TriangleNCT03735121 · OUTCOME
Part 1: Serum Trough Concentration (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
- micrograms per milliliter (μg/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2)
Analysis population: Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.
Groups in this outcome
Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
| Group | Source count |
|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 13 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 121 | 42.8 | Not reported | Not reported | Not reported |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 77.5 | 51.4 | Not reported | Not reported | Not reported |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 78.3 | 88.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 42.8
- value
- 121
- group Id
- OG001
- spread
- 51.4
- value
- 77.5
- group Id
- OG002
- spread
- 88.6
- value
- 78.3
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 35
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
- description
- Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
- description
- Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG002
- title
- Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2)
- title
- Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1
- type
- PRIMARY
- unit Of Measure
- micrograms per milliliter (μg/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice