Overview of safety-related treatment emergent adverse events (TEAE) by number (%) of patients and TEAE per 100 patient-years (PY).
| Treatment Emergent Eventsa | Any Adalimumab, n = 697, n (%) | PY = 3708.3 E (E/100 PY) |
|---|---|---|
| Any AE | 678 (97.3) | 12,979 (350) |
| Any serious AE | 320 (45.9) | 729 (19.7) |
| Any AE leading to discontinuation | 157 (22.5) | 230 (6.2) |
| Any severe AE | 300 (43.0) | 669 (18.0) |
| Infectious AE | 554 (79.5) | 3077 (83) |
| Serious infections | 78 (11.2) | 98 (2.6) |
| Opportunistic infection (excluding oral candidiasis and TB) | 1 (0.1) | 1 (< 0.1) |
| TB | 6 (0.9) | 6 (0.2) |
| Lymphoma | 6 (0.9) | 6 (0.2) |
| NMSC | 28 (4.0) | 45 (1.2) |
| Malignancy other than lymphoma, leukemia, NMSC, or melanoma | 29 (4.2) | 30 (0.8) |
| Demyelinating disorder | 2 (0.3) | 2 (< 0.1) |
| Deaths (including non-treatment emergent events) | 22 (3.2)b | 22 (0.6) |
| Injection site reaction | 81 (11.6) | 186 (5.0) |
↵* Events with unknown relationship to study drug are counted as drug related. Any TEAE is defined as any AE with an onset date on or after the day of the first ADA dose through 70 days after the last ADA dose in year 10.
↵b Standard mortality ratio (95% CI) = 0.75 (0.51, 1.07). E: events; AE: adverse event; TB: tuberculosis; NMSC: nonmelanoma skin cancer; ADA: adalimumab.