TriangleNCT01664923 · OUTCOME
Duration of Radiographic PFS
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 cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
What was measured
Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.
Analysis population: All participants with metastatic disease at study entry and randomly assigned to study treatment.
Groups in this outcome
Enzalutamide
Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.
Bicalutamide
Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.
| Group | Source count |
|---|---|
| Enzalutamide | 128 |
| Bicalutamide | 129 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | NA | Not reported | 16.7 | NA | The median duration of radiographic PFS and its upper limit of the 95% confidence interval were not available because an insufficient number of participants had an event at the time of analysis. |
| Bicalutamide | 8.3 | Not reported | 8.1 | 11.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.211
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.497
- estimate Comment
- Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.324
- statistical Comment
- P-value is based on an unstratified log-rank test.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.211
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.497
- estimate Comment
- Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.324
- statistical Comment
- P-value is based on an unstratified log-rank test.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median duration of radiographic PFS and its upper limit of the 95% confidence interval were not available because an insufficient number of participants had an event at the time of analysis.
- group Id
- OG000
- lower Limit
- 16.7
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 8.1
- upper Limit
- 11.1
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 129
- units
- Participants
- description
- Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.
- id
- OG000
- title
- Enzalutamide
- description
- Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.
- id
- OG001
- title
- Bicalutamide
- param Type
- MEDIAN
- population Description
- All participants with metastatic disease at study entry and randomly assigned to study treatment.
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
- title
- Duration of Radiographic PFS
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice