To evaluate the cytokine toxicity (CYTOX) score, a composite measure derived from 11 different cytokine levels, both prior to ICI-based therapy and after 1 cycle of ICI-based therapy as a predictive signature for the development of irAEs. To track patterns of treatment of irAEs and patterns of toxicity resolution. To measure the burden of chronic, grade 1 and 2 toxicities using methods such as toxicity over time (ToxT). To observe the trajectory of patient-reported adverse events over 12 months using serial assessment with select Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures. To observe the trajectory of patient-reported quality of life and health preferences over 12 months. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy. ![]() To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors. ![]() ![]()
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