Liver Events Assessment
Protocol defined liver chemistry event for the lab samples collected
boolean
If Yes and type of liver chemistry event is Liver Event (Interruption), interrupt investigational product, complete date interrupted on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Obtain tests as per protocol * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours) 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 (Stopping), stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)
integer
[read-only]
boolean
Liver IP Rechallenge Status
This item has to be filled out at the 2, 3 and 4 week visit for cycle 1 and cycle 2 of therapy.
boolean
Liver Events Assessment 2
Note: If a subject has been monitored for 4 weeks and continues to meet liver chemistry monitoring criteria, subject must be identified as a liver event. This Itemgroup has to be filled out at the 2, 3 and 4 week visit of cycle 1 and cycle 2 of therapy as well as for the observation visits of the treatment cycles.
boolean
If Yes and type of liver chemistry event is Liver Event (Interruption), interrupt investigational product, complete date interrupted on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours) 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 (Stopping), stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. *Obtain tests as per protocol * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)
integer
[read-only]
boolean