TriangleNCT04639219 · OUTCOME
Percentage of Participants With Anti-Drug Antibodies (ADA) to T-DXd
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
- Up to approximately 24 months
What was measured
Blood samples were collected to evaluate the presence of ADAs for T-DXd using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as the percentage of participants who were evaluable for ADA and were treatment-emergent ADA-positive. Treatment-emergent ADA was defined as either treatment-induced (baseline ADA negative, post-baseline ADA positive) or treatment-boosted ADA. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to \>=2 fold during the study period. Persistently positive was defined as \>=2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having \>=1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Analysis population: Participants in the ADA-evaluable set consisted of all participants in the Safety Analysis set (SAF- All participants who received at least 1 dose of study treatment) with a non-missing baseline ADA result and at least 1 non-missing post-baseline ADA result.
Groups in this outcome
T-DXd
Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
| Group | Source count |
|---|---|
| T-DXd | 96 |
Reported measurements
ADA positive at any visit (ADA prevalence)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 2.1 | Not reported | Not reported | Not reported | Not reported |
ADA incidence
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment-emergent ADA positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment-boosted ADA positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 0 | Not reported | Not reported | Not reported | Not reported |
Persistently positive ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 0 | Not reported | Not reported | Not reported | Not reported |
Transiently positive ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.1
- title
- ADA positive at any visit (ADA prevalence)
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- ADA incidence
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Treatment-emergent ADA positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Treatment-boosted ADA positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Persistently positive ADA
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Transiently positive ADA
- denoms
- counts
- group Id
- OG000
- value
- 96
- units
- Participants
- description
- Blood samples were collected to evaluate the presence of ADAs for T-DXd using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as the percentage of participants who were evaluable for ADA and were treatment-emergent ADA-positive. Treatment-emergent ADA was defined as either treatment-induced (baseline ADA negative, post-baseline ADA positive) or treatment-boosted ADA. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to \>=2 fold during the study period. Persistently positive was defined as \>=2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having \>=1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
- groups
- description
- Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
- id
- OG000
- title
- T-DXd
- param Type
- NUMBER
- population Description
- Participants in the ADA-evaluable set consisted of all participants in the Safety Analysis set (SAF- All participants who received at least 1 dose of study treatment) with a non-missing baseline ADA result and at least 1 non-missing post-baseline ADA result.
- reporting Status
- POSTED
- time Frame
- Up to approximately 24 months
- title
- Percentage of Participants With Anti-Drug Antibodies (ADA) to T-DXd
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice