Telithromycin Integrated Summary of Safety

1/14/03


Click here to start


Table of Contents

Telithromycin Integrated Summary of Safety

Outline

Phase 3 safety database*

Deaths in Phase 3 trials

Nonfatal serious AEs in controlled Phase 3 trials

AEs in controlled Phase 3 trials

AEs resulting in discontinuation in controlled Phase 3 trials

Cardiac Risk Profile

Cardiac toxicity: Pre-clinical/Phase 1

Cardiac AEs in controlled Phase 3 trials

Serious cardiac AEs in all Phase 3 trials

ECG data in Phase 3 trials

Hepatic Risk Profile

PPT Slide

PPT Slide

Hepatic AEs in controlled Phase 3 trials

Serious hepatic AEs in all Phase 3 clinical trials

PPT Slide

Patient 502/1069 (cont.)

Incidence of ALT increases in controlled CAP trials*

Visual Risk Profile

Blurred vision in Phase 3 trials

Blurred vision in Phase 1 studies

Serious visual adverse events

Summary of ISS

PPT Slide

Author: cooper