NCT02366143 · OUTCOME
Cmin of Bevacizumab in Arm B and Arm C
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
- Cycle 1 Day 1 and Cycle 2 Day 21 (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 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.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of 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 loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
| Group | Source count |
|---|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 325 |
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 348 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 325 |
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 348 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | NA | NA | Not reported | Not reported | Predose of Cycle 1 Day 1 administration of Bevacizumab. |
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | NA | NA | Not reported | Not reported | Predose of Cycle 1 Day 1 administration of Bevacizumab. |
Cycle 2 Day 21
| Group | Source count |
|---|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 280 |
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 316 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 98.0 | 50.9 | Not reported | Not reported | Not reported |
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 90.4 | 36.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Predose of Cycle 1 Day 1 administration of Bevacizumab.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Predose of Cycle 1 Day 1 administration of Bevacizumab.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 325
- group Id
- OG001
- value
- 348
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 50.9
- value
- 98.0
- group Id
- OG001
- spread
- 36.8
- value
- 90.4
- denoms
- counts
- group Id
- OG000
- value
- 280
- group Id
- OG001
- value
- 316
- units
- Participants
- title
- Cycle 2 Day 21
- denoms
- counts
- group Id
- OG000
- value
- 325
- group Id
- OG001
- value
- 348
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- 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
- OG000
- title
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- description
- Participants received IV infusion of 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 loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
- id
- OG001
- title
- Arm C (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
- Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)
- title
- Cmin of Bevacizumab in Arm B and Arm C
- type
- SECONDARY
- unit Of Measure
- mcg/mL
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Preserved source evidence · Not medical advice
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