TriangleNCT04744831 · OUTCOME
Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) in Participants Who Were Administered 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
- From baseline to data cut off, up to approximately 19 months
What was measured
Immunogenicity will be assessed through characterization of incidence and titer of Anti-drug Antibodies (ADAs), the number and percentage of subjects positive for NAb of T-DXd by dose level will also be determined. ADAs and NAbs were assessed in the Immunogenicity Analysis Set at data cut-off date of 01 Nov 2022.
Analysis population: The Immunogenicity Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of the study drug and who had at least 1 baseline or postbaseline immunogenicity assessment. Subjects were analyzed according to the treatment received.
Groups in this outcome
T-DXd 5.4 mg/kg Q3W
Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
T-DXd 6.4 mg/kg Q3W
Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
| Group | Source count |
|---|---|
| T-DXd 5.4 mg/kg Q3W | 82 |
| T-DXd 6.4 mg/kg Q3W | 39 |
Reported measurements
ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | 1.3 | Not reported | Not reported | Not reported | Not reported |
| T-DXd 6.4 mg/kg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
NAb
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| T-DXd 6.4 mg/kg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.3
- group Id
- OG001
- value
- 0
- title
- ADA
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- NAb
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- Immunogenicity will be assessed through characterization of incidence and titer of Anti-drug Antibodies (ADAs), the number and percentage of subjects positive for NAb of T-DXd by dose level will also be determined. ADAs and NAbs were assessed in the Immunogenicity Analysis Set at data cut-off date of 01 Nov 2022.
- groups
- description
- Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
- id
- OG000
- title
- T-DXd 5.4 mg/kg Q3W
- description
- Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
- id
- OG001
- title
- T-DXd 6.4 mg/kg Q3W
- param Type
- NUMBER
- population Description
- The Immunogenicity Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of the study drug and who had at least 1 baseline or postbaseline immunogenicity assessment. Subjects were analyzed according to the treatment received.
- reporting Status
- POSTED
- time Frame
- From baseline to data cut off, up to approximately 19 months
- title
- Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) in Participants Who Were Administered T-DXd
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice