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
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