1. Is this liver event a serious adverse event?
Item
1. Is this liver event a serious adverse event?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
text
C0023884 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2133636 (UMLS CUI [2,2])
Code List
2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5´ nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
Item
Record the details of any Adverse Events or exacerbations of Adverse Events on the AE or SAE forms. Exacerbations of AE include increases in frequency and severity.
text
C0877248 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
C1710066 (UMLS CUI [4])
Code List
Record the details of any Adverse Events or exacerbations of Adverse Events on the AE or SAE forms. Exacerbations of AE include increases in frequency and severity.
CL Item
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation. (1)
CL Item
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study (2)
3. Is the subject age 55 or older?
Item
3. Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
4. If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Code List
4. If female, is the subject pregnant?
CL Item
Yes (ensure Pregnancy Notification Form has been completed) (1)
CL Item
Not applicable (3)
5. 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
5. 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])
C1456803 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
Item
If YES, were the results normal?
text
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Code List
If YES, were the results normal?
CL Item
No, record the details on the Imaging form and ensure the overall diagnosis indicated by imaging is captured on the SAE or AE forms. (2)
Item
6. Were any liver biopsies performed?
text
C0193388 (UMLS CUI [1])
Code List
6. Were any liver biopsies performed?
CL Item
Yes, complete Liver Biopsy form (1)
Item
7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
text
C0002346 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
Code List
7. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
CL Item
Yes, record on the appropriate Concomitant Medication form (1)
8. Did the subject fast or undergo significant dietary change in the past week?
Item
8. Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1,1])
C3671772 (UMLS CUI [1,2])
Item
When did the liver event occur?
text
C0877248 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
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
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])