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])
Item
Is this liver event a serious adverse event?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Is this liver event a serious adverse event?
Date/Time Last Email to Medical Monitor
Item
Last Email Sent to Medical Monitor
partialDatetime
C1264639 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
Date/Time First Email to Medical Monitor
Item
Initial Email Sent to Medical Monitor
partialDatetime
C1264639 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
Date/Time Last Email to GCSP
Item
Last Email Sent to GCSP
partialDatetime
C1264639 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
Date/Time First Email to GCSP
Item
Initial Email Sent to GCSP
partialDatetime
C1264639 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
Date/Time Liver Event Changed to Non Serious
Item
Changed to Non Serious on
partialDatetime
C1264639 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
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])
Item
Is the subject age 55 or older?
text
C0001779 (UMLS CUI [1])
Code List
Is the subject age 55 or older?
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)
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)?
text
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])
Code List
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)?
Item
If Yes, were the results normal?
text
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])
Code List
If Yes, were the results normal?
Item
Were any liver biopsies performed?
text
C0193388 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Code List
Were any liver biopsies performed?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
text
C2347852 (UMLS CUI [1])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
Code List
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Did the subject fast or undergo significant dietary change in the past week?
text
C3671772 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
Code List
Did the subject fast or undergo significant dietary change in the past week?
Evaluation interval code
Item
Evaluation interval code [hidden]
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 the treatment period (D)
CL Item
After the treatment period (A)
Start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Investigational Product
Item
End Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Was a pharmacokinetic blood sample obtained?
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Code List
Was a pharmacokinetic blood sample obtained?
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])
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
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
Status
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
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)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Code List
Does the subject consume alcohol?
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])