NCT00451958 · OUTCOME
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy · Source last updated 2013-03-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 4 years of treatment
What was measured
This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
Analysis population: The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
Groups in this outcome
Degarelix 80 mg / Degarelix 80 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
Degarelix 160 mg / Degarelix 160 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 80 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 160 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 125 |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 126 |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 69 |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 65 |
|---|
Reported measurements
S-Potassium (mmol/L) >=5.8
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
S-Alanine aminotransferase (IU/L) >3xULN
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
S-Alkaline phosphatase (IU/L) >3xULN+25% increase
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
S-Creatinine (µmol/L) >=177
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
S-Urea nitrogen (mmol/L) >=10.7
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
B-Haematocrit (Ratio) <=0.37
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 40 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
B-Haemoglobin (g/L) <=115
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
B-Red blood cell count (10^12/L) <=3.5
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
B-Eosinophils (%) >=10
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
B-Lymphocytes (%) <=10
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Degarelix 80 mg / Degarelix 80 mg | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Degarelix 160 mg / Degarelix 160 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 80 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Leuprolide 7.5 mg / Degarelix 160 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- title
- S-Potassium (mmol/L) >=5.8
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- S-Alanine aminotransferase (IU/L) >3xULN
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- title
- S-Alkaline phosphatase (IU/L) >3xULN+25% increase
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- title
- S-Creatinine (µmol/L) >=177
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- title
- S-Urea nitrogen (mmol/L) >=10.7
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 17
- title
- B-Haematocrit (Ratio) <=0.37
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 6
- title
- B-Haemoglobin (g/L) <=115
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- title
- B-Red blood cell count (10^12/L) <=3.5
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- title
- B-Eosinophils (%) >=10
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 5
- title
- B-Lymphocytes (%) <=10
- denoms
- counts
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 126
- group Id
- OG002
- value
- 69
- group Id
- OG003
- value
- 65
- units
- Participants
- description
- This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
- groups
- description
- The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
- id
- OG000
- title
- Degarelix 80 mg / Degarelix 80 mg
- description
- The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG001
- title
- Degarelix 160 mg / Degarelix 160 mg
- description
- During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG002
- title
- Leuprolide 7.5 mg / Degarelix 80 mg
- description
- During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG003
- title
- Leuprolide 7.5 mg / Degarelix 160 mg
- param Type
- NUMBER
- population Description
- The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
- reporting Status
- POSTED
- time Frame
- Up to 4 years of treatment
- title
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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