Background

11/8/01

Click here to start

Table of Contents

Background (cont)

Results of 5-day Studies

Results of 5-day Studies (cont)

Results of 5-day Studies (cont)Bacteriologic -Study 176

Results of 5-day Studies (cont)

Results of 5-day Studies (cont)Bacteriologic -Study 128

Comparison of Exposure Among Azithromycin Regimens

Comparison of Exposure Among Azithromycin Regimens (cont)

Pivotal Studies

Study R-0581: Clinical Outcome by Age at TOC (MITT Population)

Study 1015: Clinical Outcomes by Age at TOC(MITT Population)

Study 1015: Clinical Outcome By Baseline Pathogen at EOT

Study 1015: Clinical Outcome By Baseline Pathogen at TOC

Study 95-001: Clinical Outcome by Baseline Pathogen at EOT (MITT Population)

Summary of Clinical OutcomeTOC

Summary of Bacteriological Outcome (Study1015)

Published Studies

Published Studies

All Adverse Events for AOM Studies Only

% (n/N) of Subjects Reporting Vomiting by Day and Treatment Group for AOM Studies Only

Acknowledgments

Author: CDER USER