Table 4 Treatment-related adverse events occurring in ≥10% patients.
TRAEs | RP2D, N = 18; n (%) | All patients, N = 32; n (%) | ||||
|---|---|---|---|---|---|---|
Grade 3 | Grade 4 | Any Grade | Grade 3 | Grade 4 | Any grade | |
Haematopoietic | ||||||
Thrombocytopenia | 6 (33.3) | 3 (16.7) | 14 (77.8) | 8 (25.0) | 7 (21.9) | 23 (71.9) |
Anaemia | 2 (11.1) | 0 | 11 (61.1) | 6 (18.8) | 0 | 17 (53.1) |
Leukopenia | 2 (11.1) | 0 | 5 (27.8) | 3 (9.4) | 0 | 11 (34.4) |
Neutropenia | 1 (5.6) | 0 | 6 (33.3) | 2 (6.3) | 0 | 9 (28.1) |
Gastrointestinal | ||||||
Nausea | 2 (11.1) | 0 | 14 (77.8) | 2 (6.3) | 0 | 23 (71.9) |
Decreased appetite | 1 (5.6) | 0 | 9 (50.0) | 1 (3.1) | 0 | 15 (46.9) |
Dysgeusia | 0 | 0 | 7 (38.9) | 0 | 0 | 10 (31.3) |
Diarrhoea | 0 | 0 | 3 (16.7) | 0 | 0 | 8 (25.0) |
Constipation | 0 | 0 | 2 (11.1) | 0 | 0 | 6 (18.8) |
Vomiting | 0 | 0 | 4 (22.2) | 1 (3.1) | 0 | 5 (15.6) |
Constitutional | ||||||
Fatigue | 1 (5.6) | 0 | 10 (55.6) | 3 (9.4) | 0 | 17 (53.1) |
Weight decreased | 0 | 0 | 8 (44.4) | 0 | 0 | 13 (40.6) |
Insomnia | 0 | 0 | 2 (11.1) | 0 | 0 | 4 (12.5) |
Neurology | ||||||
Peripheral neuropathy | 1 (5.6) | 0 | 5 (27.8) | 1 (3.1) | 0 | 6 (18.8) |
Other | ||||||
Dyspnoea | 0 | 0 | 1 (5.6) | 0 | 0 | 6 (18.8) |
Hyperglycaemia | 1 (5.6) | 0 | 3 (16.7) | 1 (3.1) | 1 (3.1) | 6 (18.8) |
Blurred vision | 0 | 0 | 3 (16.7) | 0 | 0 | 6 (18.8) |
Hyponatraemia | 1 (5.6) | 0 | 4 (22.2) | 1 (3.1) | 0 | 6 (18.8) |
Hypomagnaesemia | 0 | 0 | 3 (16.7) | 0 | 0 | 5 (15.6) |
Hypocalcaemia | 0 | 0 | 2 (11.1) | 0 | 0 | 4 (12.5) |
Insomnia | 0 | 0 | 2 (11.1) | 0 | 0 | 4 (12.5) |