Statistical Issues in NDA 21239 Laura Lu, Ph.D FDA/CDER

4/19/01


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Table of Contents

Statistical Issues in NDA 21239 Laura Lu, Ph.D FDA/CDER

Outline

ITT vs. Per-Protocol Population in Study 95-02

ITT Analysis

Sponsorís Argument for Per-Protocol Analysis

Patient Disposition in Patients Excluded from ITT Population

Validity of Per-Protocol Analysis?

Original Definition for A Responder in Study 95-02

Result for Responder Rate (ITT)

Later Proposed Window for Responder Definition

Window Definition by Percent of Change from Baseline

PPT Slide

Sensitivity of Responder Rate to Window Definition

Subgroup Analysis in Patients with Baseline SLEDAIɮ

Results in Study 94-01

Results in Study 94-01 (cont.)

Results in Study 95-02

Results in Baseline SLEDAIɮ Group

Results in Baseline SLEDAIɮ Group

Question

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PPT Slide

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Author: luho