Item
Is this liver event a serious adverse event?
integer
C1519255 (UMLS CUI [1,1])
C1556667 (UMLS CUI [1,2])
Code List
Is this liver event a serious adverse event?
CL Item
Yes, Please complete liver event forms and serious adverse event form (1)
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria? Check all that apply
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? Check all that apply
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotraasferase) (2)
CL Item
Total bilirunbin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5" nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
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 a liver ultrasound, computerized 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])
C1711359 (UMLS CUI [1,3])
diagnostic imaging results
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drug use
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
fasting or significant dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1])
C0015663 (UMLS CUI [2])
Item
When did the liver event occur?
integer
C1556667 (UMLS CUI [1,1])
C2348792 (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 of investigational product
Item
start date of investigational product for that treatment period
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
stop date of investigational product
Item
stop date of investigational product for that treatment period
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
start date of investigational product
Item
start date of investigational product for the most recent period prior to the liver event
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
stop date of investigational product
Item
stop date of investigational product for the most recent period prior to the liver event
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
C0200345 (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])