Table 3

Treatment-emergent adverse events by preferred term occurring in at least two patients from all pateclizumab-treated groups combined during either single or multiple ascending dose phasesa

SAD cohorts, n (%)

MAD cohorts, n (%)


Adverse events

Placebo

(n = 6)

All active

(n = 24)

Placebo

(n = 7)

1.0 mg/kg SC

(n = 8)

3.0 mg/kg SC

(n = 16)

5.0 mg/kg IV

(n = 4)

All active

(n = 28)


Any event

3 (50.0)

20 (66.7)

4 (57.1)

7 (87.5)

8 (50.0)

1 (25.0)

20 (57.1)

Fatigue

0 (0.0)

2 (8.3)

1 (14.3)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Rheumatoid arthritis

0 (0.0)

2 (8.3)

0 (0.0)

1 (12.5)

1 (6.3)

0 (0.0)

2 (7.1)

Rash

0 (0.0)

2 (8.3)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Diarrhea

0 (0.0)

1 (4.2)

0 (0.0)

3 (37.5)

1 (6.3)

0 (0.0)

4 (14.3)

Vomiting

0 (0.0)

0 (0.0)

0 (0.0)

2 (25.0)

0 (0.0)

0 (0.0)

2 (7.1)

Nasopharyngitis

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

2 (12.5)

0 (0.0)

2 (7.1)

Headache

0 (0.0)

1 (4.2)

0 (0.0)

2 (25.0)

1 (6.3)

1 (25.0)

4 (14.3)

Rhinorrhea

0 (0.0)

0 (0.0)

0 (0.0)

1 (12.5)

1 (6.3)

0 (0.0)

2 (7.1)


aIV = intravenously; MAD = multiple ascending dose; SAD = single ascending dose; SC = subcutaneously.

Emu et al. Arthritis Research & Therapy 2012 14:R6   doi:10.1186/ar3554

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