TriangleNCT03732820 · OUTCOME
Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Score
- Interval / dispersion
- Standard Error
- Time frame
- Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
What was measured
Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) total score and Functional Assessment of Cancer Therapy-General (FACT-G) total score. Total FACT-P score is the sum of Physical Well-being (PWB), Social Well-being (SWB), Emotional Well-being (EWB), Functional Well-being (FWB) and Prostate cancer subscale (PCS). FACT-P total score change from baseline values can be a minimum of -156 and a maximum of 156. A positive value indicates improvement. FACT-G total score is the sum of PWB, SWB, EWB and FWB. FACT-G Total score change from baseline values can be a minimum of -108 and a maximum of 108. A positive value indicates improvement.
Analysis population: Full Analysis Set (FAS), only patients with baseline assessment and at least one post treatment assessment are included in the analysis.
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 | 278 |
| Placebo bd + Abiraterone 1000 mg qd | 295 |
Reported measurements
Change from baseline in FACT-P Total
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | -5.84 | 1.031 | Not reported | Not reported | Not reported |
| Placebo bd + Abiraterone 1000 mg qd | -5.30 | 1.060 | Not reported | Not reported | Not reported |
Change from baseline in FACT-G Total
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | -5.06 | 0.766 | Not reported | Not reported | Not reported |
| Placebo bd + Abiraterone 1000 mg qd | -4.35 | 0.787 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.031
- value
- -5.84
- group Id
- OG001
- spread
- 1.060
- value
- -5.30
- title
- Change from baseline in FACT-P Total
- categories
- measurements
- group Id
- OG000
- spread
- 0.766
- value
- -5.06
- group Id
- OG001
- spread
- 0.787
- value
- -4.35
- title
- Change from baseline in FACT-G Total
- denoms
- counts
- group Id
- OG000
- value
- 278
- group Id
- OG001
- value
- 295
- units
- Participants
- description
- Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) total score and Functional Assessment of Cancer Therapy-General (FACT-G) total score. Total FACT-P score is the sum of Physical Well-being (PWB), Social Well-being (SWB), Emotional Well-being (EWB), Functional Well-being (FWB) and Prostate cancer subscale (PCS). FACT-P total score change from baseline values can be a minimum of -156 and a maximum of 156. A positive value indicates improvement. FACT-G total score is the sum of PWB, SWB, EWB and FWB. FACT-G Total score change from baseline values can be a minimum of -108 and a maximum of 108. A positive value indicates improvement.
- dispersion Type
- Standard Error
- 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
- LEAST_SQUARES_MEAN
- population Description
- Full Analysis Set (FAS), only patients with baseline assessment and at least one post treatment assessment are included in the analysis.
- reporting Status
- POSTED
- time Frame
- Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
- title
- Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
- type
- SECONDARY
- unit Of Measure
- Score
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice