Trial Outcomes & Findings for Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients (NCT NCT00245466)
NCT ID: NCT00245466
Last Updated: 2011-05-20
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
88 participants
Primary outcome timeframe
3 years
Results posted on
2011-05-20
Participant Flow
Participants who responded to degarelix in FE200486 CS02 (NCT00819247) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the UK or until the study was discontinued.
Participant milestones
| Measure |
Degarelix 80/80 + 40
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
46
|
40
|
|
Overall Study
Started FE200486 CS02A
|
32
|
30
|
26
|
|
Overall Study
COMPLETED
|
7
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
36
|
44
|
37
|
Reasons for withdrawal
| Measure |
Degarelix 80/80 + 40
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
8
|
4
|
|
Overall Study
Low prostate specific antigen suppr
|
16
|
14
|
5
|
|
Overall Study
Insufficient testosterone suppr
|
12
|
12
|
21
|
|
Overall Study
Insufficient PSA and testosterone suppr
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
|
Overall Study
Disease progression
|
0
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
2
|
|
Overall Study
Death
|
0
|
2
|
0
|
|
Overall Study
Administrative reasons
|
0
|
1
|
0
|
Baseline Characteristics
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Degarelix 80/80 + 40
n=43 Participants
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
n=46 Participants
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
n=40 Participants
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Age Continuous
|
72.4 years
STANDARD_DEVIATION 6.60 • n=5 Participants
|
73.7 years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
71.8 years
STANDARD_DEVIATION 7.08 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 6.97 • 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
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
42 participants
n=5 Participants
|
43 participants
n=7 Participants
|
37 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Afro-Carribean
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Gleason score
Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Gleason score
2-4
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Gleason score
5-6
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Gleason score
7-10
|
28 participants
n=5 Participants
|
34 participants
n=7 Participants
|
26 participants
n=5 Participants
|
88 participants
n=4 Participants
|
|
Number of Participants With Curative Intent
Yes
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Number of Participants With Curative Intent
No
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
39 participants
n=5 Participants
|
126 participants
n=4 Participants
|
|
Number of Participants at Each Stage of Prostate Cancer
Localized
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Number of Participants at Each Stage of Prostate Cancer
Locally advanced
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
18 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Number of Participants at Each Stage of Prostate Cancer
Metastatic
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
17 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Number of Participants at Each Stage of Prostate Cancer
Not classifiable
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Body mass index
|
26.6 kilogram per square meter
STANDARD_DEVIATION 4.15 • n=5 Participants
|
26.6 kilogram per square meter
STANDARD_DEVIATION 4.06 • n=7 Participants
|
25.9 kilogram per square meter
STANDARD_DEVIATION 3.93 • n=5 Participants
|
26.4 kilogram per square meter
STANDARD_DEVIATION 3.93 • n=4 Participants
|
|
Serum testosterone levels
|
3.74 nanogram per milliliter
n=5 Participants
|
4.11 nanogram per milliliter
n=7 Participants
|
4.70 nanogram per milliliter
n=5 Participants
|
3.98 nanogram per milliliter
n=4 Participants
|
|
Weight
|
77.6 kilogram
STANDARD_DEVIATION 11.4 • n=5 Participants
|
78.5 kilogram
STANDARD_DEVIATION 14.2 • n=7 Participants
|
76.3 kilogram
STANDARD_DEVIATION 9.78 • n=5 Participants
|
77.5 kilogram
STANDARD_DEVIATION 12.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.
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 80/80 + 40
n=43 Participants
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
n=46 Participants
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
n=40 Participants
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
|---|---|---|---|
|
Liver Function Tests
Abnormal alanine aminotransferase (ALAT)
|
18 participants
|
16 participants
|
16 participants
|
|
Liver Function Tests
Abnormal aspartate aminotransferase
|
23 participants
|
22 participants
|
17 participants
|
|
Liver Function Tests
Abnormal bilirubin
|
3 participants
|
4 participants
|
5 participants
|
|
Liver Function Tests
ALAT >3x ULN
|
2 participants
|
2 participants
|
1 participants
|
|
Liver Function Tests
ALAT >3x ULN, bilirubin >1.5x ULN
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).
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 patients in each group with normal baseline and markedly abnormal value post-baseline.
