Table 2.
Most frequent (>10% overall frequency) treatment-emergent adverse events
| Adverse event | Grade 1a | Grade 2a | Grade 3a | Total |
|---|---|---|---|---|
| Diarrhea | 8 (38.1) | 3 (14.3) | 0 (0.0) | 11 (52.4) |
| Dysgeusia | 5 (23.8) | 3 (14.3) | 0 (0.0) | 8 (38.1) |
| Palmar–plantar erythrodysesthesia | 6 (28.6) | 2 (9.5) | 0 (0.0) | 8 (38.1) |
| Hypertension | 2 (9.5) | 3 (14.3) | 3 (14.3) | 8 (38.1) |
| Mucosal inflammation | 3 (14.3) | 4 (19.0) | 0 (0.0) | 7 (33.3) |
| Decreased appetite | 3 (14.3) | 3 (14.3) | 1 (4.8) | 7 (33.3) |
| Neutropenia | 0 0.0 | 3 (14.3) | 3 (14.3) | 6 (28.6) |
| Anemia | 1 (4.8) | 1 (4.8) | 2 (9.5) | 4 (19.0) |
| Nausea | 2 (9.5) | 2 (9.5) | 0 (0.0) | 4 (19.0) |
| Dyspepsia | 3 (14.3) | 0 (0.0) | 0 (0.0) | 3 (14.3) |
| Abdominal pain | 3 (14.3) | 0 (0.0) | 0 (0.0) | 3 (14.3) |
| Peripheral edema | 3 (14.3) | 0 (0.0) | 0 (0.0) | 3 (14.3) |
| Thrombocytopenia | 0 0.0 | 1 (4.8) | 2 (9.5) | 3 (14.3) |
| Epistaxis | 2 (9.5) | 1 (4.8) | 0 (0.0) | 3 (14.3) |
| Back pain | 1 (4.8) | 1 (4.8) | 0 (0.0) | 3 (14.3)b |
a
There were no grade 4 or 5 adverse events except for one patient who exhibited grade 5 pancytopenia.
b
An additional patient reported back pain without grading.