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)
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