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NCT04803305 · OUTCOME

Number of Participants With Laboratory Test Abnormalities in Part A

Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia · Source last updated 2024-01-12

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: Days 1, 22 and 43

What was measured

Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]).

Analysis population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, with at least one observation of the given laboratory test while on study treatment or during lag time.

Groups in this outcome

Placebo

Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.

PF- 06946860 200mg Q3W

Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.

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
Placebo	5
PF- 06946860 200mg Q3W	11

Reported measurements

Hemoglobin <0.8 x lower limit of normal (LLN)

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	4	Not reported	Not reported	Not reported	Not reported

Hematocrit <0.8 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	3	Not reported	Not reported	Not reported	Not reported

Erythrocytes <0.8 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	4	Not reported	Not reported	Not reported	Not reported

Erythrocytes Mean Corpuscular Volume <0.9 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN)

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Platelets <0.5 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Platelets >1.75 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Leukocytes <0.6 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Leukocytes >1.5 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Lymphocytes <0.8 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	6	Not reported	Not reported	Not reported	Not reported

Lymphocytes >1.2 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Basophils >1.2 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Eosinophils >1.2 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Monocytes >1.2 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Bilirubin >1.5 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase >3.0 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase >3.0 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase >3.0 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	2	Not reported	Not reported	Not reported	Not reported

Protein <0.8 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Protein >1.2 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Albumin <0.8 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Albumin >1.2 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Blood Urea Nitrogen >1.3 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Creatinine >1.3 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Urate >1.2 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Sodium <0.95 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Sodium >1.05 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Potassium <0.9 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Potassium >1.1 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Chloride <0.9 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Chloride >1.1 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Calcium <0.9 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Calcium >1.1 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Bicarbonate <0.9 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Bicarbonate >1.1 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Glucose <0.6 x LLN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Glucose >1.5 x ULN

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	2	Not reported	Not reported	Not reported	Not reported

pH <4.5

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

pH >8

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Urine Glucose >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Ketones >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Urine Protein >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Urine Hemoglobin >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	2	Not reported	Not reported	Not reported	Not reported

Urobilinogen >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Urine Bilirubin >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	0	Not reported	Not reported	Not reported	Not reported

Nitrite >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Leukocyte Esterase >=1

Analysis denominator · Participants

Group	Source count
Placebo	5
PF- 06946860 200mg Q3W	11

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	2	Not reported	Not reported	Not reported	Not reported

Urine Erythrocytes (/HPF) >=20

Analysis denominator · Participants

Group	Source count
Placebo	2
PF- 06946860 200mg Q3W	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Urine Leukocytes (/HPF) >=20

Analysis denominator · Participants

Group	Source count
Placebo	3
PF- 06946860 200mg Q3W	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	1	Not reported	Not reported	Not reported	Not reported

Hyaline Casts (/LPF) >1

Analysis denominator · Participants

Group	Source count
Placebo	0
PF- 06946860 200mg Q3W	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
PF- 06946860 200mg Q3W	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Hemoglobin <0.8 x lower limit of normal (LLN)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Hematocrit <0.8 x LLN
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Erythrocytes <0.8 x LLN
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Erythrocytes Mean Corpuscular Volume <0.9 x LLN
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Platelets <0.5 x LLN
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Platelets >1.75 x ULN
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants
title
Leukocytes <0.6 x LLN

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
11
units
Participants

description

Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]).

groups

description
Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.
id
OG000
title
Placebo
description
Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
id
OG001
title
PF- 06946860 200mg Q3W

param Type

COUNT_OF_PARTICIPANTS

population Description

The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, with at least one observation of the given laboratory test while on study treatment or during lag time.

reporting Status

POSTED

time Frame

Days 1, 22 and 43

title

Number of Participants With Laboratory Test Abnormalities in Part A

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice