TriangleNCT02975934 · OUTCOME
Overall Survival in Participants With a BRCA Alteration
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
- From enrollment to completion of study (up to approximately 7 years)
What was measured
Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive.
Analysis population: ITT Population with BRCA mutated mCRPC.
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 | 201 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 101 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 23.2 | Not reported | 19.1 | 25.2 | Not reported |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 21.2 | Not reported | 18.0 | 23.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.20
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5044
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.20
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5044
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.1
- upper Limit
- 25.2
- value
- 23.2
- group Id
- OG001
- lower Limit
- 18.0
- upper Limit
- 23.1
- value
- 21.2
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 101
- units
- Participants
- description
- Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- ITT Population with BRCA mutated mCRPC.
- reporting Status
- POSTED
- time Frame
- From enrollment to completion of study (up to approximately 7 years)
- title
- Overall Survival in Participants With a BRCA Alteration
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice