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