Trial Outcomes & Findings for Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer (NCT NCT01326312)
NCT ID: NCT01326312
Last Updated: 2023-06-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
60 days
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
GTx 758 1000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
55
|
51
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
53
|
55
|
51
|
Reasons for withdrawal
| Measure |
GTx 758 1000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
11
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
13
|
7
|
1
|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
progressive disease
|
0
|
1
|
1
|
|
Overall Study
Study terminated by Sponsor
|
8
|
32
|
46
|
|
Overall Study
Treatment arm terminated
|
19
|
0
|
0
|
|
Overall Study
QTc > 500
|
0
|
1
|
0
|
Baseline Characteristics
Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
Baseline characteristics by cohort
| Measure |
GTx-758 1000mg
n=53 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
n=55 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
n=51 Participants
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
68 years
n=7 Participants
|
69 years
n=5 Participants
|
68 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
55 participants
n=7 Participants
|
51 participants
n=5 Participants
|
159 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Per-Protocol Population
Outcome measures
| Measure |
GTx- 758 1000mg
n=32 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
n=40 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
n=45 Participants
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
|---|---|---|---|
|
Number of Participants Who Are Castrate by Day 60
|
19 participants
|
34 participants
|
43 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Castrate Population
Outcome measures
| Measure |
GTx- 758 1000mg
n=19 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
n=34 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
n=43 Participants
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
|---|---|---|---|
|
Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study.
|
0 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Per-Protocol Population
Median time to castration was summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
GTx- 758 1000mg
n=32 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
n=40 Participants
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
n=45 Participants
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
|---|---|---|---|
|
Time to Castration in Participants With Prostate Cancer
|
29 days
Interval 14.0 to 62.0
|
21 days
Interval 7.0 to 68.0
|
21 days
Interval 13.0 to 42.0
|
Adverse Events
GTx- 758 1000mg
Serious events: 11 serious events
Other events: 46 other events
Deaths: 1 deaths
GTx-758 2000mg
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Lupron Depot
Serious events: 4 serious events
Other events: 48 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
GTx- 758 1000mg
n=53 participants at risk
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758 2000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
n=55 participants at risk
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758 1000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
n=51 participants at risk
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
|---|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
3.8%
2/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
Cardiac Arrest
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.7%
3/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Metabolism and nutrition disorders
Hypnonatraemia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
Lung Infection
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Bone
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.8%
2/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Cardiac disorders
Sinus Bradycardia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
Other adverse events
| Measure |
GTx- 758 1000mg
n=53 participants at risk
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758 2000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
GTx-758 2000mg
n=55 participants at risk
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758 1000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
Lupron Depot
n=51 participants at risk
Luteinizing Hormone Releasing Hormone Agonist
Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
|
|---|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
1.9%
1/53 • 1 year
|
5.5%
3/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
acute coronary syndrome
|
7.5%
4/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
angina
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
right bundle branch block
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
cardiac arrest
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
conduction disorder
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
coronary artery occlusion
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
left ventricular dysfunction
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
mitral valve disease
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
myocardial infarction
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
sinus bradycardia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Cardiac disorders
sinus tachycardia
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Cardiac disorders
ventricular arrhythmia
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Ear and labyrinth disorders
vertigo
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Endocrine disorders
hypothyroidism
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Eye disorders
conjunctival hemorrhage
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Eye disorders
conjuntivitis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Eye disorders
visual acuity reduced
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Eye disorders
vitreous floaters
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
abdominal distension
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
abdominal pain
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
abdominal pain, upper
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
colonic polyp
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
constipation
|
1.9%
1/53 • 1 year
|
7.3%
4/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
13.2%
7/53 • 1 year
|
16.4%
9/55 • 1 year
|
7.8%
4/51 • 1 year
|
|
Gastrointestinal disorders
diverticulum
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/53 • 1 year
|
5.5%
3/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
dyspepsia
|
11.3%
6/53 • 1 year
|
9.1%
5/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
