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NCT04582539 · OUTCOME

Duration of RBC-transfusion Independence (TI) Period for Participants Achieving RBC-TI for at Least 8 Consecutive Weeks During the First 24 Weeks 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
MEDIAN
Unit
days
Interval / dispersion
Standard Error
Time frame
up to 920 days

What was measured

Participants with RBC-TI were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.

Analysis population: Full Analysis Set-MDS. Only participants who were transfusion dependent at Baseline and achieved transfusion independence 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 QD0
Zilurgisertib 100 mg QD1
Zilurgisertib 200 mg QD0
Zilurgisertib 400 mg QD0
Zilurgisertib 600 mg QD0

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Zilurgisertib 100 mg QD60NANot reportedNot reportedStandard error cannot be calculated for a single participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Standard error cannot be calculated for a single participant.
        group Id
        OG001
        spread
        NA
        value
        60
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    units
    Participants
description
Participants with RBC-TI were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
dispersion Type
Standard Error
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
MEDIAN
population Description
Full Analysis Set-MDS. Only participants who were transfusion dependent at Baseline and achieved transfusion independence were analyzed.
reporting Status
POSTED
time Frame
up to 920 days
title
Duration of RBC-transfusion Independence (TI) Period for Participants Achieving RBC-TI for at Least 8 Consecutive Weeks During the First 24 Weeks of Treatment
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice