TriangleNCT03085095 · OUTCOME
Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1
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 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)
What was measured
Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
Analysis population: All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
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 | 84.6 | Not reported | 81.3 | 87.3 | Not reported |
| Leuprolide Acetate | 87.5 | Not reported | 83.0 | 90.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- -7.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.0
- estimate Comment
- Treatment difference= Relugolix - Leuprolide acetate
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Treatment difference
- param Value
- -2.9
Complete source fields
- analyses
- ci Lower Limit
- -7.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.0
- estimate Comment
- Treatment difference= Relugolix - Leuprolide acetate
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Treatment difference
- param Value
- -2.9
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 81.3
- upper Limit
- 87.3
- value
- 84.6
- group Id
- OG001
- lower Limit
- 83.0
- upper Limit
- 90.8
- value
- 87.5
- denoms
- counts
- group Id
- OG000
- value
- 622
- group Id
- OG001
- value
- 308
- units
- Participants
- description
- Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by 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 and had analyzable data at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)
- title
- Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice