Liver Events Assessment Report

Liver Events
Descrizione

Liver Events

Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Descrizione

Was there a protocol defined liver chemistry event for the lab samples collected at this visit?

Tipo di dati

boolean

If YES, specify type of liver chemistry event
Descrizione

If YES and type of liver chemistry event is Liver Monitoring, obtain tests as per protocol. If YES and type of liver chemistry event is Liver Event, stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurrence of liver by phone or fax. NOTE: If the liver event mets the definition of an SAE form must be completed inForm. If InForm is unavailable, the SAE form should be faxed to GSK. *Obtain tests as per protocol *Obtain blood samples for pharmacokinetic (PK) analysis within 72 hours of last dose *Complete Liver Events Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)

Tipo di dati

text

Similar models

Liver Events Assessment Report

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Liver Events
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
Item
If YES, specify type of liver chemistry event
text
Code List
If YES, specify type of liver chemistry event
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria) (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria, has been monitored for the protocol specified time period and continues to meet liver chemistry monitoring criteria) (2)