Endpoints
Tumors, tumor, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, ADVERSE EVENT, TUMORS, CANCER
The predefined primary endpoints were safety and the identification of hemodynamic variability induced by the EMF exposure. Safety was assessed by monitoring the incidence of adverse events during exposure procedures. Adverse events were reported by investigators and their severity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). Adverse events were not systematically monitored at other times.Exploratory patient‐reported quality‐of‐life endpoints included the proportion of patients with improvement and worsening and the time to deterioration in global health status, functional scale, and symptom scale (defined as a ≥10% change in EORTC QLQ–C30 score from baseline). Median overall survival (OS) in the intention‐to‐treat population was an exploratory safety endpoint, and was compared with OS in the historical control cohort.No tumor assessments or clinical laboratory analyses were performed as part of the study. Routine results from radiological and laboratory assessments of patients were used (with primary physician approval) for ad hoc analyses of objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,