TriangleNCT00451958 · OUTCOME
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
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 blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
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 | 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 | 66 |
Reported measurements
Diastolic blood pressure <=50 and decrease >=15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 3 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 6 | Not reported | Not reported | Not reported | Not reported |
Diastolic blood pressure >=105 and increase >=15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 3 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Systolic blood pressure <=90 and decrease >=20
| 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 | 4 | 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 |
Systolic blood pressure >=180 and increase >=20
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 13 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 4 | Not reported | Not reported | Not reported | Not reported |
Heart rate <=50 and decrease >=15
| 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Heart rate >=120 and increase >=15
| 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 | 1 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
Body weight decrease of >=7 percent
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 15 | Not reported | Not reported | Not reported | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 24 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 21 | Not reported | Not reported | Not reported | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 8 | Not reported | Not reported | Not reported | Not reported |
Body weight increase of >=7 percent
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 25 | Not reported | Not reported | Not reported | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 14 | 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 | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- title
- Diastolic blood pressure <=50 and decrease >=15
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 0
- title
- Diastolic blood pressure >=105 and increase >=15
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- title
- Systolic blood pressure <=90 and decrease >=20
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 4
- title
- Systolic blood pressure >=180 and increase >=20
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 2
- title
- Heart rate <=50 and decrease >=15
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- title
- Heart rate >=120 and increase >=15
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 8
- title
- Body weight decrease of >=7 percent
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- title
- Body weight increase of >=7 percent
- denoms
- counts
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 126
- group Id
- OG002
- value
- 69
- group Id
- OG003
- value
- 66
- units
- Participants
- description
- This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
- 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 Vital Signs and Body Weight
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice