Trial Outcomes & Findings for Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients (NCT NCT00818623)
NCT ID: NCT00818623
Last Updated: 2023-11-30
Results Overview
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value \>0.5 ng/mL at Day 28 onwards.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
3 months
Results posted on
2023-11-30
Participant Flow
Participant milestones
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
12
|
13
|
24
|
27
|
24
|
27
|
27
|
|
Overall Study
Intent-to-treat (ITT) Population
|
25
|
12
|
12
|
24
|
24
|
24
|
24
|
27
|
|
Overall Study
COMPLETED
|
24
|
8
|
9
|
19
|
23
|
21
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
5
|
4
|
3
|
4
|
1
|
Reasons for withdrawal
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Bad prostate specific antigen response
|
0
|
3
|
2
|
5
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Need of additional treatment
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of trial drug at site
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=27 Participants
Degarelix 320 mg (60 mg/mL)
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Gleason score
5-6
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
43 participants
n=6 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
29 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
21 Participants
n=6 Participants
|
143 Participants
n=6 Participants
|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 3.97 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
74.3 years
STANDARD_DEVIATION 6.48 • n=4 Participants
|
71.5 years
STANDARD_DEVIATION 8.27 • n=21 Participants
|
73.1 years
STANDARD_DEVIATION 5.96 • n=10 Participants
|
71.7 years
STANDARD_DEVIATION 9.54 • n=115 Participants
|
71.1 years
STANDARD_DEVIATION 6.87 • n=6 Participants
|
71.9 years
STANDARD_DEVIATION 7.83 • n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
27 Participants
n=6 Participants
|
172 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
25 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
24 participants
n=4 Participants
|
24 participants
n=21 Participants
|
24 participants
n=10 Participants
|
24 participants
n=115 Participants
|
27 participants
n=6 Participants
|
172 participants
n=6 Participants
|
|
Curative intent
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=6 Participants
|
7 participants
n=6 Participants
|
|
Curative intent
No
|
25 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
21 participants
n=4 Participants
|
23 participants
n=21 Participants
|
24 participants
n=10 Participants
|
24 participants
n=115 Participants
|
26 participants
n=6 Participants
|
165 participants
n=6 Participants
|
|
Gleason score
0-1
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
|
Gleason score
2-4
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
2 participants
n=10 Participants
|
5 participants
n=115 Participants
|
12 participants
n=6 Participants
|
31 participants
n=6 Participants
|
|
Gleason score
7-10
|
17 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
16 participants
n=21 Participants
|
16 participants
n=10 Participants
|
13 participants
n=115 Participants
|
9 participants
n=6 Participants
|
98 participants
n=6 Participants
|
|
Stage of prostate cancer
Localized
|
10 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
6 participants
n=10 Participants
|
8 participants
n=115 Participants
|
14 participants
n=6 Participants
|
46 participants
n=6 Participants
|
|
Stage of prostate cancer
Locally advanced
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
8 participants
n=21 Participants
|
10 participants
n=10 Participants
|
5 participants
n=115 Participants
|
9 participants
n=6 Participants
|
63 participants
n=6 Participants
|
|
Stage of prostate cancer
Metastatic
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
12 participants
n=21 Participants
|
6 participants
n=10 Participants
|
10 participants
n=115 Participants
|
2 participants
n=6 Participants
|
52 participants
n=6 Participants
|
|
Stage of prostate cancer
Not classifiable
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=10 Participants
|
1 participants
n=115 Participants
|
2 participants
n=6 Participants
|
11 participants
n=6 Participants
|
|
Body mass index
|
26.2 kilgram per square meter
STANDARD_DEVIATION 2.97 • n=5 Participants
|
26.6 kilgram per square meter
STANDARD_DEVIATION 4.58 • n=7 Participants
|
26.3 kilgram per square meter
STANDARD_DEVIATION 3.74 • n=5 Participants
|
25.9 kilgram per square meter
STANDARD_DEVIATION 2.99 • n=4 Participants
|
24.5 kilgram per square meter
STANDARD_DEVIATION 2.92 • n=21 Participants
|
26.9 kilgram per square meter
STANDARD_DEVIATION 3.18 • n=10 Participants
|
24.8 kilgram per square meter
STANDARD_DEVIATION 2.72 • n=115 Participants
|
27.1 kilgram per square meter
STANDARD_DEVIATION 3.63 • n=6 Participants
|
26.0 kilgram per square meter
STANDARD_DEVIATION 3.32 • n=6 Participants
|
|
Serum prostate-specific antigen levels
|
42.5 nanogram per milliliter
n=5 Participants
|
58.8 nanogram per milliliter
n=7 Participants
|
109 nanogram per milliliter
n=5 Participants
|
32.3 nanogram per milliliter
n=4 Participants
|
46.9 nanogram per milliliter
n=21 Participants
|
31.0 nanogram per milliliter
n=10 Participants
|
31.9 nanogram per milliliter
n=115 Participants
|
23.8 nanogram per milliliter
n=6 Participants
|
37.9 nanogram per milliliter
n=6 Participants
|
|
Serum testosterone levels
|
4.30 nanogram per milliliter
n=5 Participants
|
3.10 nanogram per milliliter
n=7 Participants
|
3.02 nanogram per milliliter
n=5 Participants
|
4.64 nanogram per milliliter
n=4 Participants
|
5.60 nanogram per milliliter
n=21 Participants
|
4.02 nanogram per milliliter
n=10 Participants
|
4.46 nanogram per milliliter
n=115 Participants
|
3.68 nanogram per milliliter
n=6 Participants
|
4.16 nanogram per milliliter
n=6 Participants
|
|
Time since prostate cancer diagnosis
|
83.2 days
STANDARD_DEVIATION 157 • n=5 Participants
|
65.9 days
STANDARD_DEVIATION 53.5 • n=7 Participants
|
222 days
STANDARD_DEVIATION 328 • n=5 Participants
|
146 days
STANDARD_DEVIATION 298 • n=4 Participants
|
252 days
STANDARD_DEVIATION 560 • n=21 Participants
|
313 days
STANDARD_DEVIATION 837 • n=10 Participants
|
121 days
STANDARD_DEVIATION 425 • n=115 Participants
|
46.6 days
STANDARD_DEVIATION 54.4 • n=6 Participants
|
156 days
STANDARD_DEVIATION 439 • n=6 Participants
|
|
Weight
|
77.8 kilogram
STANDARD_DEVIATION 12.4 • n=5 Participants
|
82.2 kilogram
STANDARD_DEVIATION 12.1 • n=7 Participants
|
80.7 kilogram
STANDARD_DEVIATION 11.8 • n=5 Participants
|
78.2 kilogram
STANDARD_DEVIATION 13.7 • n=4 Participants
|
74.2 kilogram
STANDARD_DEVIATION 9.88 • n=21 Participants
|
81.5 kilogram
STANDARD_DEVIATION 10.7 • n=10 Participants
|
73.5 kilogram
STANDARD_DEVIATION 9.55 • n=115 Participants
|
81.7 kilogram
STANDARD_DEVIATION 11.1 • n=6 Participants
|
78.4 kilogram
STANDARD_DEVIATION 11.6 • n=6 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: ITT population.
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value \>0.5 ng/mL at Day 28 onwards.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Time From Dosing Until Testosterone Levels >0.5 ng/mL
|
84 days
Interval 63.0 to 119.0
|
63 days
Interval 28.0 to 133.0
|
70 days
Interval 28.0 to 98.0
|
140 days
Interval 112.0 to 147.0
|
84 days
Interval 35.0 to 112.0
|
140 days
Interval 112.0 to 182.0
|
87.5 days
Interval 28.0 to 140.0
|
133 days
Interval 91.0 to 154.0
|
SECONDARY outcome
Timeframe: Two - six monthsPopulation: ITT population.
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
|
21 participants
Interval 66.1 to 95.8
|
8 participants
Interval 33.7 to 86.0
|
6 participants
Interval 22.9 to 78.0
|
24 participants
Interval 85.8 to 100.0
|
18 participants
Interval 52.6 to 87.9
|
22 participants
Interval 72.9 to 99.4
|
15 participants
Interval 40.3 to 78.4
|
24 participants
Interval 69.4 to 96.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT population.
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
|
11 participants
Interval 25.6 to 64.0
|
4 participants
Interval 12.1 to 64.3
|
3 participants
Interval 8.3 to 60.6
|
20 participants
Interval 61.5 to 93.4
|
11 participants
Interval 28.3 to 67.4
|
18 participants
Interval 58.8 to 92.8
|
12 participants
Interval 29.1 to 67.8
|
19 participants
Interval 49.4 to 83.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT population
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.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
|
1 days
Interval 1.0 to 7.0
|
1 days
Interval 1.0 to 3.0
|
1.5 days
Interval 1.0 to 2.0
|
1.5 days
Interval 1.0 to 7.0
|
2 days
Interval 1.0 to 14.0
|
1.5 days
Interval 1.0 to 7.0
|
2 days
Interval 1.0 to 3.0
|
1 days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Time to 50% Reduction in Prostate-specific Antigen Levels
|
14 days
Interval 7.0 to 28.0
|
21 days
Interval 7.0 to 21.0
|
14 days
Interval 7.0 to 28.0
|
14 days
Interval 7.0 to 35.0
|
14 days
Interval 7.0 to 49.0
|
14 days
Interval 7.0 to 35.0
|
14 days
Interval 7.0 to 35.0
|
14 days
Interval 7.0 to 35.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Time to 90% Reduction in Prostate-specific Antigen Levels
|
31.5 days
Interval 14.0 to 56.0
|
35 days
Interval 21.0 to 91.0
|
42 days
Interval 28.0 to 70.0
|
35 days
Interval 14.0 to 98.0
|
28 days
Interval 14.0 to 63.0
|
42 days
Interval 21.0 to 112.0
|
35 days
Interval 14.0 to 77.0
|
45.5 days
Interval 21.0 to 112.0
|
SECONDARY outcome
Timeframe: 3 monthsThe figures presents 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 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Evaluation of Liver Function Tests
Abnormal alanine aminotransferase (ALAT)
|
9 participants
|
2 participants
|
3 participants
|
7 participants
|
8 participants
|
4 participants
|
6 participants
|
6 participants
|
|
Evaluation of Liver Function Tests
Abnormal aspartate aminotransferase
|
6 participants
|
3 participants
|
1 participants
|
4 participants
|
7 participants
|
3 participants
|
5 participants
|
5 participants
|
|
Evaluation of Liver Function Tests
Abnormal bilirubin
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Evaluation of Liver Function Tests
ALAT >3x ULN
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Evaluation of Liver Function Tests
ALAT >3x ULN, bilirubin >1.5x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.
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 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=24 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure >=105 and increase >=15
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure <=90 and decrease >=20
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 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
|
3 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate <=50 and decrease >=15
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 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
|
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
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight increase of >=7 percent
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
3 participants
|
1 participants
|
Adverse Events
Degarelix 120mg (20mg/mL)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Degarelix 120mg (40mg/mL)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Degarelix 160mg (40mg/mL)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Degarelix 200mg (40mg/mL)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Degarelix 200mg (60mg/mL)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Degarelix 240mg (40mg/mL)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Degarelix 240mg (60mg/mL)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Degarelix 320mg (60mg/mL)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Condition aggravated
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Oedema
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Gangrene
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Inervertebral disc protrusion
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Areflexia
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Psychiatric disorders
Depression
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Surgical and medical procedures
Amputation revision
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Vascular disorders
Hypertension
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
Other adverse events
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Nervousness
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Eye disorders
Cataract
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Eye disorders
Glaucoma
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site pain
|
4.0%
1/25 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site erythema
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Chills
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Feeling of body temperature change
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site induration
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site pruritus
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Oedema peripheral
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site swelling
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Urinary tract infection
|
12.0%
3/25 • Number of events 3
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Blood alkaline phosphatase increased
|
12.0%
3/25 • Number of events 3
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.0%
3/25 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
4/25 • Number of events 4
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Aspartate aminotransferase increased
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Blood pressure increased
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
7.4%
2/27 • Number of events 3
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Headache
|
0.00%
0/25
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/27
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
24.0%
6/25 • Number of events 6
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
20.8%
5/24 • Number of events 6
|
20.8%
5/24 • Number of events 5
|
20.8%
5/24 • Number of events 5
|
8.3%
2/24 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Vascular disorders
Hot flush
|
16.0%
4/25 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
25.0%
3/12 • Number of events 4
|
50.0%
12/24 • Number of events 12
|
25.0%
6/24 • Number of events 6
|
37.5%
9/24 • Number of events 9
|
16.7%
4/24 • Number of events 4
|
33.3%
9/27 • Number of events 9
|
|
Vascular disorders
Flushing
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
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