Liver Events Assessment
(If no liver event, tick 'No' and enter date of study conclusion/withdrawal above) If Yes, stop investigational 1> roduct, 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 tl/2: protocol specified longer value to be inserted). * Hepatitis A: Hepatitis A IgM antibody. * Hepatitis B: Hepatitis B surface antigen ,md Hepatitis B Core Antibody (IgM). * Hepatitis C: Hepatitis C RNA. * Hepatitis E lgM ,mtibody (if subjed resides or has trnvelled in the past 3 months outside the USA or Canadll). * Cytomegalovirus lgM antibody (CMV). * EBY (Epstein Barr virn1 capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing.) * Bilirubin frnctionation, if bilirubin >= l.5xULN * CPK (serum creatine phosphokinase), * LDH (lactate dehydrogenase). The following are only needed when ALT >=3xULN and bilirubin >=t.SxULN (>35% direct) * Anti-nuclear antibody * Anti-smooth muscle antibody * Type I anti-liver kidney microsomal antibodies (if available) * Liver Imaging (ultrnsound, magnetic resonance, or computerised tomography) lf Yes, complete the Liver Event fonns displayed upon submission of this form Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form, Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.
boolean
Did ALT reach or exceed the investigational product stopping criteria?
boolean
Did AST reach or exceed the investigational product stopping criteria?
boolean
Did the total bilirubin reach or exceed the investigational product stopping criteria?
boolean
Did the alkaline phosphatase reach or exceed the investigational product stopping criteria?
boolean
Did the 5' nucleotidase reach or exceed the investigational product stopping criteria?
boolean
Did the gammaglutamyltranspeptidase reach or exceed the investigational product stopping criteria?
boolean
Did another liver chemistry result reach or exceed the investigational product stopping criteria?
boolean
Subject age
boolean
If yes, ensure Pregnancy Notification Fonn has been completed.
text
Performance of any diagnostic imaging tests of the liver or hepatobiliary syste (such as ultrasound, CAT scan, MRI, endoscopic retrograde cholangiopancreatography)
boolean
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Events form.
boolean
If yes, complete Liver Biopsy form
boolean
If yes, record on the appropriate Concomitant Medication form
boolean
Recent fasting or significant dietary change
boolean
Investigational Product (Liver)
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
date
Start Date Investigational Product Not applicable (Liver event occured during treatment period)
boolean
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
date
End Date Investigational Product Not applicable (Liver event occured during treatment period)
boolean
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
date
Start Date Investigational Product Not applicable (Liver event occured after treatment period)
boolean
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
date
End Date Investigational Product Not applicable (Liver event occured after treatment period)
boolean
Pharmacokinetics
An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2; protocol specified longer value to be inserted). If yes, document date and time sample taken in the next item as well as the date and time of last investigational product dose prior to PK sample and the Sample Identifier/Sample Number.
text
Date and time pharmacokinetic blood sample taken
datetime
Date and time of last investigational product dose prior to PK sample
datetime
Sample Identifier/Sample Number if a pharmacokinetic blood sample was obtained
text