Spontaneous Ae Signalling Methods

Spontaneous AE signals are generated when statistical or non-statistical methods are applied to spontaneous AE data (Venulet, 1973). Although the manner in which a particular drug-AE pair comes to attention (spontaneous AE signalling method) has sometimes been used synonymously with the subject matter that was identified (spontaneous AE signal), signalling methods are better defined as procedures that are independent of content. This convention is consistent with the observation that particular spontaneous AE signals are often generated simultaneously by more than one signalling method (Inman, 1970; Mey-boom et al., 1997a). AE signalling methods can be applied to report/case sets numbering from one to thousands, range in applicability from extremely limited to nearly universal, and encompass a variety of functions from simple sorting procedures for creating workable subsets of reports (Finney, 1971a; Amery, 1999) to complex analyses of case series that eventually come to be regarded as definitive (Blum et al., 1994).

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