TriangleNCT01642004 · OUTCOME
Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized 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
- From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months
What was measured
PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
| Group | Source count |
|---|---|
| Nivolumab | 135 |
| Docetaxel | 137 |
Reported measurements
PD-L1 expression >= 5%
| Group | Source count |
|---|---|
| Nivolumab | 42 |
| Docetaxel | 39 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 5.06 | Not reported | 2.10 | 7.56 | Not reported |
| Docetaxel | 3.06 | Not reported | 1.94 | 4.63 | Not reported |
PD-L1 expression < 5%
| Group | Source count |
|---|---|
| Nivolumab | 75 |
| Docetaxel | 69 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 2.23 | Not reported | 1.94 | 4.73 | Not reported |
| Docetaxel | 2.92 | Not reported | 2.07 | 3.58 | Not reported |
PD-L1 not quantifiable at baseline
| Group | Source count |
|---|---|
| Nivolumab | 18 |
| Docetaxel | 29 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 5.39 | Not reported | 2.10 | 10.45 | Not reported |
| Docetaxel | 2.23 | Not reported | 2.04 | 4.40 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.10
- upper Limit
- 7.56
- value
- 5.06
- group Id
- OG001
- lower Limit
- 1.94
- upper Limit
- 4.63
- value
- 3.06
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 39
- units
- Participants
- title
- PD-L1 expression >= 5%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.94
- upper Limit
- 4.73
- value
- 2.23
- group Id
- OG001
- lower Limit
- 2.07
- upper Limit
- 3.58
- value
- 2.92
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 69
- units
- Participants
- title
- PD-L1 expression < 5%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.10
- upper Limit
- 10.45
- value
- 5.39
- group Id
- OG001
- lower Limit
- 2.04
- upper Limit
- 4.40
- value
- 2.23
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 29
- units
- Participants
- title
- PD-L1 not quantifiable at baseline
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 137
- units
- Participants
- description
- PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
- id
- OG001
- title
- Docetaxel
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first, up to approximately 103 months
- title
- Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice