TriangleNCT04145700 · 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 6.94 months
What was measured
A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \>= 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 + Gemcitabine + Docetaxel
Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
Gemcitabine + Docetaxel
Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
| Group | Source count |
|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 7 |
| Gemcitabine + Docetaxel | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 0 | Not reported | Not reported | Not reported | Not reported |
| Gemcitabine + Docetaxel | 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
- 7
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \>= 20 (treatment-induced).
- groups
- description
- Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
- id
- OG000
- title
- Ramucirumab + Gemcitabine + Docetaxel
- description
- Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
- id
- OG001
- title
- Gemcitabine + Docetaxel
- 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 6.94 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