Helen Whamond Boucher, M.D.

10/17/01


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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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