Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
ALT reached stopping criteria
Item
Has ALT (alanine aminotransferase) result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0201836 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
AST reached stopping criteria
Item
Has AST (aspartate aminotransferase) result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0201899 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Total bilirubin reached stopping criteria
Item
Has total bilirubin result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0201913 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Alkaline phosphatase reached stopping criteria
Item
Has alkaline phosphatase result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0201850 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
5' nucleotidase reached stopping criteria
Item
Has 5' nucleotidase result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0202148 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Gamma-glutamyltranspeptidase reached stopping criteria
Item
Has gamma-glutamyltranspeptidase result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0202035 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Other liver chemistry result reached stopping criteria
Item
Has another liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0205394 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Age
Item
Is the subject age 55 or older?
boolean
C0001779 (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 of liver or hepatobiliary system perfomed, e.g. liver ultrasound, CT, MRI, ERCP
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
results of diagnostic imaging of liver or hepatobiliary system
Item
Were the results of diagnostic imaging tests of the liver or hepatobiliary system normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
Liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Concomitant Medication incl. herbals, food supplements, illicit drugs
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2347852 (UMLS CUI [1])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
Recent fasting or significant dietary change
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])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
Evaluation interval code
Item
Evaluation interval code [hidden]
text
C2826267 (UMLS CUI [1])
Start Date Investigational Product applicable
Item
Is Start Date of Investigational Product applicable?
boolean
C3897500 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
Start Date Investigational Product
Item
Start Date of Investigational Product applicable
datetime
C3897500 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
End Date Investigational Product applicable
Item
Is End Date of Investigational Product applicable?
boolean
C3899266 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
End Date Investigational Product
Item
End Date of Investigational Product
datetime
C3899266 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Date/Time of pharmacokinetic blood sample
Item
date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date/Time of last investigational product dose prior to pharmacokinetic blood sample
Item
date and time of last investigational product dose prior to PK sample
datetime
C0945778 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
pharmacokinetic blood sample identifier
Item
Sample Identifier of pharmacokinetic blood sample
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Item
Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Code List
Acute Viral Hepatitis A
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Code List
Chronic Hepatitis B
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Code List
Chronic Hepatitis C
CL Item
No Medical Condition (5)
Item
Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Code List
Cytomegalovirus Hepatitis
CL Item
No Medical Condition (5)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1])
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
No Medical Condition (5)
Item
Herpes Simplex Hepatitis
integer
C1963747 (UMLS CUI [1])
Code List
Herpes Simplex Hepatitis
CL Item
No Medical Condition (5)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Code List
Alcoholic Liver Disease
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
integer
C3241937 (UMLS CUI [1])
Code List
Non-alcoholic Steatohepatitis
CL Item
No Medical Condition (5)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Code List
Hepatic Cirrhosis
CL Item
No Medical Condition (5)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Code List
Hemochromatosis
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Code List
Autoimmune Hepatitis
CL Item
No Medical Condition (5)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
Code List
Gallbladder disease
CL Item
No Medical Condition (5)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Code List
Drug related liver disease
CL Item
No Medical Condition (5)
Sequence Number
Item
Sequence Number [hidden]
text
C2348184 (UMLS CUI [1])
Other liver disease
Item
Other Liver Disease Conditions - Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Modified Term
Item
Modified Term [hidden]
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym [hidden]
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code [hidden]
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Other Liver Disease Conditions - Status
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Code List
Other Liver Disease Conditions - Status
Item
Drug Allergies
integer
C0013182 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Item
Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Code List
Rheumatoid Arthritis
CL Item
No Medical Condition (5)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Code List
Thyroid Disease
CL Item
No Medical Condition (5)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Code List
Inflammatory Bowel Disease
CL Item
No Medical Condition (5)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Item
Sjogren's Syndrome
integer
C1527336 (UMLS CUI [1])
Code List
Sjogren's Syndrome
CL Item
No Medical Condition (5)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
CL Item
No Medical Condition (5)
Does subject consume alcohol
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Substance Use Type
Item
Substance Use Type [hidden]
text
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])