Design

8/18/99


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Table of Contents

Design

The phase III clinical program was designed to support the indication for RAPAMUNE (in combination with cyclosporine and corticosteroids) for the prophylaxis of organ rejection in patients receiving renal transplants.

Two Phase III Trials in First Renal Transplant Recipients Support the Application for Approval

Patients Continued 1-Year Follow-Up

Phase III Trials Evaluated RAPAMUNE 2 mg and 5 mg*

Study Designs of Two Phase III Trials Are Similar But Not Identical

The US Trial Was Stratified by Ethnic Origin of the Patient

Phase III US and Global Studies Included 1,295 Patients

Major Inclusion and Exclusion Criteria

Immunosuppression Regimen

Concentration-Controlled Cyclosporine Exposure

Protocol-Specified Target Trough Cyclosporine Concentrations

Similar Mean Cyclosporine Levels Across Treatment Groups

Primary Composite Endpoint

Statistical Considerations

Sample Size Determination

Author: Maureen Galie