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) |