Table of Contents
Phase III Efficacy Results
Demographic Parameters US Multicenter Trial
Demographic Parameters Global Multicenter Trial
Other Parameters: Well Matched by Treatment Groups
Primary Composite Endpoint
RAPAMUNE Significantly Reduces Efficacy Failure
Acute Rejection Is the Major Component of Composite Endpoint
Higher Rates of Efficacy Failure in Global Trial May Be Due To Multiple Factors
Secondary Efficacy Endpoints
RAPAMUNE Decreases the Incidence of Biopsy-Confirmed Acute Rejection
RAPAMUNE Decreases Incidence of Grade II/III Acute Rejection
Lower Rates of Antibody Use for Acute Rejection in RAPAMUNE Groups
Excellent 1-Year Patient Survival* in All Treatment Groups
Excellent 1-Year Graft Survival* in All Treatment Groups
Lower Rate of Efficacy Failure in Black Patients Treated With RAPAMUNE 5 mg
Lower Rate of Acute Rejection in Black Patients Treated With RAPAMUNE 5 mg
RAPAMUNE Reduces Efficacy Failure in Recipients of Cadaveric and Living Mismatched Donor Grafts
RAPAMUNE Reduces Efficacy Failure in HLA Mismatched Patients
Efficacy Conclusions I Primary Endpoint
Efficacy Conclusions II Secondary Endpoints
Efficacy Conclusions III
Phase III efficacy results support the use of RAPAMUNE for the proposed indication of the prophylaxis of organ rejection in renal transplant recipients.
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