Table 3.
Treatment-emergent (all-causality) adverse events (AEs) reported in ≥25 % of patients, according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
| Maximum grade (G), n (%) | ||||
|---|---|---|---|---|
| AE | G1 | G2 | G3 | Totala |
| Any AEb | 0 | 0 | 8 | 12 (100) |
| Diarrhea | 4 (33) | 5 (42) | 1 (8) | 10 (83) |
| Hand–foot syndrome | 1 (8) | 7 (58) | 0 | 8 (67) |
| Hypertension | 1 (8) | 7 (58) | 0 | 8 (67) |
| Fatigue | 1 (8) | 6 (50) | 0 | 7 (58) |
| Headache | 4 (33) | 3 (25) | 0 | 7 (58) |
| Neutropenia | 0 | 0 | 6 (50) | 6 (50) |
| Dysgeusia | 5 (42) | 0 | 0 | 5 (42) |
| Nasopharyngitis | 4 (33) | 1 (8) | 0 | 5 (42) |
| Nausea | 4 (33) | 1 (8) | 0 | 5 (42) |
| Pyrexia | 2 (17) | 2 (17) | 1 (8) | 5 (42) |
| Vomiting | 5 (42) | 0 | 0 | 5 (42) |
| Decreased appetite | 4 (33) | 0 | 0 | 4 (33) |
| Edema | 3 (25) | 1 (8) | 0 | 4 (33) |
| Hypothyroidism | 0 | 4 (33) | 0 | 4 (33) |
| Leukopenia | 0 | 1 (8) | 2 (17) | 3 (25) |
| Mucosal inflammation | 2 (17) | 1 (8) | 0 | 3 (25) |
| Muscle spasms | 3 (25) | 0 | 0 | 3 (25) |
| Prolonged electrocardiogram QT | 1 (8) | 1 (8) | 1 (8) | 3 (25) |
| Thrombocytopenia | 1 (8) | 1 (8) | 1 (8) | 3 (25) |
aGrade 4 AEs were observed in 4 patients: convulsion, loss of consciousness, and herpes encephalitis (n = 1), increased lipase (n = 2), and enterocolitis (n = 1); no grade 5 AEs were reported
bPatients were counted once, with only the highest grade AE listed