ALT (alanine aminotransferase) fulfilling investigational product stopping criteria
Item
Did the ALT result reach or exceed 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])
Total bilirubin fulfilling investigational product stopping criteria
Item
Did the total bilirubin result reach or exceed 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])
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 (3)
diagnostic imaging 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])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
diagnostic imaging of the liver or hepatobiliary system normal
Item
if yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
liver biopsies
Item
were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
subject use 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
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
subject recently fasted or underwent significant dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0332185 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C3671772 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
Laboratory ID
Item
Laboratory ID [read only]
text
C2986056 (UMLS CUI [1])
Item
Laboratory name and adress
text
C0022877 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C1301826 (UMLS CUI [2,2])
Code List
Laboratory name and adress
CL Item
results from the same lab as in the previous visit (1)
CL Item
please provide laboratory name and adress below (2)
Laboratory name and adress
Item
Laboratory name
text
C0022877 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Laboratory name and adress
Item
Laboratory adress
text
C0022877 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
date and time sample taken
Item
date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Item
creatine kinase
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0010287 (UMLS CUI [1,3])
Code List
creatine kinase
CL Item
numeric result (1)
CL Item
character result (2)
creatine kinase numeric result
Item
creatine kinase numeric result, please specify
text
C0201973 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
creatine kinase character result
Item
creatine kinase character result, please specify
text
C0201973 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
lactate dehydrogenase
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0202113 (UMLS CUI [1,3])
Code List
lactate dehydrogenase
CL Item
numeric result (1)
CL Item
character result (2)
lactate dehydrogenase numeric result
Item
lactate dehydrogenase numeric result, please specify
text
C0202113 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
lactate dehydrogenase character result
Item
lactate dehydrogenase character result, please specify
text
C0202113 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Actin (Smooth Muscle) IgG Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1532316 (UMLS CUI [1,3])
Code List
Actin (Smooth Muscle) IgG Antibody
CL Item
numeric result (1)
CL Item
character result (2)
Actin (Smooth Muscle) IgG Antibody numeric result
Item
Actin (Smooth Muscle) IgG Antibody numeric result, please specify
text
C1532316 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Actin (Smooth Muscle) IgG Antibody character result
Item
Actin (Smooth Muscle) IgG Antibody character result, please specify
text
C1532316 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody-Screen
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Code List
Anti-Nuclear Antibody-Screen
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody-Screen numeric result
Item
Anti-Nuclear Antibody-Screen numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody-Screen character result
Item
Anti-Nuclear Antibody-Screen character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
Code List
Anti-Nuclear Antibody
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody 2
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
Code List
Anti-Nuclear Antibody 2
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody 2 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody 2 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody 3
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
Code List
Anti-Nuclear Antibody 3
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody 3 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody 3 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody 4
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
Code List
Anti-Nuclear Antibody 4
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody 4 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody 4 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody Pattern
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
Code List
Anti-Nuclear Antibody Pattern
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody Pattern 2
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
Code List
Anti-Nuclear Antibody Pattern 2
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern 2 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern 2 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody Pattern 3
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
Code List
Anti-Nuclear Antibody Pattern 3
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern 3 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern 3 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody Pattern 4
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
Code List
Anti-Nuclear Antibody Pattern 4
CL Item
numeric result (1)
CL Item
character result (2)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern 4 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern 4 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Cytomegalovirus IgM Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272889 (UMLS CUI [1,3])
Code List
Cytomegalovirus IgM Antibody
CL Item
numeric result (1)
CL Item
character result (2)
Cytomegalovirus IgM Antibody numeric result
Item
Cytomegalovirus IgM Antibody numeric result, please specify
text
C3272889 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Cytomegalovirus IgM Antibody character result
Item
Cytomegalovirus IgM Antibody character result, please specify
text
C3272889 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272892 (UMLS CUI [1,3])
Code List
Epstein-Barr Viral Capsid Antigen IgM Antibody
CL Item
numeric result (1)
CL Item
character result (2)
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result, please specify
text
C3272892 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Epstein-Barr Viral Capsid Antigen IgM Antibody character result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody character result, please specify
text
C3272892 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272892 (UMLS CUI [1,3])
C0871362 (UMLS CUI [1,4])
Code List
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
CL Item
numeric result (1)
CL Item
character result (2)
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result, please specify
text
C3272892 (UMLS CUI [1,1])
C0871362 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result, please specify
text
C3272892 (UMLS CUI [1,1])
C0871362 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis A IgM Antibody Total (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0373852 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
Code List
Hepatitis A IgM Antibody Total (Qualitative)
CL Item
numeric result (1)
CL Item
character result (2)
Hepatitis A IgM Antibody Total (Qualitative) numeric result
Item
Hepatitis A IgM Antibody Total (Qualitative) numeric result, please specify
text
C0373852 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Hepatitis A IgM Antibody Total (Qualitative) character result
Item
Hepatitis A IgM Antibody Total (Qualitative) character result, please specify
text
C0373852 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis B Core IgM Antibody (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0201480 (UMLS CUI [1,3])
C0202084 (UMLS CUI [1,4])
C0205556 (UMLS CUI [1,5])
Code List
Hepatitis B Core IgM Antibody (Qualitative)
CL Item
numeric result (1)
CL Item
character result (2)
Hepatitis B Core IgM Antibody (Qualitative) numeric result
Item
Hepatitis B Core IgM Antibody (Qualitative) numeric result, please specify
text
C0201480 (UMLS CUI [1,1])
C0202084 (UMLS CUI [1,2])
C0205556 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,4])
Hepatitis B Core IgM Antibody (Qualitative) character result
Item
Hepatitis B Core IgM Antibody (Qualitative) character result, please specify
text
C0201480 (UMLS CUI [1,1])
C0202084 (UMLS CUI [1,2])
C0205556 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,4])
Item
Hepatitis B Surface Antigen (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0019168 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
Code List
Hepatitis B Surface Antigen (Qualitative)
CL Item
numeric result (1)
CL Item
character result (2)
Hepatitis B Surface Antigen (Qualitative) numeric result
Item
Hepatitis B Surface Antigen (Qualitative) numeric result, please specify
text
C0019168 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Hepatitis B Surface Antigen (Qualitative) character result
Item
Hepatitis B Surface Antigen (Qualitative) character result, please specify
text
C0019168 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis E IgM Antibody Total (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272944 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
Code List
Hepatitis E IgM Antibody Total (Qualitative)
CL Item
numeric result (1)
CL Item
character result (2)
Hepatitis E IgM Antibody Total (Qualitative) numeric result
Item
Hepatitis E IgM Antibody Total (Qualitative) numeric result, please specify
text
C3272944 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Hepatitis E IgM Antibody Total (Qualitative) character result
Item
Hepatitis E IgM Antibody Total (Qualitative) character result, please specify
text
C3272944 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Liver Kidney Microsomal Antibody IgG
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0051982 (UMLS CUI [1,3])
C0020852 (UMLS CUI [1,4])
Code List
Liver Kidney Microsomal Antibody IgG
CL Item
numeric result (1)
CL Item
character result (2)
Liver Kidney Microsomal Antibody IgG numeric result
Item
Liver Kidney Microsomal Antibody IgG numeric result, please specify
text
C0051982 (UMLS CUI [1,1])
C0020852 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Liver Kidney Microsomal Antibody IgG character result
Item
Liver Kidney Microsomal Antibody IgG character result, please specify
text
C0051982 (UMLS CUI [1,1])
C0020852 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis C RNA PCR
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1272251 (UMLS CUI [1,3])
C0032520 (UMLS CUI [1,4])
Code List
Hepatitis C RNA PCR
CL Item
numeric result (1)
CL Item
character result (2)
Hepatitis C RNA PCR numeric result
Item
Hepatitis C RNA PCR numeric result, please specify
text
C1272251 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
Hepatitis C RNA PCR character result
Item
Hepatitis C RNA PCR character result, please specify
text
C1272251 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
Item
Hepatitis C RNA PCR Log
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1272251 (UMLS CUI [1,3])
C3873230 (UMLS CUI [1,4])
Code List
Hepatitis C RNA PCR Log
CL Item
numeric result (1)
CL Item
character result (2)
Hepatitis C RNA PCR Log numeric result
Item
Hepatitis C RNA PCR Log numeric result, please specify
text
C1272251 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C3873230 (UMLS CUI [1,3])
Hepatitis C RNA PCR Log character result
Item
Hepatitis C RNA PCR Log character result, please specify
text
C1272251 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C3873230 (UMLS CUI [1,3])