ZOMETA® in Prostate Cancer and Solid Tumors Other Than Prostate Cancer and Breast Cancer: Placebo-Controlled Trials

2/1/02


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Table of Contents

ZOMETA® in Prostate Cancer and Solid Tumors Other Than Prostate Cancer and Breast Cancer: Placebo-Controlled Trials

Placebo-Controlled Trials Study Objective

Placebo-Controlled Trials Study Endpoints (1)

Placebo-Controlled Trials Study Endpoints (2)

Placebo-Controlled Trials Skeletal-Related Events (SREs)

Placebo-Controlled Trials Preplanned SRE Analysis

Clinical Trials History

Clinical Trial History Amendment/Patient Accrual Timeline

ZOMETA® in Prostate Cancer: Placebo-Controlled Trial (039)

Prostate Cancer Trial Design (1)

Prostate Cancer Trial Design (2)

Prostate Cancer Demographics and Prognostic Factors

Prostate Cancer Patient Disposition

Prostate Cancer Reasons for Early Discontinuation

Prostate Cancer Proportion (%) of Patients With an SRE

Why Was No Dose Effect Observed? Percent Change From Baseline N-telopeptide (039)

Prostate Cancer Combined Analysis Proportion (%) of Patients With an SRE

Prostate Cancer Components of SRE by Month 15

Prostate Cancer Time to First SRE

Prostate Cancer Mean SMR*

Prostate Cancer Andersen-Gill Multiple Event Analysis Time to SRE up to Month 15

Prostate Cancer (039) Proportion of Patients With an SRE in Patients With Different Types of Bone Lesions

Prostate Cancer Disease-Related Endpoints

Prostate Cancer Quality-of-Life Endpoints

Prostate Cancer Efficacy Summary

ZOMETA® in Prostate Cancer: Placebo-Controlled Trial (039)

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

Prostate Cancer Survival – All Patients§

Prostate Cancer Incidence of Adverse Events (? 15%) Regardless of Study Drug Relationship

Prostate Cancer NCI Grade 3/4 Hematology Electrolyte and Mineral Changes

Patients Enrolling After the 15-min Amendment NCI Grade 3/4 Serum Creatinine Changes§

Prostate Cancer Kaplan-Meier Estimates of First Serum Creatinine Increase§

Prostate Cancer Safety Summary

Prostate Cancer Overall Summary

ZOMETA® in Solid Tumors Other Than Prostate Cancer and Breast Cancer (–PC/BC): Placebo-Controlled Trial (011)

Solid Tumors –PC/BC Trial Design (1)

Solid Tumors –PC/BC Trial Design (2)

Solid Tumors –PC/BC Demographics and Prognostic Factors

Solid Tumors –PC/BC Patient Disposition

Solid Tumors –PC/BC Reasons for Early Discontinuation

Solid Tumors –PC/BC Proportion (%) of Patients With an SRE Time to First SRE

Solid Tumors –PC/BC Components of SRE by Month 9

Solid Tumors –PC/BC Mean SMR*

Solid Tumors –PC/BC Andersen-Gill Multiple Event Analysis Time to SRE up to Month 9

Other Solid Tumors (011) Proportion of Patients With an SRE in Patients With Different Types of Bone Lesions

Solid Tumors –PC/BC Disease-Related Endpoints

Solid Tumors –PC/BC Quality-of-Life Endpoints

Solid Tumors –PC/BC Efficacy Summary

ZOMETA® in Solid Tumors Other Than Prostate Cancer and Breast Cancer (–PC/BC): Placebo-Controlled Trial (011)

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

Solid Tumors –PC/BC Survival – All Patients§

Solid Tumors –PC/BC Incidence of Adverse Events (? 15%) Regardless of Study Drug Relationship

Solid Tumors –PC/BC NCI Grade 3/4 Hematology Electrolyte and Mineral Changes

Patients Enrolling After the 15-min Amendment NCI Grade 3/4 Serum Creatinine Changes§

Solid Tumors –PC/BC Kaplan-Meier Estimates of First Serum Creatinine Increase§

Solid Tumors –PC/BC Safety Summary

Solid Tumors –PC/BC Overall Summary

Author: Sarah Moesher