TriangleNCT03732820 · OUTCOME
Number of Participants With Time to Pain Progression (TTPP) Event
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 (DCO3): 12Oct2022 (Approx. 3 years 11 months)
What was measured
A TTPP event is defined as pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 (range 0-10, a higher score indicates worse pain) and opiate analgesic use (Analgesic quantification algorithm \[AQA\] score, range 0-7, a higher score indicates increased opioid use). For patients who are asymptomatic at baseline (average worst pain score of 0 and not taking opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits or initiation of opioid use; For patients who are symptomatic at baseline (average worst pain score \>0 and/or receiving opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits and an average worst pain score ≥4, and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2), or increase in opioid use (≥1-point increase, or ≥2-point increase if the starting value is 0) at 2 consecutive follow-up visits.
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 | 68 | Not reported | Not reported | Not reported | Not reported |
| Placebo bd + Abiraterone 1000 mg qd | 60 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.50
- 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
- 0.7456
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
- 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
- 0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.50
- 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
- 0.7456
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
- 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
- 68
- group Id
- OG001
- value
- 60
- denoms
- counts
- group Id
- OG000
- value
- 399
- group Id
- OG001
- value
- 397
- units
- Participants
- description
- A TTPP event is defined as pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 (range 0-10, a higher score indicates worse pain) and opiate analgesic use (Analgesic quantification algorithm \[AQA\] score, range 0-7, a higher score indicates increased opioid use). For patients who are asymptomatic at baseline (average worst pain score of 0 and not taking opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits or initiation of opioid use; For patients who are symptomatic at baseline (average worst pain score \>0 and/or receiving opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits and an average worst pain score ≥4, and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2), or increase in opioid use (≥1-point increase, or ≥2-point increase if the starting value is 0) at 2 consecutive follow-up visits.
- 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 (DCO3): 12Oct2022 (Approx. 3 years 11 months)
- title
- Number of Participants With Time to Pain Progression (TTPP) Event
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice