Teriparatide or LY333334 Eli Lilly & Company NDA 21-318

7/31/01


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Table of Contents

Teriparatide or LY333334 Eli Lilly & Company NDA 21-318

P-VALUE CAVEAT

Issues from Preclinical & Phase 1 Clinical Studies

Main Phase 3 Clinical Trials

Patient Disposition Numbers of Patients Randomized in Clinical Trials

Duration of Treatment Numbers of Patients Treated in Clinical Trials

Duration of Treatment Numbers of Patients Treated in Clinical Trials

Serious Adverse Events

Serious Adverse Events During Clinical Trials Number (%) of Patients

Adverse Events of Any Severity During Clinical Trials

Heart Rate and Blood Pressure

4-hour Postdose Serum Calcium During GHAC LY333334 20 mcg versus placebo

4-hour Postdose Serum Calcium During GHAC LY333334 20 mcg versus placebo Number (%) of Patients

24 Hour Urine Calcium During GHAC LY333334 20 mcg versus placebo

Serum Total Alkaline Phosphatase During GHAC LY333334 20 mcg versus placebo

Post-Treatment Follow-up Study GHBJ Numbers of Patients Enrolled From Clinical Trials

Serious Adverse Events in Post-treatment Follow-up Number (%) of Patients

PPT Slide

Adverse Events of Any Severity in Post-treatment Follow-up GHAC Patients Enrolled in GHBJ Number (%) of Patients Cardiovascular Disorder*

Laboratory Safety Variables in Post-treatment Follow-up GHAC Patients Enrolled in GHBJ LY333334 20 mcg versus Placebo

Osteosarcoma in U.S. Population

Osteosarcoma in Pagetís Disease

Pagetís Disease in U.S. Population

Pagetís Disease in Clinical Trial Population

Osteosarcoma Surveillance

Osteosarcoma Surveillance

Acknowledgements

Author: Jeanine Vinson