NCT02366143 · OUTCOME
PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
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
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
What was measured
PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.
Analysis population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.
Groups in this outcome
Arm A (Atezolizumab+Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 348 |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 356 |
Reported measurements
Teff-high WT
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 161 |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 155 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 6.3 | Not reported | 5.6 | 7.8 | Not reported |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 11.3 | Not reported | 9.1 | 13.0 | Not reported |
ITT-WT
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 348 |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 356 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 6.3 | Not reported | 5.6 | 7.0 | Not reported |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 8.3 | Not reported | 7.7 | 9.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 7.8
- value
- 6.3
- group Id
- OG001
- lower Limit
- 9.1
- upper Limit
- 13.0
- value
- 11.3
- denoms
- counts
- group Id
- OG000
- value
- 161
- group Id
- OG001
- value
- 155
- units
- Participants
- title
- Teff-high WT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 7.0
- value
- 6.3
- group Id
- OG001
- lower Limit
- 7.7
- upper Limit
- 9.8
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 348
- group Id
- OG001
- value
- 356
- units
- Participants
- title
- ITT-WT
- denoms
- counts
- group Id
- OG000
- value
- 348
- group Id
- OG001
- value
- 356
- units
- Participants
- description
- PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
- id
- OG000
- title
- Arm A (Atezolizumab+Paclitaxel+Carboplatin)
- description
- Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
- id
- OG001
- title
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- param Type
- MEDIAN
- population Description
- Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.
- reporting Status
- POSTED
- time Frame
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
- title
- PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice
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