Table 3 |
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|
Incidence (three or more patients) of adverse events by dose: single-dose and double-dose cohorts combined |
||||||
|
Adverse event |
Placebo (n = 13) |
Belimumab |
||||
|
|
||||||
|
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) |
|
|
||||||
|
Values are expressed as n (%). aGrade 4 potentially life-threatening adverse event. bGrade 3 severe adverse event |
||||||
|
Furie et al. Arthritis Research & Therapy 2008 10:R109 doi:10.1186/ar2506 |
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