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 Paget’s Disease
Paget’s Disease in U.S. Population
Paget’s Disease in Clinical Trial Population
Osteosarcoma Surveillance
Osteosarcoma Surveillance
Acknowledgements
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