Fig. 3

Comparison of PRO instruments’ symptom-related content and AEs reported in ICI-CTs with published PRO results (n = 26). The most frequently reported AEs (any grade) are shown for the 26 ICI-CTs identified. AE frequency (most common to least common) is depicted from left to right respectively. Symptom-related content from each PRO instrument was compared to the AEs in the corresponding trial arm. The PRO instruments used in each ICI-CT is shown. For a detailed PRO instrument content, see Table S8. Green: AEs covered; Yellow: AEs partially covered; Light yellow: AEs partially covered related to specific types of pain; Red: AEs not covered. Laboratory tests results (grey) were not included in calculations. “Asthenia” was considered covered by “fatigue” following the National Cancer Institute toxicity grading scale version 3 that included asthenia, lethargy, and malaise under the umbrella of “fatigue”. (1) “Fatigue” was considered partially covered because the term included in the FACT-G was “lack of energy”; (2) While the study protocol announced the use of SF-36, EORTC QLQ-C30, FACIT-Fatigue, and SDS questionnaires, only results from the EORTC QLQ-C30 were reported in the full-text publication. “Cough” would be covered by the SDS instrument; (3) “Chills” was partially covered as related to “fever”, included in the FACT-G; (4) “Dec. appetite” was considered as partially covered by the term “good appetite” in the FKSI-19. Ipi, Ipilimumab; Niv, Nivolumab; Pem, Pembrolizumab; Ate, Atezolizumab; Dur, Durvalumab; Inc., increased; Dec, decreased