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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

Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia · Source last updated 2020-04-08

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Moxetumomab Pasudotox 40 µg/kg80

Reported measurements

ADA positive
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg87.5Not reportedNot reportedNot reportedNot reported
ADA and NAb positive
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg83.8Not reportedNot reportedNot reportedNot reported
Specificity CD22 positive of ADA+/NAb+
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg55.2Not reportedNot reportedNot reportedNot reported
Specificity PE38 positive of ADA+/NAb+
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxetumomab Pasudotox 40 µg/kg98.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        87.5
    title
    ADA positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        83.8
    title
    ADA and NAb positive
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        55.2
    title
    Specificity CD22 positive of ADA+/NAb+
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        98.5
    title
    Specificity PE38 positive of ADA+/NAb+
denoms
  1. counts
    1. 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
  1. 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

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Preserved source evidence · Not medical advice