TABLE 2.
Adverse events reported in >10% of patients (all grades; safety population; N = 76)
| Adverse event, n (%) | All grades | Treatment related | Grade 3/4 |
|---|---|---|---|
| Fatigue | 49 (64.5) | 43 (56.6) | 3 (3.9) |
| Alopecia | 28 (36.8) | 26 (34.2) | 0 |
| Nausea | 27 (35.5) | 24 (31.6) | 2 (2.6) |
| Constipation | 23 (30.3) | 14 (18.4) | 0 |
| Peripheral neuropathy | 21 (27.6) | 16 (21.1) | 1 (1.3) |
| Decreased appetite | 17 (22.4) | 13 (17.1) | 1 (1.3) |
| Diarrhoea | 16 (21.1) | 8 (10.5) | 1 (1.3) |
| Headache | 15 (19.7) | 5 (6.6) | 0 |
| Dyspnoea | 15 (19.7) | 7 (9.2) | 4 (5.3) |
| Neutropenia | 14 (18.4) | 13 (17.1) | 7 (9.2) |
| Vomiting | 13 (17.1) | 10 (13.2) | 3 (3.9) |
| Pyrexia | 10 (13.2) | 7 (9.2) | 0 |
| Mucosal inflammation | 10 (13.2) | 8 (10.5) | 1 (1.3) |
| Arthralgia | 9 (11.8) | 3 (3.9) | 1 (1.3) |
| Cough | 9 (11.8) | 3 (3.9) | 0 |
| Stomatitis | 9 (11.8) | 8 (10.5) | 0 |
| Palmar‐plantar erythrodysaesthesia syndrome | 8 (10.5) | 7 (9.2) | 1 (1.3) |
Note: An adverse event with the same preferred term for the same patient was counted only once. If a patient had the same event more than once, the worst National Cancer Institute Common Terminology Criteria grade was selected within a same group of system/organ/class and preferred term per Medical Dictionary for Regulatory Activities version 17.0.