Adverse event reporting and harms
Cancer
ADVERSE EVENT, EVENT, CANCER
All AEs during the study will be recorded with the following data: date of onset and date of completion (if applicable), severity of AEs, investigator’s view on the relationship to dietary intervention, taken actions on AEs, treatment of the AEs, cause of the event (if known), and outcome. The AE intensities will be graded according to the National Cancer Institute’s Adverse Event Common Terminology version 4.03.