TriangleNCT01668784 · OUTCOME
Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level
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
- Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)
What was measured
Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H\&E process before the tumor biopsy specimen was sent for evaluation or from H\&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.
Analysis population: PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline
Groups in this outcome
Nivolumab
Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Everolimus
Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
| Group | Source count |
|---|---|
| Nivolumab | 370 |
| Everolimus | 386 |
Reported measurements
Participant PD-L1 expression >=1%
| Group | Source count |
|---|---|
| Nivolumab | 94 |
| Everolimus | 87 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 5.36 | Not reported | 2.04 | 7.46 | Not reported |
| Everolimus | 4.17 | Not reported | 3.09 | 5.52 | Not reported |
Participant PD-L1 expression <1%
| Group | Source count |
|---|---|
| Nivolumab | 276 |
| Everolimus | 299 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 3.94 | Not reported | 3.68 | 5.36 | Not reported |
| Everolimus | 4.67 | Not reported | 3.71 | 5.72 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.04
- upper Limit
- 7.46
- value
- 5.36
- group Id
- OG001
- lower Limit
- 3.09
- upper Limit
- 5.52
- value
- 4.17
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 87
- units
- Participants
- title
- Participant PD-L1 expression >=1%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.68
- upper Limit
- 5.36
- value
- 3.94
- group Id
- OG001
- lower Limit
- 3.71
- upper Limit
- 5.72
- value
- 4.67
- denoms
- counts
- group Id
- OG000
- value
- 276
- group Id
- OG001
- value
- 299
- units
- Participants
- title
- Participant PD-L1 expression <1%
- denoms
- counts
- group Id
- OG000
- value
- 370
- group Id
- OG001
- value
- 386
- units
- Participants
- description
- Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H\&E process before the tumor biopsy specimen was sent for evaluation or from H\&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG001
- title
- Everolimus
- param Type
- MEDIAN
- population Description
- PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline
- reporting Status
- POSTED
- time Frame
- Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)
- title
- Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice