TriangleNCT02987543 · OUTCOME
Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
What was measured
The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Analysis population: Full Analysis Set
Groups in this outcome
Cohort A Olaparib 300mg bd
2x150mg film-coated tablets
Cohort A Investigators Choice of NHA
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
| Group | Source count |
|---|---|
| Cohort A Olaparib 300mg bd | 256 |
| Cohort A Investigators Choice of NHA | 131 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A Olaparib 300mg bd | 5.82 | Not reported | 5.52 | 7.36 | Not reported |
| Cohort A Investigators Choice of NHA | 3.52 | Not reported | 2.2 | 3.65 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.63
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.49
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.63
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.49
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.52
- upper Limit
- 7.36
- value
- 5.82
- group Id
- OG001
- lower Limit
- 2.2
- upper Limit
- 3.65
- value
- 3.52
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 131
- units
- Participants
- description
- The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 2x150mg film-coated tablets
- id
- OG000
- title
- Cohort A Olaparib 300mg bd
- description
- either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
- id
- OG001
- title
- Cohort A Investigators Choice of NHA
- param Type
- MEDIAN
- population Description
- Full Analysis Set
- reporting Status
- POSTED
- time Frame
- Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
- title
- Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice