TriangleNCT03735121 · OUTCOME
Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab
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
- Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
What was measured
1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.
Analysis population: PK-evaluable population included all participants who received at least one dose of atezolizumab (atezolizumab SC or atezolizumab IV) and had at least 1 evaluable post dose 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 | 179 | 38.8 | Not reported | Not reported | Not reported |
| Part 2: Atezolizumab SC 1875 mg | 205 | 58.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 38.8
- value
- 179
- group Id
- OG001
- spread
- 58.1
- value
- 205
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.
- 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 who received at least one dose of atezolizumab (atezolizumab SC or atezolizumab IV) and had at least 1 evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
- title
- Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab
- type
- SECONDARY
- unit Of Measure
- μg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice