Pramlintide Acetate Safety Review Dragos Roman MD

7/31/01


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Table of Contents

Pramlintide Acetate Safety Review Dragos Roman MD

Pramlintide Acetate Safety Review Outline

Pramlintide Acetate Safety Review Outline

Phase 3 Clinical Trials

Phase 3 Clinical Trials (Type 1 Diabetes)

First Month Nausea-Related Withdrawals -Type 1 Diabetes

Phase 3 Clinical Trials (Type 2 Diabetes)

First Month Nausea-Related Withdrawals -Type 2 Diabetes

Pramlintide Acetate-Safety Review Outline

Assisted Hypoglycemia: Definition

Assisted Hypoglycemia-Type 1 Diabetes Phase 3 Trials: First Month Incidence

Assisted Hypoglycemia-Type 1 Diabetes Phase 3 Trials: End of the First Month to The End of the Trial Incidence

Change in HbA1c: Study 137-121 Type 1 Diabetes

Assisted Hypoglycemia-Type 1 Diabetes Phase 3 Trials: Summary

Assisted Hypoglycemia-Type 1 Diabetes Phase 3 Trials: Summary

Assisted Hypoglycemia-Type 2 Diabetes Phase 3 Trials: First Month Incidence

Assisted Hypoglycemia-Type 2 Diabetes Phase 3 Trials: End of the First Month to The End of the Trial Incidence

Assisted Hypoglycemia-Type 2 Diabetes Phase 3 Trials: Summary

Assisted Hypoglycemia-Type 2 Diabetes Phase 3 Trials: Summary

Assisted Hypoglycemia: Summary

Pramlintide Acetate Safety Review Outline

Serious Adverse Events-Definition

Deaths Possibly Related to Hypoglycemia

Pramlintide Acetate Safety Review Outline

Hypoglycemia and Accidents-Type 1 Diabetes

MVAs and Automobile-Related Adverse Events-Type 1 Diabetes (All Clinical Development Program)

Driving-Related Events Associated With Hypoglycemia -Phase 3 Trials (Type 1 Diabetes)

Driving-Related Events Associated With Hypoglycemia - Type 1 Diabetes: Conclusion

Other Accidents and Injuries-Type 1 Diabetes (All Clinical Development Program)

Other Accidents and Injuries-Phase 3 Trials (Type 1 Diabetes)

Other Accidents and Injuries- Type 1 Diabetes: Conclusion

Severe Hypoglycemia: Labeling Question

Severe Hypoglycemia: Labeling Question

Severe Hypoglycemia: Labeling Question

Accidents Associated With Hypoglycemia-Labeling Question

PPT Slide

Summary

Author: CDER.USER