TriangleNCT01212991 · OUTCOME
Time to Prostate-specific Antigen (PSA) Progression
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 PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.
Analysis population: Intent to Treat (ITT) - All patients randomized.
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 | 11.2 | Not reported | 11.1 | 13.7 | Not reported |
| Placebo | 2.8 | Not reported | 2.8 | 2.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.147
- ci Pct Value
- 95
- ci Upper Limit
- 0.195
- 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 0.0167 for this analysis.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.169
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.147
- ci Pct Value
- 95
- ci Upper Limit
- 0.195
- 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 0.0167 for this analysis.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.169
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- 13.7
- value
- 11.2
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- 2.9
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 872
- group Id
- OG001
- value
- 845
- units
- Participants
- description
- Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was 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 randomized.
- reporting Status
- POSTED
- time Frame
- During study period (up to 3 years)
- title
- Time to Prostate-specific Antigen (PSA) Progression
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice