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pain, eye itch, eye redness, dry eyes, sandy/gritty eyes, crusty eyes, watery eyes, pain with eye movement,
eyelid swelling, and eyelid itch); hematologic (bleeding, bleeding easily, bleeding gums, bleeding nose,
pinpoint bleeding-petechiae, bruising, bruising easily, and lymph swelling); mood (depressed, nervous/
anxious, irritable, and mood changes); and miscellaneous/constitutional (general pain, fatigue, headache,
weight loss, weight gain, appetite increase, appetite decrease, lightheaded/dizziness, malaise, weakness,
paleness, jaundice, fevers, low-grade fever, chills, sweating excessive/nocturnal, palpitations, dry mouth,
taste changes, thirst, sinus pain, blurred vision, decrease vision, loss of vision, vision floaters, impaired color
vision, pain radiating to the back, swelling, urinary frequency, urinary infrequency, foamy urine, blood in
urine, dark urine, tooth decay, moon face appearance, heat intolerance, cold intolerance, food sensitivity,
cold fingers, cold toes, groin pain, new allergies, and acute treatment reactions).

Item mapping
For the FACIT Immunotherapy Item Library, 142 unique symptoms were identified for item mapping,
which included 48 from the Primary Symptom List. Once symptom content had been fully determined, the
study team met to align symptoms with candidate items from the overall FACIT item library. We identified
all items related to a given symptom (e.g., for fatigue, there were 16 items covering fatigue experience and
impact), and then selected the one(s) that best captured symptom experience or impact related to ICM
therapy. We used descriptions from experts and the literature to corroborate item selection. This process
yielded a final total of 239 PRO items retained for immunotherapy item library inclusion, which includes
a subset of 66 items from the Primary Symptom List. The full set of immunotherapy items can be found at
https://wizard.facit.org/.

DISCUSSION
The FACIT Immunotherapy Item Library was developed with input from the literature, clinicians, and
researchers and constitutes the first published compendium of PRO items targeting the vast array of irAEs
in ICM therapy. Library content is aligned with current practice guidelines and conceptually organized by
organ system, inflammatory reaction/condition, and their associated toxicity symptom profiles. PRO items
address adverse events associated with immunotherapy generally, and a subset of items for ICM treatments,
which include the related functional, social, and/or emotional impact of those symptoms when applicable.
Use of items from the widely-used FACIT Measurement System ensures PRO assessment based on well-
validated items that have undergone extensive face and content validity, are written at the sixth grade
reading level or less, and are available in as many as 70 languages. All items use a standard five-point Likert
scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much) and seven-day recall
period.

Library format permits for custom form development, as well as expansion based on new or combination
therapies and into other immunotherapy classifications. Asking every question in the library would of
course be burdensome to a patient in clinical research, especially when other questionnaires are also likely
to be desired to measure disease-related symptoms, function, health perceptions, and quality of life. We
advocate for the thoughtful, judicious use of subsets of these questions, assembled by a survey builder
(FACIT Build-a-PRO; https://wizard.facit.org/), to track the most likely or relevant adverse events in a
[31]
given trial. This practice of custom building has been recommended for use of the PRO-CTCAE and
we endorse that same approach here. Users can draw items from the full library (n = 239) or select from
a targeted subset of expert-endorsed items (Primary Symptom List; n = 66). The Functional Assessment
of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) is also newly available from Hansen
[58]
and colleagues - a 25-item toxicity subscale for patients receiving ICM therapy . The FACT-ICM was
developed using a mixed methods approach and is designed to assess HRQOL in the context of ICM irAEs,
providing value in research and clinical settings related to symptom assessment and quality of life. Hansen