NCT03038100 · OUTCOME
Maximum Serum Concentration (Cmax) of Atezolizumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- µg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
Analysis population: PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.
Groups in this outcome
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
| Group | Source count |
|---|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 538 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 538 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 487 | 163 | Not reported | Not reported | Not reported |
Cycle 3 Day 1
| Group | Source count |
|---|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 499 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 614 | 209 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 163
- value
- 487
- denoms
- counts
- group Id
- OG000
- value
- 538
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 209
- value
- 614
- denoms
- counts
- group Id
- OG000
- value
- 499
- units
- Participants
- title
- Cycle 3 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 538
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
- id
- OG000
- title
- Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
- param Type
- MEAN
- population Description
- PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
- title
- Maximum Serum Concentration (Cmax) of Atezolizumab
- type
- SECONDARY
- unit Of Measure
- µg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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