TriangleNCT01847274 · OUTCOME
Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
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 date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
What was measured
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Analysis population: Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
Groups in this outcome
Non-gBRCAmut HRD+ Niraparib
Niraparib (300 mg) once daily in 28-day cycles until disease progression in participants with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
Non-gBRCAmut HRD+ Placebo
Placebo once daily in 28-day cycles until disease progression patients with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
| Group | Source count |
|---|---|
| Non-gBRCAmut HRD+ Niraparib | 106 |
| Non-gBRCAmut HRD+ Placebo | 56 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-gBRCAmut HRD+ Niraparib | 12.9 | Not reported | 8.1 | 15.9 | Not reported |
| Non-gBRCAmut HRD+ Placebo | 3.8 | Not reported | 3.5 | 5.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.243
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.586
- estimate Comment
- Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested
- param Type
- Hazard Ratio (HR)
- param Value
- 0.38
- statistical Comment
- Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.243
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.586
- estimate Comment
- Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested
- param Type
- Hazard Ratio (HR)
- param Value
- 0.38
- statistical Comment
- Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.1
- upper Limit
- 15.9
- value
- 12.9
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- 5.7
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 56
- units
- Participants
- description
- PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Niraparib (300 mg) once daily in 28-day cycles until disease progression in participants with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
- id
- OG000
- title
- Non-gBRCAmut HRD+ Niraparib
- description
- Placebo once daily in 28-day cycles until disease progression patients with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio
- id
- OG001
- title
- Non-gBRCAmut HRD+ Placebo
- param Type
- MEDIAN
- population Description
- Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.
- reporting Status
- POSTED
- time Frame
- From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
- title
- Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice