Table 2.
Treatment-related adverse events observed
| Adverse Event (AE) | Any Grade, n (%) N = 42 |
Grade ≥ 3, n (%) N = 42 |
|---|---|---|
| Subjects with ≥1 AE related to study treatment | 40 (95.2) | 9 (21.4) |
| Subjects with ≥1 SAE related to study treatment | 7 (16.7) | 5 (11.9) |
| Fatigue | 18 (42.9) | 4 (9.5) |
| Nausea | 18 (42.9) | 1 (2.4) |
| Vomiting | 14 (33.3) | 0 |
| Decreased appetite | 16 (38.1) | 1 (2.4) |
| Diarrhea | 12 (28.6) | 0 |
| Rash | 8 (19.0) | 3 (7.1) |
| Oral Mucositis | 5 (11.9) | 0 |
| Mucosal inflammation | 4 (9.5) | 0 |
| Pruritus | 4 (9.5) | 2 (4.8) |
| Blood creatinine increased | 4 (9.5) | 0 |
| Weight decreased | 4 (9.5) | 0 |
AE adverse event, N total number of patients, n number of patients in the specified category, SAE serious adverse event