gastritis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
GI pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
hemmorhoidal hemmorhage
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
hemorrhoids
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
impaired gastric emptying
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
large intestinal ulcer
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
lip swelling
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
nausea
|
13.2%
7/53 • 1 year
|
5.5%
3/55 • 1 year
|
7.8%
4/51 • 1 year
|
|
Gastrointestinal disorders
oral pain
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
rectal discharge
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
swollen tongue
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
tooth ache
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Gastrointestinal disorders
vomiting
|
5.7%
3/53 • 1 year
|
5.5%
3/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
General disorders
chest pain
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
General disorders
chills
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
General disorders
fatigue
|
11.3%
6/53 • 1 year
|
14.5%
8/55 • 1 year
|
17.6%
9/51 • 1 year
|
|
General disorders
influenza like illness
|
0.00%
0/53 • 1 year
|
7.3%
4/55 • 1 year
|
7.8%
4/51 • 1 year
|
|
General disorders
infusion site pain
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
General disorders
injection site reaction
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
General disorders
irritability
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
General disorders
localized edema
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
General disorders
non cardiac chest pain
|
3.8%
2/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
General disorders
edema, peripheral
|
3.8%
2/53 • 1 year
|
5.5%
3/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
General disorders
pyrexia
|
7.5%
4/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
General disorders
vessel puncture site hematoma
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Hepatobiliary disorders
hepatobiliary disease
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Immune system disorders
hypersensitivity
|
3.8%
2/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
bronchitis
|
3.8%
2/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
cellulitis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
eye infection
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
gingival infection
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
laryngitis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
lung infection
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
nail infection
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
nasopharyngitis
|
3.8%
2/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
oral herpes
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
otitis externa
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
pharyngitis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Infections and infestations
pneumonia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
sinusitis
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Infections and infestations
skin infections
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
tooth infections
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
upper respiratory tract infections
|
5.7%
3/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
urinary tract infections
|
7.5%
4/53 • 1 year
|
9.1%
5/55 • 1 year
|
5.9%
3/51 • 1 year
|
|
Infections and infestations
urosepsis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
contusion
|
3.8%
2/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
excoriation
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
fall
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Injury, poisoning and procedural complications
procedural pain
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
radiation associated pain
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Injury, poisoning and procedural complications
recall phenomenon
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Injury, poisoning and procedural complications
spinal column injury
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Investigations
alanine aminotransferase increase
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Investigations
aspartate aminotransferase increase
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Investigations
blood alkaline phosphatase increase
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Investigations
blood bilirubin increase
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Investigations
blood creatinine increase
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Investigations
gamma-glutamyltransferase increase
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Investigations
troponin-I increase
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Investigations
weight decreased
|
1.9%
1/53 • 1 year
|
5.5%
3/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Investigations
weight increased
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
9.8%
5/51 • 1 year
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Investigations
dehydration
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Metabolism and nutrition disorders
hyperlipidemia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Metabolism and nutrition disorders
hypokalemia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Metabolism and nutrition disorders
hyponatremia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Metabolism and nutrition disorders
increased appetite
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Metabolism and nutrition disorders
iron overload
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Metabolism and nutrition disorders
vitamin D deficiency
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
3.8%
2/53 • 1 year
|
1.8%
1/55 • 1 year
|
7.8%
4/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.9%
1/53 • 1 year
|
5.5%
3/55 • 1 year
|
9.8%
5/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
exostosis
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
groin pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
joint effusion
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
joint range of motion decreased
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
5.7%
3/53 • 1 year
|
7.3%
4/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
neck mass
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
3.8%
2/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
7.5%
4/53 • 1 year
|
3.6%
2/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pathological fracture
