TriangleNCT02302807 · OUTCOME
Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
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
- Up to approximately 25 months after first participant enrolled
What was measured
PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of \>/= 5 millimeters (mm).
Analysis population: Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.
Groups in this outcome
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
IC2/3 Chemotherapy
PD-L1 immunohistochemistry (IHC) score of IC2/3
IC2/3 Atezolizumab
PD-L1 immunohistochemistry (IHC) score of IC2/3
IC1/2/3 Chemotherapy
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
IC1/2/3 Atezolizumab
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
| Group | Source count |
|---|---|
| Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 464 |
| Atezolizumab | 467 |
| IC2/3 Chemotherapy | 118 |
| IC2/3 Atezolizumab | 116 |
| IC1/2/3 Chemotherapy | 309 |
| IC1/2/3 Atezolizumab | 316 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 4.0 | Not reported | 3.4 | 4.2 | Not reported |
| Atezolizumab | 2.1 | Not reported | 2.1 | 2.2 | Not reported |
| IC2/3 Chemotherapy | 4.2 | Not reported | 3.7 | 5.0 | Not reported |
| IC2/3 Atezolizumab | 2.4 | Not reported | 2.1 | 4.2 | Not reported |
| IC1/2/3 Chemotherapy | 4.1 | Not reported | 3.6 | 4.2 | Not reported |
| IC1/2/3 Atezolizumab | 2.1 | Not reported | 2.1 | 2.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.4
- upper Limit
- 4.2
- value
- 4.0
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 2.2
- value
- 2.1
- group Id
- OG002
- lower Limit
- 3.7
- upper Limit
- 5.0
- value
- 4.2
- group Id
- OG003
- lower Limit
- 2.1
- upper Limit
- 4.2
- value
- 2.4
- group Id
- OG004
- lower Limit
- 3.6
- upper Limit
- 4.2
- value
- 4.1
- group Id
- OG005
- lower Limit
- 2.1
- upper Limit
- 2.2
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 464
- group Id
- OG001
- value
- 467
- group Id
- OG002
- value
- 118
- group Id
- OG003
- value
- 116
- group Id
- OG004
- value
- 309
- group Id
- OG005
- value
- 316
- units
- Participants
- description
- PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of \>/= 5 millimeters (mm).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
- id
- OG000
- title
- Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
- description
- Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
- id
- OG001
- title
- Atezolizumab
- description
- PD-L1 immunohistochemistry (IHC) score of IC2/3
- id
- OG002
- title
- IC2/3 Chemotherapy
- description
- PD-L1 immunohistochemistry (IHC) score of IC2/3
- id
- OG003
- title
- IC2/3 Atezolizumab
- description
- PD-L1 immunohistochemistry (IHC) score of IC1/2/3
- id
- OG004
- title
- IC1/2/3 Chemotherapy
- description
- PD-L1 immunohistochemistry (IHC) score of IC1/2/3
- id
- OG005
- title
- IC1/2/3 Atezolizumab
- param Type
- MEDIAN
- population Description
- Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.
- reporting Status
- POSTED
- time Frame
- Up to approximately 25 months after first participant enrolled
- title
- Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice