TriangleNCT03735121 · OUTCOME
Part 2: Observed Serum 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
- Predose on Day 1 of Cycle 2 (Cycle length =21 days)
Analysis population: Per Protocol PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms who did not have protocol deviations that could affect Cycle 1 observed Ctrough results.
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 | 97 |
| Part 2: Atezolizumab SC 1875 mg | 205 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Atezolizumab IV 1200 mg | 85.4 | 34.1 | Not reported | Not reported | Not reported |
| Part 2: Atezolizumab SC 1875 mg | 89.4 | 127.1 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.88
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90.0
- ci Upper Limit
- 1.24
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% confidence interval \[CI\] of the geometric mean ratio is greater than or equal to (≥) the non-inferiority margin 0.8.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Geometric mean ratio
- param Value
- 1.05
Complete source fields
- analyses
- ci Lower Limit
- 0.88
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90.0
- ci Upper Limit
- 1.24
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% confidence interval \[CI\] of the geometric mean ratio is greater than or equal to (≥) the non-inferiority margin 0.8.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Geometric mean ratio
- param Value
- 1.05
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 34.1
- value
- 85.4
- group Id
- OG001
- spread
- 127.1
- value
- 89.4
- denoms
- counts
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 205
- 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
- Per Protocol PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms who did not have protocol deviations that could affect Cycle 1 observed Ctrough results.
- reporting Status
- POSTED
- time Frame
- Predose on Day 1 of Cycle 2 (Cycle length =21 days)
- title
- Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1
- type
- PRIMARY
- unit Of Measure
- μg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice