He's a dbag: See e.g. EMA definition: "An a

He's a dbag:

See e.g. EMA definition:

"An adverse event (AE) can therefore be any unfavourable and unintended sign (including an
abnormal laboratory finding, for example), symptom, or disease temporally associated with
the use of a medicinal product, whether or not considered related to the medicinal product."

AND

"Adverse Event – is defined by the FDA and by NCI as any untoward medical occurrence
associated with the use of a drug in humans, whether or not considered drug related. Therefore
an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding),
symptom or disease temporally associated with the use of a medicinal (investigational) product
whether or not considered related to the medicinal (investigational) product (attribution of
unrelated, unlikely, possible, probable, or definite).
Attribution – is an assessment of the relationship between the AE and the medical intervention.
Attributions are one of the following: Unrelated (the AE is clearly NOT related to the
intervention), Unlikely (the AE is doubtfully related to the intervention), Possible (the AE may
be related to the intervention), Probable (the AE is likely related to the intervention), and
Definite (the AE is clearly related to the intervention)."