Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 18

This includes any AE for which there is a reasonable possibility that the drug caused the AE. For the purposes of IND safety reporting, “reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the AE. Suspected adverse reaction implies a lesser degree of certainty about causality than adverse reaction, which means any AE caused by a drug.

The point here is the word suspected, which means some level of causality with the drug in question, is present. It may be serious or non-serious.