Table of Contents
GLIADEL® WAFER sNDA 20-637s
GLIADEL® Wafer Indication
Clinical Trials: Recurrent Malignant Glioma
Clinical Trials: Newly Diagnosed Malignant Glioma
GLIADEL® Approvals (1996-2000)
Phase III Multicenter Trials of GLIADEL® Wafer in Newly-diagnosed Malignant Glioma
GLIADEL® Wafer Proposed Indication
Agenda
Guilford Invited Guests
Overview of Primary Malignant Glioma: Clinical Features and Treatment
Primary Malignant Glioma
Primary Malignant Glioma
Primary Malignant Glioma
Glioblastoma: Treatment Outcome
Natural History of High Grade Glioma: Effects of PCV Chemotherapy
Natural History of High Grade Glioma: Effects of PCV Chemotherapy
Prognostic Factors: Primary Malignant Glioma
Limitations of Systemic BCNU
The GLIADEL® Wafer
Phase III Trial of GLIADEL® Wafer in Newly Diagnosed Malignant Glioma
6 Month Survival Recurrent GBM (8802)
Overall Survival (ITT) Primary Malignant Glioma (0190)
Clinical Experience To Date
Rationale for Phase III Study T-301
Phase III Multicenter Trials of GLIADEL® Wafer in Newly-Diagnosed Malignant Glioma
Phase III Multicenter Trials of GLIADEL® Wafer in Newly-diagnosed Malignant Glioma
Study 0190: Trial Design
Study 0190: Baseline Patient Characteristics
Overall Survival (ITT) Primary Malignant Glioma (0190)
Study 0190: Overall Survival Adjusted for Prognostic Factors - GBM Patients1
Study 0190: Efficacy Conclusions1
Study T-301: Objectives
Study T-301: Trial Design
Study T-301: Trial Design
Study T-301: Clinical Sites
Study T-301: Inclusion Criteria
Study T-301: Baseline Characteristics
Study T-301: Baseline Characteristics
Study T-301: Tumor Size*
Statistical Methodology
Outline
Features to Eliminate Bias in T-301 Study
Key Pre-specified Features in SAP
Approach to Analysis
Stratified Analysis
Stratification of Clinical Trials
Stratification by Center vs. Country
Effect of Country-of-Treatment on Survival: Placebo-Group (T-301)
PPT Slide
Assessing the Influence of Prognostic Factors on Survival
Univariable Prognostic Factors1
Multivariable Proportional Hazards Analysis (ITT)
Summary of Statistical Methodology
Phase III Multicenter Trials of GLIADEL® Wafer in Newly-Diagnosed Malignant Glioma
Study T-301: Overall Survival Analysis (ITT)
Overall Survival – Adjusted for Prognostic Factors1 – (ITT)
Study T-301: Conclusion
Study T-301: Reoperation for Disease Progression
Study T-301: Overall Survival Analysis - Reoperation for Disease Progression (ITT)
Study T-301: Secondary Efficacy Endpoints
Study T-301: Overall Survival (GBM Patients)
Study T-301: Overall Survival Adjusted for Prognostic Factors1 (GBM Patients)
Study T-301: Karnofsky Performance Decline (ITT)
Study T-301: Neuroperformance Decline (ITT)
Study T-301: Neuroperformance Decline in Speech (ITT)
Study T-301: Neuroperformance Decline in Cranial Nerves III, IV, VI (ITT)
Study T-301: Neuroperformance Decline in Motor Status (ITT)
Study T-301: Neuroperformance Decline in Cerebellar Status (ITT)
GLIADEL® Wafer Safety
Safety Summary GLIADEL® Wafer in Primary Surgery
Safety Summary GLIADEL® Wafer in Primary Surgery
Study T-301: Neurologic Adverse Events Occurring in ɱ% of Patients
Study T-301: Neurologic Adverse Events Occurring in ɱ% of Patients
Convulsions (T-301)
Healing Abnormality: Fluid, CSF or Subdural Collections (T-301)
Healing Abnormality: CSF Leak (T-301)
Healing Abnormality: Wound Dehiscence, Breakdown or Poor Healing (T-301)
Healing Abnormality: Subgaleal or Wound Effusion (T-301)
Study T-301: Intracranial Infections
Post-operative Surgical Complications: Comparison of T-301 to Published Series
Comparison of Post-operative Surgical Infections
Comparison of Post-operative Surgical Seizures
Comparison of Post-operative Surgical Hemorrhage/Stroke
Post-Operative Surgical Complications: Conclusion
GLIADEL® Wafer in Primary Malignant Glioma: Summary of Benefits and Risks
GLIADEL® Wafer in Primary Malignant Glioma: Summary of Benefits and Risks
Consistency of GLIADEL® Wafer Phase III Trial Results
Summary of Efficacy Results from Randomized Controlled Trials of GLIADEL® Wafer (ITT)
Summary of Efficacy Results from Randomized Controlled Trials of GLIADEL® Wafer (GBM)
Summary of Benefits and Risks
GLIADEL® Wafer Proposed Indication
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