TriangleNCT02888743 · OUTCOME
Prognostic Effect of PD-L1 Expression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percent expression
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 2 years
What was measured
NSCLC participants only: Pre-treatment levels of PD-L1 percent will be compared according to RECIST response using Wilcoxon rank-sum testing. PD-L1 percent: The percentage of tumor cells that positively express the PD-L1 protein (programmed cell death ligand 1). Tumors that express high amounts of PD-L1 (\>50%) may respond well to checkpoint inhibitors (a type of immunotherapy drug).
Analysis population: Participants in the NSCLC cohort with PD-L1 IHC evaluation. This analysis was pre-specified in the protocol to collect, analyze, and report data according to response and not by treatment Arm. Patients were classified into responders and non-responders according to RECIST criteria. PD-L1 percent was compared between these two groups of patients.
Groups in this outcome
Confirmed Responders
Participants with confirmed RECIST response of CR or PR.
Non-responders
Participants without confirmed response of CR or PR.
| Group | Source count |
|---|---|
| Confirmed Responders | 6 |
| Non-responders | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Confirmed Responders | 15.8 | 31.7 | Not reported | Not reported | Not reported |
| Non-responders | 15.3 | 25.2 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.68
- p Value Comment
- Unadjusted p-value.
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.68
- p Value Comment
- Unadjusted p-value.
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 31.7
- value
- 15.8
- group Id
- OG001
- spread
- 25.2
- value
- 15.3
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 43
- units
- Participants
- description
- NSCLC participants only: Pre-treatment levels of PD-L1 percent will be compared according to RECIST response using Wilcoxon rank-sum testing. PD-L1 percent: The percentage of tumor cells that positively express the PD-L1 protein (programmed cell death ligand 1). Tumors that express high amounts of PD-L1 (\>50%) may respond well to checkpoint inhibitors (a type of immunotherapy drug).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with confirmed RECIST response of CR or PR.
- id
- OG000
- title
- Confirmed Responders
- description
- Participants without confirmed response of CR or PR.
- id
- OG001
- title
- Non-responders
- param Type
- MEAN
- population Description
- Participants in the NSCLC cohort with PD-L1 IHC evaluation. This analysis was pre-specified in the protocol to collect, analyze, and report data according to response and not by treatment Arm. Patients were classified into responders and non-responders according to RECIST criteria. PD-L1 percent was compared between these two groups of patients.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Prognostic Effect of PD-L1 Expression
- type
- SECONDARY
- unit Of Measure
- Percent expression
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice