Spontaneous Signalling Argument

Places reports into meaningful subsets of workable size based on content and/or number

Uses an explicit or implicit statistical model to screen for product-AE pairs of interest

Applies a case definition and case series methods to create an argument in favor of association

Describes the characteristics and patterns of product-AE case series, focusing on reporting, demographics, risk factors, and possible mechanisms of action

Figure 19.1. Steps in the spontaneous AE signalling process. Reproduced from Clark et al. (2001), Epidemiologic Reviews 23(2), 191-210, Fig. 1, with permission from Oxford University Press.

exposure leads to an adverse reaction, factors associated with the initiation of reporting behavior, and unintended benefits that can be developed as secondary indications (Bateman et al, 1986; Hart et al., 1987; Rawlins, 1988; Moride et al., 1997; Tubert-Bitter et al., 1998).

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