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NCT04266301 · OUTCOME

ADA Prevalence at Baseline and ADA-positive Participants On-treatment

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

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 approx. 39 months

What was measured

Anti-drug Antibody (ADA) prevalence is the number of participants with at least one sample meeting the criteria at baseline. ADA-positive participants were calculated as the number of participants with at least one on-treatment ADA-positive sample divided by the number of participants with a determinant baseline IG sample and at least one determinant post-baseline IG sample.

Analysis population: Immunogenicity Incidence Set includes all participants in the Immunogenicity prevalence set with a non-missing baseline ADA sample and at least one non-missing post-baseline ADA sample. The Immunogenicity prevalence set includes all participants in the Safety Set with a non-missing baseline ADA sample or at least one non-missing post-baseline ADA sample.

Groups in this outcome

Sabatolimab (MBG453)

Participants received sabatolimab

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

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453)249

Reported measurements

ADA prevalence (i.e., ADA positive) at baseline
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453)24Not reportedNot reportedNot reportedNot reported
ADA-positive participants on-treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453)34Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    ADA prevalence (i.e., ADA positive) at baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    ADA-positive participants on-treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      249
    units
    Participants
description
Anti-drug Antibody (ADA) prevalence is the number of participants with at least one sample meeting the criteria at baseline. ADA-positive participants were calculated as the number of participants with at least one on-treatment ADA-positive sample divided by the number of participants with a determinant baseline IG sample and at least one determinant post-baseline IG sample.
groups
  1. description
    Participants received sabatolimab
    id
    OG000
    title
    Sabatolimab (MBG453)
param Type
COUNT_OF_PARTICIPANTS
population Description
Immunogenicity Incidence Set includes all participants in the Immunogenicity prevalence set with a non-missing baseline ADA sample and at least one non-missing post-baseline ADA sample. The Immunogenicity prevalence set includes all participants in the Safety Set with a non-missing baseline ADA sample or at least one non-missing post-baseline ADA sample.
reporting Status
POSTED
time Frame
Baseline, up to approx. 39 months
title
ADA Prevalence at Baseline and ADA-positive Participants On-treatment
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice