Assessment of safety and toxicity
toxicity, toxicities
ADVERSE EVENT
AEs were recorded, and their severity graded according to the Common Terminology Criteria for Adverse Events v3.0. Clinical investigators evaluated the severity and relatedness of any registered AEs to the trial participation, study drug(s) and ablative procedure. Any AEs that could be related to trial participation were defined as treatment emergent. Any severe AEs, defined as AEs ≥ grade 3, were reported to the sponsor within 48 h. To establish the maximum tolerated dose and recommended phase II trial dose of iDCs, the toxicity was defined as dose limiting if patients experienced any persistent grade 4 toxicity. Maximum tolerated dose was defined as the dose level below which dose limiting toxicities were seen in ≥ 1 of 3 subjects. Given the observed tolerability of DC-based therapy in part 1, subjects in part 2 were treated with the highest iDC dose. Dose-limiting toxicity of cryoablation plus iDC treatment was evaluated separately (