NCT02366143 · OUTCOME
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)
Analysis population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 354 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 345 |
|---|
Reported measurements
Cycle 1 Day 21
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 354 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 345 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 76.4 | 37.7 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 80.8 | 41.4 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 21
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 322 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 319 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 119 | 55.7 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 130 | 57.1 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 21
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 312 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 307 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 146 | 58.9 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 160 | 102 | Not reported | Not reported | Not reported |
|---|
Cycle 7 Day 21
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 230 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 249 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 219 | 89.6 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 220 | 99.0 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 37.7
- value
- 76.4
- group Id
- OG001
- spread
- 41.4
- value
- 80.8
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 345
- units
- Participants
- title
- Cycle 1 Day 21
- categories
- measurements
- group Id
- OG000
- spread
- 55.7
- value
- 119
- group Id
- OG001
- spread
- 57.1
- value
- 130
- denoms
- counts
- group Id
- OG000
- value
- 322
- group Id
- OG001
- value
- 319
- units
- Participants
- title
- Cycle 2 Day 21
- categories
- measurements
- group Id
- OG000
- spread
- 58.9
- value
- 146
- group Id
- OG001
- spread
- 102
- value
- 160
- denoms
- counts
- group Id
- OG000
- value
- 312
- group Id
- OG001
- value
- 307
- units
- Participants
- title
- Cycle 3 Day 21
- categories
- measurements
- group Id
- OG000
- spread
- 89.6
- value
- 219
- group Id
- OG001
- spread
- 99.0
- value
- 220
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 249
- units
- Participants
- title
- Cycle 7 Day 21
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 345
- units
- Participants
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.
- reporting Status
- POSTED
- time Frame
- Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)
- title
- Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
- type
- SECONDARY
- unit Of Measure
- mcg/mL
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Preserved source evidence · Not medical advice
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