TriangleNCT02555657 · OUTCOME
Progression-Free Survival Per RECIST 1.1 in All Participants
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 approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
What was measured
Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Analysis population: All participants who were included in a treatment group at randomization
Groups in this outcome
Pembrolizumab
Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).
Chemotherapy
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
| Group | Source count |
|---|---|
| Pembrolizumab | 312 |
| Chemotherapy | 310 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 2.1 | Not reported | 2.0 | 2.1 | Not reported |
| Chemotherapy | 3.3 | Not reported | 2.7 | 4.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.33
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.92
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 1.0000
- param Type
- Hazard Ratio (HR)
- param Value
- 1.60
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 1.33
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.92
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 1.0000
- param Type
- Hazard Ratio (HR)
- param Value
- 1.60
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 2.1
- value
- 2.1
- group Id
- OG001
- lower Limit
- 2.7
- upper Limit
- 4.0
- value
- 3.3
- denoms
- counts
- group Id
- OG000
- value
- 312
- group Id
- OG001
- value
- 310
- units
- Participants
- description
- Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- All participants who were included in a treatment group at randomization
- reporting Status
- POSTED
- time Frame
- Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
- title
- Progression-Free Survival Per RECIST 1.1 in All Participants
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice