ID

40801

Description

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis) Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).

Keywords

Versions (1)
  1. 5/15/20 5/15/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 15, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

English

Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Local Laboratory Result Data - [Clinical Chemistry]
Description

Local Laboratory Result Data - [Clinical Chemistry]

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken
Description

Date and time sample taken - clinical chemistry

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urea
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0523961
UMLS CUI [1,2]
C0005768
Creatinine
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0005768
Total Bilirubin
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0005768
Total Protein
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C0005768
Albumin
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C0005768
Creatine Phosphokinase
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C0005768
Alkaline Phosphatase
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0005768
Aspartate Transaminase
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0005768
Alanine Transaminase
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0005768
Gamma Glutamyl Transpeptidase
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C0005768
Glucose
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0005768
Potassium
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C0005768
Sodium
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C0005768
Calcium
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201925
UMLS CUI [1,2]
C0005768
Cholesterol
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0201950
UMLS CUI [1,2]
C0005768
Triglycerides
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0202236
UMLS CUI [1,2]
C0005768
Laboratory result data - [Haematology]
Description

Laboratory result data - [Haematology]

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date and time sample taken
Description

Date and time sample taken - haematology

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haemoglobin
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0518015
Red Blood Cell Count
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0014772
Mean Cell Volume
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C1948043
Mean Cell Haemoglobin
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C1261502
Mean Cell Haemoglobin Concentration
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0474535
Haematocrit
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0018935
Platelet Count
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0032181
White Blood Cell Count
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0023508
Neutrophils
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0948762
Lymphocytes
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C3544087
Monocytes
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0200637
Eosinophils
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0200638
Basophils
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1]
C0200641
Large Unclassified Cells
Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias
UMLS CUI [1,1]
C0584609
UMLS CUI [1,2]
C0549177
UMLS CUI [1,3]
C0007584
Urinalysis (Dipstick) Test
Description

Urinalysis (Dipstick) Test

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Date and time sample taken
Description

Date and time sample taken - Urinalysis

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis (Dipstick) Test: Protein
Description

Protein Urine

Data type

text

Alias
UMLS CUI [1]
C0262923
Urinalysis (Dipstick) Test: Glucose
Description

Glucose Urine

Data type

text

Alias
UMLS CUI [1]
C0004076
Urinalysis (Dipstick) Test: Ketones
Description

Ketones Urine

Data type

text

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test: Nitrates
Description

Nitrates Urine

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0028125
Urinalysis (Dipstick) Test: Bilirubin
Description

Bilirubin Urine

Data type

text

Alias
UMLS CUI [1]
C0042040
Urinalysis (Dipstick) Test: Blood
Description

Blood Urine

Data type

text

Alias
UMLS CUI [1]
C0430372
Urinalysis (Dipstick) Test: Urobilinogen
Description

Urobilinogen Urine

Data type

text

Alias
UMLS CUI [1]
C0427736
Urinalysis (Dipstick) Test: Leucocytes
Description

Leucocytes Urine

Data type

text

Alias
UMLS CUI [1]
C1256582
Urinalysis (Microscopy) Test
Description

Urinalysis (Microscopy) Test

Alias
UMLS CUI-1
C0430397
Was sedimentary microscopy performed?
Description

Sedimentary microscopy should only be performed if the dipstick result for protein, nitrates, blood or leucocytes is abnormal.

Data type

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Urinalysis (Microscopy) Test: White blood cells
Description

Urinalysis Microscopy - White blood cells

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0023508
Urinalysis (Microscopy) Test: Red blood cells
Description

Urinalysis Microscopy - Red blood cells

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0014772
Urinalysis (Microscopy) Test: Hyaline casts
Description

Urinalysis Microspocy - Hyaline casts

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1254537
Urinalysis (Microscopy) Test: Granular casts
Description

Urinalysis Microscopy - Granular casts

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2697521
Urinalysis (Microscopy) Test: Cellular casts
Description

Urinalysis Microscopy - Cellular casts

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2699157
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Similar models

Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Screening (Screening)
(Comment:en)
CL Item
Treatment Period 1 Predose (Treatment Period 1 Predose)
(Comment:en)
CL Item
Treatment Period 1 Prior to Discharge (Treatment Period 1 Prior to Discharge)
(Comment:en)
CL Item
Treatment Period 2 Predose (Treatment Period 2 Predose)
(Comment:en)
CL Item
Treatment Period 2 Prior to Discharge (Treatment Period 2 Prior to Discharge)
(Comment:en)
Item Group
Local Laboratory Result Data - [Clinical Chemistry]
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken - clinical chemistry
Item
Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Urea measured in blood
Item
Urea
text
C0523961 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Creatinine measured in blood
Item
Creatinine
text
C0201975 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Total bilirubin measured in blood
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Total protein measured in blood
Item
Total Protein
text
C0555903 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Albumin measured in blood
Item
Albumin
text
C0201838 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Creatine kinase measured in blood
Item
Creatine Phosphokinase
text
C0201973 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Alkaline phosphatase measured in blood
Item
Alkaline Phosphatase
text
C0201850 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Aspartate transaminase measured in blood
Item
Aspartate Transaminase
text
C0201899 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Alanine transaminase measured in blood
Item
Alanine Transaminase
text
C0201836 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Gamma glutamyl transpeptidase measured in blood
Item
Gamma Glutamyl Transpeptidase
text
C0202035 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Glucose measured in blood
Item
Glucose
text
C0337438 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Potassium measured in blood
Item
Potassium
text
C0202194 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Sodium measured in blood
Item
Sodium
text
C0337443 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Calcium measured in blood
Item
Calcium
text
C0201925 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Cholesterol measured in blood
Item
Cholesterol
text
C0201950 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Triglycerides measured in blood
Item
Triglycerides
text
C0202236 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
Item Group
Laboratory result data - [Haematology]
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken - haematology
Item
Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Haemoglobin measurement
Item
Haemoglobin
text
C0518015 (UMLS CUI [1])
Red blood cell count
Item
Red Blood Cell Count
text
C0014772 (UMLS CUI [1])
Mean cell volume
Item
Mean Cell Volume
text
C1948043 (UMLS CUI [1])
Mean cell haemoglobin
Item
Mean Cell Haemoglobin
text
C1261502 (UMLS CUI [1])
Mean cell haemoglobin concentration
Item
Mean Cell Haemoglobin Concentration
text
C0474535 (UMLS CUI [1])
Haematocrit
Item
Haematocrit
text
C0018935 (UMLS CUI [1])
Platelet count
Item
Platelet Count
text
C0032181 (UMLS CUI [1])
White blood cell count
Item
White Blood Cell Count
text
C0023508 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
text
C0948762 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
text
C3544087 (UMLS CUI [1])
Monocytes
Item
Monocytes
text
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
text
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
text
C0200641 (UMLS CUI [1])
Large unstained cells
Item
Large Unclassified Cells
text
C0584609 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0007584 (UMLS CUI [1,3])
Item Group
Urinalysis (Dipstick) Test
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Date and time sample taken - Urinalysis
Item
Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Protein Urine
Item
Urinalysis (Dipstick) Test: Protein
text
C0262923 (UMLS CUI [1])
Glucose Urine
Item
Urinalysis (Dipstick) Test: Glucose
text
C0004076 (UMLS CUI [1])
Ketones Urine
Item
Urinalysis (Dipstick) Test: Ketones
text
C1991100 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Nitrates Urine
Item
Urinalysis (Dipstick) Test: Nitrates
text
C0430370 (UMLS CUI [1,1])
C0028125 (UMLS CUI [1,2])
Bilirubin Urine
Item
Urinalysis (Dipstick) Test: Bilirubin
text
C0042040 (UMLS CUI [1])
Blood Urine
Item
Urinalysis (Dipstick) Test: Blood
text
C0430372 (UMLS CUI [1])
Urobilinogen Urine
Item
Urinalysis (Dipstick) Test: Urobilinogen
text
C0427736 (UMLS CUI [1])
Leucocytes Urine
Item
Urinalysis (Dipstick) Test: Leucocytes
text
C1256582 (UMLS CUI [1])
Item Group
Urinalysis (Microscopy) Test
C0430397 (UMLS CUI-1)
Sedimentary microscopy
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Urinalysis Microscopy - White blood cells
Item
Urinalysis (Microscopy) Test: White blood cells
text
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Urinalysis Microscopy - Red blood cells
Item
Urinalysis (Microscopy) Test: Red blood cells
text
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Urinalysis Microspocy - Hyaline casts
Item
Urinalysis (Microscopy) Test: Hyaline casts
text
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
Urinalysis Microscopy - Granular casts
Item
Urinalysis (Microscopy) Test: Granular casts
text
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
Urinalysis Microscopy - Cellular casts
Item
Urinalysis (Microscopy) Test: Cellular casts
text
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
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