TriangleNCT01288911 · OUTCOME
Time to PSA ≤ 4 ng/mL
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
What was measured
Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization
Analysis population: Full analysis set
Groups in this outcome
Enzalutamide
Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Bicalutamide
Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
| Group | Source count |
|---|---|
| Enzalutamide | 184 |
| Bicalutamide | 191 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 3.0 | Not reported | 2.9 | 5.6 | Not reported |
| Bicalutamide | NA | Not reported | NA | NA | Not reached due to the low number of events |
Source statistical analyses
- ci Lower Limit
- 3.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.09
- estimate Comment
- Estimated by use of Cox proportional hazards model.
- group Description
- Time to PSA Enzalutamide Vs. Bicalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 5.07
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 3.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.09
- estimate Comment
- Estimated by use of Cox proportional hazards model.
- group Description
- Time to PSA Enzalutamide Vs. Bicalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 5.07
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.9
- upper Limit
- 5.6
- value
- 3.0
- comment
- Not reached due to the low number of events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 191
- units
- Participants
- description
- Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- id
- OG000
- title
- Enzalutamide
- description
- Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
- id
- OG001
- title
- Bicalutamide
- param Type
- MEDIAN
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
- title
- Time to PSA ≤ 4 ng/mL
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice