Table 3 |
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|
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 |
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|
SAD cohorts, n (%) |
MAD cohorts, n (%) |
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|
|
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|
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) |
|
|
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|
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) |
|
|
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|
aIV = intravenously; MAD = multiple ascending dose; SAD = single ascending dose; SC = subcutaneously. |
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|
Emu et al. Arthritis Research & Therapy 2012 14:R6 doi:10.1186/ar3554 |
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