Table 2.
Treatment-related adverse events (TRAEs)
| Any Grade | Grade 3 | Grade 4 | ||||
|---|---|---|---|---|---|---|
| Event | N | % | N | % | N | % |
| Any TRAEs | 42 | 97.7 | 33 | 76.7 | 2 | 4.7 |
| Hematologic | ||||||
| Neutrophil count decreased | 20 | 46.5 | 17 | 39.5 | 1 | 2.3 |
| Anemia | 14 | 32.6 | 7 | 16.3 | 0 | 0 |
| Platelet count decreased | 7 | 16.3 | 3 | 7 | 0 | 0 |
| Febrile neutropenia | 5 | 11.6 | 4 | 9.3 | 0 | 0 |
| Non-hematologic | ||||||
| Anorexia | 17 | 39.5 | 2 | 4.7 | 0 | 0 |
| Nausea | 14 | 32.6 | 0 | 0 | 0 | 0 |
| Creatinine increased | 13 | 30.2 | 2 | 4.7 | 0 | 0 |
| Diarrhea | 13 | 30.2 | 1 | 2.3 | 0 | 0 |
| Hand-foot syndrome | 10 | 23.3 | 0 | 0 | 0 | 0 |
| Oral mucositis | 10 | 23.3 | 1 | 2.3 | 0 | 0 |
| General weakness | 8 | 18.6 | 1 | 2.3 | 0 | 0 |
| Peripheral neuropathy | 8 | 18.6 | 0 | 0 | 0 | 0 |
| Abdominal pain | 6 | 14 | 0 | 0 | 0 | 0 |
| Fever | 6 | 14 | 0 | 0 | 0 | 0 |
| Hypoalbuminemia | 2 | 4.7 | 1 | 2.3 | 0 | 0 |
| Hyperkalemia | 2 | 4.7 | 2 | 4.7 | 0 | 0 |
| Tinnitus | 2 | 4.7 | 0 | 0 | 0 | 0 |
| Thromboembolic event | 2 | 4.7 | 0 | 0 | 1 | 2.3 |
| Immune-related | ||||||
| Hypothyroidism | 5 | 11.6 | 0 | 0 | 0 | 0 |
| Allergic reaction | 4 | 9.3 | 1 | 2.3 | 0 | 0 |
| Pruritus | 4 | 9.3 | 0 | 0 | 0 | 0 |
| Colitis | 3 | 7 | 3 | 7 | 0 | 0 |
| Adrenal insufficiency | 2 | 4.7 | 0 | 0 | 0 | 0 |
| Hyperglycemia | 2 | 4.7 | 0 | 0 | 0 | 0 |
| Skin rash | 2 | 4.7 | 0 | 0 | 0 | 0 |
One patient died from Grade 5 pneumonia related to disease progression.