TriangleNCT03703297 · OUTCOME
Durvalumab: Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug (Day 1) up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
What was measured
Blood samples were collected to determine the presence of ADAs for durvalumab using validated assays. Treatment-emergent ADA-positive was defined as either treatment-induced (post-baseline ADA-positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to ≥4 fold during the study period). Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher level (greater than the analytical variance of the assay) following drug administration. Number of participants with treatment-emergent ADA (ADA incidence) are presented.
Analysis population: The ADA population included all participants in the safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result of the study drug.
Groups in this outcome
Durvalumab
Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
| Group | Source count |
|---|---|
| Durvalumab | 206 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Durvalumab | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 206
- units
- Participants
- description
- Blood samples were collected to determine the presence of ADAs for durvalumab using validated assays. Treatment-emergent ADA-positive was defined as either treatment-induced (post-baseline ADA-positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to ≥4 fold during the study period). Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher level (greater than the analytical variance of the assay) following drug administration. Number of participants with treatment-emergent ADA (ADA incidence) are presented.
- groups
- description
- Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
- id
- OG000
- title
- Durvalumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The ADA population included all participants in the safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result of the study drug.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug (Day 1) up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
- title
- Durvalumab: Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice