Table 2.

TOSCA PASS objectives and main variables

Objectives	Main variables
To document the long-term safety and tolerability profile of everolimus in the treatment of patients with TSC residing in the European Union who are prescribed everolimus for approved indications	Incidence of AEs, SAEs, and everolimus-related AEs in the observation period
	Incidence of events of special interest (e.g., noninfectious pneumonitis, severe infections, hypersensitivity, stomatitis, secondary amenorrhea in post-adolescent females, etc.)
To collect everolimus therapeutic drug monitoring data within routine clinical practice as per the Summary of Product Characteristics	Everolimus blood concentration, if available

Abbreviations: AE adverse event, PASS post-authorization safety study, SAE serious adverse event, TOSCA TuberOus SClerosis registry to increase disease Awareness, TSC tuberous sclerosis complex.