Table of Contents
Large Comparative Safety Trial in an Usual Care Setting ________________________________________________________________________________________________
Study 3014: Elements of Study Design (1) _______________________________________________________________________________________________
Elements of Study Design (2) _______________________________________________________________________________________________
Definition of Adverse Events of Special Interest (AESIs) _________________________________________________________________________
Overall Adverse Event Rates _______________________________________________________________________________________________
Adverse Events: Subgroups ____________________________
Hepatic AESI: Investigation Process _______________________________________________________________________________________________
Hepatic AESI Resolution ____________________________
Changes in ALT: Normal Baseline ____________________________
Changes in AST: Normal Baseline ____________________________
Changes in Hepatic Analytes at any Post-Therapy Time Point ____________________________________________________________________________________
Combined ALT and Bilirubin Changes at any Post-Therapy Time Point ____________________________________________________________________________________
Changes in ALT among Telithromycin-treated Subjects: By Duration ____________________________
Subjects who Met Hepatic Endpoint Definition _______________________________________________________________________________________________
Case # 0187-026 ___________________________________________________________________________________________________________________________________________________________________________________
Case # 3440-001 ___________________________________________________________________________________________________________________________________________________________________________________
Case 2004-002 ___________________________________________________________________________________________________________________________________________________________________________________
Summary ________________________________________________________________________________________________________________________________________________
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