An adverse event requires the evaluation of the presence of the following criteria by the sponsor:
- Is it a serious event?
- Is there reason to suspect a causal relationship with the administration of the investigational medicinal product?
- Is the adverse reaction, by its nature and severity, inconsistent with the reference information for the investigational medicinal product?
If the investigator or the sponsor judges all these criteria to be fulfilled, this constitutes a case of a suspected unexpected serious adverse reaction (SUSAR).