sNDA 20-571

4/13/00


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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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Author: CDER User