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. 2022 Aug 14;56(3):398–408. doi: 10.2478/raon-2022-0021

Table 1.

Primary objectives

Primary objective Definition of objectives Timepoint of objectives evaluation
Assessment of the safety of intratumoral phIL12 GET Assessment of adverse events in accordance with the CTCAE v5 criteria From the beginning of therapy until the follow-up examination on day 30 after the treatment (day 1, 3, 8 and 31)
Assessment of the tolerability of intratumoral phIL12 GET Assessment by the quality of patient of life questionnaire reported outcome EORTC QLQ-C30 A follow-up examination on day 0, 8 and 31

CTCAE = Common Terminology Criteria for Adverse Events; GET = gene electrotransfer