Table of Contents
Zometa for Prostate Cancer Bone Metastases
PPT Slide
Overview of Prostate Cancer Trial
Proportions of Patients with SREs: Protocol defined Primary Endpoint
Time To First Event: FDA preferred Primary Endpoint
PPT Slide
Secondary Endpoints - 039
Exploratory analysis
Pooled analysis: Zometa vs. Placebo - 039 exploratory analysis
PPT Slide
Proportions (%) of Patients with any SRE in Blastic Metastasis in Solid Tumor Trial-011 exploratory analysis - support for prostate cancer study
PPT Slide
Early discontinuations were not the cause of inconsistency
Summary of Results Prostate Cancer Trial - 039
FDA Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
FDA Guidance for Industry FDA approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
Summary of Issues
PPT Slide
Zometa for Bone Metastases of Solid Tumors other than Breast Cancer and Prostate Cancer
Overview of the Solid Tumor Trial
Proportions of Patients with SREs: Protocol defined Primary Endpoint
Time To First Event: FDA preferred Primary Endpoint
PPT Slide
Heterogeneous Population
PPT Slide
Response of bone metastases to chemotherapy
PPT Slide
PPT Slide
PPT Slide
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