TriangleNCT02855944 · OUTCOME
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
What was measured
A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Analysis population: Efficacy population with measurable disease at baseline. Efficacy population defined as all randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation.
Groups in this outcome
Rucaparib
Patients randomized to the rucaparib arm.
Chemotherapy
Patients randomized to the chemotherapy arm.
| Group | Source count |
|---|---|
| Rucaparib | 211 |
| Chemotherapy | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 40.3 | Not reported | 33.6 | 47.2 | Not reported |
| Chemotherapy | 32.3 | Not reported | 23.1 | 42.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.6
- upper Limit
- 47.2
- value
- 40.3
- group Id
- OG001
- lower Limit
- 23.1
- upper Limit
- 42.6
- value
- 32.3
- denoms
- counts
- group Id
- OG000
- value
- 211
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients randomized to the rucaparib arm.
- id
- OG000
- title
- Rucaparib
- description
- Patients randomized to the chemotherapy arm.
- id
- OG001
- title
- Chemotherapy
- param Type
- NUMBER
- population Description
- Efficacy population with measurable disease at baseline. Efficacy population defined as all randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation.
- reporting Status
- POSTED
- time Frame
- Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
- title
- Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice