TriangleNCT00002874 · OUTCOME
Distant Failure (12-year Rates Reported)
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
- From date of randomization to 12 years.
What was measured
Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Analysis population: Eligible patients who did not withdraw consent.
Groups in this outcome
Placebo
Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Bicalutamide
Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
| Group | Source count |
|---|---|
| Placebo | 376 |
| Bicalutamide | 384 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 23.0 | Not reported | 18.8 | 27.5 | Not reported |
| Bicalutamide | 14.5 | Not reported | 11.1 | 18.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Reference level = placebo arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Comment
- One-sided test
- statistical Method
- Gray's test
Complete source fields
- analyses
- ci Lower Limit
- 0.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Reference level = placebo arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Comment
- One-sided test
- statistical Method
- Gray's test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.8
- upper Limit
- 27.5
- value
- 23.0
- group Id
- OG001
- lower Limit
- 11.1
- upper Limit
- 18.5
- value
- 14.5
- denoms
- counts
- group Id
- OG000
- value
- 376
- group Id
- OG001
- value
- 384
- units
- Participants
- description
- Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- id
- OG000
- title
- Placebo
- description
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- id
- OG001
- title
- Bicalutamide
- param Type
- NUMBER
- population Description
- Eligible patients who did not withdraw consent.
- reporting Status
- POSTED
- time Frame
- From date of randomization to 12 years.
- title
- Distant Failure (12-year Rates Reported)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice