TriangleNCT03732820 · OUTCOME
Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months)
What was measured
An rPFS event is defined as progression determined by Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\] and/or Prostate Cancer Working Group 3 \[PCWG-3\] or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression. Per RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified. Per PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required.
Analysis population: Full Analysis Set (FAS)
Groups in this outcome
Olaparib 300 mg bd + Abiraterone 1000 mg qd
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Placebo bd + Abiraterone 1000 mg qd
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
| Group | Source count |
|---|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 399 |
| Placebo bd + Abiraterone 1000 mg qd | 397 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 168 | Not reported | Not reported | Not reported | Not reported |
| Placebo bd + Abiraterone 1000 mg qd | 226 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- estimate Comment
- HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Comment
- Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- estimate Comment
- HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Comment
- Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 226
- denoms
- counts
- group Id
- OG000
- value
- 399
- group Id
- OG001
- value
- 397
- units
- Participants
- description
- An rPFS event is defined as progression determined by Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\] and/or Prostate Cancer Working Group 3 \[PCWG-3\] or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression. Per RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified. Per PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required.
- groups
- description
- Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
- id
- OG000
- title
- Olaparib 300 mg bd + Abiraterone 1000 mg qd
- description
- Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
- id
- OG001
- title
- Placebo bd + Abiraterone 1000 mg qd
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full Analysis Set (FAS)
- reporting Status
- POSTED
- time Frame
- Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months)
- title
- Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice