Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
ALT reached stopping criteria
Item
ALT (alanine aminotransferase)
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
AST (aspartate aminotransferase)
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
Total bilirubin
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
Alkaline phosphatase
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
5' nucleotidase
boolean
C0202148 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Gammaglutamyltranspeptidase reached stopping criteria
Item
Gammaglutamyltranspeptidase
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
Other
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 (Not applicable)
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
If Yes, were the results 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
text
C2826267 (UMLS CUI [1])
Item
When did the liver event occur?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Code List
When did the liver event occur?
CL Item
During treatment period (During treatment period)
CL Item
After treatment period (After treatment period)
Start Date Investigational Product not applicable
Item
Start Date Investigational Product not applicable
boolean
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Start Date Investigational Product
Item
Start Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Investigational Product not applicable
Item
End Date Investigational Product not applicable
boolean
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End Date Investigational Product
Item
End Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0806020 (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/Sample Number
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Item
Acute Viral Hepatitis A
text
C0276434 (UMLS CUI [1])
Code List
Acute Viral Hepatitis A
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Chronic Hepatitis B
text
C0524909 (UMLS CUI [1])
Code List
Chronic Hepatitis B
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
Code List
Chronic Hepatitis C
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
Code List
Cytomegalovirus Hepatitis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0021345 (UMLS CUI [1])
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Herpes Simplex Hepatitis
text
C1963747 (UMLS CUI [1])
Code List
Herpes Simplex Hepatitis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Alcoholic Liver Disease
text
C0023896 (UMLS CUI [1])
Code List
Alcoholic Liver Disease
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
Code List
Hepatic Cirrhosis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
Code List
Hemochromatosis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
Code List
Autoimmune Hepatitis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Gallbladder disease
text
C0016977 (UMLS CUI [1])
Code List
Gallbladder disease
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Code List
Drug related liver disease
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Other liver disease
Item
Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
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
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
CL Item
Current (Current)
Item
Drug Allergies
text
C0013182 (UMLS CUI [1])
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Rheumatoid Arthritis
text
C0003873 (UMLS CUI [1])
Code List
Rheumatoid Arthritis
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Psoriasis
text
C0033860 (UMLS CUI [1])
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Thyroid Disease
text
C0040128 (UMLS CUI [1])
Code List
Thyroid Disease
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Inflammatory Bowel Disease
text
C0021390 (UMLS CUI [1])
Code List
Inflammatory Bowel Disease
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Lupus
text
C0409974 (UMLS CUI [1])
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Sjogren's Syndrome
text
C1527336 (UMLS CUI [1])
Code List
Sjogren's Syndrome
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Item
Vitiligo
text
C0042900 (UMLS CUI [1])
CL Item
Current (Current)
CL Item
No Medical Condition (No Medical Condition)
Alcohol consumption?
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
text
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])