TriangleNCT00002874 · OUTCOME
Progression-free Survival (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
Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Progression-free Survival" is more accurate wording for the protocol endpoint of "Freedom from Progression", and matches the protocol definition.
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 | 23.9 | Not reported | 19.4 | 28.4 | Not reported |
| Bicalutamide | 38.8 | Not reported | 33.7 | 43.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Reference level = placebo arm
- p Value
- < 0.001
- param Type
- Cox Proportional Hazard
- param Value
- 0.60
- statistical Comment
- One-side test
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Reference level = placebo arm
- p Value
- < 0.001
- param Type
- Cox Proportional Hazard
- param Value
- 0.60
- statistical Comment
- One-side test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.4
- upper Limit
- 28.4
- value
- 23.9
- group Id
- OG001
- lower Limit
- 33.7
- upper Limit
- 43.9
- value
- 38.8
- denoms
- counts
- group Id
- OG000
- value
- 376
- group Id
- OG001
- value
- 384
- units
- Participants
- description
- Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Progression-free Survival" is more accurate wording for the protocol endpoint of "Freedom from Progression", and matches the protocol definition.
- 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
- Progression-free Survival (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