Table 3.
Comparison of adverse events by the best objective response on target lesions
| Adverse events | All grades (%) | Grades 3/4 (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| All cases (n = 50) | CR/PR (n = 12) | SD (n = 22) | PD (n = 6) | NE (n = 10) | All cases (n = 50) | CR/PR (n = 12) | SD (n = 22) | PD (n = 6) | NE (n = 10) | |
| Any | 100 | 100 | 100 | 100 | 100 | 30 | 25 | 27 | 50 | 30 |
| Hematologic | ||||||||||
| Anemia | 58 | 58 | 54 | 67 | 60 | 4 | 0 | 0 | 17 | 10 |
| Neutorophils decreased | 44 | 50 | 46 | 67 | 20 | 6 | 0 | 5 | 33 | 0 |
| Lymphocyte decreased | 36 | 42 | 36 | 50 | 20 | 6 | 8 | 5 | 0 | 10 |
| Platelet decreased | 58 | 67 | 50 | 83 | 50 | 24 | 17 | 27 | 50 | 10 |
| Creatinine increased | 38 | 33 | 41 | 33 | 40 | 0 | – | – | – | – |
| Non-hematologic | ||||||||||
| Hypertension* | 56 | 84 | 59 | 33 | 30 | 2 | 0 | 5 | 0 | 0 |
| Hypothyroidism* | 46 | 42 | 59 | 33 | 30 | 0 | – | – | – | – |
| Fatigue | 36 | 33 | 32 | 50 | 40 | 0 | – | – | – | – |
| Diarrhea | 30 | 33 | 36 | 0 | 30 | 0 | – | – | – | – |
| Mucositis oral | 28 | 17 | 46 | 17 | 10 | 0 | – | – | – | – |
| Hand-foot syndrome | 20 | 25 | 27 | 17 | 0 | 0 | – | – | – | – |
| Fever up | 18 | 25 | 9 | 33 | 20 | 0 | – | – | – | – |
| Hemorrhage | 16 | 8 | 23 | 17 | 10 | 0 | – | – | – | – |
| Heart failure | 4 | 8 | 5 | 0 | 0 | 0 | – | – | – | – |
All the statistical analysis is performed with Fisher’s exact test, * P < 0.05
CR complete response; PR pertial response; SD stable disease; PD progressive disease; NE not evaluable