TriangleNCT03125902 · OUTCOME
Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
Analysis population: PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
Groups in this outcome
Placebo and Paclitaxel
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Placebo and Paclitaxel | 18 |
| Atezolizumab and Paclitaxel | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo and Paclitaxel | 1.51 | NA | Not reported | Not reported | Insufficient number of samples analyzed. |
| Atezolizumab and Paclitaxel | 1.67 | NA | Not reported | Not reported | Insufficient number of samples analyzed. |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of samples analyzed.
- group Id
- OG000
- spread
- NA
- value
- 1.51
- comment
- Insufficient number of samples analyzed.
- group Id
- OG001
- spread
- NA
- value
- 1.67
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 29
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Placebo and Paclitaxel
- description
- Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Atezolizumab and Paclitaxel
- param Type
- GEOMETRIC_MEAN
- population Description
- PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
- reporting Status
- POSTED
- time Frame
- Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
- title
- Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice