Table 3 Incidence (three or more patients) of adverse events by dose: single-dose and double-dose cohorts combined
Adverse event | Placebo (n = 13) | Belimumab | ||||
|---|---|---|---|---|---|---|
| Â | Â | 1.0 mg/kg (n = 15) | 4.0 mg/kg (n = 14) | 10 mg/kg (n = 14) | 20 mg/kg (n = 14) | All active (n = 57) |
Arthralgia | 4 (31) | 3 (20) | 2 (14) | 7 (50) | 3 (21) | 15 (26) |
Headache | 1 (8) | 3 (20) | 3 (21) | 4 (29) | 2 (14) | 12 (21) |
Rash | 0 | 4 (27) | 2 (14) | 2 (14) | 4 (29) | 12 (21) |
Diarrhea | 0 | 5 (33) | 1 (7) | 1 (7) | 3 (21) | 10 (18) |
Nausea | 4 (31) | 2 (13) | 3 (21) | 2 (14) | 3 (21) | 10 (18) |
Fatigue | 0 | 1 (7) | 2 (14) | 3 (21) | 1 (7) | 7 (12) |
Back pain | 1 (8) | 0 | 2 (14) | 1 (7) | 3 (21) | 6 (11) |
Joint swelling | 2 (15) | 0 | 1 (7) | 0 | 4 (29) | 5 (9) |
Synovitis | 1 (8) | 2 (13) | 0 | 3 (21) | 0 | 5 (9) |
Depression | 0 | 3 (20) | 0 | 0 | 0 | 3 (5) |
Infections and infestations | 8 (62) | 4 (27) | 8 (57) | 4 (29) | 5 (36) | 21 (37) |
Upper respiratory tract infection | 2 (15) | 0 | 3 (21) | 1 (7) | 3 (21) | 7 (12) |
Thrombocytopeniaa | 0 | 0 | 1 (7) | 0 | 0 | 1 (2) |
Pancreatitisb | 0 | 0 | 0 | 0 | 1 (7) | 1 (2) |
Cellulitis staphylococcalb | 0 | 0 | 0 | 1 (7) | 0 | 1(2) |
Sepsisb | 1 (8) | 0 | 0 | 0 | 0 | 0 |
Aspartate aminotransferase increasedb | 0 | 0 | 0 | 0 | 1 (7) | 1 (2) |
Blood creatinine increasedb | 0 | 0 | 0 | 0 | 1 (7) | 1 (2) |
Neutrophil count decreasedb | 0 | 0 | 0 | 2 (14) | 0 | 2 (4) |
Dehydrationb | 0 | 0 | 0 | 0 | 1 (7) | 1 (2) |
Pain in extremityb | 0 | 0 | 1 (7) | 0 | 0 | 1 (2) |
Headacheb | 0 | 0 | 0 | 1 (7) | 0 | 1 (2) |
Sinus headacheb | 0 | 1 (7) | 0 | 0 | 0 | 1 (2) |
Angioneurotic edemab | 0 | 0 | 1 (7) | 0 | 0 | 1 (2) |
Urticariab | 0 | 0 | 0 | 0 | 1 (7) | 1 (2) |