Table of Contents
Statistical Review of Intergel
Outline
Part I. Original Study Protocol, Design, and Results
Sponsor’s Proposed Sample Size
Sponsor’s Proposed Protocol and Analysis Plan
Pooling: Conditions for Pooling Data Across Continents
Pooling: Comparison of Baseline Adhesion Scores by Continent
Pooling: Comparison of Change in mAFS from Baseline Results by Continent
Pooling: Comparison of Change in mAFS from Baseline Results by Continent
Pooling: Comparison of Change in Number of Adhesions from Baseline by Continent
Pooling: Comparison of Change in Number of Adhesions from Baseline by Continent
Pooling: Subjects cannot be Pooled across Continents
Effectiveness of Intergel
U.S. ITT Results for mAFS and Number of Adhesions
Are Intergel and the Control Different for the mAFS and Number of Adhesions?
Conclusion: mAFS and Adhesion Data
Part II. Post-Panel Amendment: Revised ‘Indication for Use’
Review of Secondary Endpoints
Average Number of Adhesions at Second Look for Secondary Endpoints
No Statistical Difference in Secondary Endpoints
Analysis of AFS Scores
AFS Status Stratified by Baseline AFS Status (US, ITT)
Analysis of AFS Scores (cont.)
SUMMARY
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