Trial Outcomes & Findings for Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients (NCT NCT00117312)
NCT ID: NCT00117312
Last Updated: 2011-05-23
Results Overview
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
3 years
Results posted on
2011-05-23
Participant Flow
Participants who responded to degarelix in FE200486 CS06 (NCT00117949) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the US or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS06.
Participant milestones
| Measure |
Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
|
Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
|
Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
|
Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
24
|
24
|
24
|
|
Overall Study
Started FE200486 CS06A
|
1
|
11
|
16
|
9
|
|
Overall Study
COMPLETED
|
0
|
4
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
20
|
24
|
21
|
Reasons for withdrawal
| Measure |
Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
|
Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
|
Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
|
Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
|
|---|---|---|---|---|
|
Overall Study
Testosterone >1.0 ng/mL
|
9
|
9
|
5
|
9
|
|
Overall Study
Testosterone 0.5 - 1.0 ng/mL
|
1
|
0
|
3
|
2
|
|
Overall Study
Prostate-specific antigen increase >=25%
|
0
|
1
|
5
|
3
|
|
Overall Study
Other
|
0
|
1
|
3
|
1
|
|
Overall Study
Patient choice
|
0
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
3
|
0
|
|
Overall Study
PSA decrease <=50%
|
0
|
2
|
2
|
4
|
|
Overall Study
PSA increase >= 10ng/mL
|
0
|
1
|
1
|
0
|
|
Overall Study
Hepatic abnormality
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Degarelix 40 mg
n=10 Participants
Degarelix 40 mg (10 mg/mL)
|
Degarelix 80 mg
n=24 Participants
Degarelix 80 mg (20 mg/mL)
|
Degarelix 120 mg
n=24 Participants
Degarelix 120 mg (30 mg/mL)
|
Degarelix 160 mg
n=24 Participants
Degarelix 160 mg (40 mg/mL)
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
74 Participants
n=36 Participants
|
|
Age Continuous
|
72.0 years
STANDARD_DEVIATION 5.72 • n=93 Participants
|
77.5 years
STANDARD_DEVIATION 6.38 • n=4 Participants
|
75.9 years
STANDARD_DEVIATION 5.79 • n=27 Participants
|
74.7 years
STANDARD_DEVIATION 8.37 • n=483 Participants
|
75.6 years
STANDARD_DEVIATION 6.90 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
82 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
1 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 participants
n=93 Participants
|
23 participants
n=4 Participants
|
15 participants
n=27 Participants
|
20 participants
n=483 Participants
|
63 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
7 participants
n=27 Participants
|
3 participants
n=483 Participants
|
13 participants
n=36 Participants
|
|
Gleason score
Unknown
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Gleason score
2-4
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
3 participants
n=36 Participants
|
|
Gleason score
5-6
|
3 participants
n=93 Participants
|
14 participants
n=4 Participants
|
12 participants
n=27 Participants
|
13 participants
n=483 Participants
|
42 participants
n=36 Participants
|
|
Gleason score
7-10
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
11 participants
n=27 Participants
|
11 participants
n=483 Participants
|
36 participants
n=36 Participants
|
|
Stage of prostate cancer
Localized
|
5 participants
n=93 Participants
|
11 participants
n=4 Participants
|
12 participants
n=27 Participants
|
10 participants
n=483 Participants
|
38 participants
n=36 Participants
|
|
Stage of prostate cancer
Locally advanced
|
0 participants
n=93 Participants
|
6 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
16 participants
n=36 Participants
|
|
Stage of prostate cancer
Metastatic
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Stage of prostate cancer
Not classifiable
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
7 participants
n=483 Participants
|
18 participants
n=36 Participants
|
|
Body mass index
|
26.7 kilogram per square meter
STANDARD_DEVIATION 5.66 • n=93 Participants
|
26.6 kilogram per square meter
STANDARD_DEVIATION 3.54 • n=4 Participants
|
27.2 kilogram per square meter
STANDARD_DEVIATION 3.15 • n=27 Participants
|
26.6 kilogram per square meter
STANDARD_DEVIATION 3.39 • n=483 Participants
|
26.8 kilogram per square meter
STANDARD_DEVIATION 3.64 • n=36 Participants
|
|
Time since prostate cancer diagnosis
|
851 days
STANDARD_DEVIATION 1077 • n=93 Participants
|
954 days
STANDARD_DEVIATION 1329 • n=4 Participants
|
1609 days
STANDARD_DEVIATION 1836 • n=27 Participants
|
1095 days
STANDARD_DEVIATION 1385 • n=483 Participants
|
1181 days
STANDARD_DEVIATION 1494 • n=36 Participants
|
|
Weight
|
79.0 kilogram
STANDARD_DEVIATION 11.7 • n=93 Participants
|
81.7 kilogram
STANDARD_DEVIATION 11.5 • n=4 Participants
|
80.8 kilogram
STANDARD_DEVIATION 12.8 • n=27 Participants
|
81.4 kilogram
STANDARD_DEVIATION 14.4 • n=483 Participants
|
81.0 kilogram
STANDARD_DEVIATION 12.6 • n=36 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Outcome measures
| Measure |
Degarelix 40 mg
n=10 Participants
Degarelix 40 mg (10 mg/mL)
|
Degarelix 80 mg
n=24 Participants
Degarelix 80 mg (20 mg/mL)
|
Degarelix 120 mg
