ID

25738

Description

Safety Lab - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 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

Keywords

  1. 9/16/17 9/16/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 16, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Safety Lab - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

Safety Lab - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

Hematology
Description

Hematology

Alias
UMLS CUI-1
C0018941
WBC
Description

Leukocytes (WBC)

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0023508
10^9/L
Red cells
Description

Red Blood Count

Data type

float

Measurement units
  • 10^12/ L
Alias
UMLS CUI [1]
C1287262
10^12/ L
Hematocrit (PCV)
Description

Hematocrit

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0518014
%
Mean cell volume
Description

Mean cell volume

Data type

integer

Measurement units
  • FL
Alias
UMLS CUI [1]
C0524587
FL
Mean cell hemoglobin (MCH)
Description

Mean cell hemoglobin (MCH)

Data type

float

Measurement units
  • pg
Alias
UMLS CUI [1]
C0369183
pg
MCHC
Description

MCHC

Data type

float

Measurement units
  • g/dl
Alias
UMLS CUI [1]
C0474535
g/dl
RBC distribution width
Description

rdw

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0427460
%
Platelets
Description

Platelets

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0005821
10^9/L
Mean platelet volume
Description

Mean platelet volume

Data type

integer

Measurement units
  • FL
Alias
UMLS CUI [1]
C0200665
FL
Neutrophils
Description

Neutrophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0948762
10^9/L
Lymphocytes
Description

Lymphocytes

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0024264
10^9/L
Monocytes
Description

Monocytes

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0026473
10^9/L
Eosinophils
Description

Eosinophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0200638
10^9/L
Basophils
Description

Basophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0200641
10^9/L
Reticulocytes
Description

Reticulocytes

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0035286
10^9/L
Blood Chemistry
Description

Blood Chemistry

Alias
UMLS CUI-1
C0005774
Total Protein
Description

Total Protein

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0036836
g/dL
Albumin
Description

Albumin

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0201838
g/dL
Calcium total
Description

Calcium total

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0600069
mg/dL
Glucose
Description

Glucose

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0202042
mg/dl
Total Bilirubin
Description

Bilirubin, total

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Direct Bilirubin
Description

Direct Bilirubin

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201916
mg/dL
Indirect Bilirubin
Description

Indirect Bilirubin

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C1881193
mg/dl
AST (SGOT)
Description

AST

Data type

float

Measurement units
  • IU/L
Alias
UMLS CUI [1]
C0201899
IU/L
ALT (SGPT)
Description

ALT

Data type

float

Measurement units
  • IU/L
Alias
UMLS CUI [1]
C0201836
IU/L
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Chloride
Description

Chloride

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201952
mmol/L
Uric acid
Description

Uric acid

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0041980
mg/dL
GGT
Description

GGT

Data type

float

Measurement units
  • IU/L
Alias
UMLS CUI [1]
C0202035
IU/L
Hep B surface antigen
Description

Hep B surface antigen

Data type

integer

Alias
UMLS CUI [1]
C0201477
Hepatitis C antibody
Description

Hepatitis C antibody

Data type

integer

Alias
UMLS CUI [1]
C0281863
HIV antibody
Description

HIV antibody

Data type

integer

Alias
UMLS CUI [1]
C0019683
Total carbon dioxide
Description

carbon dioxide

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201930
mmol/L
Phosphate
Description

Phosphate

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0523826
mg/dL
Haptoglobin
Description

Haptoglobin

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0919773
mg/dL
Lactate Dehydrogenase
Description

Lactate Dehydrogenase

Data type

float

Measurement units
  • IU/L
Alias
UMLS CUI [1]
C0202113
IU/L
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Specific gravity
Description

Urine Specific Gravity

Data type

float

Alias
UMLS CUI [1]
C0202517
PH
Description

PH urine

Data type

integer

Alias
UMLS CUI [1]
C0042044
Protein
Description

Urine Protein

Data type

integer

Alias
UMLS CUI [1]
C0262923
Urine glucose
Description

Urine glucose

Data type

integer

Alias
UMLS CUI [1]
C0004076
Ketones
Description

Urine Ketones

Data type

float

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0042014
Occult blood
Description

occult blood dipstick

Data type

integer

Alias
UMLS CUI [1]
C2188744
Urine RBC
Description

urine RBC

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C1972472
/HPF
urine WBC
Description

urine WBC

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C1975554
/HPF
Squamous epithelial cells
Description

