Table 2. Most common treatment-related toxicitiesa.
All adverse events |
Grade 3/4 adverse events
|
||||
---|---|---|---|---|---|
Total | Cohort 1 | Cohort 2 | Cohort 3 | ||
N=32 (%) | N=32 (%) | N=3 (%) | N=20 (%) | N=9 (%) | |
Thrombocytopaenia | 18 (56) | 11 (35) | 3 (100) | 10 (50) | 4 (44) |
Neutropaenia | 19 (59) | 17 (53) | 3 (100) | 7 (35) | 1 (11) |
Febrile neutropaenia | 9 (28) | 9 (28) | 0 | 4 (20) | 1 (11) |
Anaemia | 5 (16) | 0 | |||
Nausea | 20 (63) | 1 (3) | 0 | 1 (5) | 0 |
Vomiting | 10 (31) | 2 (6) | 0 | 2 (10) | 0 |
Constipation | 14 (44) | 0 | |||
Diarrhoea | 6 (19) | 1 (3) | 1 (33) | 0 | 0 |
Fatigue | 13 (41) | 1 (3) | 0 | 1 (5) | 0 |
Cough | 9 (28) | 0 | |||
Anorexia | 9 (28) | 0 | |||
Headache | 12 (38) | 0 | |||
Dizziness | 8 (25) | 0 | |||
Treatment delayed | 24 (75) | 3 (100) | 13 (65) | 8 (89) |
Adverse events considered possibly, probably or highly probably related to treatment occurring in 15% or more patients in any study arm.