A POST-MARKETING EVALUATION OF SAFETY CAMPTOSAR + 5-FU/LV FOR FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER

1/3/02


Click here to start


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

SPONSORíS PROPOSED LABEL CHANGE Populations at Risk

QUESTION POPULATIONS AT RISK

LICENSING TRIALS: Safety Profile

SPONSORíS PROPOSED LABEL CHANGE Supportive Care and Monitoring

SPONSORíS 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

Author: CDER.USER