Pivotal Study 011


Click here to start

Table of Contents

Pivotal Study 011

PPT Slide

Statistical Considerations

Eligibility Criteria

PPT Slide

Pretreatment Characteristics (I)

Pretreatment Characteristics (II)

Planned Survival Analyses


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


Author: Bristol-Myers Squibb Pharmaceutical Research Institute