Hepatic Effects of Ketek (Telithromycin)

5/16/01


Click here to start


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

Author: Edward Cox