Incidents As Controls

Unless the incident group contains unrecognised adverse reactions, it should represent the background noise and this should be generally similar for drugs of similar indication. If the incident rates are similar for comparator drugs, then it can be assumed that reporting bias is not present. If there are statistically significant differences between the incident profiles of comparator drugs, then this may be due to the presence of an unrecognised adverse reaction or confounding, e.g. by indication or reporting bias. Any such differences are therefore investigated. There is no automated process of signal identification.

Incidents are also used as within-drug controls for characterising adverse reactions. The variables associated with, respectively, the reactions and incidents for a drug are compared and also the patient characteristics, and should there be differences these may indicate risk factors for the reaction under study, e.g. a gender or dose difference. An example of the use of incidents as

Table 27.4. Comparison of prescription event monitoring rates (% of cohort who sustained an event).

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