ZOMETA® in Breast Cancer and Multiple Myeloma: Pamidronate-Controlled Trial (010)

2/1/02


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Table of Contents

ZOMETA® in Breast Cancer and Multiple Myeloma: Pamidronate-Controlled Trial (010)

Breast Cancer and Multiple Myeloma Trial Design (1)

Breast Cancer and Multiple Myeloma Trial Design (2)

Breast Cancer and Multiple Myeloma Study Objectives

Breast Cancer and Multiple Myeloma Study Endpoints (1)

Breast Cancer and Multiple Myeloma Study Endpoints (2)

Breast Cancer and Multiple Myeloma Skeletal-Related Events (SREs)

Breast Cancer and Multiple Myeloma Preplanned SRE Analysis

Clinical Trial History

Clinical Trial History Breast Cancer and Multiple Myeloma (010)

Breast Cancer and Multiple Myeloma Demographics and Prognostic Factors

Breast Cancer and Multiple Myeloma Patient Disposition

Breast Cancer and Multiple Myeloma Reasons for Early Discontinuation

Breast Cancer and Multiple Myeloma Proportion (%) of Patients With an SRE

Noninferiority Margin for Study 010 (Using Pamidronate 12, 18, and 19)

Breast Cancer and Multiple Myeloma Components of SRE by Month 13

Breast Cancer and Multiple Myeloma Time to First SRE

Breast Cancer and Multiple Myeloma Mean SMR

Breast Cancer and Multiple Myeloma Andersen-Gill Multiple Event Analysis Time to SRE up to Month 13

Breast Cancer (010) Proportion of Patients With an SRE Patients With Different Types of Bone Lesions

Breast Cancer and Multiple Myeloma Disease- and QOL-Related Endpoints

Breast Cancer and Multiple Myeloma Disease-Related Endpoints

Breast Cancer and Multiple Myeloma Quality-of-Life Endpoints

Breast Cancer and Multiple Myeloma Efficacy Summary

ZOMETA® in Breast Cancer and Multiple Myeloma: Pamidronate-Controlled Trial (010)

Primary Cause of Death During the Trial or Within 28 Days After Study Drug Termination§

Breast Cancer and Multiple Myeloma Survival – All Patients§

Breast Cancer and Multiple Myeloma Incidence of Adverse Events (? 15%) Regardless of Study Drug Relationship

Breast Cancer and Multiple Myeloma NCI Grade 3/4 Hematology Electrolyte and Mineral Changes

Breast Cancer and Multiple Myeloma Definition of Serum Creatinine Increase

Breast Cancer and Multiple Myeloma Kaplan-Meier Estimates of First Serum Creatinine Increase§

Breast Cancer and Multiple Myeloma Patients Enrolling After the 15-min Amendment NCI Grade 3/4 Serum Creatinine Changes§

Breast Cancer and Multiple Myeloma Safety Summary

Breast Cancer and Multiple Myeloma Overall Summary

Author: Sarah Moesher