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
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