Trial Outcomes & Findings for Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 (NCT NCT00117949)
NCT ID: NCT00117949
Last Updated: 2011-05-23
Results Overview
Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone \>1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
3 months
Results posted on
2011-05-23
Participant Flow
The patients were followed until they met a pre-defined criterion for insufficient testosterone or prostate-specific antigen (PSA).
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
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
24
|
24
|
24
|
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
|
10
|
18
|
17
|
15
|
|
Overall Study
Testosterone 0.5 - 1.0 ng/mL
|
0
|
1
|
3
|
2
|
|
Overall Study
Prostate-specific antigen increase >=25%
|
0
|
1
|
1
|
2
|
|
Overall Study
PSA increase >=10ng/mL
|
0
|
1
|
1
|
0
|
|
Overall Study
PSA reduction <=50%
|
0
|
2
|
2
|
4
|
|
Overall Study
Hepatic abnormalities
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
74 Participants
n=390 Participants
|
|
Age Continuous
|
72.0 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
77.5 years
STANDARD_DEVIATION 6.4 • n=107 Participants
|
75.9 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
74.7 years
STANDARD_DEVIATION 8.4 • n=157 Participants
|
75.6 years
STANDARD_DEVIATION 6.9 • n=390 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
82 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Oriental/Asian
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=157 Participants
|
0 participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=157 Participants
|
6 participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 participants
n=99 Participants
|
23 participants
n=107 Participants
|
15 participants
n=206 Participants
|
20 participants
n=157 Participants
|
63 participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
7 participants
n=206 Participants
|
3 participants
n=157 Participants
|
13 participants
n=390 Participants
|
|
Gleason score
Unknown
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=157 Participants
|
1 participants
n=390 Participants
|
|
Gleason score
2-4
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=157 Participants
|
3 participants
n=390 Participants
|
|
Gleason score
5-6
|
3 participants
n=99 Participants
|
14 participants
n=107 Participants
|
12 participants
n=206 Participants
|
13 participants
n=157 Participants
|
42 participants
n=390 Participants
|
|
Gleason score
7-10
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
11 participants
n=206 Participants
|
11 participants
n=157 Participants
|
36 participants
n=390 Participants
|
|
Stage of prostate cancer
Localized
|
5 participants
n=99 Participants
|
11 participants
n=107 Participants
|
12 participants
n=206 Participants
|
10 participants
n=157 Participants
|
38 participants
n=390 Participants
|
|
Stage of prostate cancer
Locally advanced
|
0 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
5 participants
n=157 Participants
|
16 participants
n=390 Participants
|
|
Stage of prostate cancer
Metastatic
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=157 Participants
|
10 participants
n=390 Participants
|
|
Stage of prostate cancer
Not classifiable
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
7 participants
n=157 Participants
|
18 participants
n=390 Participants
|
|
Body mass index
|
26.70 kilogram per square meter
STANDARD_DEVIATION 5.72 • n=99 Participants
|
26.61 kilogram per square meter
STANDARD_DEVIATION 3.55 • n=107 Participants
|
27.22 kilogram per square meter
STANDARD_DEVIATION 3.16 • n=206 Participants
|
26.64 kilogram per square meter
STANDARD_DEVIATION 3.38 • n=157 Participants
|
26.70 kilogram per square meter
STANDARD_DEVIATION 5.72 • n=390 Participants
|
|
Serum prostate-specific antigen levels
|
9.30 nanogram per milliliter
n=99 Participants
|
13.40 nanogram per milliliter
n=107 Participants
|
9.10 nanogram per milliliter
n=206 Participants
|
6.40 nanogram per milliliter
n=157 Participants
|
9.35 nanogram per milliliter
n=390 Participants
|
|
Serum testosterone levels
|
3.98 nanogram per milliliter
n=99 Participants
|
4.10 nanogram per milliliter
n=107 Participants
|
3.96 nanogram per milliliter
n=206 Participants
|
3.89 nanogram per milliliter
n=157 Participants
|
3.93 nanogram per milliliter
n=390 Participants
|
|
Time since prostate cancer diagnosis
|
851 days
STANDARD_DEVIATION 1077 • n=99 Participants
|
954 days
STANDARD_DEVIATION 1328 • n=107 Participants
|
1609 days
STANDARD_DEVIATION 1836 • n=206 Participants
|
1095 days
STANDARD_DEVIATION 1385 • n=157 Participants
|
1181 days
STANDARD_DEVIATION 1494 • n=390 Participants
|
|
Weight
|
78.97 kilogram
STANDARD_DEVIATION 11.73 • n=99 Participants
|
81.73 kilogram
STANDARD_DEVIATION 11.50 • n=107 Participants
|
80.77 kilogram
STANDARD_DEVIATION 12.83 • n=206 Participants
|
81.40 kilogram
STANDARD_DEVIATION 14.36 • n=157 Participants
|
81.01 kilogram
STANDARD_DEVIATION 12.61 • n=390 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).
Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone \>1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
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)
|
|---|---|---|---|---|
|
Time to Meet Insufficient Testosterone Response
|
14 days
Interval 14.0 to 70.0
|
77 days
Interval 14.0 to 140.0
|
98 days
Interval 14.0 to 219.0
|
28 days
Interval 14.0 to 126.0
|
PRIMARY outcome
Timeframe: 28 daysThe number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
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)
|
|---|---|---|---|---|
|
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
|
1 participants
Interval 0.3 to 44.5
|
17 participants
Interval 48.9 to 87.4
|
19 participants
Interval 57.8 to 92.9
|
13 participants
Interval 32.8 to 74.4
|
SECONDARY outcome
Timeframe: 1, 3, 7, 14, 21, 28, 42 daysPopulation: Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made.
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
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)
|
|---|---|---|---|---|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
21 days
|
0 days
|
1 days
|
0 days
|
0 days
|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
28 days
|
0 days
|
1 days
|
0 days
|
0 days
|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
42 days
|
0 days
|
1 days
|
0 days
|
0 days
|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
1 day
|
1 days
Interval 3.0 to
|
3 days
Interval 3.0 to 7.0
|
11 days
Interval 1.0 to 3.0
|
6 days
|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
3 days
|
3 days
|
12 days
|
12 days
|
14 days
|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
7 days
|
1 days
|
2 days
|
0 days
|
1 days
|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
14 days
|
0 days
|
2 days
|
0 days
|
0 days
|
SECONDARY outcome
Timeframe: 3 monthsSufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone \>1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
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)
|
|---|---|---|---|---|
|
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
|
0 participants
Interval 0.0 to 0.0
|
9 participants
Interval 22.0 to 63.4
|
14 participants
Interval 41.8 to 81.3
|
7 participants
Interval 15.8 to 55.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
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)
|
|---|---|---|---|---|
|
Time to 50% Reduction in Prostate-specific Antigen Levels
|
10.5 days
Interval 7.0 to 14.0
|
14 days
Interval 7.0 to 42.0
|
14 days
Interval 7.0 to 35.0
|
14 days
Interval 7.0 to 42.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
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)
|
|---|---|---|---|---|
|
Time to 90% Reduction in Prostate-specific Antigen Levels
|
28 days
Interval 28.0 to 28.0
|
35 days
Interval 28.0 to 98.0
|
35 days
Interval 28.0 to 84.0
|
31.5 days
Interval 14.0 to 56.0
|
SECONDARY outcome
Timeframe: 3 monthsThe number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas 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
|
3 participants
|
3 participants
|
6 participants
|
|
Liver Function Tests
Abnormal aspartate aminotransferase
|
1 participants
|
11 participants
|
13 participants
|
9 participants
|
|
Liver Function Tests
Abnormal bilirubin
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Liver Function Tests
ALAT >3x upper limit of normal (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
|
Adverse Events
Degarelix 40 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Degarelix 80 mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Degarelix 120 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Degarelix 160 mg
Serious events: 0 serious events
Other events: 13 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)
|
|---|---|---|---|---|
|
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
|
0.00%
0/24
|
12.5%
3/24 • 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
Diarrhoea
|
0.00%
0/10
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
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
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
General disorders
Injection site pain
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
12.5%
3/24 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Injection site pruritus
|
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
|
8.3%
2/24 • Number of events 4
|
0.00%
0/24
|
0.00%
0/24
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
|
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
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/10
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
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
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
|
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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10
|
8.3%
2/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
|
Vascular disorders
Hot flush
|
20.0%
2/10 • Number of events 2
|
50.0%
12/24 • Number of events 12
|
20.8%
5/24 • Number of events 6
|
20.8%
5/24 • Number of events 5
|
|
Vascular disorders
Hypertension
|
0.00%
0/10
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
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