Table of Contents
AREAS OF MAJOR STATISTICAL CONCERNS IN THE M01 STUDY
Overall Finding
PROBLEM 1: Strength of Evidence of Efficacy - Results of Survival Analysis in ITT Population
PROBLEM 2: Multiple Survival Analyses
Adjusted Analyses
SUMMARY OF OVERALL (ITT POPULATION) FINDING
LIVER METASTASIS SUBGROUP FINDING
PROBLEM 1: In the absence of overall survival benefit, any subgroup advantage is questionable
PROBLEM 2: Imbalances
PPT Slide
Adjusted Survival Analysis: Model Selection
ADJUSTED ANALYSES - Covariates specified in the Statistical Plan submitted 11/18/99
Survival Analyses Adjusted for Imbalances in the Liver Subgroup
Survival Analyses Adjusted for Covariates in the Liver Metastasis Subgroup
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Author: Gary M. Gensinger
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