Table of Contents
Helen Whamond Boucher, M.D.
Voriconazole Clinical Program
The Global Comparative Aspergillosis Study (307/602)
Global Comparative Aspergillosis Study (307/602)
Global Comparative Aspergillosis Study (307/602) Key Inclusion Criteria
Global Comparative Aspergillosis Study (307/602) Umbrella Analysis: Sample Size and Statistical Considerations
Global Comparative Aspergillosis Study (307/602) Study Design - Background
Global Comparative Aspergillosis Study (307/602) Study Procedures: End of Randomized Therapy
Global Comparative Aspergillosis Study (307/602) Study Procedures: Week 12
Global Comparative Aspergillosis Study (307/602) Endpoints
Global Comparative Aspergillosis Study (307/602) Blinded Data Review Committee Composition
Global Comparative Aspergillosis Study (307/602) Blinded Data Review Committee Process*
Global Comparative Aspergillosis Study (307/602) Diagnosis - Patient 3181
Global Comparative Aspergillosis Study (307/602)
Global Comparative Aspergillosis Study (307/602) Enrollment
Global Comparative Aspergillosis Study (307/602) Patient Disposition
Global Comparative Aspergillosis Study (307/602) Demographic and Clinical Characteristics (MITT)
Global Comparative Aspergillosis Study (307/602) Demographics by Stratification Factors as Assessed by the DRC (MITT)
Global Comparative Aspergillosis Study (307/602) DRC-Assessed Certainty of Infection by Study (MITT)
Global Comparative Aspergillosis Study (307/602) Study Procedures: Progress Over Time
Global Comparative Aspergillosis Study (307/602) Disposition Over Time: Voriconazole Arm (MITT)
Global Comparative Aspergillosis Study (307/602) Disposition Over Time: Amphotericin B Arm (MITT)
Global Comparative Aspergillosis Study (307/602)
Global Comparative Aspergillosis Study (307/602) DRC-Assessed Success at Week 12 (MITT)
Global Comparative Aspergillosis Study (307/602) DRC-Assessed Success at Week 12 (MITT)
Global Comparative Aspergillosis Study (307/602) DRC-Assessed Success at Week 12 (MITT)
Global Comparative Aspergillosis Study (307/602)
Global Comparative Aspergillosis Study (307/602) DRC-Assessed Success at End of Randomized Therapy (MITT)
Global Comparative Aspergillosis Study (307/602)
Global Comparative Aspergillosis Study (307/602) Time to Death (MITT)
Global Comparative Aspergillosis Study (307/602) DRC-Assessed Cause of Death at Day 84 (MITT)
Global Comparative Aspergillosis Study (307/602) Conclusions
Non-Comparative Aspergillosis Study (304)* Outcome
Non-Comparative and Historical Control Aspergillosis Studies (304,1003) Success
Invasive Aspergillosis Summary
Voriconazole Clinical Efficacy Data
Voriconazole Efficacy Database Emerging Pathogens
Success in Scedosporium By Site of Infection
Success in Fusarium By Site of Infection
Voriconazole Clinical Efficacy Data
Voriconazole Efficacy Database Candida Infections
Esophageal Candidiasis Study (305)* Outcome (Per Protocol)
Systemic Candida Infections Salvage Therapy (N = 43)
Candida Infections Conclusions
Voriconazole Clinical Efficacy Data
Empirical Therapy
Empirical Therapy Study (603/MSG42) Objectives
Empirical Therapy Study (603/MSG42) Key Inclusion Criteria
Empirical Therapy Study (603/MSG42) Sample Size and Statistical Considerations
Empirical Therapy Study (603/MSG42)
Empirical Therapy Study (603/MSG42) Blinded Data Review Committee
Empirical Therapy Study (603/MSG42)
Empirical Therapy Study (603/MSG42) Patient Disposition
Empirical Therapy Study (603/MSG42) Demographic and Clinical Characteristics (MITT)
Empirical Therapy Study (603/MSG42) Demographic and Clinical Characteristics (MITT)
Empirical Therapy Study (603/MSG42) Treatment Duration (MITT)
Empirical Therapy Study (603/MSG42) Analysis of Primary Endpoint (MITT)
Empirical Therapy Study (603/MSG42) Composite Endpoint
Empirical Therapy Study (603/MSG42) Breakthrough Fungal Infections (MITT)*
Empirical Therapy Study (603/MSG42) Documented Breakthrough Fungal Infections
Empirical Therapy Study (603/MSG42) Composite Endpoint
Empirical Therapy Study (603/MSG42) Deaths Within 7 days of End Of Therapy (MITT)
Empirical Therapy Study (603/MSG42) Deaths Within 7 days of End Of Therapy (MITT)
Empirical Therapy Study (603/MSG42) Composite Endpoint
Empirical Therapy Study (603/MSG42) Discontinuation Due to Toxicity or Lack of Efficacy Prior to Recovery from Neutropenia (MITT)*
Empirical Therapy Study (603/MSG42) Discontinuation Due to Lack of Efficacy Prior to Recovery from Neutropenia (MITT)
Empirical Therapy Study (603/MSG42) Composite Endpoint
Empirical Therapy Study (603/MSG42) Defervescence*
Empirical Therapy Study (603/MSG42) Composite Endpoint
Empirical Therapy Study (603/MSG42) DRC-Assessment of Baseline Infection Outcome at End of Therapy
Empirical Therapy Study (603/MSG42) Response to Empirical Therapy (MITT)
Empirical Therapy Study (603/MSG42) Breakthrough Infections by Risk and Prophylaxis (MITT)
Empirical Therapy Study (603/MSG42) Overall Response by Randomization Stratum (MITT)
Empirical Therapy Study (603/MSG42) Response to Empirical Therapy (MITT) High and Moderate Risk
Empirical Therapy Study (603/MSG42) Infusion Related Reactions (MITT) - All*
Voriconazole
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