Table 5.
Summary of adverse events (efficacy population)
| BLyS ≥ 2 ng/mL at baseline |
BLyS < 2 ng/mL at baseline |
|||
|---|---|---|---|---|
| Placebo (N = 136) | Belimumab 10 mg/kg (N = 121) | Placebo (N = 419) | Belimumab 10 mg/kg (N = 432) | |
| Any AE, n (%)a | 126 (92.6) | 115 (95.0) | 384 (91.6) | 395 (91.4) |
| Headache | 24 (17.6) | 24 (19.8) | 89 (21.2) | 83 (19.2) |
| Upper respiratory tract infection | 22 (16.2) | 19 (15.7) | 81 (19.3) | 71 (16.4) |
| Nausea | 12 (8.8) | 24 (19.8) | 46 (11.0) | 42 (9.7) |
| Urinary tract infection | 14 (10.3) | 18 (14.9) | 53 (12.6) | 51 (11.8) |
| Arthralgia | 15 (11.0) | 15 (12.4) | 62 (14.8) | 56 (13.0) |
| Diarrhea | 7 (5.1) | 15 (12.4) | 39 (9.3) | 47 (10.9) |
| Nasopharyngitis | 10 (7.4) | 14 (11.6) | 36 (8.6) | 49 (11.3) |
| Anemia | 11 (8.1) | 13 (10.7) | 20 (4.8) | 15 (3.5) |
| Cough | 14 (10.3) | 12 (9.9) | 26 (6.2) | 30 (6.9) |
| Pyrexia | 12 (8.8) | 13 (10.7) | 26 (6.2) | 36 (8.3) |
| Edema peripheral | 10 (7.4) | 13 (10.7) | 32 (7.6) | 29 (6.7) |
| Hypertension | 14 (10.3) | 7 (5.8) | 35 (8.4) | 25 (5.8) |
| Any SAE, n (%) | 32 (23.5) | 25 (20.7) | 57 (13.6) | 76 (17.6) |
| Any treatment-related AE, n (%) | 58 (42.6) | 48 (39.7) | 174 (41.5) | 158 (36.6) |
| AEs resulting in study discontinuation, n (%) | 22 (16.2) | 10 (8.3) | 20 (4.8) | 27 (6.3) |
| SAEs resulting in study discontinuation, n (%) | 13 (9.6) | 9 (7.4) | 13 (3.1) | 17 (3.9) |
AE: adverse event; BLyS: B-lymphocyte stimulator; SAE: serious adverse event.
a
Only AEs occurring in ≥ 10% of patients in any treatment arm are listed.