Voriconazole NDAs 21-266 and 21-267 Empiric Antifungal Therapy of Febrile Neutropenic Patients Study 603

10/17/01


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Table of Contents

Voriconazole NDAs 21-266 and 21-267 Empiric Antifungal Therapy of Febrile Neutropenic Patients Study 603

Introduction

Background fungal infections in neutropenic hosts

Background basis for treatment

Background prior discussion of study design

Background important points from workshops

Background

Trial Design and Analysis

Background previous approvals in ETFN

Overall Response Rate in Study 603

Overall Response Rate in Study 603

Overall Response Rate in Study 603

Overall Response Rate in Study 603

Previous Trials in ETFN

Previous Trials in ETFN

Secondary Endpoints and Subset Analyses

Secondary Endpoints and Subset Analyses

Overall Response Rate in Study 603 subset analysis by risk of fungal infection

Secondary Endpoints

Breakthrough Infections

Breakthrough Infections sensitivity analysis

Breakthrough Infections subset analysis by risk of infection and prophylaxis

Survival at 7 days after EOT

Discontinuations

Discontinuations lack of efficacy and toxicity

Discontinuations lack of efficacy

Defervescence Prior to RFN

Defervescence Prior to RFN rates of fever resolution prior to recovery from neutropenia in ETFN trials

Defervescence Prior to RFN

Baseline Infections

Baseline Infections

Summary

Summary

Considerations for the Committee

Author: Authorized User