Statistical Review of Intergel

9/4/01


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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

Author: Richard Kotz