TriangleNCT02855944 · OUTCOME
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT 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: Intent-to-treat (ITT) population with measurable disease at baseline. ITT population defined as all randomized patients.
Groups in this outcome
Rucaparib
Patients randomized to the rucaparib arm.
Chemotherapy
Patients randomized to the chemotherapy arm.
| Group | Source count |
|---|---|
| Rucaparib | 224 |
| Chemotherapy | 106 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 37.9 | Not reported | 31.6 | 44.7 | Not reported |
| Chemotherapy | 30.2 | Not reported | 21.7 | 39.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.6
- upper Limit
- 44.7
- value
- 37.9
- group Id
- OG001
- lower Limit
- 21.7
- upper Limit
- 39.9
- value
- 30.2
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 106
- 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
- Intent-to-treat (ITT) population with measurable disease at baseline. ITT population defined as all randomized patients.
- 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 (ITT Population)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice