AREAS OF MAJOR STATISTICAL CONCERNS IN THE M01 STUDY

12/21/00


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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

Author: Gary M. Gensinger