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Table 2 Definitions of safety signals in clinical trials

From: Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)—study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial

Adverse event

AE

Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment

Adverse drug reaction

ADR

All untoward and unintended responses to an investigational medicinal product related to any dose administered

Serious adverse event

SAE

A serious adverse event/reaction is any untoward medical occurrence or effect that at any dose:

Results in death

Is life-threatening

Requires hospitalization or extension of existing hospitalization

Results in persistent or significant disability or incapacity

Is a congenital anomaly or birth defect

Serious adverse reaction

SADR

Unexpected adverse reaction

UADR

Adverse reaction, the nature, severity or outcome of which is not consistent with the product information (SmPC)

Suspected unexpected serious adverse reaction

SUSAR

Any suspected adverse reaction related to the study treatment that is both serious and unexpected