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NCT01546038 · OUTCOME

Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria 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
Participants
Interval / dispersion
Not reported
Time frame
1 year

What was measured

Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with QTcF meeting the following criteria is presented: QTcF interval:\<450 msec; QTcF interval: 450 to \<480 msec; QTcF interval: 480 to \<500 msec; QTcF interval \>=500 msec; QTcF interval increase from baseline: \<30 msec; QTcF interval increase from baseline: 30 to \<60 msec; QTcF interval increase from baseline \>=60 msec. Arms in the time frame description are defined as: Arm A, Glasdegib +LDAC; Arm B, Glasdegib + Decitabine; Arm C, Glasdegib + Cytarabine/Daunorubicin. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.

Analysis population: QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.

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 + LDAC21
Phase 1B: Glasdegib + Decitabine7
Phase 1B: Glasdegib + Cytarabine/Daunorubicin22

Reported measurements

QTcF interval increase < 30 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC16Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine2Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin14Not reportedNot reportedNot reportedNot reported
QTcF interval increase: 30 to < 60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC5Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine3Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin6Not reportedNot reportedNot reportedNot reported
QTcF interval increase >= 60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC0Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine2Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin2Not reportedNot reportedNot reportedNot reported
Maximum QTcF interval < 450 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC10Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine4Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin10Not reportedNot reportedNot reportedNot reported
Maximum QTcF interval: 450 to < 480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC11Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine2Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin10Not reportedNot reportedNot reportedNot reported
Maximum QTcF interval: 480 to < 500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC0Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine0Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin1Not reportedNot reportedNot reportedNot reported
Maximum QTcF interval >= 500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + LDAC0Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Decitabine1Not reportedNot reportedNot reportedNot reported
Phase 1B: Glasdegib + Cytarabine/Daunorubicin1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        14
    title
    QTcF interval increase < 30 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
    title
    QTcF interval increase: 30 to < 60 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
    title
    QTcF interval increase >= 60 msec
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        10
    title
    Maximum QTcF interval < 450 msec
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        10
    title
    Maximum QTcF interval: 450 to < 480 msec
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Maximum QTcF interval: 480 to < 500 msec
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Maximum QTcF interval >= 500 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      22
    units
    Participants
description
Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with QTcF meeting the following criteria is presented: QTcF interval:\<450 msec; QTcF interval: 450 to \<480 msec; QTcF interval: 480 to \<500 msec; QTcF interval \>=500 msec; QTcF interval increase from baseline: \<30 msec; QTcF interval increase from baseline: 30 to \<60 msec; QTcF interval increase from baseline \>=60 msec. Arms in the time frame description are defined as: Arm A, Glasdegib +LDAC; Arm B, Glasdegib + Decitabine; Arm C, Glasdegib + Cytarabine/Daunorubicin. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.
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
QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.
reporting Status
POSTED
time Frame
1 year
title
Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria at Phase 1B
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice