Methods
We performed a retrospective chart review from September 2019 to April
2020 at two European Reference Centers for Vascular Anomalies
(Freiburg/Germany, and Rome/Italy), three national referral centers for
Vascular Anomalies (Barcelona/Spain, Montpellier/France and
Bern/Switzerland) and two German Pediatric Oncology units (Köln and Ulm)
to identify patients treated with sirolimus that developed an SAE.
Medical history of the identified patients were analyzed using a
pre-designed algorithm. Definition of SAE was according to Good Clinical
Practice (GCP) rules and included any event that resulted in death, was
life-threatening, required inpatient hospitalization or caused
prolongation of existing hospitalization, resulted in persistent or
significant disability/incapacity, might have caused a congenital
anomaly/birth defect, or required intervention to prevent permanent
impairment or damage. The treating physician had received
patient/parental informed consent before transferring data for the
study. This study is covered by the ethical committee numbers Freiburg
310/14 and 464/19.