ABSTRACT
In order to be of clinical value, any treatment must provide sufficient benefits to justify its use, and it must have a good safety profile relative to its benefits. In other words, the treatment must have a positive “benefit-risk” profile; that is, any harms caused by the treatment (also referred to here as adverse drug reactions or toxicities) must be of less clinical importance than the benefits it provides. Therefore, the assessment of the safety of any new drug is of critical importance [3, 22].
