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NCT01546038 · OUTCOME

Percentage of Participants With Complete Response (CR) at Phase 2 Unfit

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.

Analysis population: Full analysis set: all randomized participants of Phase 2 Unfit arm.

Groups in this outcome

Phase 2 Unfit: Glasdegib 100 mg + LDAC

Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.

Phase 2 Unfit: LDAC Alone

Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.

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 2 Unfit: Glasdegib 100 mg + LDAC88
Phase 2 Unfit: LDAC Alone44

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC18.2Not reported12.923.5Not reported
Phase 2 Unfit: LDAC Alone2.3Not reported0.05.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.3057
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    80
    ci Upper Limit
    13.9994
    estimate Comment
    Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0112
    param Type
    Odds Ratio (OR)
    param Value
    4.2755
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.3057
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    80
    ci Upper Limit
    13.9994
    estimate Comment
    Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0112
    param Type
    Odds Ratio (OR)
    param Value
    4.2755
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.9
        upper Limit
        23.5
        value
        18.2
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        5.2
        value
        2.3
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    2. group Id
      OG001
      value
      44
    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.
dispersion Type
80% Confidence Interval
groups
  1. description
    Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
    id
    OG000
    title
    Phase 2 Unfit: Glasdegib 100 mg + LDAC
  2. description
    Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
    id
    OG001
    title
    Phase 2 Unfit: LDAC Alone
param Type
NUMBER
population Description
Full analysis set: all randomized participants of Phase 2 Unfit arm.
reporting Status
POSTED
time Frame
4 years
title
Percentage of Participants With Complete Response (CR) at Phase 2 Unfit
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice