Table 3.
TEAEs during the DB, placebo-controlled period (weeks 0–4).
| Placebo N = 103 n (%) |
Adalimumab N = 102 n (%) |
|
|---|---|---|
| Any AE | 38 (37) | 38 (37) |
| Any serious AE | 1 (1) | 2 (2) |
| Any AE leading to discontinuation of study drug | 5 (5) | 3 (3) |
| Any severe AE | 2 (2) | 1 (1) |
| Any AE with reasonable possibility of being related to study drug* | 17 (17) | 18 (18) |
| Any infection | 9 (9) | 8 (8) |
| Any serious infection | 0 | 0 |
| Any active TB | 0 | 0 |
| Any latent TB† | 3 (3) | 1 (1) |
| Any malignancy | 0 | 0 |
| Any AE leading to death | 0 | 0 |
AE, adverse event; CT, computed tomography; DB, double blind; QFT, QuantiFERON-TB Gold; TB, tuberculosis; TEAE, treatment-emergent adverse event.
*
Assessed by the investigator.
†
Serial QFT testing and chest radiographs or CT scans were performed during the study. Patients with positive or repeated indeterminate QFT result or findings of active/latent TB on chest radiograph/CT scan were to be discontinued from the study. These instances were reported as an AE of latent TB.