n=24 Participants
Degarelix 120 mg (30 mg/mL)
|
Degarelix 160 mg
n=24 Participants
Degarelix 160 mg (40 mg/mL)
|
|---|---|---|---|---|
|
Liver Function Tests
Abnormal alanine aminotransferase (ALAT)
|
0 participants
|
4 participants
|
5 participants
|
6 participants
|
|
Liver Function Tests
Abnormal aspartate aminotransferase
|
1 participants
|
13 participants
|
18 participants
|
9 participants
|
|
Liver Function Tests
Abnormal bilirubin
|
2 participants
|
0 participants
|
4 participants
|
2 participants
|
|
Liver Function Tests
ALAT >3x ULN
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Liver Function Tests
ALAT >3x ULN, bilirubin >1.5x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
Outcome measures
| Measure |
Degarelix 40 mg
n=10 Participants
Degarelix 40 mg (10 mg/mL)
|
Degarelix 80 mg
n=24 Participants
Degarelix 80 mg (20 mg/mL)
|
Degarelix 120 mg
n=24 Participants
Degarelix 120 mg (30 mg/mL)
|
Degarelix 160 mg
n=24 Participants
Degarelix 160 mg (40 mg/mL)
|
|---|---|---|---|---|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure >=105 and increase >=15
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure <=90 and decrease >=20
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure >=180 and increase >=20
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate <=50 and decrease >=15
|
0 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate >=120 and increase >=15
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight decrease of >=7 percent
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight increase of >=7 percent
|
0 participants
|
1 participants
|
6 participants
|
1 participants
|
Adverse Events
Degarelix 40 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Degarelix 80 mg
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Degarelix 120 mg
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
Degarelix 160 mg
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
|
Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
|
Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
|
Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
|
|---|---|---|---|---|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/10
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Investigations
Blood potassium increased
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Chest pain
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
Other adverse events
| Measure |
Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
|
Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
|
Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
|
Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
20.8%
5/24 • Number of events 8
|
0.00%
0/24
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
16.7%
4/24 • Number of events 4
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
16.7%
4/24 • Number of events 4
|
0.00%
0/24
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/10
|
12.5%
3/24 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
12.5%
3/24 • Number of events 4
|
0.00%
0/24
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
12.5%
3/24 • Number of events 4
|
|
General disorders
Injection site pruritus
|
0.00%
0/10
|
16.7%
4/24 • Number of events 4
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Injection site pain
|
0.00%
0/10
|
12.5%
3/24 • Number of events 4
|
12.5%
3/24 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Chest pain
|
0.00%
0/10
|
12.5%
3/24 • Number of events 7
|
0.00%
0/24
|
0.00%
0/24
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10
|
12.5%
3/24 • Number of events 3
|
12.5%
3/24 • Number of events 4
|
12.5%
3/24 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10
|
12.5%
3/24 • Number of events 8
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10
|
12.5%
3/24 • Number of events 4
|
0.00%
0/24
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
Investigations
Weight increased
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/10
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10
|
8.3%
2/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
12.5%
3/24 • Number of events 4
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10
|
8.3%
2/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10
|
12.5%
3/24 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/10
|
16.7%
4/24 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular atrophy
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10
|
8.3%
2/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10
|
8.3%
2/24 • Number of events 4
|
0.00%
0/24
|
0.00%
0/24
|
|
Vascular disorders
Hot flush
|
20.0%
2/10 • Number of events 2
|
58.3%
14/24 • Number of events 16
|
25.0%
6/24 • Number of events 8
|
20.8%
5/24 • Number of events 5
|
|
Vascular disorders
Hypertension
|
0.00%
0/10
|
0.00%
0/24
|
16.7%
4/24 • Number of events 4
|
0.00%
0/24
|
|
Eye disorders
Diabetic retinopathy
|
10.0%
1/10 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
Investigations
Breath sounds abnormal
|
10.0%
1/10 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 3
|
12.5%
3/24 • Number of events 4
|
|
Renal and urinary disorders
Urine flow decreased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
- Publication restrictions are in place
Restriction type: OTHER