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NCT04582539 · OUTCOME

Change From Baseline in Hemoglobin at the End of Treatment

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
MEAN
Unit
grams per liter
Interval / dispersion
Standard Deviation
Time frame
up to 950 days

What was measured

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Analysis population: Full Analysis Set-MDS. Only participants with available data were analyzed.

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 QD4
Zilurgisertib 100 mg QD5
Zilurgisertib 200 mg QD4
Zilurgisertib 400 mg QD5
Zilurgisertib 600 mg QD3

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Zilurgisertib 50 mg QD4
Zilurgisertib 100 mg QD5
Zilurgisertib 200 mg QD4
Zilurgisertib 400 mg QD5
Zilurgisertib 600 mg QD3
Values in grams per liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD77.77505.83688Not reportedNot reportedNot reported
Zilurgisertib 100 mg QD75.72004.00899Not reportedNot reportedNot reported
Zilurgisertib 200 mg QD74.93545.98330Not reportedNot reportedNot reported
Zilurgisertib 400 mg QD74.67677.94708Not reportedNot reportedNot reported
Zilurgisertib 600 mg QD79.41394.14997Not reportedNot reportedNot reported
Change from Baseline at end of treatment

Analysis denominator · Participants

GroupSource count
Zilurgisertib 50 mg QD2
Zilurgisertib 100 mg QD3
Zilurgisertib 200 mg QD2
Zilurgisertib 400 mg QD3
Zilurgisertib 600 mg QD3
Values in grams per liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD-1.75004.59619Not reportedNot reportedNot reported
Zilurgisertib 100 mg QD10.133312.87685Not reportedNot reportedNot reported
Zilurgisertib 200 mg QD4.01827.61104Not reportedNot reportedNot reported
Zilurgisertib 400 mg QD16.955612.34055Not reportedNot reportedNot reported
Zilurgisertib 600 mg QD69.666710.40833Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.83688
        value
        77.7750
      2. group Id
        OG001
        spread
        4.00899
        value
        75.7200
      3. group Id
        OG002
        spread
        5.98330
        value
        74.9354
      4. group Id
        OG003
        spread
        7.94708
        value
        74.6767
      5. group Id
        OG004
        spread
        4.14997
        value
        79.4139
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        3
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.59619
        value
        -1.7500
      2. group Id
        OG001
        spread
        12.87685
        value
        10.1333
      3. group Id
        OG002
        spread
        7.61104
        value
        4.0182
      4. group Id
        OG003
        spread
        12.34055
        value
        16.9556
      5. group Id
        OG004
        spread
        10.40833
        value
        69.6667
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        3
      units
      Participants
    title
    Change from Baseline at end of treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      3
    units
    Participants
description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
dispersion Type
Standard Deviation
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
MEAN
population Description
Full Analysis Set-MDS. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
up to 950 days
title
Change From Baseline in Hemoglobin at the End of Treatment
type
SECONDARY
unit Of Measure
grams per liter

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Preserved source evidence · Not medical advice