TriangleNCT01288911 · OUTCOME
Best PSA Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- percent change
- Interval / dispersion
- Full Range
- Time frame
- Baseline to 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
The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.
Analysis population: Full analysis set with available PSA data
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 | 174 |
| Bicalutamide | 168 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | -92.96 | Not reported | -100.0 | 287.7 | Not reported |
| Bicalutamide | 0.18 | Not reported | -99.8 | 25700.0 | Not reported |
Source statistical analyses
- group Description
- Best PSA Response Enzalutamide Vs. Bicalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- statistical Method
- Wilcoxon rank sum test
Complete source fields
- analyses
- group Description
- Best PSA Response Enzalutamide Vs. Bicalutamide.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- statistical Method
- Wilcoxon rank sum test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -100.0
- upper Limit
- 287.7
- value
- -92.96
- group Id
- OG001
- lower Limit
- -99.8
- upper Limit
- 25700.0
- value
- 0.18
- denoms
- counts
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 168
- units
- Participants
- description
- The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.
- dispersion Type
- Full Range
- 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 with available PSA data
- reporting Status
- POSTED
- time Frame
- Baseline to 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
- Best PSA Response
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice