Item
Notification Sent [read-only]
integer
C0422202 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Code List
Notification Sent [read-only]
CL Item
Last Email Sent to Medical Monitor (1)
CL Item
Initial Email Sent to Medical Monitor (2)
CL Item
Last Email Sent to GCSP (3)
CL Item
lnitial Email Sent to GCSP (4)
CL Item
Changed to Non Serious (5)
Date of notification
Item
Date of notification
date
C1302584 (UMLS CUI [1])
Time of notification
Item
Time of notification
time
C0040223 (UMLS CUI [1,1])
C0422202 (UMLS CUI [1,2])
Item
Is this liver event a serious adverse event?
text
C1710056 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Code List
Is this liver event a serious adverse event?
alanine aminotransferase stop criterion
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria? ALT (alanine aminotransferase)
boolean
C0151905 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
aspartate aminotransferase stop criterion
Item
AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Total bilirubin stop criterion
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Alkaline phosphatase stop criterion
Item
Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
5' nucleotidase stop criterion
Item
5' nucleotidase
boolean
C2700357 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Gammaglutamyltranspeptidase stop criterion
Item
Gammaglutamyltranspeptidase
boolean
C0541979 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Other stop criterion
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
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 cholanglopancreatography, or other)?
text
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1275400 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0008310 (UMLS CUI [5])
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 cholanglopancreatography, or other)?
Item
If diagnostic imaging tests were performed, were the results normal?
text
C1274040 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Code List
If diagnostic imaging tests were performed, were the results normal?
Item
were any liver biopsies performed?
text
C0193388 (UMLS CUI [1])
Code List
were any liver biopsies performed?
Item
Does the subject use herbals, complementary or altemative medicines, food supplements (vitamins) or illicit drugs?
text
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2,1])
C0002346 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
Code List
Does the subject use herbals, complementary or altemative medicines, food supplements (vitamins) or illicit drugs?
Item
Did the subject fast or undergo significant dietary change In the past week?
text
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [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
C2985767 (UMLS CUI [1])
Item
When did the liver event occur?
text
C2985916 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
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])
investigational product Start date not applicable
Item
Start date not applicable
boolean
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End Date investigational Product
Item
End Date investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
investigational product end date not applicable
Item
End date not applicable
boolean
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Item
Was a pharmacokinetic blood sample obtained?
text
C0031328 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Code List
Was a pharmacokinetic blood sample obtained?
Date sample taken
Item
If a pharmacokinetic blood sample was taken note the Date
date
C1302413 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Time sample taken
Item
If a pharmacokinetic blood sample was taken note the time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Date of last investigational product dose
Item
If a pharmacokinetic blood sample was taken note the 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 a pharmacokinetic blood sample was taken note the time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Sample Identifier/Sample Number Pharmacokinetics
Item
Sample Identifier/Sample Number
text
C1299222 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
Specific Condition
CL Item
Acute Viral Hepatitis A (1)
CL Item
Chronic Hepatitis B (2)
CL Item
Chronic Hepatitis C (3)
CL Item
Cytomegalovirus Hepatitis (4)
CL Item
Epstein Barr Virus Infectious Mononucleosis (5)
CL Item
Herpes Simplex Hepatitis (6)
CL Item
Alcoholic Liver Disease (7)
CL Item
Non-alcoholic Steatohepatitis (8)
CL Item
Hepatic Cirrhosis (10)
CL Item
Hemochromatosis (11)
CL Item
Autoimmune Hepatitis (12)
CL Item
Gallbladder disease (13)
Item
Presence of disease
integer
C3854307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Code List
Presence of disease
CL Item
No Medical Condition (5)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Code List
Drug related liver disease
CL Item
No Medical Condition (3)
Sequence Number
Item
Sequence Number [hidden]
integer
C2348184 (UMLS CUI [1])
Specific condition
Item
Specific condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Modified Term
Item
Modified Term [hidden]
text
C2826302 (UMLS CUI [1])
MeDRA Synonym
Item
MeDRA 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
C0449438 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Disease
integer
C0012634 (UMLS CUI [1])
CL Item
Drug Allergies (1)
CL Item
Rheumatoid Arthritis (2)
CL Item
Thyroid Disease (4)
CL Item
Inflammatory Bowel Disease (5)
CL Item
Sjogren's Syndrome (7)
Item
Presence of disease
integer
C3854307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Code List
Presence of disease
CL Item
Current (1)
(Comment:en)
CL Item
Past (2)
(Comment:en)
CL Item
No Medical Condition (5)
(Comment:en)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Code List
Does the subject consume alcohol?
Alcohol consumption per week
Item
If alcohol consumption, record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Substance use type
Item
Substance use type [hidden]
text
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])