All participants in clinical trials are closely monitored and assessed for possible side effects or adverse events (AEs) during all phases of the trials. AEs are any unfavourable and unintended signs, symptoms or diseases that are caused or can be linked to the medicine/treatment being studied. Most adverse events are not serious. An adverse event is considered serious or severe if it:
- results in-patient hospitalization,
- results in prolonged hospitalization,
- results in persistent/significant disability/incapacity,
- causes congenital anomaly/birth defect,
- threatens the life of a person,
- causes death of a child of the participant who was exposed to the study medication or medical device during pregnancy ,
- causes death.