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


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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