TriangleNCT01288911 · OUTCOME
Prostate-specific Antigen (PSA) Response by Week 13
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 Week 13
What was measured
The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 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 | 171 |
| Bicalutamide | 163 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | -89.03 | Not reported | -100.0 | 287.7 | Not reported |
| Bicalutamide | 0.36 | Not reported | -98.5 | 25700.0 | Not reported |
Source statistical analyses
- group Description
- 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
- 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
- -89.03
- group Id
- OG001
- lower Limit
- -98.5
- upper Limit
- 25700.0
- value
- 0.36
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 163
- units
- Participants
- description
- The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 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 Week 13
- title
- Prostate-specific Antigen (PSA) Response by Week 13
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice