Prostate Cancer
Conditions
Brief summary
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Detailed description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked YES). The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.
Interventions
DRUGDegarelix
Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males aged 18 or over * Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy) * Has completed Study FE200486 CS07 * Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Function Tests | 3 years | 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. |
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | 3 years | 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. |
Participant flow
Recruitment details
Participants who responded to degarelix in FE200486 CS07 (NCT00818623) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS07.
Pre-assignment details
180 participants started the main study CS07 and 172 participants received degarelix treatment (intention-to-treat population). Of these, 131 participants were recruited into the extension study CS07A
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 120mg (20mg/mL) Degarelix 120 mg (20 mg/mL) | 25 |
| Degarelix 120mg (40mg/mL) Degarelix 120 mg (40 mg/mL) | 12 |
| Degarelix 160mg (40mg/mL) Degarelix 160 mg (40 mg/mL) | 12 |
| Degarelix 200mg (40mg/mL) Degarelix 200 mg (40 mg/mL) | 24 |
| Degarelix 200mg (60mg/mL) Degarelix 200 mg (60 mg/mL) | 24 |
| Degarelix 240mg (40mg/mL) Degarelix 240 mg (40 mg/mL) | 24 |
| Degarelix 240mg (60mg/mL) Degarelix 240 mg (60 mg/mL) | 24 |
| Degarelix 320mg (60mg/mL) Degarelix 320 mg (60 mg/mL) | 27 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 | 3 | 0 | 3 | 1 | 0 | 3 |
| Overall Study | Insufficient testosterone response | 5 | 4 | 1 | 12 | 8 | 12 | 4 | 7 |
| Overall Study | Insuff prostate specific antigen resp | 3 | 2 | 2 | 2 | 1 | 2 | 3 | 2 |
| Overall Study | Other | 3 | 1 | 2 | 3 | 5 | 4 | 6 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 3 | 3 | 1 | 6 | 1 | 10 | 3 |
Baseline characteristics
| Characteristic | Degarelix 120mg (40mg/mL) | Degarelix 160mg (40mg/mL) | Degarelix 200mg (40mg/mL) | Degarelix 200mg (60mg/mL) | Degarelix 120mg (20mg/mL) | Degarelix 240mg (40mg/mL) | Degarelix 240mg (60mg/mL) | Degarelix 320mg (60mg/mL) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 10 Participants | 22 Participants | 20 Participants | 18 Participants | 22 Participants | 18 Participants | 21 Participants | 143 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants | 4 Participants | 7 Participants | 2 Participants | 6 Participants | 6 Participants | 29 Participants |
| Age Continuous | 73.8 years STANDARD_DEVIATION 3.97 | 70.1 years STANDARD_DEVIATION 8.08 | 74.3 years STANDARD_DEVIATION 6.48 | 71.5 years STANDARD_DEVIATION 8.27 | 70.0 years STANDARD_DEVIATION 10.3 | 73.1 years STANDARD_DEVIATION 5.96 | 71.7 years STANDARD_DEVIATION 9.54 | 71.1 years STANDARD_DEVIATION 6.87 | 71.9 years STANDARD_DEVIATION 7.83 |
| Body mass index | 26.6 kilogram per square meter STANDARD_DEVIATION 4.58 | 26.3 kilogram per square meter STANDARD_DEVIATION 3.74 | 25.9 kilogram per square meter STANDARD_DEVIATION 2.99 | 24.5 kilogram per square meter STANDARD_DEVIATION 2.92 | 26.2 kilogram per square meter STANDARD_DEVIATION 2.97 | 26.9 kilogram per square meter STANDARD_DEVIATION 3.18 | 24.8 kilogram per square meter STANDARD_DEVIATION 2.72 | 27.1 kilogram per square meter STANDARD_DEVIATION 3.63 | 26.0 kilogram per square meter STANDARD_DEVIATION 3.32 |
| Curative intent No | 12 participants | 10 participants | 21 participants | 23 participants | 25 participants | 24 participants | 24 participants | 26 participants | 165 participants |
| Curative intent Yes | 0 participants | 2 participants | 3 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 7 participants |
| Gleason score 2-4 | 0 participants | 2 participants | 1 participants | 5 participants | 4 participants | 2 participants | 5 participants | 12 participants | 31 participants |
| Gleason score 5-6 | 7 participants | 5 participants | 6 participants | 3 participants | 4 participants | 6 participants | 6 participants | 6 participants | 43 participants |
| Gleason score 7-10 | 5 participants | 5 participants | 17 participants | 16 participants | 17 participants | 16 participants | 13 participants | 9 participants | 98 participants |
| Race/Ethnicity, Customized Caucasian | 12 participants | 12 participants | 24 participants | 24 participants | 25 participants | 24 participants | 24 participants | 27 participants | 172 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants | 24 Participants | 25 Participants | 24 Participants | 24 Participants | 27 Participants | 172 Participants |
| Stage of prostate cancer Localized | 1 participants | 3 participants | 3 participants | 1 participants | 10 participants | 6 participants | 8 participants | 14 participants | 46 participants |
| Stage of prostate cancer Locally advanced | 6 participants | 5 participants | 14 participants | 8 participants | 6 participants | 10 participants | 5 participants | 9 participants | 63 participants |
| Stage of prostate cancer Metastatic | 3 participants | 4 participants | 6 participants | 12 participants | 9 participants | 6 participants | 10 participants | 2 participants | 52 participants |
| Stage of prostate cancer Not classifiable | 2 participants | 0 participants | 1 participants | 3 participants | 0 participants | 2 participants | 1 participants | 2 participants | 11 participants |
| Time since prostate cancer diagnosis | 66 days STANDARD_DEVIATION 53 | 222 days STANDARD_DEVIATION 328 | 146 days STANDARD_DEVIATION 298 | 252 days STANDARD_DEVIATION 560 | 83 days STANDARD_DEVIATION 157 | 303 days STANDARD_DEVIATION 837 | 121 days STANDARD_DEVIATION 425 | 47 days STANDARD_DEVIATION 54 | 156 days STANDARD_DEVIATION 439 |
| Weight | 82.2 kilogram STANDARD_DEVIATION 12.1 | 80.7 kilogram STANDARD_DEVIATION 11.8 | 78.2 kilogram STANDARD_DEVIATION 13.7 | 74.2 kilogram STANDARD_DEVIATION 9.88 | 77.8 kilogram STANDARD_DEVIATION 12.4 | 81.5 kilogram STANDARD_DEVIATION 10.7 | 73.5 kilogram STANDARD_DEVIATION 9.55 | 81.7 kilogram STANDARD_DEVIATION 11.1 | 78.4 kilogram STANDARD_DEVIATION 11.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / — | 10 / — | 9 / — | 24 / — | 17 / — | 22 / — | 12 / — | 19 / — |
| serious Total, serious adverse events | 8 / — | 4 / — | 3 / — | 7 / — | 8 / — | 5 / — | 3 / — | 9 / — |
Outcome results
Primary
Liver Function Tests
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.
Time frame: 3 years
Population: The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 120mg (20mg/mL) | Liver Function Tests | ALAT >3x ULN | 4 participants |
| Degarelix 120mg (20mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 1 participants |
| Degarelix 120mg (20mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 11 participants |
| Degarelix 120mg (20mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 9 participants |
| Degarelix 120mg (20mg/mL) | Liver Function Tests | Abnormal bilirubin | 4 participants |
| Degarelix 120mg (40mg/mL) | Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 120mg (40mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 4 participants |
| Degarelix 120mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 0 participants |
| Degarelix 120mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 120mg (40mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 4 participants |
| Degarelix 160mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 160mg (40mg/mL) | Liver Function Tests | Abnormal bilirubin | 0 participants |
| Degarelix 160mg (40mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 2 participants |
| Degarelix 160mg (40mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 3 participants |
| Degarelix 160mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 0 participants |
| Degarelix 200mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 0 participants |
| Degarelix 200mg (40mg/mL) | Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 200mg (40mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 7 participants |
| Degarelix 200mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 200mg (40mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 6 participants |
| Degarelix 200mg (60mg/mL) | Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 200mg (60mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 0 participants |
| Degarelix 200mg (60mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 8 participants |
| Degarelix 200mg (60mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 7 participants |
| Degarelix 200mg (60mg/mL) | Liver Function Tests | Abnormal bilirubin | 0 participants |
| Degarelix 240mg (40mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 6 participants |
| Degarelix 240mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN | 2 participants |
| Degarelix 240mg (40mg/mL) | Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 240mg (40mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 7 participants |
| Degarelix 240mg (40mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 1 participants |
| Degarelix 240mg (60mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 7 participants |
| Degarelix 240mg (60mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 6 participants |
| Degarelix 240mg (60mg/mL) | Liver Function Tests | Abnormal bilirubin | 0 participants |
| Degarelix 240mg (60mg/mL) | Liver Function Tests | ALAT >3x ULN | 1 participants |
| Degarelix 240mg (60mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 0 participants |
| Degarelix 320mg (60mg/mL) | Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 9 participants |
| Degarelix 320mg (60mg/mL) | Liver Function Tests | Abnormal aspartate aminotransferase | 7 participants |
| Degarelix 320mg (60mg/mL) | Liver Function Tests | ALAT >3x ULN | 1 participants |
| Degarelix 320mg (60mg/mL) | Liver Function Tests | ALAT >3x ULN, bilirubin >2x ULN | 0 participants |
| Degarelix 320mg (60mg/mL) | Liver Function Tests | Abnormal bilirubin | 1 participants |
Primary
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
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.
Time frame: 3 years
Population: These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 4 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 2 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 2 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 2 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 3 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 9 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 5 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 1 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 3 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 2 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 2 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 8 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 6 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 7 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 1 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 2 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 1 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 3 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 2 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |