Has the patient actually received the suspect drug? Did the AE occur in a reasonabl e temporal relationship to the administration of suspect drug? • Consistency with known drug profile . Was the AE consistent with the previous knowledge of the suspect drug (pharmacology and toxicology) or drugs of the same pharmacological class? OR could the AE be anticipated from its pharmacological properties? • Dechallenge experience. Did the AE resolve or improve on stopping or reducing the dose of the suspect drug? • No alternative cause. The AE cannot be reasonably explained by another aetiology such as the underlying disease, other drugs, other host or environmental factors. • Rechallenge experience. Did the AE reoccur if the suspected drug was reintroduced after having been stopped? Targovax would not normally recommend or support a rechallenge. • Laboratory tests .