Table 3.
Adverse events of major clinical concern(all grades) irrespective of relation to study drug treatment (n = 30 patients who received at least on dose of study drugs)
| Adverse event (maximum grade per patient) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||||
|---|---|---|---|---|---|---|---|---|
| Number | Percent | Number | Percent | Number | Percent | Number | Percent | |
| Anemia | 5 | 17 | 6 | 20 | 0 | 0 | ||
| Leukocytopenia | 5 | 17 | 4 | 13 | 7 | 23 | 7 | 23 |
| Infection | 7 | 23 | 13 | 43 | 1 | 3 | 1 | 3 |
| Herpes zoster | 0 | 1 | 3 | 0 | 0 | |||
| Thrombocytopenia | 12 | 40 | 5 | 17 | 2 | 7 | 0 | |
| Bleeding | 1 | 3 | 0 | 1 | 3 | 0 | ||
| Neuropathy | 12 | 40 | 4 | 13 | 3 | 10 | 0 | |
| Fatigue | 3 | 10 | 4 | 13 | 0 | 0 | ||
| Constipation | 6 | 20 | 1 | 3 | 0 | 0 | ||
| Diarrhea | 2 | 7 | 3 | 10 | 0 | 0 | ||
| Liver, AST/ASL | 3 | 10 | 2 | 7 | 0 | 0 | ||
| Renal failure | 0 | 0 | 1 | 3 | 0 | |||
| Hyperglycemia | 1 | 3 | 0 | 0 | 0 | |||
| Cardiovascular events | 3 | 10 | 0 | 0 | 0 | |||
| Hypotension | 1 | 3 | 0 | 0 | 0 | |||
| Dyspnea | 5 | 17 | 0 | 1 | 3 | 0 | ||
| Edema | 4 | 13 | 0 | 0 | 0 | |||
| Venous thromboembolic events | 0 | 2 | 7 | 0 | 0 | |||
| Myopathy | 0 | 0 | 0 | 0 | ||||
| Mucositis | 1 | 3 | 1 | 3 | 0 | 0 | ||
| Skin | 8 | 27 | 1 | 3 | 0 | 0 | ||
The adverse event category “infection” summarizes the following events: infection, pneumonia, pharyngitis, upper respiratory tract infection, bronchitis, febrile aplasia, febrile neutropenia, respiratory tract infection bacterial, tonsillitis, urinary tract infection, rhinitis, and nasopharyngitis.
AST serum aspartate amino transferase, ASL serum alanine aminotransferase