Spontaneous Ae Signals

The primary focus of spontaneous safety data review is the detection of AE signals, which can be defined as any potential product-AE relationship that deserves further attention (including clarification of a product-AE relationship that has already been described) (Lindquist et al., 1999). While newly discovered product-AE causal pairs are generally the most important findings of AE surveillance programs, a causal argument is not the only kind of relationship that has been investigated using spontaneous reports. Other potentially important observations include the identification of non-causal associations, the clinical spectrum of a product-AE pair, the patient subtypes and medical circumstances associated with a product-induced adverse reaction, clues to the mechanism of action by which product

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