Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure, systolic
Item
Blood pressure, systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure, diastolic
Item
Blood pressure, diastolic
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Haematocrit (HCT)
Item
Haematocrit (HCT)
float
C0018935 (UMLS CUI [1])
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
float
C0518015 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
float
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
float
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
float
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
float
C3544087 (UMLS CUI [1])
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Code List
Investigational Product
investigational product start date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
investigational product stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
investigational product dosage
Item
Dose
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If there were any dosing deviations / changes, give reason
text
C1515926 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If there were any dosing deviations / changes, give reason
CL Item
Hypertension (17)
CL Item
Other Toxicity (22)
CL Item
Recovered from Toxicity (23)
CL Item
lntercurrent Illness (24)
CL Item
Subject Non-compliance (25)
CL Item
Investigator Error (26)
CL Item
Other, specify (CT)