1. Adverse Event (AE) versus Adverse Reaction (adverse drug reaction ADR) – the distinction
1.3. Unexpected adverse reaction
An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics [DIR 2001/83/EC Art 1(13)]
In the context of a clinical trial, an unexpected serious adverse reaction, a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information [Reg (EU) No 536/2014 Art 2(2)(34)].
This includes class-related reactions which are mentioned in the summary of product characteristics (SmPC) but which are not specifically described as occurring with this product.