TriangleNCT04145349 · OUTCOME
Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)
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
- Baseline Up to 23 months
What was measured
A TE-ADA evaluable participant is considered TE-ADA positive if they have at least one post-baseline ADA titer that is a 4-fold or greater increase from their baseline titer (treatment-boosted); alternatively, if the baseline ADA result is Not Present, the participant is considered TE-ADA positive if there is at least one post-baseline ADA result that is Present with a titer greater than or equal to 1:20 (treatment-induced).
Analysis population: All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value.
Groups in this outcome
Ramucirumab + Cyclophosphamide + Vinorelbine
Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Cyclophosphamide + Vinorelbine
Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
| Group | Source count |
|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine | 13 |
| Cyclophosphamide + Vinorelbine | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine | 0 | Not reported | Not reported | Not reported | Not reported |
| Cyclophosphamide + Vinorelbine | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- A TE-ADA evaluable participant is considered TE-ADA positive if they have at least one post-baseline ADA titer that is a 4-fold or greater increase from their baseline titer (treatment-boosted); alternatively, if the baseline ADA result is Not Present, the participant is considered TE-ADA positive if there is at least one post-baseline ADA result that is Present with a titer greater than or equal to 1:20 (treatment-induced).
- groups
- description
- Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
- id
- OG000
- title
- Ramucirumab + Cyclophosphamide + Vinorelbine
- description
- Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
- id
- OG001
- title
- Cyclophosphamide + Vinorelbine
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value.
- reporting Status
- POSTED
- time Frame
- Baseline Up to 23 months
- title
- Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice