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NCT02367456 · OUTCOME

Number of Participants With Laboratory Abnormalities 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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: maximum of around 23 months in AML cohort and 40 months in MDS cohort

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. Number Analyzed = number of participants with at least 1 observation of the given lab test.

Groups in this outcome

AML Cohort

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

MDS Cohort

Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously 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

Group	Source count
AML Cohort	30
MDS Cohort	30

Reported measurements

Activated partial thromboplastin time prolonged

Analysis denominator · Participants

Group	Source count
AML Cohort	2
MDS Cohort	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	0	Not reported	Not reported	Not reported	Not reported
MDS Cohort	0	Not reported	Not reported	Not reported	Not reported

Anemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	30	Not reported	Not reported	Not reported	Not reported
MDS Cohort	29	Not reported	Not reported	Not reported	Not reported

Hemoglobin increased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	0	Not reported	Not reported	Not reported	Not reported
MDS Cohort	0	Not reported	Not reported	Not reported	Not reported

international normalized ratio increased

Analysis denominator · Participants

Group	Source count
AML Cohort	2
MDS Cohort	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	0	Not reported	Not reported	Not reported	Not reported
MDS Cohort	2	Not reported	Not reported	Not reported	Not reported

Leukocytosis

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	0	Not reported	Not reported	Not reported	Not reported
MDS Cohort	1	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	27

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	23	Not reported	Not reported	Not reported	Not reported
MDS Cohort	24	Not reported	Not reported	Not reported	Not reported

Lymphocyte count increased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	27

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	6	Not reported	Not reported	Not reported	Not reported
MDS Cohort	2	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	28

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	25	Not reported	Not reported	Not reported	Not reported
MDS Cohort	25	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	29	Not reported	Not reported	Not reported	Not reported
MDS Cohort	26	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	22	Not reported	Not reported	Not reported	Not reported
MDS Cohort	27	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	13	Not reported	Not reported	Not reported	Not reported
MDS Cohort	12	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	7	Not reported	Not reported	Not reported	Not reported
MDS Cohort	8	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	11	Not reported	Not reported	Not reported	Not reported
MDS Cohort	9	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	3	Not reported	Not reported	Not reported	Not reported
MDS Cohort	10	Not reported	Not reported	Not reported	Not reported

creatine phosphokinase increased

Analysis denominator · Participants

Group	Source count
AML Cohort	29
MDS Cohort	28

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	5	Not reported	Not reported	Not reported	Not reported
MDS Cohort	4	Not reported	Not reported	Not reported	Not reported

creatinine increased

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	29	Not reported	Not reported	Not reported	Not reported
MDS Cohort	28	Not reported	Not reported	Not reported	Not reported

Hypercalcemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	3	Not reported	Not reported	Not reported	Not reported
MDS Cohort	0	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	3	Not reported	Not reported	Not reported	Not reported
MDS Cohort	4	Not reported	Not reported	Not reported	Not reported

Hyperkalemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	6	Not reported	Not reported	Not reported	Not reported
MDS Cohort	6	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	1	Not reported	Not reported	Not reported	Not reported
MDS Cohort	2	Not reported	Not reported	Not reported	Not reported

Hypernatremia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	2	Not reported	Not reported	Not reported	Not reported
MDS Cohort	1	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	22	Not reported	Not reported	Not reported	Not reported
MDS Cohort	19	Not reported	Not reported	Not reported	Not reported

Hypocalcemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	3	Not reported	Not reported	Not reported	Not reported
MDS Cohort	11	Not reported	Not reported	Not reported	Not reported

Hypoglycemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	4	Not reported	Not reported	Not reported	Not reported
MDS Cohort	3	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	8	Not reported	Not reported	Not reported	Not reported
MDS Cohort	3	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	12	Not reported	Not reported	Not reported	Not reported
MDS Cohort	10	Not reported	Not reported	Not reported	Not reported

Hyponatremia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	18	Not reported	Not reported	Not reported	Not reported
MDS Cohort	12	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia

Analysis denominator · Participants

Group	Source count
AML Cohort	30
MDS Cohort	29

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AML Cohort	13	Not reported	Not reported	Not reported	Not reported
MDS Cohort	7	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
units
Participants
title
Activated partial thromboplastin time prolonged
categories
measurements
group Id
OG000
value
30
group Id
OG001
value
29
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
29
units
Participants
title
Anemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
29
units
Participants
title
Hemoglobin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
units
Participants
title
international normalized ratio increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
29
units
Participants
title
Leukocytosis
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
24
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
27
units
Participants
title
Lymphocyte count decreased
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
27
units
Participants
title
Lymphocyte count increased
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
25
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
28
units
Participants
title
Neutrophil count decreased
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
26
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
29
units
Participants
title
Platelet count decreased
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
27
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
29
units
Participants
title
White blood cell decreased
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
12
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
29
units
Participants
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
8
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
29
units
Participants
title
Alkaline phosphatase increased

denoms

counts
group Id
OG000
value
30
group Id
OG001
value
30
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

description
Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
id
OG000
title
AML Cohort
description
Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
id
OG001
title
MDS 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. Number Analyzed = number of participants with at least 1 observation of the given lab test.

reporting Status

POSTED

time Frame

maximum of around 23 months in AML cohort and 40 months in MDS cohort

title

Number of Participants With Laboratory Abnormalities in the AML and MDS Cohorts

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice