NCT03735121 · OUTCOME
Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- μg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 (Cycle length=21 days)
Analysis population: PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms with at least one post-baseline PK sample. Overall number analyzed is the number of participants with data available for analysis.
Groups in this outcome
Part 2: Atezolizumab IV 1200 mg
Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
Part 2: Atezolizumab SC 1875 mg
Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
| Group | Source count |
|---|---|
| Part 2: Atezolizumab IV 1200 mg | 122 |
| Part 2: Atezolizumab SC 1875 mg | 246 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Atezolizumab IV 1200 mg | 88.7 | 26.2 | Not reported | Not reported | Not reported |
| Part 2: Atezolizumab SC 1875 mg | 97.2 | 42.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26.2
- value
- 88.7
- group Id
- OG001
- spread
- 42.3
- value
- 97.2
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 246
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
- id
- OG000
- title
- Part 2: Atezolizumab IV 1200 mg
- description
- Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
- id
- OG001
- title
- Part 2: Atezolizumab SC 1875 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms with at least one post-baseline PK sample. Overall number analyzed is the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (Cycle length=21 days)
- title
- Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1
- 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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