liver event
Item
Is this liver event a serious adverse event?
boolean
C1556667 (UMLS CUI [1])
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/ interruption criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/ interruption criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspactate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
Gammaglutamyltranspeptidase (6)
subject age
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
integer
C0032961 (UMLS CUI [1])
Code List
If female, is the subject pregnant?
CL Item
Not applicable (3)
diagnostic imaging tests of the liver or hepatobiliary system
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])
C0023884 (UMLS CUI [1,3])
diagnostic imaging tests of the liver or hepatobiliary system results
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
liver biopsy
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
use of supplements or alternative medicines
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1])
Item
When did the liver event occur?
integer
C1556667 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Code List
When did the liver event occur?
CL Item
During the treatment period (1)
CL Item
After the treatment period (2)
Start Date Investigational Product
Item
Start Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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 sample taken
Item
If Yes, date sample taken
date
C1302413 (UMLS CUI [1])
time sample taken
Item
If Yes, time sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
date of last investigational product dose
Item
If Yes, date of last investigational product dose prior to PK sample
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
time of last investigational product dose
Item
If Yes, time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
date of last medication dose
Item
If Yes, date of last medication dose prior to PK sample
date
C0013227 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
time of last medication dose
Item
If Yes, time of last medication dose prior to PK sample
time
C0013227 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Medication name
Item
Medication: Insert drug name
text
C2360065 (UMLS CUI [1])
Item
Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Code List
Acute Viral Hepatitis A
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Code List
Chronic Hepatitis B
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Code List
Chronic Hepatitis C
CL Item
No Medical Condition (3)
Item
Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Code List
Cytomegalovirus Hepatitis
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
No Medical Condition (3)
Item
Herpes Simplex Hepatitis
integer
C1963747 (UMLS CUI [1])
Code List
Herpes Simplex Hepatitis
CL Item
No Medical Condition (3)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Code List
Alcoholic Liver Disease
CL Item
No Medical Condition (3)
Item
Non-alcoholic Steatohepatltls
integer
C3241937 (UMLS CUI [1])
Code List
Non-alcoholic Steatohepatltls
CL Item
No Medical Condition (3)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
CL Item
No Medical Condition (3)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Code List
Hepatic Cirrhosis
CL Item
No Medical Condition (3)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Code List
Hemochromatosis
CL Item
No Medical Condition (3)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Code List
Autoimmune Hepatitis
CL Item
No Medical Condition (3)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
Code List
Gallbladder disease
CL Item
No Medical Condition (3)
Item
Drug related liver disease
integer
Code List
Drug related liver disease
CL Item
No Medical Condition (3)
Item
Other liver disease
integer
C0023895 (UMLS CUI [1])
Code List
Other liver disease
CL Item
No Medical Condition (3)
Item
Drug Allergies
integer
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
CL Item
No Medical Condition (3)
Item
Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Code List
Rheumatoid Arthritis
CL Item
No Medical Condition (3)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
CL Item
No Medical Condition (3)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Code List
Thyroid Disease
CL Item
No Medical Condition (3)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Code List
Inflammatory Bowel Disease
CL Item
No Medical Condition (3)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
CL Item
No Medical Condition (3)
Item
Sjogrens Syndrome
integer
C1527336 (UMLS CUI [1])
Code List
Sjogrens Syndrome
CL Item
No Medical Condition (3)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
CL Item
No Medical Condition (3)
alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
average number or units of alcohol consumed per week
Item
Yes, record the average number or units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])