Overview of adverse events at week 24
| Number of patients (%) | Tabalumab | |||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (N=36) | 1 mg (N=30) | 3 mg (N=20) | 10 mg (N=15) | 30 mg (N=18) | 60 mg (N=13) | 120 mg (N=26) | All tabalumab doses combined (N=122) | |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SAEs | 5 (13.9) | 4 (13.3) | 0 | 0 | 3 (16.7) | 2 (15.4) | 1 (3.8) | 10 (8.2) |
| Patients who discontinued due to an AE | 0 | 1 (3.3) | 2 (10.0) | 0 | 0 | 0 | 2 (7.7) | 5 (4.1) |
| TEAEs | 22 (61.1) | 20 (66.7) | 12 (60) | 9 (60) | 12 (66.7) | 9 (69.2) | 13 (50) | 75 (61.5) |
| TEAEs that occurred in ≥3% of patients in the combined tabalumab group | ||||||||
| Injection-site pain | 0 | 1 (3.3) | 0 | 4 (26.7) | 1 (5.6) | 1 (7.7) | 2 (7.7) | 9 (7.4) |
| Upper respiratory tract infection | 1 (2.8) | 3 (10.0) | 0 | 3 (20.0) | 0 | 2 (15.4) | 1 (3.8) | 9 (7.4) |
| RA worsening | 7 (19.4) | 3 (10.0) | 2 (10.0) | 0 | 0 | 0 | 1 (3.8) | 6 (4.9) |
| Hypertension | 0 | 1 (3.3) | 1 (5.0) | 0 | 1 (5.6) | 0 | 2 (7.7) | 5 (4.1) |
| Anemia | 0 | 1 (3.3) | 2 (10.0) | 1 (6.7) | 0 | 1 (7.7) | 0 | 5 (4.1) |
| Pharyngitis | 0 | 0 | 1 (5.0) | 1 (6.7) | 1 (5.6) | 0 | 1 (3.8) | 4 (3.3) |
| Pyrexia | 1 (2.8) | 2 (6.7) | 1 (5.0) | 0 | 0 | 0 | 1 (3.8) | 4 (3.3) |
| Urinary tract infection | 1 (2.8) | 1 (3.3) | 2 (10.0) | 1 (6.7) | 0 | 0 | 0 | 4 (3.3) |
| Weight increased | 0 | 1 (3.3) | 1 (5.0) | 0 | 1 (5.6) | 1 (7.7) | 0 | 4 (3.3) |
| Respiratory tract infection | 0 | 1 (3.3) | 2 (10.0) | 0 | 0 | 1 (7.7) | 0 | 4 (3.3) |
| Nasopharyngitis | 2 (5.6) | 2 (6.7) | 0 | 0 | 2 (11.1) | 0 | 0 | 4 (3.3) |
AE, adverse event; RA, rheumatoid arthritis; SAEs, serious adverse events; TEAEs, treatment-emergent adverse events.
Percentages are based on the number of patients in each column.