TriangleNCT01847274 · OUTCOME
Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
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 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
Groups in this outcome
Non-gBRCA Niraparib
Niraparib (300 mg) once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
Non-gBRCA Placebo
Placebo once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
| Group | Source count |
|---|---|
| Non-gBRCA Niraparib | 234 |
| Non-gBRCA Placebo | 116 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-gBRCA Niraparib | 9.3 | Not reported | 7.2 | 11.2 | Not reported |
| Non-gBRCA Placebo | 3.9 | Not reported | 3.7 | 5.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.338
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.607
- 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
- 0.45
- 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
- 0.338
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.607
- 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
- 0.45
- 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
- 7.2
- upper Limit
- 11.2
- value
- 9.3
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 5.5
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 234
- group Id
- OG001
- value
- 116
- 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 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 patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
- id
- OG000
- title
- Non-gBRCA Niraparib
- description
- Placebo once daily in 28-day cycles until disease progression in patients without germline BRCA mutation Niraparib vs. Placebo 2:1 ratio
- id
- OG001
- title
- Non-gBRCA Placebo
- param Type
- MEDIAN
- population Description
- Intent-to-treat population
- 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 BRCA Mutation
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice