NCT05673785 · OUTCOME
Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb)
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
- Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days
Analysis population: The immunogenicity analysis set consisted of participants who have received at least 1 dose of any of the study treatments and have had an ADA status assessment at baseline and at least 1 postbaseline sample.
Groups in this outcome
Brentuximab Vedotin + CHP
Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
| Group | Source count |
|---|---|
| Brentuximab Vedotin + CHP | 52 |
Reported measurements
NAb Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin + CHP | 0 | Not reported | Not reported | Not reported | Not reported |
NAb Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin + CHP | 52 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- NAb Positive
- categories
- measurements
- group Id
- OG000
- value
- 52
- title
- NAb Negative
- denoms
- counts
- group Id
- OG000
- value
- 52
- units
- Participants
- groups
- description
- Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
- id
- OG000
- title
- Brentuximab Vedotin + CHP
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The immunogenicity analysis set consisted of participants who have received at least 1 dose of any of the study treatments and have had an ADA status assessment at baseline and at least 1 postbaseline sample.
- reporting Status
- POSTED
- time Frame
- Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days
- title
- Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle