TriangleNCT01950364 · OUTCOME
Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 of Cycle 1 and 3
What was measured
Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.
Analysis population: Safety analysis set included all participants who received at least 1 dose of study drug.
Groups in this outcome
Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab Vedotin + Rifampicin
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
| Group | Source count |
|---|---|
| Brentuximab Vedotin | 10 |
| Brentuximab Vedotin + Rifampicin | 10 |
Reported measurements
Negative in both Cycle 1 and 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 5 | Not reported | Not reported | Not reported | Not reported |
| Brentuximab Vedotin + Rifampicin | 7 | Not reported | Not reported | Not reported | Not reported |
Positive in both Cycle 1 and 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 1 | Not reported | Not reported | Not reported | Not reported |
| Brentuximab Vedotin + Rifampicin | 0 | Not reported | Not reported | Not reported | Not reported |
Transient Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin | 2 | Not reported | Not reported | Not reported | Not reported |
| Brentuximab Vedotin + Rifampicin | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- title
- Negative in both Cycle 1 and 3
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Positive in both Cycle 1 and 3
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- Transient Positive
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.
- groups
- description
- Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
- id
- OG000
- title
- Brentuximab Vedotin
- description
- Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
- id
- OG001
- title
- Brentuximab Vedotin + Rifampicin
- param Type
- NUMBER
- population Description
- Safety analysis set included all participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 and 3
- title
- Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice