Table 2.
Characteristics of potential safety signals identified from the US Food and Drug Administration (FDA) Adverse Event Reporting System publicly reported by the FDA, 2014-15
No (%) of signals | |
Total No of signals | 82 (100) |
Associated product type: | |
Drug | 66 (80.5) |
Biologic | 16 (19.5) |
Therapeutic area: | |
Autoimmune/musculoskeletal | 3 (3.7) |
Cancer | 10 (12.2) |
Cardiovascular, diabetes, or lipids | 19 (23.2) |
Dermatology | 1 (1.2) |
Infectious disease | 13 (15.9) |
Neurology | 3 (3.7) |
Other | 28 (34.1) |
Psychiatry | 5 (6.1) |
Associated adverse event type: | |
Cardiovascular adverse event | 7 (8.5) |
Non-cardiovascular adverse event | 75 (91.5) |