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Table 2 Number (percentage) of subjects with at least one suspected (or not assessable) adverse event, according to intensity

From: Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study

Initial phase
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%)   
  1. 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).