Liver Events Assessment Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

Beschreibung

Subject identifier

Datentyp

text

Alias

UMLS CUI [1]

C2348585

Beschreibung

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 The following are only needed when ALT >3xULN and bilirubin >1.5xULN (>35% direct) • Anti-nuclear antibody • Anti-smooth muscle antibody • Type 1 anti-liver kidney microsomal antibodies (if available) • Liver Imaging (ultrasound, magnetic resonance, or computerised tomography)

Datentyp

text

Alias

UMLS CUI [1,1]

C0023901

UMLS CUI [1,2]

C1556667