Table of Contents
A POST-MARKETING EVALUATION OF SAFETY CAMPTOSAR + 5-FU/LV FOR FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER
EARLY DEATHS IN IRINOTECAN+5FU/LV
DEFINITION OF REGIMENS
PLAN OF ACTION
PLAN OF ACTION
PLAN OF ACTION
FDA REVIEW
EARLY DEATHS NCCTG 9741 AND CALGB 89803
EARLY DEATHS NCCTG 9741 AND CALGB 89803
DEATH ANALYSIS Methods
PPT Slide
EARLY DEATHS Metastatic Disease
EARLY DEATHS Adjuvant Treatment
LICENSING TRIALS
LICENSING TRIALS: EARLY DEATHS Patient Characteristics
LICENSING TRIALS Patient Characteristics
LICENSING TRIALS Performance Status
LICENSING TRIALS Performance Status
SPONSOR’S PROPOSED LABEL CHANGE Populations at Risk
QUESTION POPULATIONS AT RISK
LICENSING TRIALS: Safety Profile
SPONSOR’S PROPOSED LABEL CHANGE Supportive Care and Monitoring
SPONSOR’S PROPOSED LABEL CHANGE Dose Modifications
MODIFICATIONS ADOPTED BY NCCTG
CHOICE OF CONTROL ARM
LICENSING TRIALS: Safety Profile
LICENSING TRIALS: Overall Toxicity
INFUSION vs. BOLUS 5-FU
INFUSION vs. BOLUS 5-FU
PPT Slide
POTENTIAL ACTION
POTENTIAL ACTION
POTENTIAL ACTION
POTENTIAL ACTION
PPT Slide
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