Safety & Efficacy of Alosetron

3/19/01


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Table of Contents

Safety & Efficacy of Alosetron

Alosetron

Study Design (S3BA3001/S3BA3002)

Primary Endpoint

“In the Past Seven Days Have You Had Adequate Relief of Your Irritable Bowel Syndrome Pain and Discomfort?”

“Have You Felt or Experienced a Sense of Urgency Today?”

“Please Enter the Number of Times You Have Passed Stool Today”

“Please Rate the Consistency Of Your Stool Today”

Efficacy Update

International Comparator

In the past seven days have you had adequate relief of your irritable bowel syndrome pain and discomfort? (Diarrhea-Predominant)

S3B30011

IBS Global Improvement Question

Global Improvement Responder

Efficacy Conclusion

Safety

Agreements With FDA Prior To June 27, 2000

2 Databases (June 1, 2000)

Constipation

Constipation (Phase II/III)

Constipation (Phase III) Management

Constipation

Constipation - Clinical Trials (Hospitalized)

Constipation - Spontaneous Reports (Hospitalized)

Constipation Conclusion

Ischemic Colitis

Ischemic Colitis - Clinical Trials

Ischemic Colitis - Spontaneous (June 1, 2000)

Chronic Colitis

Ischemic Colitis

Ischemic Colitis Conclusion

Hepatic Function

ALT (ɯx Normal)

Alkaline Phosphatase/ Bilirubin

Elevated Liver Enzymes

Hepatic Function Conclusions

“Other” Serious Events (21 Total - 11 Reviewed) (130,000 Prescriptions)

Overall Conclusion

Overall Conclusion (continued)

Author: stj11454