Table of Contents
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sNDA 20-571
APPROVED SCHEDULES (SINGLE AGENT)
PROPOSED SCHEDULES (CPT-11 + 5FU/LV)
STUDY DESIGN 0038 (U.S.)
STUDY DESIGN v303 (EUROPE)
EFFICACY ENDPOINTS (U.S.)
STUDY DESIGN (Europe)
DATA ANALYSIS
INCLUSION CRITERIA
PATIENT DEMOGRAPHICS (U.S. and Europe)
DEATHS (Europe)
SURVIVAL v303 (Europe)
DEATHS (U.S.)
SURVIVAL 0038 (U.S.)
CROSS OVER TO CPT-11
TIME TO TUMOR PROGRESSION (Months)
TIME TO TREATMENT FAILURE (Months)
RESPONSE RATE
SUMMARY OF EFFICACY
ACCRUAL: TREATMENT SUBGROUPS (EUROPE)
EFFICACY: TREATMENT SUBGROUPS (EUROPE)
SAFETY REVIEW
GRADE 3/4 TOCIXITY (Europe)
GRADES 3/4 TOXICITY (CPT-11+5FU/LV Subgroups, Europe)
GRADE 3/4 TOXICITY (U.S.)
DISCONTINUATION 2o TO TOXICITY
SUMMARY OF SAFETY CPT-11+5FU/LV REGIMENS
CONSIDERATIONS FOR APPROVAL
CONSIDERATIONS FOR APPROVAL
CONSIDERATIONS FOR APPROVAL
DOSE/ADMINISTRATION SCHEDULES ?
REVIEW TEAM
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