Table 2 |
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|
Number (percentage) of subjects with at least one suspected (or not assessable) adverse event, according to intensity |
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|
Initial phase |
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|
|
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|
System organ class/preferred terma |
All (n = 43) |
Mild |
Moderate |
Severe |
|
At least one suspected AEb |
40 (93.0%) |
29 (67.4%) |
27 (62.8%) |
9 (20.9%) |
|
Rash-All categories |
13 (30.2%) |
7 (16.3%) |
8 (18.6%) |
2 (4.7%) |
|
Oedema-All categories |
11 (25.6%) |
2 (4.7%) |
6 (14.0%) |
3 (7.0%) |
|
Nausea |
10 (23.3%) |
6 (14.0%) |
5 (11.6%) |
|
|
Diarrhoea |
8 (18.6%) |
5 (11.6%) |
2 (4.7%) |
1 (2.3%) |
|
Headache |
6 (14.0%) |
4 (9.3%) |
2 (4.7%) |
|
|
Abdominal pain, upper |
5 (11.6%) |
4 (9.3%) |
1 (2.3%) |
|
|
Vomiting |
5 (11.6%) |
1 (2.3%) |
4 (9.3%) |
|
|
Asthenia |
5 (11.6%) |
4 (9.3%) |
1 (2.3%) |
|
|
Pyrexia |
3 (7.0%) |
1 (2.3%) |
1 (2.3%) |
1 (2.3%) |
|
Herpes simplex |
3 (7.0%) |
2 (4.7%) |
1 (2.3%) |
|
|
Weight decreased |
3 (7.0%) |
2 (4.7%) |
1 (2.3%) |
|
|
Dyspnoea |
3 (7.0%) |
1 (2.3%) |
1 (2.3%) |
1 (2.3%) |
|
Abdominal pain |
2 (4.7%) |
1 (2.3%) |
1 (2.3%) |
|
|
Dry mouth |
2 (4.7%) |
1 (2.3%) |
1 (2.3%) |
|
|
Hyperthermia |
2 (4.7%) |
1 (2.3%) |
1 (2.3%) |
|
|
Gastroenteritis |
2 (4.7%) |
2 (4.7%) |
||
|
Blood creatinine increased |
2 (4.7%) |
1 (2.3%) |
1 (2.3%) |
|
|
Cough |
2 (4.7%) |
1 (2.3%) |
1 (2.3%) |
|
|
Alopecia |
2 (4.7%) |
2 (4.7%) |
||
|
Petechiae |
2 (4.7%) |
1 (2.3%) |
1 (2.3%) |
|
|
Extension phase |
||||
|
|
||||
|
System organ class/preferred term |
All (n = 21) |
Mild |
Moderate |
Severe |
|
At least one suspected AE |
10 (47.6%) |
4 (19.0%) |
3 (14.3%) |
3 (14.3%) |
|
Oedema-All categories |
2 (9.5%) |
2 (9.5%) |
||
|
Leukopenia |
1 (4.8%) |
1 (4.8%) |
||
|
Vertigo |
1 (4.8%) |
1 (4.8%) |
||
|
Aphthous stomatitis |
1 (4.8%) |
1 (4.8%) |
||
|
Asthenia |
1 (4.8%) |
1 (4.8%) |
||
|
Pyrexia |
1 (4.8%) |
1 (4.8%) |
||
|
Liver disorder |
1 (4.8%) |
1 (4.8%) |
||
|
Gastroenteritis |
1 (4.8%) |
1 (4.8%) |
||
|
Nasopharyngitis |
1 (4.8%) |
1 (4.8%) |
||
|
Rhinitis |
1 (4.8%) |
1 (4.8%) |
||
|
Neutrophil count decreased |
1 (4.8%) |
1 (4.8%) |
||
|
Rheumatoid arthritis |
1 (4.8%) |
1 (4.8%) |
||
|
Bronchopneumopathy |
1 (4.8%) |
1 (4.8%) |
||
|
Pleural effusion |
1 (4.8%) |
1 (4.8%) |
||
|
Eczema |
1 (4.8%) |
1 (4.8%) |
||
|
Onychoclasis |
1 (4.8%) |
1 (4.8%) |
||
|
Photosensitivity reaction |
1 (4.8%) |
1 (4.8%) |
||
|
|
||||
|
Table includes those adverse events (AEs) that occurred commonly (that is, in greater than 4% of patients). aMedDRA (medical dictionary for regulatory activities) terminology. bAE intensity count is cumulative. AEs were recorded only once (at their start date). |
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|
Tebib et al. Arthritis Research & Therapy 2009 11:R95 doi:10.1186/ar2740 |
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