Large Comparative Safety Trial in an Usual Care Setting ________________________________________________________________________________________________

1/14/03


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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 ________________________________________________________________________________________________________________________________________________

Author: george rochester