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
Sponsor’s 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
PPT Slide
PPT Slide
PPT Slide
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