TriangleNCT00005044 · OUTCOME
Time to Second Biochemical Failure (SBF) (10-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 randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
What was measured
Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.
Analysis population: Eligible patients with follow-up data
Groups in this outcome
TAS x 8 Weeks
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS x 28 Weeks
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
| Group | Source count |
|---|---|
| TAS x 8 Weeks | 752 |
| TAS x 28 Weeks | 737 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS x 8 Weeks | 10 | Not reported | 7 | 12 | Not reported |
| TAS x 28 Weeks | 9 | Not reported | 7 | 12 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- estimate Comment
- Reference level = TAS x 8 weeks
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.62
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- estimate Comment
- Reference level = TAS x 8 weeks
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.62
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7
- upper Limit
- 12
- value
- 10
- group Id
- OG001
- lower Limit
- 7
- upper Limit
- 12
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 752
- group Id
- OG001
- value
- 737
- units
- Participants
- description
- Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- id
- OG000
- title
- TAS x 8 Weeks
- description
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- id
- OG001
- title
- TAS x 28 Weeks
- param Type
- NUMBER
- population Description
- Eligible patients with follow-up data
- reporting Status
- POSTED
- time Frame
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- title
- Time to Second Biochemical Failure (SBF) (10-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