TriangleNCT00295750 · OUTCOME
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3 days
What was measured
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
Analysis population: ITT population.
Groups in this outcome
Degarelix 240/160 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
Degarelix 240/80 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
Leuprolide 7.5 mg
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
| Group | Source count |
|---|---|
| Degarelix 240/160 mg | 202 |
| Degarelix 240/80 mg | 207 |
| Leuprolide 7.5 mg | 201 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 240/160 mg | 95.5 | Not reported | 91.7 | 97.9 | Not reported |
| Degarelix 240/80 mg | 96.1 | Not reported | 92.5 | 98.3 | Not reported |
| Leuprolide 7.5 mg | 0 | Not reported | 0 | 1.8 | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 91.7
- upper Limit
- 97.9
- value
- 95.5
- group Id
- OG001
- lower Limit
- 92.5
- upper Limit
- 98.3
- value
- 96.1
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 1.8
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 202
- group Id
- OG001
- value
- 207
- group Id
- OG002
- value
- 201
- units
- Participants
- description
- This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
- id
- OG000
- title
- Degarelix 240/160 mg
- description
- Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
- id
- OG001
- title
- Degarelix 240/80 mg
- description
- Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
- id
- OG002
- title
- Leuprolide 7.5 mg
- param Type
- MEAN
- population Description
- ITT population.
- reporting Status
- POSTED
- time Frame
- 3 days
- title
- Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice