TriangleNCT03125902 · OUTCOME
Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)
Analysis population: Anti-Drug Antibody (ADA) population: * Baseline ADA-evaluable population: all participants with at least one evaluable ADA assay result from a baseline sample * Post baseline ADA-Evaluable population: all participants with at least one evaluable ADA assay result from at least one post-baseline 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
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 |
|---|---|
| Atezolizumab and Paclitaxel | 334 |
Reported measurements
Percentage of participants positive for ADA at Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab and Paclitaxel | 1.5 | Not reported | Not reported | Not reported | Not reported |
Percentage of participants positive for ADA Post-baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab and Paclitaxel | 14.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.5
- title
- Percentage of participants positive for ADA at Baseline
- categories
- measurements
- group Id
- OG000
- value
- 14.7
- title
- Percentage of participants positive for ADA Post-baseline
- denoms
- counts
- group Id
- OG000
- value
- 334
- units
- Participants
- groups
- 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
- OG000
- title
- Atezolizumab and Paclitaxel
- param Type
- NUMBER
- population Description
- Anti-Drug Antibody (ADA) population: * Baseline ADA-evaluable population: all participants with at least one evaluable ADA assay result from a baseline sample * Post baseline ADA-Evaluable population: all participants with at least one evaluable ADA assay result from at least one post-baseline 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 Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)
- title
- Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice