sNDA 21-386, Zometa Safety Review

2/1/02


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Table of Contents

sNDA 21-386, Zometa Safety Review

Protocol Amendments Affecting Safety

Renal Deterioration by Baseline Creatinine 15-Minute Infusion, Study 010, Breast and Myeloma

Summary of Safety Study 010 (Zometa 4 vs. Aredia)

Renal Deterioration by Baseline Creatinine 15-Minute Infusion, Study 039, Prostate

Renal Deterioration by Baseline Creatinine 15 Minute Infusion, Study 011, Solid Tumors

Summary of Safety Studies 039 and 011

Safety Conclusions

Author: CDER USER