ppt课件-fdaanalysesofmaravirocsafetydata.pptVIP

FDA Analyses of Maraviroc Safety Data Scott Proestel, M.D. Division of Antiviral Products Food and Drug Administration April 24, 2007 Presentation Outline Overall Summary of AEs Mortality Malignancies Hepatic AEs Infections Additional AEs Selected Laboratory Data Summary of AEs During Double-Blind PhaseStudies 1027 and 1028 Duration of Therapy During Double-Blind PeriodStudies 1027 and 1028 Median Treatment Days MVC QD 236 MVC BID 239 Placebo 145 Days to Individual AEs During Double-Blind PeriodPlacebo Arms, Studies 1027 and 1028 Days to Subject Discontinuation From the Double-Blind