Summary of adverse events during the treatment period
| Events, n (%) | All safety population patients* | Week 16 Non-responders† | ||
|---|---|---|---|---|
| Tabalumab 120/Q4W | Tabalumab 90/Q2W | Placebo | ||
| N=153 | N=147 | N=154 | N=93 | |
| Patients with ≥1 TEAE | 91 (59.5) | 76 (51.7) | 81 (52.6) | 38 (40.9) |
| Discontinuations due to TEAE | 4 (2.6) | 4 (2.7) | 4 (2.6) | 2 (2.2) |
| Patients with ≥1 SAE | 7 (4.6) | 6 (4.1) | 6 (3.9) | 4 (4.3) |
| Deaths | 0 | 0 | 0 | 0 |
| TEAEs in ≥5% of patients (any group) | ||||
| Rheumatoid arthritis | 9 (5.9) | 7 (4.8) | 12 (7.8) | 4 (4.3) |
| Upper respiratory tract infection | 9 (5.9) | 7 (4.8) | 9 (5.8) | 2 (2.2) |
120/Q4W=120 mg subcutaneous (SQ) tabalumab injection every 4 weeks; 90/Q2W=90 mg SQ tabalumab injection every 2 weeks.
*Safety data include events up to week 1 for week 16 non-responders; data are reported for the safety population.
†Safety data collected after week 16 are reported.
SAE, serious adverse event; TEAE, treatment-emergent adverse event.