Description
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 tests: • PK blood sample within 24 hours of last dose (or 3x the investigational product half-life or t1/2) • Hepatitis A: Hepatitis A lgM antibody. • Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (lgM). • Hepatitis C: Hepatitis C RNA. • Hepatitis E IgM antibody (if subject resides or has travelled in past 3 months outside the USA or Canada). • Cytomegalovirus IgM antibody (CMV) • EBV (Epstein Barr viral capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing. • CPK (serum creatine phosphokinase) • LDH (lactate dehydrogenase) • Bilirubin fractionation, if bilirubin >1.5xULN
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0023901
- UMLS CUI [1,2]
- C0439093
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [1,4]
- C2746065
- UMLS CUI [1,5]
- C0243161
- UMLS CUI [2]
- C0001899
- UMLS CUI [3]
- C0004002
- UMLS CUI [4]
- C0002059
- UMLS CUI [5]
- C0368753
- UMLS CUI [6]
- C0017040