
nausea
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
peptic ulcer
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
rectal stenosis
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
poor dental condition
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Gastrointestinal disorders
vomiting
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
asthenia
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
chest pain
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
chills
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
fatigue
|
18.4%
7/38 • From time of screening to end of study, up to 4 years
|
10.3%
4/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
foaming at mouth
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
oedema peripheral
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
pain
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
polyp
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
General disorders
xerosis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Hepatobiliary disorders
cholelelithiasis
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Hepatobiliary disorders
hepatic cyst
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Hepatobiliary disorders
hepatic steatosis
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Immune system disorders
allergy to venom
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Immune system disorders
drug hypersensitivity
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Immune system disorders
seasonal allergy
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
acarodermatitis
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
acute sinusitis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
cystitis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
diverticulitis
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
echinococciasis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
fungal skin infection
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
herpes virus infection
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
herpes zoster
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
labyrinthitis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
sinusitis
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
upper respiratory tract infection
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Infections and infestations
urinary tract infection
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
back injury
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
clavicle fracture
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
facial bones fracture
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
forearm fracture
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
hip fracture
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
humerus fracture
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
infection related reaction
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
jaw fracture
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
joint injury
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
limb injury
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
pelvic fracture
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
rib fracture
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
road traffic accident
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
skeletal injury
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
spinal compression fracture
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
tendon rupture
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Injury, poisoning and procedural complications
wrist fracture
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
ARTHROSCOPY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
cardiac murmur
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
COMPUTERISED TOMOGRAM ABNORMAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
GLUCOSE URINE PRESENT
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
HEART RATE IRREGULAR
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
PROSTATE EXAMINATION ABNORMAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
URINE KETONE BODY PRESENT
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
VISUAL TRACKING TEST ABNORMAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
WEIGHT DECREASED
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
10.3%
4/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
28.9%
11/38 • From time of screening to end of study, up to 4 years
|
15.4%
6/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
13.2%
5/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
IMPAIRED FASTING GLUCOSE
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
13.2%
5/38 • From time of screening to end of study, up to 4 years
|
10.3%
4/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
VITAMIN B12 DEFICIENCY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
10.3%
4/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
18.4%
7/38 • From time of screening to end of study, up to 4 years
|
10.3%
4/39 • From time of screening to end of study, up to 4 years
|
|
Metabolism and nutrition disorders
BACK PAIN
|
15.8%
6/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
JUVENILE IDIOPATHIC ARTHRITIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
KYPHOSCOLIOSIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
OSTEITIS DEFORMANS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
18.4%
7/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
10.5%
4/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOSCLEROSIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL DISORDER
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA IN SITU
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MESOTHELIOMA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
DEMENTIA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
DIABETIC NEUROPATHY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
DIZZINESS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
DYSGEUSIA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
ESSENTIAL TREMOR
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
GUILLAIN-BARRE SYNDROME
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
HEADACHE
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
MIGRAINE
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
PARAESTHESIA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
PIRIFORMIS SYNDROME
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
RADICULOPATHY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Nervous system disorders
VERTEBROBASILAR INSUFFICIENCY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
ANXIETY
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
CLAUSTROPHOBIA
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
DEPRESSION
|
15.8%
6/38 • From time of screening to end of study, up to 4 years
|
10.3%
4/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
DRUG ABUSE
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
INSOMNIA
|
15.8%
6/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
LIBIDO DECREASED
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
MIDDLE INSOMNIA
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Psychiatric disorders
PSYCHOTIC DISORDER DUE TO GENERA MEDICAL CONDITION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
BLADDER DIVERTICULUM
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
BLADDER NECK OBSTRUCTION
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
CHROMATURIA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
DYSURIA
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
HAEMATURIA
|
10.5%
4/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
HYPERTONIC BLADDER
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
LOWER URINARY TRACT SYMPTOMS
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
NOCTURIA
|
36.8%
14/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
POLLAKIURIA
|
21.1%
8/38 • From time of screening to end of study, up to 4 years
|
10.3%
4/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
TERMINAL DRIBBLING
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
URINARY HESITATION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
10.5%
4/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
URINE FLOW DECREASED
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
URINE ODOUR ABNORMAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
BALANITIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
13.2%
5/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
BREAST PAIN
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
44.7%
17/38 • From time of screening to end of study, up to 4 years
|
12.8%
5/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
PROSTATE INDURATION
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL CYST
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY GRANULOMA
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Skin and subcutaneous tissue disorders
SOLAR DERMATITIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
ABDOMINAL HERNIA REPAIR
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
APPENDICECTOMY
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
ARTIFICIAL URINARY SPHINCTER IMPLANT
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
BLADDER CALCULUS REMOVAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
BLADDER NEOPLASM SURGERY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
CYST REMOVAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
DEBRIDEMENT
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
DUODENAL ULCER REPAIR
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
FRACTURE TREATMENT
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
GASTRIC ULCER SURGERY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
HAEMORRHOID OPERATION
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
HERNIA REPAIR
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • Number of events 1 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
HIP SURGERY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
INGUINAL HERNIA REPAIR
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
JOINT DISLOCATION REDUCTION
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
KNEE OPERATION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
OPEN REDUCTION OF FRACTURE
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
RETINAL OPERATION
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
CHONDROPLASTY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
SKIN NEOPLASM EXCISION
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
SPINAL FUSION SURGERY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
SPINAL LAMINECTOMY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
STENT PLACEMENT
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
TENDON OPERATION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
THYROIDECTOMY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
TONSILLECTOMY
|
7.9%
3/38 • From time of screening to end of study, up to 4 years
|
7.7%
3/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
TYMPANOPLASTY
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
URETHROTOMY
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
VARICOSE VEIN OPERATION
|
0.00%
0/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
VASECTOMY
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
5.1%
2/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
WISDOM TEETH REMOVAL
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
AORTIC ANEURYSM
|
5.3%
2/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Surgical and medical procedures
AORTIC DISSECTION
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
2.6%
1/39 • From time of screening to end of study, up to 4 years
|
|
Vascular disorders
EMBOLISM
|
2.6%
1/38 • From time of screening to end of study, up to 4 years
|
0.00%
0/39 • From time of screening to end of study, up to 4 years
|
|
Vascular disorders
HOT FLUSH
|
26.3%
10/38 • From time of screening to end of study, up to 4 years
|
28.2%
11/39 • From time of screening to end of study, up to 4 years
|
|
Vascular disorders
HYPERTENSION
|
63.2%
24/38 • From time of screening to end of study, up to 4 years
|
59.0%
23/39 • From time of screening to end of study, up to 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place