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 | | | 3/7 | 2 | 1 | | |
Headaches | 4/9 | 3 | 1 | | | 6/7 | 5 | 1 | | |
anorexia | 7/9 | 7 | | | | 3/7 | 3 | | | |
diarrhoea | 1/9 | 1 | 1 | | | 2/7 | 2 | | | |
Nausea/vomiting | 1/9 | 1 | | | | 3/7 | 3 | | | |
Arthralgia | 1/9 | | | 1 | | 5/7 | 1 | 3 | 1 | |
Insomnia | 6/9 | 4 | 2 | | | 3/7 | 2 | 1 | | |
vertigo | 5/9 | 4 | 1 | | | 0/7 | | | | |
Skin rash | 5/9 | 4 | 1 | | | 2/7 | 1 | 1 | | |
Death | 1/9 | | | | 1 | 1/7 | | | | 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 | | |