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hepatic cancer, metastatic
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lipoma
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastases to bone
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
seborrheic keratosis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
amnesia
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
dizziness
|
3.8%
2/53 • 1 year
|
10.9%
6/55 • 1 year
|
9.8%
5/51 • 1 year
|
|
Nervous system disorders
dysgeusia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Nervous system disorders
headache
|
3.8%
2/53 • 1 year
|
9.1%
5/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
lethargy
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Nervous system disorders
neuralgia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Nervous system disorders
paraesthesia
|
5.7%
3/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
parosmia
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Nervous system disorders
radiculitis
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
sinus headache
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
somnolence
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Nervous system disorders
syncope
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
tremor
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Psychiatric disorders
anxiety
|
3.8%
2/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Psychiatric disorders
confusional state
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Psychiatric disorders
depression
|
1.9%
1/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Psychiatric disorders
hallucination
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Psychiatric disorders
insomnia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Psychiatric disorders
libido decreased
|
0.00%
0/53 • 1 year
|
5.5%
3/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Psychiatric disorders
mood swings
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
azotemia
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
bladder spasm
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
calculus ureteric
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
cystitis noninfective
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
hematuria
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Renal and urinary disorders
lower urinary tract symptoms
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
micturition urgency
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
nocturia
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
pollakiuria
|
3.8%
2/53 • 1 year
|
10.9%
6/55 • 1 year
|
7.8%
4/51 • 1 year
|
|
Renal and urinary disorders
renal failure
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
renal pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
terminal dribbling
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
urinary hesitation
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
urinary incontinence
|
3.8%
2/53 • 1 year
|
1.8%
1/55 • 1 year
|
5.9%
3/51 • 1 year
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
urinary tract pain
|
3.8%
2/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
urinary flow decreased
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
breast discharge
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
breast discomfort
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
breast pain
|
28.3%
15/53 • 1 year
|
38.2%
21/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
breast tenderness
|
1.9%
1/53 • 1 year
|
7.3%
4/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
ejaculation disorder
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
erectile dysfunction
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Reproductive system and breast disorders
gynecomastia
|
9.4%
5/53 • 1 year
|
7.3%
4/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Reproductive system and breast disorders
nipple pain
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
edema, genital
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
pelvic pain
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
perineal erythema
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
prostatic obstruction
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
testicular atrophy
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Reproductive system and breast disorders
testicular pain
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.9%
1/53 • 1 year
|
9.1%
5/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.8%
2/53 • 1 year
|
9.1%
5/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
1.9%
1/53 • 1 year
|
3.6%
2/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
5.7%
3/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary infarction
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis, allergic
|
1.9%
1/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
upper airway cough syndrome
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
actinic keratosis
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
angioedema
|
0.00%
0/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermatitis, allergic
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermatitis, atopic
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/53 • 1 year
|
5.5%
3/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
lentigo
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
onychoclasis
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
photosensitivity reaction
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
pruritus
|
3.8%
2/53 • 1 year
|
0.00%
0/55 • 1 year
|
3.9%
2/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
rash, maculo-papular
|
5.7%
3/53 • 1 year
|
5.5%
3/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
swelling face
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Skin and subcutaneous tissue disorders
urticaria
|
1.9%
1/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Vascular disorders
deep vein thrombosis
|
15.1%
8/53 • 1 year
|
3.6%
2/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Vascular disorders
hot flush
|
28.3%
15/53 • 1 year
|
20.0%
11/55 • 1 year
|
76.5%
39/51 • 1 year
|
|
Vascular disorders
hypotension
|
0.00%
0/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Vascular disorders
lymphedema
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Vascular disorders
orthostatic hypotension
|
0.00%
0/53 • 1 year
|
0.00%
0/55 • 1 year
|
2.0%
1/51 • 1 year
|
|
Vascular disorders
thrombophlebitis
|
1.9%
1/53 • 1 year
|
0.00%
0/55 • 1 year
|
0.00%
0/51 • 1 year
|
|
Vascular disorders
thrombophlebitis, superficial
|
1.9%
1/53 • 1 year
|
1.8%
1/55 • 1 year
|
0.00%
0/51 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place