Table 2.
Summary of adverse events per MedDRA preferred term (≥ 30% of patients for any adverse events or ≥ 5% treatment-related adverse events)
| Patients with an AE, n (%) N = 26 | All AEs | Treatment-related AEs | ||
|---|---|---|---|---|
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Nausea | 15 (57.7) | 0 | 13 (50.0) | 3 (11.5) |
| Decreased appetite | 14 (53.8) | 0 | 8 (30.8) | 0 |
| Febrile neutropenia | 14 (53.8) | 14 (53.8) | 3 (11.5) | 0 |
| Hypomagnesemia | 13 (50.0) | 0 | 1 (3.8) | 0 |
| Diarrhea | 13 (50.0) | 1 (3.8) | 13 (50.0) | 1 (3.8) |
| Hypokalemia | 11 (42.3) | 6 (23.1) | 0 | 0 |
| Vomiting | 10 (38.5) | 0 | 9 (34.6) | 0 |
| Constipation | 10 (38.5) | 0 | 0 | 0 |
| Fatigue | 10 (38.5) | 1 (3.8) | 7 (26.9) | 1 (3.8) |
| Stomatitis | 9 (34.6) | 3 (11.5) | 5 (19.2) | 1 (3.8) |
| Hypotension | 9 (34.6) | 0 | 0 | 0 |
| Edema peripheral | 9 (34.6) | 0 | 1 (3.8) | 0 |
| Hypophosphatemia | 8 (30.8) | 3 (11.5) | 0 | 0 |
| Hyperphosphatemia | 8 (30.8) | 0 | 0 | 0 |
| Abdominal pain | 8 (30.8) | 1 (3.8) | 5 (19.2) | 0 |
| Epistaxis | 5 (19.2) | 2 (7.7) | 3 (11.5) | 2 (7.7) |
| Dyspepsia | 4 (15.4) | 0 | 2 (7.7) | 0 |
| Alopecia | 4 (15.4) | 0 | 4 (15.4) | 0 |
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities