TriangleNCT02366143 · OUTCOME
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
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 1 of Cycle 1 and 3 (Cycle length=21 days)
What was measured
The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
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 | Source count |
|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 378 |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 364 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 378 |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 364 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 410 | 157 | Not reported | Not reported | Not reported |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 414 | 127 | Not reported | Not reported | Not reported |
Cycle 3 Day 1
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 310 |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 302 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 498 | 160 | Not reported | Not reported | Not reported |
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 540 | 198 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 157
- value
- 410
- group Id
- OG001
- spread
- 127
- value
- 414
- denoms
- counts
- group Id
- OG000
- value
- 378
- group Id
- OG001
- value
- 364
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 160
- value
- 498
- group Id
- OG001
- spread
- 198
- value
- 540
- denoms
- counts
- group Id
- OG000
- value
- 310
- group Id
- OG001
- value
- 302
- units
- Participants
- title
- Cycle 3 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 378
- group Id
- OG001
- value
- 364
- units
- Participants
- description
- The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
- 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 1 of Cycle 1 and 3 (Cycle length=21 days)
- title
- Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
- type
- SECONDARY
- unit Of Measure
- mcg/mL
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Preserved source evidence · Not medical advice