Squamous epithelial cells

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C2699511
/HPF
Transitional epithelial cells
Description

Transitional epithelial cells

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C2984936
/HPF
Hyaline casts
Description

Hyaline casts

Data type

float

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C0427894
/LPF
unknown cells
Description

unknown cells urine

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C0854148
/HPF
Coarse gran casts
Description

Coarse granulocytes

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C1868540
/LPF
Uric acid crystals
Description

Uric acid crystals

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C2700121
/HPF
Tri phosphate crystals
Description

Tri phosphate crystals

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C0370102
/HPF
Unknown crystals
Description

urine crystals

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C0427897
/HPF
WBC casts
Description

WBC casts

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C2700271
/LPF
Epithelial cell casts
Description

Epithelial cells urine

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C1318314
/LPF
fine granular casts
Description

fine granular casts

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C2697522
/LPF
mixed cellular casts
Description

mixed cellular casts

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C1317541
/LPF
Renal tubular epithelial
Description

Renal tubular epithelial

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C2700087
/HPF
RBC casts
Description

RBC casts

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C2699019
/LPF
Waxy casts
Description

Waxy casts

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C2700267
/LPF
unknown casts
Description

unknown casts

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1,1]
C4048266
UMLS CUI [1,2]
C0439673
/LPF
Amorphous phosphate crystals
Description

Amorphous phosphate crystals

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C2984932
/HPF
Amorphous urate crystals
Description

Amorphous urate crystals

Data type

integer

Measurement units
  • /HPF
Alias
UMLS CUI [1]
C2984933
/HPF
Bacteria
Description

bacteriuria

Data type

integer

Alias
UMLS CUI [1]
C0004659
Oval fat body
Description

Oval fat body

Data type

integer

Alias
UMLS CUI [1]
C1699553
Urine yeast
Description

Urine yeast

Data type

integer

Alias
UMLS CUI [1]
C2188427
Trichomonas
Description

Trichomonas

Data type

boolean

Alias
UMLS CUI [1]
C2984927
Hemosiderin
Description

Hemosiderin

Data type

boolean

Alias
UMLS CUI [1]
C0019113
Urine Chemistry
Description

Urine Chemistry

Alias
UMLS CUI-1
C0864414
Alk Phos total
Description

Alk Phos Value

Data type

float

Measurement units
  • IU/L
IU/L
Pregnancy test
Description

Pregnancy dipstick

Data type

integer

Alias
UMLS CUI [1]
C0032976
Blood Urea Nitrogen
Description

Blood Urea Nitrogen

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0005845
mg/dl
Creatinine
Description

Creatinine

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201975
mg/dL
FSH
Description

FSH

Data type

float

Measurement units
  • MIU/ML
Alias
UMLS CUI [1]
C0202022
MIU/ML
Triglycerides
Description

Triglycerides

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0202236
mg/dL
Ethanol
Description

Ethanol

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0202304
mg/dL
Creatinine kinase
Description

Creatinine kinase

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0201973
mg/dl
Cholesterol
Description

Cholesterol

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C1445957
mg/dL
Estradiol
Description

Estradiol

Data type

float

Measurement units
  • pg/mL
Alias
UMLS CUI [1,1]
C0014912
UMLS CUI [1,2]
C0008000
pg/mL
Calcium oxalate crystals
Description

Calcium oxalate crystals

Data type

integer

Measurement units
  • /LPF
Alias
UMLS CUI [1]
C0368818
/LPF
Urine drug screening
Description

Urine drug screening

Alias
UMLS CUI-1
C0202274
Amphetamine
Description

Amphetamine

Data type

boolean

Alias
UMLS CUI [1]
C0002667
Barbiturates
Description

Barbiturates

Data type

integer

Alias
UMLS CUI [1]
C0004745
Benzodiazepines
Description

Benzodiazepines

Data type

integer

Alias
UMLS CUI [1]
C0005064
Cannabinoids
Description

Cannabinoids

Data type

integer

Alias
UMLS CUI [1]
C0006864
Cocaine/Metabs
Description

Cocaine

Data type

integer

Alias
UMLS CUI [1]
C0009170
Opiates
Description

Opiates

Data type

integer

Alias
UMLS CUI [1]
C0376196
PCP
Description

PCP

Data type

integer

Alias
UMLS CUI [1]
C1744653
Cotinine
Description

Cotinine

Data type

integer

Alias
UMLS CUI [1]
C0202363
Blood smear
Description

Blood smear

Alias
UMLS CUI-1
C2238079
Blood smear normal or abnormal?
Description

Blood smear

Data type

text

Alias
UMLS CUI [1]
C1167864
UMLS CUI [2]
C1167865

Similar models

Safety Lab - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Hematology
C0018941 (UMLS CUI-1)
Leukocytes (WBC)
Item
WBC
float
C0023508 (UMLS CUI [1])
Red Blood Count
Item
Red cells
float
C1287262 (UMLS CUI [1])
Hematocrit
Item
Hematocrit (PCV)
float
C0518014 (UMLS CUI [1])
Mean cell volume
Item
Mean cell volume
integer
C0524587 (UMLS CUI [1])
Mean cell hemoglobin (MCH)
Item
Mean cell hemoglobin (MCH)
float
C0369183 (UMLS CUI [1])
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1])
rdw
Item
RBC distribution width
float
C0427460 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Mean platelet volume
Item
Mean platelet volume
integer
C0200665 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Reticulocytes
Item
Reticulocytes
float
C0035286 (UMLS CUI [1])
Item Group
Blood Chemistry
C0005774 (UMLS CUI-1)
Total Protein
Item
Total Protein
float
C0036836 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Calcium total
Item
Calcium total
float
C0600069 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Bilirubin, total
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Direct Bilirubin
Item
Direct Bilirubin
float
C0201916 (UMLS CUI [1])
Indirect Bilirubin
Item
Indirect Bilirubin
float
C1881193 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Uric acid
Item
Uric acid
float
C0041980 (UMLS CUI [1])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1])
Item
Hep B surface antigen
integer
C0201477 (UMLS CUI [1])
Code List
Hep B surface antigen
CL Item
positive (1)
CL Item
negative (2)
Item
Hepatitis C antibody
integer
C0281863 (UMLS CUI [1])
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
HIV antibody
integer
C0019683 (UMLS CUI [1])
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
carbon dioxide
Item
Total carbon dioxide
float
C0201930 (UMLS CUI [1])
Phosphate
Item
Phosphate
float
C0523826 (UMLS CUI [1])
Haptoglobin
Item
Haptoglobin
float
C0919773 (UMLS CUI [1])
Lactate Dehydrogenase
Item
Lactate Dehydrogenase
float
C0202113 (UMLS CUI [1])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Urine Specific Gravity
Item
Specific gravity
float
C0202517 (UMLS CUI [1])
PH urine
Item
PH
integer
C0042044 (UMLS CUI [1])
Item
Protein
integer
C0262923 (UMLS CUI [1])
Code List
Protein
CL Item
negative (1)
CL Item
positive (2)
Item
Urine glucose
integer
C0004076 (UMLS CUI [1])
Code List
Urine glucose
CL Item
negative (1)
CL Item
positive (2)
Urine Ketones
Item
Ketones
float
C1991100 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item
Occult blood
integer
C2188744 (UMLS CUI [1])
Code List
Occult blood
CL Item
positive (1)
CL Item
negative (2)
urine RBC
Item
Urine RBC
integer
C1972472 (UMLS CUI [1])
urine WBC
Item
urine WBC
integer
C1975554 (UMLS CUI [1])
Squamous epithelial cells
Item
Squamous epithelial cells
integer
C2699511 (UMLS CUI [1])
Transitional epithelial cells
Item
Transitional epithelial cells
integer
C2984936 (UMLS CUI [1])
Hyaline casts
Item
Hyaline casts
float
C0427894 (UMLS CUI [1])
unknown cells urine
Item
unknown cells
integer
C0854148 (UMLS CUI [1])
Coarse granulocytes
Item
Coarse gran casts
integer
C1868540 (UMLS CUI [1])
Uric acid crystals
Item
Uric acid crystals
integer
C2700121 (UMLS CUI [1])
Tri phosphate crystals
Item
Tri phosphate crystals
integer
C0370102 (UMLS CUI [1])
urine crystals
Item
Unknown crystals
integer
C0427897 (UMLS CUI [1])
WBC casts
Item
WBC casts
integer
C2700271 (UMLS CUI [1])
Epithelial cells urine
Item
Epithelial cell casts
integer
C1318314 (UMLS CUI [1])
fine granular casts
Item
fine granular casts
integer
C2697522 (UMLS CUI [1])
mixed cellular casts
Item
mixed cellular casts
integer
C1317541 (UMLS CUI [1])
Renal tubular epithelial
Item
Renal tubular epithelial
integer
C2700087 (UMLS CUI [1])
RBC casts
Item
RBC casts
integer
C2699019 (UMLS CUI [1])
Waxy casts
Item
Waxy casts
integer
C2700267 (UMLS CUI [1])
unknown casts
Item
unknown casts
integer
C4048266 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Amorphous phosphate crystals
Item
Amorphous phosphate crystals
integer
C2984932 (UMLS CUI [1])
Amorphous urate crystals
Item
Amorphous urate crystals
integer
C2984933 (UMLS CUI [1])
Item
Bacteria
integer
C0004659 (UMLS CUI [1])
Code List
Bacteria
CL Item
negative (1)
CL Item
positive (2)
Item
Oval fat body
integer
C1699553 (UMLS CUI [1])
Code List
Oval fat body
CL Item
negative (1)
CL Item
positive (2)
Item
Urine yeast
integer
C2188427 (UMLS CUI [1])
Code List
Urine yeast
CL Item
negative (1)
CL Item
positive (2)
Trichomonas
Item
Trichomonas
boolean
C2984927 (UMLS CUI [1])
Hemosiderin
Item
Hemosiderin
boolean
C0019113 (UMLS CUI [1])
Item Group
Urine Chemistry
C0864414 (UMLS CUI-1)
Alk Phos Value
Item
Alk Phos total
float
Item
Pregnancy test
integer
C0032976 (UMLS CUI [1])
Code List
Pregnancy test
CL Item
negative (1)
CL Item
positive (2)
Blood Urea Nitrogen
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201975 (UMLS CUI [1])
FSH
Item
FSH
float
C0202022 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Ethanol
Item
Ethanol
float
C0202304 (UMLS CUI [1])
Creatinine kinase
Item
Creatinine kinase
float
C0201973 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Estradiol
Item
Estradiol
float
C0014912 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Calcium oxalate crystals
Item
Calcium oxalate crystals
integer
C0368818 (UMLS CUI [1])
Item Group
Urine drug screening
C0202274 (UMLS CUI-1)
Amphetamine
Item
Amphetamine
boolean
C0002667 (UMLS CUI [1])
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Code List
Benzodiazepines
CL Item
negative (1)
CL Item
positive (2)
Item
Cannabinoids
integer
C0006864 (UMLS CUI [1])
Code List
Cannabinoids
CL Item
negative (1)
CL Item
positive (2)
Item
Cocaine/Metabs
integer
C0009170 (UMLS CUI [1])
Code List
Cocaine/Metabs
CL Item
positive (1)
CL Item
negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Code List
Opiates
CL Item
positive (1)
CL Item
negative (2)
Item
PCP
integer
C1744653 (UMLS CUI [1])
Code List
PCP
CL Item
negative (1)
CL Item
positive (2)
Item
Cotinine
integer
C0202363 (UMLS CUI [1])
Code List
Cotinine
CL Item
negative (1)
CL Item
positive (2)
Item Group
Blood smear
C2238079 (UMLS CUI-1)
Item
Blood smear normal or abnormal?
text
C1167864 (UMLS CUI [1])
C1167865 (UMLS CUI [2])
Code List
Blood smear normal or abnormal?
CL Item
normal (1)
CL Item
abnormal (2)

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