AE assessment
Cancer
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, EVENTS, CANCER
Adverse events were scored using a modified version of the National Cancer Institute Common Terminology Criteria for Adverse Events tables, version 4.0. Study ophthalmologists added additional details regarding ocular AEs to the CTCAE tables for this study. The tables were used to classify and score the severity of adverse events. Briefly, grade 1 AEs are mild events that would not prevent participants from working or performing household chores. Grade 2 AEs are moderate events that would prevent work or performance of household chores. Records of participants with AEs with severity of grade 3 or higher that interfered with activities of daily living were to be evaluated by an independent medical monitor who was not part of the research team. The medical monitor’s role was to review the report with the lead study physician to determine whether it met criteria for a serious adverse event (SAE) and whether the AE was related to the study treatment [