TriangleNCT02975934 · OUTCOME
Duration of Response (DOR) by IRR 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 primary completion of study (Total follow-up was up to approximately 4 years)
What was measured
DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.
Analysis population: ITT Population with BRCA mutated mCRPC and measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response.
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 | 37 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 7.4 | Not reported | 6.4 | 12.7 | Not reported |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 7.4 | Not reported | 3.5 | NA | The upper limit of the confidence interval is inestimable likely due to the small number of participants in this treatment group. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 12.7
- value
- 7.4
- comment
- The upper limit of the confidence interval is inestimable likely due to the small number of participants in this treatment group.
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- NA
- value
- 7.4
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.
- 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 and measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response.
- reporting Status
- POSTED
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- title
- Duration of Response (DOR) by IRR 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