date of visit/assessment
Item
date of visit/assessment
text
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
ALT (alanine aminotransferase)
Item
ALT (alanine aminotransferase)
boolean
C0201836 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1])
Subject age
Item
Is the subject age 55 or older?
boolean
C2348575 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Code List
If female, is the subject pregnant?
CL Item
Not applicable (X)
Diagnostic imaging tests of the liver or hepatobiliary system (i.e. liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography)
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0023884 (UMLS CUI [3,1])
C1456803 (UMLS CUI [3,2])
C0023884 (UMLS CUI [4,1])
C0040405 (UMLS CUI [4,2])
C0023884 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
C0008310 (UMLS CUI [6])
Diagnostic imaging tests of the liver or hepatobiliary system, results
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C1274040 (UMLS CUI [2,3])
Liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Usage of Herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
C1360419 (UMLS CUI [4])
C4053461 (UMLS CUI [5])
Recent fasting or dietary changes
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0015663 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Evaluation interval
Item
Evaluation interval code
text
C2826267 (UMLS CUI [1])
Pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Pharmacokinetic blood sample, date and time
Item
If yes, date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0031328 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Pharmacokinetic blood sample, date and time of last investigational product
Item
If yes, date and time of last investigational product dose prior to PK sample
datetime
C1517741 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
Start Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
Code List
Start Date Investigational Product not applicable
CL Item
Date applicable (99)
CL Item
Not applicable (98)
Adverse event during treatment, Start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
Item
End/Interruption Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0877248 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
C1272460 (UMLS CUI [2,7])
Code List
End/Interruption Date Investigational Product not applicable
CL Item
Date applicable (99)
CL Item
Not applicable (98)
Adverse event during treatment, End/Interruption Date Investigational Product
Item
End/Interruption Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C0877248 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0806020 (UMLS CUI [2,5])
C0304229 (UMLS CUI [2,6])
Item
Start Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
Code List
Start Date Investigational Product not applicable
CL Item
Date applicable (99)
CL Item
Not applicable (98)
Adverse event after treatment, start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
Item
End/Interruption Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
C1272460 (UMLS CUI [2,7])
Code List
End/Interruption Date Investigational Product not applicable
CL Item
Date applicable (99)
CL Item
Not applicable (98)
Adverse event after treatment, End/Interruption Date Investigational Product
Item
End/Interruption Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
Item
Acute Viral Hepatitis A
text
C0276434 (UMLS CUI [1])
Code List
Acute Viral Hepatitis A
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis B
text
C0524909 (UMLS CUI [1])
Code List
Chronic Hepatitis B
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
Code List
Chronic Hepatitis C
CL Item
No Medical Condition (5)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
Code List
Cytomegalovirus Hepatitis
CL Item
No Medical Condition (5)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
No Medical Condition (5)
Item
Herpes Simplex Hepatitis
text
C1963747 (UMLS CUI [1])
Code List
Herpes Simplex Hepatitis
CL Item
No Medical Condition (5)
Item
Alcoholic Liver Disease
text
C0023896 (UMLS CUI [1])
Code List
Alcoholic Liver Disease
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
Code List
Non-alcoholic Steatohepatitis
CL Item
No Medical Condition (5)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
Code List
Hepatic Cirrhosis
CL Item
No Medical Condition (5)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
Code List
Hemochromatosis
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
Code List
Autoimmune Hepatitis
CL Item
No Medical Condition (5)
Item
Gallbladder disease
text
C0016977 (UMLS CUI [1])
Code List
Gallbladder disease
CL Item
No Medical Condition (5)
Item
Liver metastases
text
C0494165 (UMLS CUI [1])
Code List
Liver metastases
CL Item
No Medical Condition (5)
Item
Hepatitis E IgM antibody
text
C3272944 (UMLS CUI [1])
Code List
Hepatitis E IgM antibody
CL Item
No Medical Condition (5)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Code List
Drug related liver disease
CL Item
No Medical Condition (5)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific condition
Item
Specific condition
text
C0023895 (UMLS CUI [1])
Modified Term
Item
Modified Term
text
C2826923 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Status
text
C0449438 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Item
Drug allergies
text
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
CL Item
No Medical Condition (5)
Item
Rheumatoid Arthritis
text
C0003873 (UMLS CUI [1])
Code List
Rheumatoid Arthritis
CL Item
No Medical Condition (5)
Item
Psoriasis
text
C0033860 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Item
Thyroid Disease
text
C0040128 (UMLS CUI [1])
Code List
Thyroid Disease
CL Item
No Medical Condition (5)
Item
Inflammatory Bowel Disease
text
C0021390 (UMLS CUI [1])
Code List
Inflammatory Bowel Disease
CL Item
No Medical Condition (5)
Item
Lupus
text
C0409974 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Item
Sjogrens Syndrome
text
C1527336 (UMLS CUI [1])
Code List
Sjogrens Syndrome
CL Item
No Medical Condition (5)
Item
Vitiligo
text
C0042900 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Average number of units per week
Item
If yes, record the average number of units of alcohol consumed per week
integer
C0560579 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])