TriangleNCT01212991 · OUTCOME
Radiographic Progression-free Survival (rPFS)
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
- During study period (up to 20 months)
What was measured
Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.
Analysis population: Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.
Groups in this outcome
Enzalutamide
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Placebo
Participants received placebo, administered as four capsules, once per day by mouth.
| Group | Source count |
|---|---|
| Enzalutamide | 832 |
| Placebo | 801 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | NA | Not reported | 13.8 | NA | The median time to radiographic progression-free survival and its upper 95% confidence limit were not yet reached in the enzalutamide group because an insufficient number of patients had an event at the time of analysis. |
| Placebo | 3.9 | Not reported | 3.7 | 5.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.149
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.231
- estimate Comment
- The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- p Value Comment
- The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.186
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.149
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.231
- estimate Comment
- The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- p Value Comment
- The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.186
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median time to radiographic progression-free survival and its upper 95% confidence limit were not yet reached in the enzalutamide group because an insufficient number of patients had an event at the time of analysis.
- group Id
- OG000
- lower Limit
- 13.8
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 5.4
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 832
- group Id
- OG001
- value
- 801
- units
- Participants
- description
- Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- id
- OG000
- title
- Enzalutamide
- description
- Participants received placebo, administered as four capsules, once per day by mouth.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.
- reporting Status
- POSTED
- time Frame
- During study period (up to 20 months)
- title
- Radiographic Progression-free Survival (rPFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice