TriangleNCT02987543 · OUTCOME
Time to Pain Progression - Cohort A Only
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
- Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
What was measured
Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain \[Item 3\] and Analgesic Quantification Algorithm \[AQA\] score.
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 | 162 |
| Cohort A Investigators Choice of NHA | 83 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A Olaparib 300mg bd | NA | Not reported | NA | NA | NA - Not calculated, estimates cannot be calculated due to too few events. |
| Cohort A Investigators Choice of NHA | 9.92 | Not reported | 5.39 | NA | NA - Not calculated, estimates cannot be calculated due to too few events. |
Source statistical analyses
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.91
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0192
- param Type
- Hazard Ratio (HR)
- param Value
- 0.44
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.91
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0192
- param Type
- Hazard Ratio (HR)
- param Value
- 0.44
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- comment
- NA - Not calculated, estimates cannot be calculated due to too few events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA - Not calculated, estimates cannot be calculated due to too few events.
- group Id
- OG001
- lower Limit
- 5.39
- upper Limit
- NA
- value
- 9.92
- denoms
- counts
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 83
- units
- Participants
- description
- Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain \[Item 3\] and Analgesic Quantification Algorithm \[AQA\] score.
- 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
- Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
- title
- Time to Pain Progression - Cohort A Only
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice