Study Assessments
death
ADVERSE EVENTS, ADVERSE EVENT
Feasibility, side effects, and adverse events (AE) were consistently monitored. All subjects who received at least one dose of avelumab were analyzed for safety. AEs were assessed according to the NCI Common Terminology Criteria for Adverse Events version 4.03. In addition, two independent neuroradiologists evaluated the response rate by MRI using the modified radiophraphic response assessment in neuro-oncology (mRANO) criteria every 8 weeks. The proportion of patients who achieved complete response or partial response (PR) determined the objective response rate. OS and median PFS were determined using the Kaplan–Meier method and calculated from enrollment to death from any cause or progression on MRI. Estimating median survival time and median PFS, 95% confidence intervals (CI) were calculated and included sex as a variable. Patients who did not progress or die were censored on the date of the last assessment.