TriangleNCT01847274 · OUTCOME
Progression-Free Survival 2 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 treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
What was measured
Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
Analysis population: Intent-to-treat population
Groups in this outcome
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
| 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 | 19.5 | Not reported | 17.1 | 22.3 | Not reported |
| Non-gBRCA Placebo | 16.1 | Not reported | 13.6 | 22.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.627
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.022
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0748
- p Value Comment
- Two-sided P-value.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.627
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.022
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0748
- p Value Comment
- Two-sided P-value.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.1
- upper Limit
- 22.3
- value
- 19.5
- group Id
- OG001
- lower Limit
- 13.6
- upper Limit
- 22.8
- value
- 16.1
- denoms
- counts
- group Id
- OG000
- value
- 234
- group Id
- OG001
- value
- 116
- units
- Participants
- description
- Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
- id
- OG000
- title
- Non-gBRCA Niraparib
- description
- Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
- id
- OG001
- title
- Non-gBRCA Placebo
- param Type
- MEDIAN
- population Description
- Intent-to-treat population
- reporting Status
- POSTED
- time Frame
- From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
- title
- Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice