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
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Author: CDER USER
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