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NCT04582539 · OUTCOME

Percentage of Participants With Anemia Response

To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma · Source last updated 2025-10-22

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
95% Confidence Interval
Time frame
up to Week 24

What was measured

Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of \<8.5 g/dL, in the absence of bleeding or treatment-induced anemia.

Analysis population: Full Analysis Set-MDS. Participants must have been on treatment for ≥8 consecutive weeks or discontinued treatment before Week 8. Only participants who were transfusion independent at baseline were analyzed. The 95% confidence interval was calculated using exact binomial distribution.

Groups in this outcome

Zilurgisertib 50 mg QD

Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.

Zilurgisertib 100 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.

Zilurgisertib 200 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.

Zilurgisertib 400 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.

Zilurgisertib 600 mg QD

Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.

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

Analysis denominator · Participants

GroupSource count
Zilurgisertib 50 mg QD2
Zilurgisertib 100 mg QD4
Zilurgisertib 200 mg QD2
Zilurgisertib 400 mg QD4
Zilurgisertib 600 mg QD2

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD0.0Not reported0.084.2Not reported
Zilurgisertib 100 mg QD0.0Not reported0.060.2Not reported
Zilurgisertib 200 mg QD0.0Not reported0.084.2Not reported
Zilurgisertib 400 mg QD0.0Not reported0.060.2Not reported
Zilurgisertib 600 mg QD0.0Not reported0.084.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        84.2
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        60.2
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        84.2
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        60.2
        value
        0.0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        84.2
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      2
    units
    Participants
description
Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of \<8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
    id
    OG000
    title
    Zilurgisertib 50 mg QD
  2. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
    id
    OG001
    title
    Zilurgisertib 100 mg QD
  3. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
    id
    OG002
    title
    Zilurgisertib 200 mg QD
  4. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
    id
    OG003
    title
    Zilurgisertib 400 mg QD
  5. description
    Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
    id
    OG004
    title
    Zilurgisertib 600 mg QD
param Type
NUMBER
population Description
Full Analysis Set-MDS. Participants must have been on treatment for ≥8 consecutive weeks or discontinued treatment before Week 8. Only participants who were transfusion independent at baseline were analyzed. The 95% confidence interval was calculated using exact binomial distribution.
reporting Status
POSTED
time Frame
up to Week 24
title
Percentage of Participants With Anemia Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice