1. Is this liver event a serious adverse event?
Item
1. Is this liver event a serious adverse event?
boolean
Item
2. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
text
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
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
Item
4. If female, is the subject pregnant?
text
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
Item
If YES, were the results normal?
text
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
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
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
Item
When did the liver event occur?
text
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
End Date Investigational Product
Item
End Date Investigational Product
date