3.3.1. Adverse events
allergic reactions–21, neoplasms, infections, cardiac disorders, vascular disorders, nervous systems disorders
ADVERSE EVENTS, NEOPLASMS, RESPIRATORY DISORDERS, INFECTIONS, DISORDERS, CARDIAC DISORDERS, IMMUNE SYSTEM DISORDER, MUSCULOSKELETAL DISORDERS, VASCULAR DISORDERS, EVENTS, COMPLICATIONS
During the trial, 40 adverse events (AE) were reported; 6 were classified as serious adverse events (SAE). The majority were associated with immune system disorders (allergic reactions–21). Additional categories included cardiac disorders (1), musculoskeletal disorders (3), general disorders (1), infections (1), injury or procedure complications (3), neoplasms benign, malignant and unspecified (1), nervous systems disorders (1), respiratory disorders (1), and vascular disorders (2). Twenty-one AEs were determined to be related to the study and 3 had insufficient information to make a determination. The 21 related AEs were all associated with a skin irritation as result of the application of the accelerometer used in the study. One SAE also associated with the application of the accelerometer led to a severe reaction and hospitalization. Overall events were equally balanced between groups, with 13 in SC, 11 in Class/IVR, and 14 in DVD/IVR.