TriangleNCT03735121 · OUTCOME
Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration
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
- From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months)
What was measured
The percentage of ADA-positive participants after atezolizumab SC formulated with rHuPH20 administration was reported. Participants who received atezolizumab SC formulated with rHuPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following rHuPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place.
Analysis population: Safety-evaluable population included all participants who received at least one dose of atezolizumab SC formulated with rHuPH20. Overall number analyzed is the number of participants with data available for analysis.
Groups in this outcome
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 SC 1875 mg | 228 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Atezolizumab SC 1875 mg | 5.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 228
- units
- Participants
- description
- The percentage of ADA-positive participants after atezolizumab SC formulated with rHuPH20 administration was reported. Participants who received atezolizumab SC formulated with rHuPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following rHuPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place.
- groups
- 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
- OG000
- title
- Part 2: Atezolizumab SC 1875 mg
- param Type
- NUMBER
- population Description
- Safety-evaluable population included all participants who received at least one dose of atezolizumab SC formulated with rHuPH20. Overall number analyzed is the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months)
- title
- Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice