TriangleNCT01642004 · OUTCOME
Objective Response Rate (ORR) 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
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
What was measured
ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
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 | 21.4 | Not reported | 10.3 | 36.8 | Not reported |
| Docetaxel | 7.7 | Not reported | 1.6 | 20.9 | Not reported |
PD-L1 expression < 5%
| Group | Source count |
|---|---|
| Nivolumab | 75 |
| Docetaxel | 69 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 14.7 | Not reported | 7.6 | 24.7 | Not reported |
| Docetaxel | 11.6 | Not reported | 5.1 | 21.6 | Not reported |
PD-L1 not quantifiable at baseline
| Group | Source count |
|---|---|
| Nivolumab | 18 |
| Docetaxel | 29 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 38.9 | Not reported | 17.3 | 64.3 | Not reported |
| Docetaxel | 3.4 | Not reported | 0.1 | 17.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.3
- upper Limit
- 36.8
- value
- 21.4
- group Id
- OG001
- lower Limit
- 1.6
- upper Limit
- 20.9
- value
- 7.7
- 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
- 7.6
- upper Limit
- 24.7
- value
- 14.7
- group Id
- OG001
- lower Limit
- 5.1
- upper Limit
- 21.6
- value
- 11.6
- 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
- 17.3
- upper Limit
- 64.3
- value
- 38.9
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 17.8
- value
- 3.4
- 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
- ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.
- 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
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From the date of randomization up to the date of objectively documented progression, up to approximately 103 months
- title
- Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice