TriangleNCT01212991 · OUTCOME
Time to First Skeletal-related Event
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 3 years)
What was measured
Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.
Analysis population: Intent to Treat (ITT) - All patients randomly assigned to treatment.
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 | 872 |
| Placebo | 845 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 31.1 | Not reported | 29.5 | NA | The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
| Placebo | 31.3 | Not reported | 23.9 | NA | The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
Source statistical analyses
- ci Lower Limit
- 0.610
- ci Pct Value
- 95
- ci Upper Limit
- 0.844
- 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 Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.718
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.610
- ci Pct Value
- 95
- ci Upper Limit
- 0.844
- 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 Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.718
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG000
- lower Limit
- 29.5
- upper Limit
- NA
- value
- 31.1
- comment
- The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG001
- lower Limit
- 23.9
- upper Limit
- NA
- value
- 31.3
- denoms
- counts
- group Id
- OG000
- value
- 872
- group Id
- OG001
- value
- 845
- units
- Participants
- description
- Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.
- 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.
- reporting Status
- POSTED
- time Frame
- During study period (up to 3 years)
- title
- Time to First Skeletal-related Event
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice