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Table 3 Relationship of adverse events to antimalarial agents

From: Pharmacovigilance of antimalarial treatment in Africa: is it possible?

Classification Definition
Definitely related Events have no uncertainty in their relationship to test drug administration: meaning that a re-challenge was positive.
Probable The suspected adverse event follows a reasonable temporal sequence from study drug administration, abates upon discontinuation of the drug, and cannot be reasonably explained by the known characteristics of the subject's clinical state.
Possible The suspected adverse event may or may not follow a reasonable temporal sequence from study drug administration but seems to be the type of reaction that cannot be dismissed as unlikely. The event could have been produced or mimicked by the subject's clinical state or by other modes of therapy concomitantly administered to the subject.
Unlikely There is no reasonable temporal association between the study drug and the suspected event and the event could have been produced by the subject's clinical state or other modes of therapy administered to the subject.
Definitely unrelated Events which occur prior to test drug administration or for those events which cannot be even remotely related to study participation (e.g. injury caused by a third party).
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