TriangleNCT01212991 · OUTCOME
Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- During study period (up to 3 years)
What was measured
PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.
Analysis population: Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.
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 | 854 |
| Placebo | 777 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 78 | Not reported | 75.1 | 80.7 | Not reported |
| Placebo | 3.5 | Not reported | 2.3 | 5.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 71.45
- ci Pct Value
- 95
- ci Upper Limit
- 77.57
- 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 0.025 for this analysis.
- param Type
- Difference in response rates
- param Value
- 74.51
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 71.45
- ci Pct Value
- 95
- ci Upper Limit
- 77.57
- 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 0.025 for this analysis.
- param Type
- Difference in response rates
- param Value
- 74.51
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75.1
- upper Limit
- 80.7
- value
- 78
- group Id
- OG001
- lower Limit
- 2.3
- upper Limit
- 5.0
- value
- 3.5
- denoms
- counts
- group Id
- OG000
- value
- 854
- group Id
- OG001
- value
- 777
- units
- Participants
- description
- PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline 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
- NUMBER
- population Description
- Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.
- reporting Status
- POSTED
- time Frame
- During study period (up to 3 years)
- title
- Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice