CsA Elimination Studies

2/6/02


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Table of Contents

CsA Elimination Studies

Summary of Safety Assessments

Study 310 Equivalent 12 Month Graft Survival

Study 310 Etiologies of Graft Loss*

Study 310 Equivalent 12 Month Patient Survival*

Study 310 Etiologies of Patient Death*

Summary of Safety Assessments

Study 310: Incidence (%) of Significantly Different Treatment-Emergent Adverse Events*

Study 310 Incidence (%) of Infections

Study 310 Similar Incidence (%) of Neoplasia

Summary of Safety Assessments

Study 310 Improved Mean Blood Pressure (mmHg)

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Summary of Safety Assessments

Study 310: Similar Use of Lipid-Lowering Agents*

Study 310: Similar Fasting Cholesterol Values

Study 310: Similar Mean Fasting HDL- and LDL-Cholesterol Values

Study 310: Similar Fasting Triglyceride Values

Study 310: Mean ALT/SGPT and AST/SGOT Values

Study 310: Randomized Patients With at Least 1 SGPT Value Greater Than 5 Times the Upper Limit of Normal (SGPT ? 275 IU/L)

Study 310: Mean White Blood Cell and Platelet Counts

Study 310: Safety Summary

Study 212 Similar 12 Month Graft Survival

Study 212 Etiologies of Graft Loss*

Study 212 Similar 12 Month Patient Survival*

Study 212 Etiologies of Patient Death*

Study 212: Treatment Emergent Adverse Events (%)

Atrial Fibrillation Incidence in Study 212 Not Observed in Other Studies

Study 212: Similar Incidence (%) of Infections at Month 12*

Study 212: Incidence (%) of Malignancy at Month 12

Study 212: Safety Summary

Study 310 Patient Disposition by Month 12

Study 310: Similar Incidence of Discontinuations (%) at ? Month 15

Study 310: Treatment of Patients Discontinued from the RAPAMUNE Group

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PPT Slide

Study 212 Discontinuations (%) by Month 12

Study 212 Successful Elimination of Cyclosporine

Safety Summary (I)

PPT Slide

 Author: Erik Hornyak