Table 2.
Treatment-emergent adverse events that occurred in ≥10% of patients in either cohort (N = 54)
| Adverse eventa | Cohort A (n = 37) |
Cohort B (n = 17) |
||
|---|---|---|---|---|
| Any, n (%) | Grade ≥3, n (%) | Any, n (%) | Grade ≥3, n (%) | |
| All | 37 (100.0) | 29 (78.4) | 17 (100.0) | 14 (82.4) |
| Nausea | 22 (59.5) | 1 (2.7) | 8 (47.1) | 0 (0) |
| Diarrhoea | 14 (37.8) | 1 (2.7) | 10 (58.8) | 2 (11.8) |
| Vomiting | 15 (40.5) | 2 (5.4) | 8 (47.1) | 1 (5.9) |
| Stomatitis | 9 (24.3) | 1 (2.7) | 2 (11.8) | 0 (0) |
| Abdominal pain | 7 (18.9) | 0 (0) | 3 (17.6) | 0 (0) |
| Constipation | 6 (16.2) | 0 (0) | 2 (11.8) | 0 (0) |
| Paraesthesia | 9 (24.3) | 0 (0) | 7 (41.2) | 1 (5.9) |
| Peripheral sensory neuropathy | 14 (37.8) | 1 (2.7) | 4 (23.5) | 0 (0) |
| Neuropathy peripheral | 4 (10.8) | 0 (0) | 4 (23.5) | 1 (5.9) |
| Neurotoxicity | 0 (0) | 0 (0) | 2 (11.8) | 0 (0) |
| Headache | 5 (13.5) | 0 (0) | 1 (5.9) | 0 (0) |
| Dizziness | 4 (10.8) | 0 (0) | 1 (5.9) | 0 (0) |
| Dysgeusia | 3 (8.1) | 0 (0) | 2 (11.8) | 0 (0) |
| Fatigue | 13 (35.1) | 3 (8.1) | 8 (47.1) | 4 (23.5) |
| Asthenia | 12 (32.4) | 2 (5.4) | 7 (41.2) | 0 (0) |
| Pyrexia | 8 (21.6) | 0 | 3 (17.6) | 0 (0) |
| Neutropenia/decreased neutrophil count | 28 (75.7) | 14 (37.8) | 12 (70.6) | 8 (47.1) |
| Thrombocytopenia/decreased platelet count | 12 (32.4) | 1 (2.7) | 6 (35.3) | 2 (11.8) |
| Anaemia/decreased haemoglobin | 10 (27.0) | 3 (8.1) | 5 (29.4) | 3 (17.6) |
| Weight decreased | 5 (13.5) | 1 (2.7) | 3 (17.6) | 0 (0) |
| Back pain | 4 (10.8) | 0 (0) | 2 (11.8) | 0 (0) |
| Arthralgia | 4 (10.8) | 0 (0) | 0 (0) | 0 (0) |
| Decreased appetite | 13 (35.1) | 1 (2.7) | 6 (35.3) | 0 (0) |
| Epistaxis | 4 (10.8) | 0 (0) | 0 (0) | 0 (0) |
| Hiccups | 1 (2.7) | 0 (0) | 2 (11.8) | 0 (0) |
| Pulmonary embolism | 0 (0) | 0 (0) | 2 (11.8) | 1 (5.9) |
| Hypertension | 7 (18.9) | 6 (16.2) | 0 (0) | 0 (0) |
| Malignant neoplasm progression | 4 (10.8) | 4 (10.8) | 3 (17.6) | 1 (5.9) |
| Insomnia | 4 (10.8) | 0 (0) | 0 (0) | 0 (0) |
a
Adverse events were coded using MedDRA 21.0 (MedDRA is registered by IFPMA on behalf of ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use]).