TriangleNCT00005044 · OUTCOME
Time to First Biochemical Failure (BF) (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
Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates 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
Protocol definition
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS x 8 Weeks | 56 | Not reported | 52 | 59 | Not reported |
| TAS x 28 Weeks | 59 | Not reported | 56 | 63 | Not reported |
Phoenix definition
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS x 8 Weeks | 27 | Not reported | 23 | 30 | Not reported |
| TAS x 28 Weeks | 27 | Not reported | 23 | 30 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.17
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Protocol definition
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.74
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Phoenix definition
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.77
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
Complete source fields
- analyses
- ci Lower Limit
- 0.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.17
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Protocol definition
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.74
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- estimate Comment
- Reference level = TAS x 8 weeks
- group Description
- Phoenix definition
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.77
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Comment
- 2-sided significance level = 0.05
- statistical Method
- Gray's test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52
- upper Limit
- 59
- value
- 56
- group Id
- OG001
- lower Limit
- 56
- upper Limit
- 63
- value
- 59
- title
- Protocol definition
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23
- upper Limit
- 30
- value
- 27
- group Id
- OG001
- lower Limit
- 23
- upper Limit
- 30
- value
- 27
- title
- Phoenix definition
- denoms
- counts
- group Id
- OG000
- value
- 752
- group Id
- OG001
- value
- 737
- units
- Participants
- description
- Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates 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 First Biochemical Failure (BF) (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