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=43 Participants
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
n=46 Participants
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
n=40 Participants
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
|---|---|---|---|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
1 participants
|
0 participants
|
2 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure >=105 and increase >=15
|
0 participants
|
2 participants
|
0 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
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure >=180 and increase >=20
|
8 participants
|
7 participants
|
1 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate <=50 and decrease >=15
|
0 participants
|
1 participants
|
2 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate >=120 and increase >=15
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight decrease of >=7 percent
|
5 participants
|
4 participants
|
5 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight increase of >=7 percent
|
17 participants
|
14 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Degarelix 80/80 + 40
n=43 Participants
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
n=46 Participants
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
n=40 Participants
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
|---|---|---|---|
|
Serum Levels of Testosterone After 1, 2, and 3 Years
1 year (n=25,17,14)
|
0.120 nanogram per milliliter
Interval 0.025 to 0.345
|
0.086 nanogram per milliliter
Interval 0.025 to 0.372
|
0.170 nanogram per milliliter
Interval 0.025 to 0.68
|
|
Serum Levels of Testosterone After 1, 2, and 3 Years
2 years (n=16,9,8)
|
0.143 nanogram per milliliter
Interval 0.025 to 0.805
|
0.133 nanogram per milliliter
Interval 0.025 to 0.557
|
0.305 nanogram per milliliter
Interval 0.064 to 0.454
|
|
Serum Levels of Testosterone After 1, 2, and 3 Years
3 years (n=8,5,6)
|
0.104 nanogram per milliliter
Interval 0.05 to 0.171
|
0.132 nanogram per milliliter
Interval 0.025 to 0.22
|
0.198 nanogram per milliliter
Interval 0.05 to 0.391
|
Adverse Events
Degarelix 80/80 + 40
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Degarelix 40/40 + 40
Serious events: 14 serious events
Other events: 40 other events
Deaths: 0 deaths
Degarelix 80 + 20
Serious events: 10 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 80/80 + 40
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Confusional state
|
2.3%
1/43 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/43
|
6.5%
3/46 • Number of events 5
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis fibrosing
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Social circumstances
Convalescent
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Surgical and medical procedures
Suprapubic catheter insertion
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Angina pectoris
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
2.3%
1/43 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43
|
2.2%
1/46 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Asthenia
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Catheter related complication
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Condition aggravated
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Sepsis
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Arthraligia
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Syncope
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Depression
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Alcoholism
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.3%
1/43 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Chest pain
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Cellulitis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Cerebrovascular accident
|
4.7%
2/43 • Number of events 2
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Hemiparesis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Nervous system disorders
Lethargy
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/43
|
2.2%
1/46 • Number of events 2
|
0.00%
0/40
|
Other adverse events
| Measure |
Degarelix 80/80 + 40
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 40/40 + 40
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
Degarelix 80 + 20
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
2/43 • Number of events 2
|
6.5%
3/46 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43
|
6.5%
3/46 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.6%
5/43 • Number of events 5
|
10.9%
5/46 • Number of events 6
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
20.9%
9/43 • Number of events 17
|
6.5%
3/46 • Number of events 3
|
7.5%
3/40 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/43 • Number of events 4
|
6.5%
3/46 • Number of events 3
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43
|
6.5%
3/46 • Number of events 3
|
0.00%
0/40
|
|
General disorders
Oedema peripheral
|
9.3%
4/43 • Number of events 4
|
15.2%
7/46 • Number of events 9
|
2.5%
1/40 • Number of events 2
|
|
General disorders
Influenza like illness
|
7.0%
3/43 • Number of events 8
|
4.3%
2/46 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Malaise
|
7.0%
3/43 • Number of events 4
|
0.00%
0/46
|
0.00%
0/40
|
|
Infections and infestations
Lower respiratory tract infection
|
14.0%
6/43 • Number of events 7
|
13.0%
6/46 • Number of events 13
|
7.5%
3/40 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
16.3%
7/43 • Number of events 14
|
6.5%
3/46 • Number of events 6
|
10.0%
4/40 • Number of events 6
|
|
Infections and infestations
Nasopharangytis
|
7.0%
3/43 • Number of events 4
|
10.9%
5/46 • Number of events 7
|
5.0%
2/40 • Number of events 5
|
|
Injury, poisoning and procedural complications
Injury
|
7.0%
3/43 • Number of events 3
|
4.3%
2/46 • Number of events 3
|
7.5%
3/40 • Number of events 5
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
2/43 • Number of events 2
|
10.9%
5/46 • Number of events 5
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Blood cholesterol increased
|
9.3%
4/43 • Number of events 4
|
10.9%
5/46 • Number of events 5
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.0%
3/43 • Number of events 4
|
8.7%
4/46 • Number of events 5
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
7.0%
3/43 • Number of events 3
|
4.3%
2/46 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
2.3%
1/43 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
5.0%
2/40 • Number of events 3
|
|
Investigations
Blood urea increased
|
2.3%
1/43 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
5.0%
2/40 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
4/43 • Number of events 4
|
4.3%
2/46 • Number of events 2
|
0.00%
0/40
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43 • Number of events 3
|
4.3%
2/46 • Number of events 2
|
0.00%
0/40
|
|
Investigations
Haematocrit decreased
|
0.00%
0/43
|
8.7%
4/46 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
2.3%
1/43 • Number of events 1
|
6.5%
3/46 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/43
|
8.7%
4/46 • Number of events 5
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.0%
3/43 • Number of events 3
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
2/43 • Number of events 4
|
10.9%
5/46 • Number of events 6
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
6/43 • Number of events 6
|
10.9%
5/46 • Number of events 5
|
7.5%
3/40 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.7%
2/43 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
10.0%
4/40 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
3/43 • Number of events 3
|
4.3%
2/46 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
4.7%
2/43 • Number of events 2
|
8.7%
4/46 • Number of events 4
|
7.5%
3/40 • Number of events 5
|
|
Nervous system disorders
Headache
|
14.0%
6/43 • Number of events 9
|
4.3%
2/46 • Number of events 2
|
7.5%
3/40 • Number of events 4
|
|
Psychiatric disorders
Confusional state
|
2.3%
1/43 • Number of events 2
|
6.5%
3/46 • Number of events 4
|
0.00%
0/40
|
|
Psychiatric disorders
Depression
|
0.00%
0/43
|
6.5%
3/46 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
7.0%
3/43 • Number of events 3
|
6.5%
3/46 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Nocturia
|
9.3%
4/43 • Number of events 4
|
8.7%
4/46 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
7.0%
3/43 • Number of events 5
|
4.3%
2/46 • Number of events 2
|
7.5%
3/40 • Number of events 5
|
|
Renal and urinary disorders
Pollakiuria
|
4.7%
2/43 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/43
|
6.5%
3/46 • Number of events 3
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43 • Number of events 6
|
10.9%
5/46 • Number of events 5
|
7.5%
3/40 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.3%
4/43 • Number of events 4
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
2/43 • Number of events 2
|
8.7%
4/46 • Number of events 5
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.0%
3/43 • Number of events 4
|
0.00%
0/46
|
0.00%
0/40
|
|
Vascular disorders
Hot flush
|
55.8%
24/43 • Number of events 25
|
54.3%
25/46 • Number of events 25
|
57.5%
23/40 • Number of events 27
|
|
Vascular disorders
Hypertension
|
11.6%
5/43 • Number of events 6
|
8.7%
4/46 • Number of events 5
|
10.0%
4/40 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
9.3%
4/43 • Number of events 5
|
10.9%
5/46 • Number of events 6
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
4.7%
2/43 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
5.0%
2/40 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
7.5%
3/40 • Number of events 3
|
|
General disorders
Fatigue
|
4.7%
2/43 • Number of events 3
|
8.7%
4/46 • Number of events 5
|
0.00%
0/40
|
|
General disorders
Pyrexia
|
7.0%
3/43 • Number of events 4
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Suprapubic pain
|
0.00%
0/43
|
0.00%
0/46
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Cardiac murmur
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Weight increased
|
0.00%
0/43
|
0.00%
0/46
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Lethargy
|
4.7%
2/43 • Number of events 2
|
6.5%
3/46 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular atrophy
|
7.0%
3/43 • Number of events 3
|
4.3%
2/46 • Number of events 2
|
12.5%
5/40 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.0%
3/43 • Number of events 3
|
0.00%
0/46
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/43
|
0.00%
0/46
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
3/43 • Number of events 3
|
6.5%
3/46 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
7.0%
3/43 • Number of events 3
|
0.00%
0/46
|
0.00%
0/40
|
|
Vascular disorders
Flushing
|
9.3%
4/43 • Number of events 4
|
13.0%
6/46 • Number of events 6
|
5.0%
2/40 • Number of events 2
|
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