Liver Events Assessment
If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following test: 1.Blood sample for PK analysis, obtained within three half-lives(21 days) of last dose; 2.Hepatitis A: IgM antibody; 3, Hepatitis B surface antigen and Core Antibody (IgM); 4. Hepatitis C: RNA; 5.Hepatitis E IgM antibody (if subject resides or has travelled in past 3 month outside the USA or Canada); 6. Cytomegalovirus IgM antibody (CMV); 7. EBV (Epstein Barr Viral capsid antigen IgM antibody)or if unavailable, obtain heterophile antibody or monospot testing; 8.CPK (Serum creatine phosphokinase); 9. LDH (lactate dehydrogenase); 10. Bilirubin fractionation, if bilirubin >=1.5xULN (If ALT >=3xULN and bilirubin >1.5xULN(>35% direct), the following are needed: anti-nuclear antibody, anti-smooth muscle antibody, tape 1 anti-liver kidney microsomal antibodies, liver imaging).
boolean
Liver Events
SAE / AE reference number
integer
Date of assessment
date
check all that apply
text
If Other, specify
text
Is the subject 55 or older?
boolean
if Yes, complete the Pregnancy Notification Form
text
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
if No, record the details on the Non-Serious Adverse Events form or Serious Adverse Events form.
boolean
Were any liver biopsies performed?
boolean
If Yes, record on the appropriate Concomitant Medication form
boolean
Did the subject fast or undergo significant dietary change in the past week?
boolean
An unscheduled PK blood sample must be obtained within three half-lives (21 days) of last dose.
boolean
Date of sample taken
date
Time of sample taken
time
Record date and time of last investigational product dose prior to PK sample (if administered at subject's home, please do not record the time)
datetime
Alcohol Intake
Liver Disease Medical Conditions
1. Acute viral Hepatitis A
text
2. Chronic Hepatitis B
text
3. Chronic Hepatitis C
text
4. Cytomegalovirus Hepatitis
text
5. Epstein Barr virus infectious mononucleosis
text
6. Herpes Simplex Hepatitis
text
7. Alcoholic liver disease
text
8. Non-alcoholic steatohepatitis
text
9. Fatty Liver
text
10. Hepatic Cirrhosis
text
11. Hemochromatosis
text
12. Autoimmune Hepatitis
text
13. Gallbladder disease or biliary disease
text
Drug Related Liver Disease Conditions
specify here
text
Status of condition
text
15. Specific condition
text
Status of condition
text
15. Specific condition
text
Status of condition
text
Other Medical Conditions
17. Drug allergies
text
18. Rheumatoid Arthritis
text
19. Psoriasis
text
20. Thyroid disease
text
21. Inflammatory bowel disease
text
22. Lupus
text
23. Sjoren's syndrome
text
24. Vitiligo
text