A signal is a set of data constituting a hypothesis that is relevant to the rational and safe use of a drug in humans- R. Meyboom et al. 1997
A signal is reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously- Edwards et al. 2000
Signal Generation:
i) three convincing ADR-reports
ii) # specified ADR-Reports/ # Prescriptions
iii)# specified ADR-Reports (PRRs)/ all Reports
iv) # specified Reports / Exposed Persons //Background Incidence
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