TriangleNCT02855944 · OUTCOME
Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)
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
- Assessments every 8 weeks from Cycle 1 Day 1 (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
The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Analysis population: Efficacy Population - All randomized patients in the treatment part of study with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.
Groups in this outcome
Rucaparib
Patients randomized to the rucaparib arm.
Chemotherapy
Patients randomized to the chemotherapy arm.
| Group | Source count |
|---|---|
| Rucaparib | 220 |
| Chemotherapy | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rucaparib | 7.4 | Not reported | 7.3 | 9.1 | Not reported |
| Chemotherapy | 5.7 | Not reported | 5.5 | 7.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.489
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.835
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Cox Proportional Hazard
- param Value
- 0.639
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.489
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.835
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Cox Proportional Hazard
- param Value
- 0.639
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.3
- upper Limit
- 9.1
- value
- 7.4
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- 7.3
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 220
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- 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
- MEDIAN
- population Description
- Efficacy Population - All randomized patients in the treatment part of study with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.
- reporting Status
- POSTED
- time Frame
- Assessments every 8 weeks from Cycle 1 Day 1 (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 Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice