Safety
nausea, urinary tract reactions, pelvic osteomyelitis, death
COLD SYMPTOMS, EVENTS, ADVERSE EVENTS, ADMINISTRATION SITE REACTIONS
In total, 73 AEs were reported, whereof 32 were possibly or probably associated with participation in the trial. No dose-limiting toxic effects were recorded. The most frequently reported events were mild or moderate urinary tract reactions, administration site reactions, nausea, and influenza-like and common cold symptoms. Only two grade 3 AEs associated with the treatment were reported: one urine retention requiring hospitalization and one pelvic osteomyelitis requiring protracted intravenous antibiotics before full recovery (Table Treatment-emergent adverse eventsData are numbers in all treated patients. Treatment-emergent adverse events definitely, probably, or possibly attributed to cryoablation and/or iDC and/or PD-1i/CTLA-4i are shown. No grade 4 or grade 5 adverse events were attributed to treatment as definite, probable, or possible. iDC = immature dendritic cells. CTLA-4i = cytotoxic T-lymphocyte-associated protein 4 inhibitor. PD-1i = programmed cell death protein 1 inhibitor