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NCT04299048 · OUTCOME

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. · Source last updated 2023-12-14

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: From Day 1 up to Week 24

What was measured

Participants with laboratory test abnormalities (without regard to baseline abnormality) that met pre-specified criteria included Hemoglobin\< 0.8x lower limit of normal (LLN); Hematocrit\< 0.8x LLN; Erythrocytes (Ery.)\< 0.8x LLN; Ery. Mean Corpuscular Volume\< 0.9x LLN; Leukocytes\< 0.6x LLN; Lymphocytes\< 0.8x LLN; Bilirubin\> 1.5x upper limit of normal (ULN); Aspartate Aminotransferase\> 3.0x ULN; Alkaline Phosphatase\> 3.0x ULN; Protein\< 0.8x LLN; Sodium\< 0.95x LLN; Chloride\< 0.9x LLN; Calcium\< 0.9x LLN; Bicarbonate\< 0.9x LLN; Glucose\> 1.5x ULN; C Reactive Protein\> 1.1x ULN; for urinalysis, Urine Glucose ≥1, Ketones ≥1, Urine Protein ≥1, Urine Hemoglobin ≥1, Urobilinogen ≥1, Nitrite ≥1, and Leukocyte ≥1 Esterase ≥1; Hyaline Casts \>1/LPF.

Analysis population: Overall number of participants analyzed included participants with at least one observation of the given laboratory test while on study treatment or during lag time.

Groups in this outcome

PF-06946860 Q3W

During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.

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
PF-06946860 Q3W	8

Reported measurements

Hemoglobin (g/dL)< 0.8x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Hematocrit (%)< 0.8x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Erythrocytes (10^6/mm^3)< 0.8x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Ery. Mean Corpuscular Volume (um^3)< 0.9x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Leukocytes (10^3/mm^3)< 0.6x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Lymphocytes (10^3/mm^3)< 0.8x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Bilirubin (mg/dL)> 1.5x ULN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Aspartate Aminotransferase (U/L)> 3.0x ULN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Alkaline Phosphatase (U/L)> 3.0x ULN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Protein (g/dL)< 0.8x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Sodium (mEq/L)< 0.95x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Chloride (mEq/L)< 0.9x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Calcium (mg/dL)< 0.9x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Bicarbonate (mEq/L)< 0.9x LLN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Glucose (mg/dL)> 1.5x ULN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

C Reactive Protein (mg/dL)> 1.1x ULN

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PF-06946860 Q3W	5	Not reported	Not reported	Not reported	Not reported

URINE Glucose ≥1

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Ketones ≥1

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

URINE Protein ≥1

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

URINE Hemoglobin ≥1

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Urobilinogen ≥1

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Nitrite ≥1

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Leukocyte Esterase ≥1

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	8

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

Hyaline Casts >1/LPF

Analysis denominator · Participants

Group	Source count
PF-06946860 Q3W	3

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

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
8
units
Participants
title
Hemoglobin (g/dL)< 0.8x LLN
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
8
units
Participants
title
Hematocrit (%)< 0.8x LLN
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
8
units
Participants
title
Erythrocytes (10^6/mm^3)< 0.8x LLN
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
8
units
Participants
title
Ery. Mean Corpuscular Volume (um^3)< 0.9x LLN
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
8
units
Participants
title
Leukocytes (10^3/mm^3)< 0.6x LLN
categories
measurements
group Id
OG000
value
3
denoms
counts
group Id
OG000
value
8
units
Participants
title
Lymphocytes (10^3/mm^3)< 0.8x LLN
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
8
units
Participants
title
Bilirubin (mg/dL)> 1.5x ULN
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
8
units
Participants
title
Aspartate Aminotransferase (U/L)> 3.0x ULN
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
8
units
Participants
title
Alkaline Phosphatase (U/L)> 3.0x ULN
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
8
units
Participants
title
Protein (g/dL)< 0.8x LLN
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
8
units
Participants
title
Sodium (mEq/L)< 0.95x LLN
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
8
units
Participants
title
Chloride (mEq/L)< 0.9x LLN

denoms

counts
group Id
OG000
value
8
units
Participants

description

Participants with laboratory test abnormalities (without regard to baseline abnormality) that met pre-specified criteria included Hemoglobin\< 0.8x lower limit of normal (LLN); Hematocrit\< 0.8x LLN; Erythrocytes (Ery.)\< 0.8x LLN; Ery. Mean Corpuscular Volume\< 0.9x LLN; Leukocytes\< 0.6x LLN; Lymphocytes\< 0.8x LLN; Bilirubin\> 1.5x upper limit of normal (ULN); Aspartate Aminotransferase\> 3.0x ULN; Alkaline Phosphatase\> 3.0x ULN; Protein\< 0.8x LLN; Sodium\< 0.95x LLN; Chloride\< 0.9x LLN; Calcium\< 0.9x LLN; Bicarbonate\< 0.9x LLN; Glucose\> 1.5x ULN; C Reactive Protein\> 1.1x ULN; for urinalysis, Urine Glucose ≥1, Ketones ≥1, Urine Protein ≥1, Urine Hemoglobin ≥1, Urobilinogen ≥1, Nitrite ≥1, and Leukocyte ≥1 Esterase ≥1; Hyaline Casts \>1/LPF.

groups

description
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
id
OG000
title
PF-06946860 Q3W

param Type

COUNT_OF_PARTICIPANTS

population Description

Overall number of participants analyzed included participants with at least one observation of the given laboratory test while on study treatment or during lag time.

reporting Status

POSTED

time Frame

From Day 1 up to Week 24

title

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice