Clinical | Arm A | Arm B | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Events | Grade | Adverse Events | Grade | |||||||
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |||
Asthenia/fatigue | 5/9 | 4 | 1 | Â | Â | 3/7 | 2 | 1 | Â | Â |
Headaches | 4/9 | 3 | 1 | Â | Â | 6/7 | 5 | 1 | Â | Â |
anorexia | 7/9 | 7 | Â | Â | Â | 3/7 | 3 | Â | Â | Â |
diarrhoea | 1/9 | 1 | 1 | Â | Â | 2/7 | 2 | Â | Â | Â |
Nausea/vomiting | 1/9 | 1 | Â | Â | Â | 3/7 | 3 | Â | Â | Â |
Arthralgia | 1/9 | Â | Â | 1 | Â | 5/7 | 1 | 3 | 1 | Â |
Insomnia | 6/9 | 4 | 2 | Â | Â | 3/7 | 2 | 1 | Â | Â |
vertigo | 5/9 | 4 | 1 | Â | Â | 0/7 | Â | Â | Â | Â |
Skin rash | 5/9 | 4 | 1 | Â | Â | 2/7 | 1 | 1 | Â | Â |
Death | 1/9 | Â | Â | Â | 1 | 1/7 | Â | Â | Â | 1 |
Laboratory | ||||||||||
 Anaemia | 9/9 | 2 | 3 | 2 | 2 | 7/7 | 3 | 2 | 1 | 1 |
 Leukopenia | 3/9 | 3 |  |  |  | 1/7 | 1 |  |  |  |
 Neutropenia | 1/9 | 1 |  |  |  | 2/7 | 1 | 1 |  |  |
 Thrombopenia | 0/9 |  |  |  |  | 1/7 |  | 2 |  |  |
 ALT elevated | 6/9 | 4 | 2 |  |  | 0/7 |  |  |  |  |
 ASAT elevated | 7/9 | 6 | 1 |  |  | 3/7 | 3 |  |  |  |
 Amylasemia elevated | 3/9 | 3 |  |  |  | 2/7 |  | 2 |  |  |
 Bilirubinemia T elevated | 4/9 | 4 |  |  |  | 5/7 | 3 | 2 |  |  |