TriangleNCT00295750 · OUTCOME
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
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
- 12 months
What was measured
Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
Analysis population: Intent-to-treat (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 | 98.3 | Not reported | 94.8 | 99.4 | Not reported |
| Degarelix 240/80 mg | 97.2 | Not reported | 93.5 | 98.8 | Not reported |
| Leuprolide 7.5 mg | 96.4 | Not reported | 92.5 | 98.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.8
- ci Pct Value
- 97.5
- ci Upper Limit
- 5.7
- group Description
- A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.
- group Ids
- OG000
- OG002
- non Inferiority Comment
- The non-inferiority limit was -10 percentage points.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Difference in cumulative probability
- param Value
- 1.9
- tested Non Inferiority
- true
- ci Lower Limit
- -3.2
- ci Pct Value
- 97.5
- ci Upper Limit
- 5.0
- group Description
- A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.
- group Ids
- OG001
- OG002
- non Inferiority Comment
- The non-inferiority limit was -10 percentage points.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Difference in cumulative probability
- param Value
- 0.9
- tested Non Inferiority
- true
Complete source fields
- analyses
- ci Lower Limit
- -1.8
- ci Pct Value
- 97.5
- ci Upper Limit
- 5.7
- group Description
- A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.
- group Ids
- OG000
- OG002
- non Inferiority Comment
- The non-inferiority limit was -10 percentage points.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Difference in cumulative probability
- param Value
- 1.9
- tested Non Inferiority
- true
- ci Lower Limit
- -3.2
- ci Pct Value
- 97.5
- ci Upper Limit
- 5.0
- group Description
- A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.
- group Ids
- OG001
- OG002
- non Inferiority Comment
- The non-inferiority limit was -10 percentage points.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Difference in cumulative probability
- param Value
- 0.9
- tested Non Inferiority
- true
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 94.8
- upper Limit
- 99.4
- value
- 98.3
- group Id
- OG001
- lower Limit
- 93.5
- upper Limit
- 98.8
- value
- 97.2
- group Id
- OG002
- lower Limit
- 92.5
- upper Limit
- 98.2
- value
- 96.4
- denoms
- counts
- group Id
- OG000
- value
- 202
- group Id
- OG001
- value
- 207
- group Id
- OG002
- value
- 201
- units
- Participants
- description
- Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
- 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
- Intent-to-treat (ITT) population.
- reporting Status
- POSTED
- time Frame
- 12 months
- title
- Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice