Treatment-emergent AEs
| Event (Event/100 PY) | Any adalimumab n=165 PYs=390.7 |
| Any AE | 1194 (305.6) |
| Severe AE | 36 (9.2) |
| Serious AE | 29 (7.4) |
| AE leading to study discontinuation | 31 (7.9) |
| Infectious AE | 376 (96.2) |
| Serious infectious AE | 4 (1.0) |
| Opportunistic infections (excluding oral candidiasis and tuberculosis) | 1 (0.3) |
| Tuberculosis* | 2 (0.5) |
| Lymphoma | 0 |
| NMSC | 1 (0.3) |
| Malignancies (excluding lymphoma, HSTCL, leukaemia, NMSC or melanoma) | 2 (0.5) |
| Demyelinating disorder | 0 |
| Deaths | 2 (0.5) |
*Category captured active and latent tuberculosis; however, only latent cases were reported.
AE, adverse event; HSTCL, hepatosplenic T-cell lymphoma; NMSC, non-melanoma skin cancer; PY, patient-year.