Table 3.
Treatment-related adverse events (AEs) reported at an incidence ≥10 %
| AE | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total |
|---|---|---|---|---|---|
| Any AE | 7 (13.5) | 11 (21.2) | 12 (23.1) | 19 (36.5) | 50 (96.2)a |
| Hematologic AEs | |||||
| Neutropenia | 0 (0) | 2 (3.8) | 8 (15.4) | 16 (30.8) | 26 (50.0) |
| Leukopenia | 0 (0) | 1 (1.9) | 9 (17.3) | 2 (3.8) | 12 (23.1) |
| Non-hematologic AEs | |||||
| Alopecia | 26 (50.0) | 9 (17.3) | 0 (0) | 0 (0) | 35 (67.3) |
| Decreased appetite | 14 (26.9) | 11 (21.2) | 4 (7.7) | 0 (0) | 29 (55.8) |
| Peripheral sensory neuropathy | 12 (23.1) | 10 (19.2) | 3 (5.8) | 0 (0) | 25 (48.1) |
| Fatigue | 5 (9.6) | 12 (23.1) | 5 (9.6) | 0 (0) | 22 (42.3) |
| Rash | 11 (21.2) | 5 (9.6) | 1 (1.9) | 0 (0) | 17 (32.7) |
| Diarrhea | 10 (19.2) | 1 (1.9) | 3 (5.8) | 0 (0) | 14 (26.9) |
| Constipation | 9 (17.3) | 4 (7.7) | 0 (0) | 0 (0) | 13 (25.0) |
| Nausea | 8 (15.4) | 4 (7.7) | 1 (1.9) | 0 (0) | 13 (25.0) |
| Myalgia | 9 (17.3) | 2 (3.8) | 1 (1.9) | 0 (0) | 12 (23.1) |
| Arthralgia | 7 (13.5) | 4 (7.7) | 0 (0) | 0 (0) | 11 (21.2) |
| Weight decreased | 2 (3.8) | 9 (17.3) | 0 (0) | 0 (0) | 11 (21.2) |
| Pruritus | 6 (11.5) | 3 (5.8) | 0 (0) | 0 (0) | 9 (17.3) |
| Pyrexia | 8 (15.4) | 0 (0) | 0 (0) | 0 (0) | 8 (15.4) |
| Vomiting | 5 (9.6) | 3 (5.8) | 0 (0) | 0 (0) | 8 (15.4) |
| Stomatitis | 2 (3.8) | 3 (5.8) | 2 (3.8) | 0 (0) | 7 (13.5) |
| Asthenia | 1 (1.9) | 5 (9.6) | 0 (0) | 0 (0) | 6 (11.5) |
| Dysgeusia | 5 (9.6) | 1 (1.9) | 0 (0) | 0 (0) | 6 (11.5) |
| Hypoesthesia | 2 (3.8) | 3 (5.8) | 1 (1.9) | 0 (0) | 6 (11.5) |
| Nail disorder | 5 (9.6) | 0 (0) | 1 (1.9) | 0 (0) | 6 (11.5) |
aIncludes 1 patient with grade 5 pneumonia and neutropenic sepsis