February, 2003
© 2000, 2001 Scott S. Emerson, M.D., Ph.D.
Session 3: 65
Monitoring Secondary Endpoints
Safety issues to be addressed
Is there evidence that individual patients might be being harmed?
·Serious adverse experiences
·Individual abnormal lab values
·
Is there evidence of trends toward harm in the population of treated patients
·Proportion with adverse experiences
·Average (median) lab values