TriangleNCT02555657 · OUTCOME
Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- 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
Overall Response Rate (ORR), based on a Blinded Independent Central Review (BICR) assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
Analysis population: All participants with PD-L1 CPS ≥10 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 | 96 |
| Chemotherapy | 98 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 17.7 | Not reported | 10.7 | 26.8 | Not reported |
| Chemotherapy | 9.2 | Not reported | 4.3 | 16.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.4
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0457
- param Type
- Difference in percentages
- param Value
- 8.3
- statistical Method
- Miettinen & Nurminen method
Complete source fields
- analyses
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.4
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0457
- param Type
- Difference in percentages
- param Value
- 8.3
- statistical Method
- Miettinen & Nurminen method
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.7
- upper Limit
- 26.8
- value
- 17.7
- group Id
- OG001
- lower Limit
- 4.3
- upper Limit
- 16.7
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- Overall Response Rate (ORR), based on a Blinded Independent Central Review (BICR) assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
- 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
- NUMBER
- population Description
- All participants with PD-L1 CPS ≥10 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
- Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice