Adverse event reporting and harms {22}
delirium, death
URINARY TRACT INFECTIONS, SPINAL METASTASES, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, PRESSURE SORES, ADVERSE DRUG EVENTS
Adverse events during hospital stay will be evaluated using the most recent version of the CTCAE (version 5.0, version 6.0 when available at the start of the study). Due to the natural course of the disease, we expect that many patients with spinal metastases suffer from study unrelated AEs. Therefore, only study-related AEs with grade 2 or higher (either expected or unexpected) reported spontaneously by the patient or observed by the research team will be recorded up to three months after treatment.Grade 3 or higher adverse events are considered serious (S) AEs. (S)AEs that are common in this patient category include urinary tract infections, delirium, pressure sores, and opioid-related adverse drug events and will be recorded but not reported to the ethics committee. Study-related SAEs within 3 months after start of treatment that are life threatening or that resulted in death will be directly reported (within 7 days) to the ethics committee. Other study-related SAEs will be reported to the ethics committee within 15 days. SAEs unrelated to the study will not be directly reported to the ethics committee but documented in the yearly progress report.