Table of Contents
Hepatic Effects of Ketek (Telithromycin)
Ketek - Hepatic Effects
Pre-Clinical
Phase I
Phase I
Phase III
Laboratory Abnormalities
AST Changes at On-Therapy (Day 2 to 5) in Patients Normal at Baseline – CAP Studies
AST Changes at Post-Therapy (Day 17 to 21) in Patients Normal at Baseline – CAP Studies
ALT Changes at On-Therapy (Day 2 to 5) in Patients Normal at Baseline – CAP Studies
ALT Changes at Post-Therapy (Day 17 to 21) in Patients Normal at Baseline – CAP Studies
Combined ALT/AST & T. Bili. Abnormalities > ULN & < 2xULN
Combined ALT/AST & T. Bili. Abnormalities
Serious Adverse Events Phase III Studies
Serious Adverse Events
Serious Adverse Events
Serious Adverse Events
Serious Adverse Events
Serious Adverse Events
Review of the Pathology
Summary of Ketek - Hepatic Effects
Summary of Ketek - Hepatic Effects
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