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NCT04582539 · OUTCOME

Percentage of Participants With an Event of Leukemia or Death

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
Not reported
Time frame
up to 920 days

What was measured

Data have been reported as the percentage of participants with an event of leukemia or death rather than LFS (the interval from the first dose of study drug until the first documented leukemia transformation or death from any cause) because 3 participants had an event of leukemia or death. It was pre-specified in the SAP that the number of participants with leukemia transformation or death was to be summarized.

Analysis population: Full Analysis Set-MDS

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

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zilurgisertib 50 mg QD25.0Not reportedNot reportedNot reportedNot reported
Zilurgisertib 100 mg QD20.0Not reportedNot reportedNot reportedNot reported
Zilurgisertib 200 mg QD0.0Not reportedNot reportedNot reportedNot reported
Zilurgisertib 400 mg QD20.0Not reportedNot reportedNot reportedNot reported
Zilurgisertib 600 mg QD0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25.0
      2. group Id
        OG001
        value
        20.0
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        20.0
      5. group Id
        OG004
        value
        0.0
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
Data have been reported as the percentage of participants with an event of leukemia or death rather than LFS (the interval from the first dose of study drug until the first documented leukemia transformation or death from any cause) because 3 participants had an event of leukemia or death. It was pre-specified in the SAP that the number of participants with leukemia transformation or death was to be summarized.
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
reporting Status
POSTED
time Frame
up to 920 days
title
Percentage of Participants With an Event of Leukemia or Death
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice