TriangleNCT03085095 · OUTCOME
Castration Rate At Week 1 Day 4
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
- Week 1 Day 4 (Day 4)
What was measured
Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
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 | 56.04 | Not reported | 52.18 | 59.97 | Not reported |
| Leuprolide Acetate | 0.00 | Not reported | NA | NA | Not estimable due to insufficient number of participants with events. |
Source statistical analyses
- group Description
- Alpha-protected statistical analysis.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- Statistically significance was met if p-value \< 0.05.
- statistical Comment
- Two-sided type I error rate of 0.05.
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Description
- Alpha-protected statistical analysis.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- Statistically significance was met if p-value \< 0.05.
- statistical Comment
- Two-sided type I error rate of 0.05.
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52.18
- upper Limit
- 59.97
- value
- 56.04
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 622
- group Id
- OG001
- value
- 308
- units
- Participants
- description
- Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
- 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
- Week 1 Day 4 (Day 4)
- title
- Castration Rate At Week 1 Day 4
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice