TriangleNCT03085095 · OUTCOME
Sustained Castration Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
What was measured
Sustained castration rate defined as the cumulative probability of testosterone suppression to \< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.
Analysis population: All randomized participants who received at least 1 dose of study drug.
Groups in this outcome
Relugolix
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide Acetate
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
| Group | Source count |
|---|---|
| Relugolix | 622 |
| Leuprolide Acetate | 308 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix | 96.7 | Not reported | 94.9 | 97.9 | Not reported |
| Leuprolide Acetate | 88.8 | Not reported | 84.6 | 91.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 4.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.8
- estimate Comment
- Treatment difference= Relugolix - Leuprolide acetate
- group Description
- Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Treatment difference
- param Value
- 7.9
- group Description
- Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- statistical Comment
- Two-sided type I error of 0.05.
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- ci Lower Limit
- 4.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.8
- estimate Comment
- Treatment difference= Relugolix - Leuprolide acetate
- group Description
- Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Treatment difference
- param Value
- 7.9
- group Description
- Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- statistical Comment
- Two-sided type I error of 0.05.
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 94.9
- upper Limit
- 97.9
- value
- 96.7
- group Id
- OG001
- lower Limit
- 84.6
- upper Limit
- 91.8
- value
- 88.8
- denoms
- counts
- group Id
- OG000
- value
- 622
- group Id
- OG001
- value
- 308
- units
- Participants
- description
- Sustained castration rate defined as the cumulative probability of testosterone suppression to \< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
- id
- OG000
- title
- Relugolix
- description
- Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
- id
- OG001
- title
- Leuprolide Acetate
- param Type
- NUMBER
- population Description
- All randomized participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
- title
- Sustained Castration Rate
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice