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NCT02367456 · OUTCOME

Number of Participants With Laboratory Abnormalities in the LIC

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
maximum of approximately 16 months

What was measured

Hematology lab parameters included activated partial thromboplastin time, hemoglobin, prothrombin international normalized ratio, lymphocyte, neutrophil, platelet, white blood cell; chemistry parameters included alanine aminotransferase, aspartate aminotransferase, alkaline aminotransferase, blood bilirubin, creatine phosphokinase, creatinine, calcium, blood glucose, potassium, magnesium, sodium, albumin, phosphate. Grades of lab abnormalities were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated. Grade 1-4 results are reported.

Analysis population: The safety analysis population included all participants who received at least 1 dose of any study treatment. Number of participants analyzed = number of participants evaluable for this outcome measure (OM). Number analyzed = number of participants evaluable for this OM with at least 1 result of the specified laboratory parameter.

Groups in this outcome

Lead-in Cohort

Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.

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

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12

Reported measurements

Activated partial thromboplastin time prolonged

Analysis denominator · Participants

GroupSource count
Lead-in Cohort10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort5Not reportedNot reportedNot reportedNot reported
Anemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort12Not reportedNot reportedNot reportedNot reported
Hemoglobin increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort0Not reportedNot reportedNot reportedNot reported
international normalized ratio increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort8Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort9Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort3Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort10Not reportedNot reportedNot reportedNot reported
Platelet count decreased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort12Not reportedNot reportedNot reportedNot reported
White blood cell decreased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort11Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort4Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increase

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort0Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort2Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort6Not reportedNot reportedNot reportedNot reported
creatine phosphokinase increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort0Not reportedNot reportedNot reportedNot reported
Creatinine increased

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort11Not reportedNot reportedNot reportedNot reported
Hypercalcemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort1Not reportedNot reportedNot reportedNot reported
Hyperglycemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort1Not reportedNot reportedNot reportedNot reported
Hyperkalemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort3Not reportedNot reportedNot reportedNot reported
Hypermagnesemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort2Not reportedNot reportedNot reportedNot reported
Hypernatremia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort1Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort5Not reportedNot reportedNot reportedNot reported
Hypocalcemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort3Not reportedNot reportedNot reportedNot reported
Hypoglycemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort1Not reportedNot reportedNot reportedNot reported
Hypokalemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort3Not reportedNot reportedNot reportedNot reported
Hypomagnesemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort2Not reportedNot reportedNot reportedNot reported
Hyponatremia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort6Not reportedNot reportedNot reportedNot reported
Hypophosphatemia

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-in Cohort4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Activated partial thromboplastin time prolonged
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Hemoglobin increased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    international normalized ratio increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Lymphocyte count decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Lymphocyte count increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Neutrophil count decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Platelet count decreased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    White blood cell decreased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Alanine aminotransferase increased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Alkaline phosphatase increase
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Aspartate aminotransferase increased
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Hematology lab parameters included activated partial thromboplastin time, hemoglobin, prothrombin international normalized ratio, lymphocyte, neutrophil, platelet, white blood cell; chemistry parameters included alanine aminotransferase, aspartate aminotransferase, alkaline aminotransferase, blood bilirubin, creatine phosphokinase, creatinine, calcium, blood glucose, potassium, magnesium, sodium, albumin, phosphate. Grades of lab abnormalities were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated. Grade 1-4 results are reported.
groups
  1. description
    Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
    id
    OG000
    title
    Lead-in Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis population included all participants who received at least 1 dose of any study treatment. Number of participants analyzed = number of participants evaluable for this outcome measure (OM). Number analyzed = number of participants evaluable for this OM with at least 1 result of the specified laboratory parameter.
reporting Status
POSTED
time Frame
maximum of approximately 16 months
title
Number of Participants With Laboratory Abnormalities in the LIC
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice