Issues in the Practical Application of Data Mining Techniques to Pharmacovigilance. A. Lawrence Gould Merck Research Laboratories May 18, 2005. Spontaneous AE Reports. Clinical trial safety information is incomplete Few patients -- rare events likely to be missed
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A. Lawrence Gould
Merck Research Laboratories
May 18, 2005
respond to reports involving severe, potential life-threatening events eg., Stevens-Johnson syndrome, agranulocytosis, anaphylactic shock
Flag when R = a/E(a) is “large”