NCT01829711 · OUTCOME
Percentage of Participants With Positive Anti-drug Antibodies (ADA), Neutralizing Anti-drug Antibodies (nAb) and Specificity (CD22 and PE38) Positive to Moxetumomab Pasudotox
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
- Pre-infusion on Day 1 of Cycles 1, 2, 3, and 5; at the End of Treatment (4 to 6 weeks after the last dose; approximately 7 months)
What was measured
Participants with ADA positive, nAb positive, cluster of differentiation 22 (CD22) positive of ADA positive/NAb positive, and pseudomonas exotoxin 38 (PE38) positive of ADA positive/NAb positive to moxetumomab pasudotox at any visit are reported.
Analysis population: Safety population included participants who received at least 1 dose of moxetumomab pasudotox.
Groups in this outcome
Moxetumomab Pasudotox 40 µg/kg
Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
| Group | Source count |
|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 80 |
Reported measurements
ADA positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 87.5 | Not reported | Not reported | Not reported | Not reported |
ADA and NAb positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 83.8 | Not reported | Not reported | Not reported | Not reported |
Specificity CD22 positive of ADA+/NAb+
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 55.2 | Not reported | Not reported | Not reported | Not reported |
Specificity PE38 positive of ADA+/NAb+
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 98.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 87.5
- title
- ADA positive
- categories
- measurements
- group Id
- OG000
- value
- 83.8
- title
- ADA and NAb positive
- categories
- measurements
- group Id
- OG000
- value
- 55.2
- title
- Specificity CD22 positive of ADA+/NAb+
- categories
- measurements
- group Id
- OG000
- value
- 98.5
- title
- Specificity PE38 positive of ADA+/NAb+
- denoms
- counts
- group Id
- OG000
- value
- 80
- units
- Participants
- description
- Participants with ADA positive, nAb positive, cluster of differentiation 22 (CD22) positive of ADA positive/NAb positive, and pseudomonas exotoxin 38 (PE38) positive of ADA positive/NAb positive to moxetumomab pasudotox at any visit are reported.
- groups
- description
- Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
- id
- OG000
- title
- Moxetumomab Pasudotox 40 µg/kg
- param Type
- NUMBER
- population Description
- Safety population included participants who received at least 1 dose of moxetumomab pasudotox.
- reporting Status
- POSTED
- time Frame
- Pre-infusion on Day 1 of Cycles 1, 2, 3, and 5; at the End of Treatment (4 to 6 weeks after the last dose; approximately 7 months)
- title
- Percentage of Participants With Positive Anti-drug Antibodies (ADA), Neutralizing Anti-drug Antibodies (nAb) and Specificity (CD22 and PE38) Positive to Moxetumomab Pasudotox
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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