Table of Contents
Pivotal Study 011
PPT Slide
Statistical Considerations
Eligibility Criteria
PPT Slide
Pretreatment Characteristics (I)
Pretreatment Characteristics (II)
Planned Survival Analyses
Survival
Updated Survival
Updated Survival Cox Regression Model
Secondary Endpoint: Time to Progression
Secondary Endpoint: Response Rate
Hematologic Toxicities (I)
Hematologic Toxicities (II)
Gastrointestinal Toxicities
Percent of On-Study Days with Diarrhea
Mucosal Toxicities
Hand-Foot Syndrome
Liver Function Tests
Concomitant Medications
UFT Compliance
Percentage of Patients with Dose Reductions
Percentage of Patients with Dose Delays
Dose Intensity
Conclusions
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Author: Bristol-Myers Squibb Pharmaceutical Research Institute
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