TriangleNCT01664923 · OUTCOME
Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.
Analysis population: Intent-to-treat population: all participants 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 | 198 |
| Bicalutamide | 198 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 8.4 | Not reported | 6.3 | 11.4 | Not reported |
| Bicalutamide | 8.3 | Not reported | 6.1 | 11.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.695
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.192
- estimate Comment
- Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4945
- p Value Comment
- This secondary endpoint was not adjusted for multiple comparisons.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.910
- statistical Comment
- P-value is based on a log-rank test stratified by disease stage at study entry.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.695
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.192
- estimate Comment
- Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4945
- p Value Comment
- This secondary endpoint was not adjusted for multiple comparisons.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.910
- statistical Comment
- P-value is based on a log-rank test stratified by disease stage at study entry.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.3
- upper Limit
- 11.4
- value
- 8.4
- group Id
- OG001
- lower Limit
- 6.1
- upper Limit
- 11.1
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 198
- units
- Participants
- description
- The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.
- 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
- Intent-to-treat population: all participants 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
- Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice