TriangleNCT02657889 · OUTCOME
Phase 2: Progression Free Survival (PFS) as Measured by RECIST v1.1
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
- Up to a maximum of 54 months
What was measured
PFS is defined as the time from first dose of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression based on the time of first documentation of disease progression per RECIST v1.1. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.
Analysis population: Full Analysis Set. Only those participants with data available at specified time point were analyzed.
Groups in this outcome
Phase 2 OC: Niraparib 200 mg + Pembrolizumab
Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Phase 2 OC: Niraparib 200 mg + Pembrolizumab | 53 |
| Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 OC: Niraparib 200 mg + Pembrolizumab | 3.4 | Not reported | 2.1 | 8.2 | Not reported |
| Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab | 2.5 | Not reported | 1.4 | 6.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 8.2
- value
- 3.4
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 6.4
- value
- 2.5
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- PFS is defined as the time from first dose of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression based on the time of first documentation of disease progression per RECIST v1.1. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Phase 2 OC: Niraparib 200 mg + Pembrolizumab
- description
- Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
- param Type
- MEDIAN
- population Description
- Full Analysis Set. Only those participants with data available at specified time point were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to a maximum of 54 months
- title
- Phase 2: Progression Free Survival (PFS) as Measured by RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice