TriangleNCT02975934 · OUTCOME
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- From enrollment to up to approximately 25 weeks
What was measured
Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
Analysis population: ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Groups in this outcome
Rucaparib
Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
Abiraterone Acetate or Enzalutamide or Docetaxel
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
| Group | Source count |
|---|---|
| Rucaparib | 136 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 2.4 | 1.23 | Not reported | Not reported | Not reported |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 1.8 | 2.39 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.23
- value
- 2.4
- group Id
- OG001
- spread
- 2.39
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 36
- units
- Participants
- description
- Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
- dispersion Type
- Standard Error
- groups
- description
- Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
- id
- OG000
- title
- Rucaparib
- description
- Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
- id
- OG001
- title
- Abiraterone Acetate or Enzalutamide or Docetaxel
- param Type
- LEAST_SQUARES_MEAN
- population Description
- ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From enrollment to up to approximately 25 weeks
- title
- Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice