Outcome measures of adverse effects
Cancer
ADVERSE EFFECTS, ADVERSE EFFECTS, HYPERCHOLESTEROLEMIA, CANCER
We investigated adverse effects possibly or probably related to everolimus treatment mapped and graded by the National Cancer Institute Common Terminology Criteria version 5 [Hypercholesterolemia was not graded using this terminology. Grading was based on total cholesterol levels (grade 1: increased from start or under treatment to above the upper limit of normal (ULN) to 7.75 mmol/L, grade 2: 7.75–10.34 mmol/L, grade 3: 10.34–12 mmol/L). Adverse effects were described every year they occurred. Adverse effects without information of date and without information of grade were described and included in the entire treatment period. We further investigated dose modifications (interruptions, and dose reductions), discontinuation, reason for discontinuation, and association between adverse effects ≥ grade 3 and age.