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NCT02367456 · OUTCOME

Duration of CR in the AML and MDS Cohorts

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients · Source last updated 2024-01-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
maximum of 23 months in AML cohort and 34 months in MDS cohort

What was measured

Duration of CR was defined as the duration from date of first achieving CR to the date of disease progression (relapse) after CR, or death due to any cause. Participants last known to be alive who were free from disease progression or relapse after CR were censored at the date of the last assessment that verified their disease status. Duration of CR was analyzed using the Kaplan-Meier method. Disease progression was defined as: percentage of bone marrow blasts increased by ≥50% to \>5% (for participants with \<5% blasts at screening), \>10% (for participants with 5-10% blasts at screening), \>20% (for participants with 11-20% blasts at screening) or \>30% (for participants with 21-30% blasts at screening), and with any of the following condition: at least 50% decrease from maximum remission/response in granulocytes or platelets; reduction in hemoglobin by ≥2 g/dL; transfusion dependence.

Analysis population: The analysis population included all participants who received at least 1 dose of any study treatment.

Groups in this outcome

AML Cohort

Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.

MDS Cohort

Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.

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

Analysis denominator · Participants

GroupSource count
AML Cohort30
MDS Cohort30

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
AML Cohort5.78Not reported0.0316.85Not reported
MDS Cohort6.18Not reported0.7218.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.03
        upper Limit
        16.85
        value
        5.78
      2. group Id
        OG001
        lower Limit
        0.72
        upper Limit
        18.07
        value
        6.18
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Duration of CR was defined as the duration from date of first achieving CR to the date of disease progression (relapse) after CR, or death due to any cause. Participants last known to be alive who were free from disease progression or relapse after CR were censored at the date of the last assessment that verified their disease status. Duration of CR was analyzed using the Kaplan-Meier method. Disease progression was defined as: percentage of bone marrow blasts increased by ≥50% to \>5% (for participants with \<5% blasts at screening), \>10% (for participants with 5-10% blasts at screening), \>20% (for participants with 11-20% blasts at screening) or \>30% (for participants with 21-30% blasts at screening), and with any of the following condition: at least 50% decrease from maximum remission/response in granulocytes or platelets; reduction in hemoglobin by ≥2 g/dL; transfusion dependence.
dispersion Type
Full Range
groups
  1. description
    Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.
    id
    OG000
    title
    AML Cohort
  2. description
    Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.
    id
    OG001
    title
    MDS Cohort
param Type
MEDIAN
population Description
The analysis population included all participants who received at least 1 dose of any study treatment.
reporting Status
POSTED
time Frame
maximum of 23 months in AML cohort and 34 months in MDS cohort
title
Duration of CR in the AML and MDS Cohorts
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice