TriangleNCT00002874 · OUTCOME
Overall 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
Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. 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 | 394 |
| Bicalutamide | 376 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 71.3 | Not reported | 66.5 | 76.0 | Not reported |
| Bicalutamide | 76.3 | Not reported | 71.9 | 80.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.98
- estimate Comment
- Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.020
- p Value Comment
- One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.98
- estimate Comment
- Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.020
- p Value Comment
- One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 66.5
- upper Limit
- 76.0
- value
- 71.3
- group Id
- OG001
- lower Limit
- 71.9
- upper Limit
- 80.8
- value
- 76.3
- denoms
- counts
- group Id
- OG000
- value
- 394
- group Id
- OG001
- value
- 376
- units
- Participants
- description
- Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. 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
- Overall Survival (12-year Rates Reported)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice