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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
Versions (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
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
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])
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])
CL Item
positive (1)
CL Item
negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
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])
Urine Specific Gravity
Item
Specific gravity
float
C0202517 (UMLS CUI [1])
PH urine
Item
PH
integer
C0042044 (UMLS CUI [1])
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
Urine Ketones
Item
Ketones
float
C1991100 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
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])
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])
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
Trichomonas
Item
Trichomonas
boolean
C2984927 (UMLS CUI [1])
Hemosiderin
Item
Hemosiderin
boolean
C0019113 (UMLS CUI [1])
Alk Phos Value
Item
Alk Phos total
float
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])
C0008000 (UMLS CUI [1,2])
Calcium oxalate crystals
Item
Calcium oxalate crystals
integer
C0368818 (UMLS CUI [1])
Amphetamine
Item
Amphetamine
boolean
C0002667 (UMLS CUI [1])
CL Item
positive (1)
CL Item
negative (2)
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
Item
Blood smear normal or abnormal?
text
C1167864 (UMLS CUI [1])
C1167865 (UMLS CUI [2])
C1167865 (UMLS CUI [2])
CL Item
normal (1)
CL Item
abnormal (2)
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