Table 2 Summary of most common ( > 20%) adverse events and grade 3/4 adverse events in > 5% of patients
Overall population (n = 51) | Dose level 3 (recommended dose) (n = 26) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
Alopecia | 1 (2%) | 38 (75%) | 0 | 0 | 39 (76%) | 0 | 24 (92%) | 0 | 0 | 24 (92%) |
Nausea | 21 (41%) | 9 (18%) | 3 (6%) | 2 (4%) | 35 (69%) | 16 (62%) | 3 (12%) | 1 (4%) | 1 (4%) | 21 (81%) |
Fatigue | 12 (24%) | 17 (33%) | 0 | 0 | 29 (57%) | 8 (31%) | 8 (31%) | 0 | 0 | 16 (62%) |
Stomatitis | 18 (35%) | 6 (12%) | 2 (4%) | 0 | 26 (51%) | 8 (31%) | 4 (15%) | 2 (8%) | 0 | 14 (54%) |
Hand-foot syndrome | 7 (14%) | 6 (12%) | 7 (14%) | 0 | 20 (39%) | 5 (19%) | 4 (15%) | 4 (15%) | 0 | 13 (50%) |
Nail disorder | 7 (14%) | 11 (22%) | 0 | 1 (2%) | 19 (37%) | 4 (15%) | 6 (23%) | 0 | 0 | 10 (38%) |
Constipation | 14 (27%) | 5 (10%) | 0 | 0 | 19 (37%) | 5 (19%) | 3 (12%) | 0 | 0 | 8 (31%) |
Arthralgia | 6 (12%) | 9 (18%) | 1 (2%) | 0 | 1 (31%) | 4 (15%) | 3 (12%) | 1 (4%) | 0 | 8 (31%) |
Bone pain | 7 (14%) | 5 (10%) | 0 | 0 | 12 (24%) | 5 (19%) | 3 (12%) | 0 | 0 | 8 (31%) |
Paraesthesia | 6 (12%) | 4 (8%) | 1 (2%) | 1 (2%) | 12 (24%) | 3 (12%) | 3 (12%) | 0 | 0 | 6 (23%) |
Diarrhoea | 5 (10%) | 3 (6%) | 2 (4%) | 2 (4%) | 12 (24%) | 1 (4%) | 2 (8%) | 1 (4%) | 1 (4%) | 5 (19%) |
Headache | 5 (10%) | 4 (8%) | 2 (4%) | 0 | 11 (22%) | 3 (12%) | 0 | 1 (4%) | 0 | 4 (15%) |
Anorexia | 6 (12%) | 5 (10%) | 0 | 0 | 11 (22%) | 4 (15%) | 1 (4%) | 0 | 0 | 5 (19%) |
Vomiting | 7 (14%) | 2 (4%) | 4 (8%) | 2 (4%) | 15 (29%) | 3 (12%) | 0 | 2 (8%) | 2 (8%) | 7 (27%) |
Febrile neutropenia | 0 | 0 | 3 (6%) | 3 (6%) | 6 (12%) | 0 | 0 | 2 (8%) | 0 | 2 (8%) |
Neutropenia | 0 | 1 (2%) | 1 (2%) | 2 (4%) | 4 (8%) | 0 | 1 (4%) | 1 (4%) | 1 (4%) | 3 (12%) |
Impaired healing | 0 | 0 | 1 (2%) | 1 (2%) | 2 (4%) | 0 | 0 | 1 (4%) | 1 (4%) | 2 (8%) |
Myalgia | 6 (12%) | 2 (4%) | 0 | 0 | 8 (16%) | 6 (23%) | 1 (4%) | 0 | 0 | 7 (27%) |
Hypersensitivity | 3 (6%) | 2 (4%) | 1 (2%) | 0 | 6 (12%) | 3 (12%) | 2 (8%) | 1 (4%) | 0 | 6 (23%) |