NCT03038100 · OUTCOME
Minimum Serum Concentration (Cmin) of Atezolizumab
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2023-02-17
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 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 532 |
|---|
Reported measurements
Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 532 |
|---|
Values in µg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 88.9 | 35.8 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 519 |
|---|
Values in µg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 146 | 93.0 | Not reported | Not reported | Not reported |
|---|
Cycle 4 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 502 |
|---|
Values in µg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 149 | 88.1 | Not reported | Not reported | Not reported |
|---|
Cycle 8 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 339 |
|---|
Values in µg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 242 | 96.3 | Not reported | Not reported | Not reported |
|---|
Cycle 16 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 213 |
|---|
Values in µg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 286 | 111 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 35.8
- value
- 88.9
- title
- Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 93.0
- value
- 146
- title
- Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 88.1
- value
- 149
- title
- Cycle 4 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 96.3
- value
- 242
- title
- Cycle 8 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 111
- value
- 286
- title
- Cycle 16 Day 1
- 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 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
- title
- Minimum Serum Concentration (Cmin) of Atezolizumab
- type
- SECONDARY
- unit Of Measure
- µg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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