Abstract

Immune-related Adverse Events (IrAEs) present a new challenge to patient safety. The use of Patient-Reported Outcomes (PROs) to monitor adverse events is increasing. Existing measures like the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) do not offer clear guidance how to select the symptoms to monitor in different populations. The wide spectrum of toxicities of more recent treatments such as Immune Checkpoint Inhibitors (ICIs) is not fully covered. We aimed to a) reach expert consensus on PRO-CTCAE™ symptom to be monitored in cancer patients treated with ICIs; b) gather expert opinion on additional symptom terms that could be used to broaden its reach in the ICI toxicity spectrum; and c) reach expert consensus on a set of priority symptom terms to monitor symptomatic IrAEs in this population.

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