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NCT01546038 · OUTCOME

Percentage of Participants With CR / Complete Response With Incomplete Blood Count Recovery (CRi) at Phase 1B

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03

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
80% Confidence Interval
Time frame
4 years

What was measured

For AML participants:CR were those with repeat bone marrow showing \<5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils\>=1000/mcL and platelets\>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing \<=5% myeloblasts, peripheral blood showing neutrophils\>=1000/mcL, platelets\>=100,000/mcL, 0% blast and hemoglobin (Hgb)\>= 11 g/dL, normal maturation of all cell lines.For AML and MDS participants, complete response with incomplete blood count recovery(CRi)were those with repeat bone marrow showing \<5% myeloblasts with either platelets or neutrophils not recovered (platelets \<100,000/mcL or neutrophils \<1000/mcL).

Analysis population: Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.

Groups in this outcome

Phase 1B: Glasdegib + LDAC

Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.

Phase 1B: Glasdegib + Decitabine

Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.

Phase 1B: Glasdegib + Cytarabine/Daunorubicin

Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.

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

Analysis denominator · Participants

GroupSource count
Phase 1B: Glasdegib + LDAC23
Phase 1B: Glasdegib + Decitabine7
Phase 1B: Glasdegib + Cytarabine/Daunorubicin22

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC8.7Not reported2.321.5Not reported
Phase 1B: Glasdegib + Decitabine28.6Not reported7.959.6Not reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin54.5Not reported38.969.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.3
        upper Limit
        21.5
        value
        8.7
      2. group Id
        OG001
        lower Limit
        7.9
        upper Limit
        59.6
        value
        28.6
      3. group Id
        OG002
        lower Limit
        38.9
        upper Limit
        69.5
        value
        54.5
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      22
    units
    Participants
description
For AML participants:CR were those with repeat bone marrow showing \<5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils\>=1000/mcL and platelets\>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing \<=5% myeloblasts, peripheral blood showing neutrophils\>=1000/mcL, platelets\>=100,000/mcL, 0% blast and hemoglobin (Hgb)\>= 11 g/dL, normal maturation of all cell lines.For AML and MDS participants, complete response with incomplete blood count recovery(CRi)were those with repeat bone marrow showing \<5% myeloblasts with either platelets or neutrophils not recovered (platelets \<100,000/mcL or neutrophils \<1000/mcL).
dispersion Type
80% Confidence Interval
groups
  1. description
    Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.
    id
    OG000
    title
    Phase 1B: Glasdegib + LDAC
  2. description
    Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.
    id
    OG001
    title
    Phase 1B: Glasdegib + Decitabine
  3. description
    Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
    id
    OG002
    title
    Phase 1B: Glasdegib + Cytarabine/Daunorubicin
param Type
NUMBER
population Description
Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.
reporting Status
POSTED
time Frame
4 years
title
Percentage of Participants With CR / Complete Response With Incomplete Blood Count Recovery (CRi) at Phase 1B
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice