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
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