Table 3.
Treatment Related Adverse Events
| Adverse Event | Level 1 (N=3) | Level 2 (N=12) | Level 3 (N=3) | Total (N=18) N (%) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 | All Cycles | Cycle 1 | All Cycles | Cycle 1 | All Cycles | ||||||||
| Grade ≥3 | Grade 1/2 | Grade 3/4 | Total N (%) | Grade ≥3 | Grade 1/2 | Grade 3/4 | Total N (%) | Grade ≥3 | Grade 1/2 | Grade 3/4 | Total N (%) | ||
| Abdominal infection | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Anemia | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 (17) | 0 | 1 | 0 | 1 (33) | 3 (17) |
| Anorexia | 0 | 2 | 0 | 2 (67) | 0 | 7 | 1 | 8 (67) | 1 | 2 | 1 | 3 (100) | 13 (72) |
| Blurred vision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Cheilitis | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Constipation | 0 | 2 | 0 | 2 (67) | 0 | 7 | 0 | 7 (58) | 0 | 1 | 0 | 1 (33) | 10 (56) |
| Diarrhea | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 4 (33) | 0 | 0 | 0 | 0 | 4 (22) |
| Dizziness | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Dysgeusia | 0 | 1 | 0 | 1 (33) | 0 | 1 | 0 | 1 (8) | 0 | 1 | 0 | 1 (33) | 3 (17) |
| Dyspepsia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 1 | 0 | 1 (33) | 2 (11) |
| Edema | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Fatigue | 0 | 1 | 0 | 1 (33) | 1 | 6 | 2 | 8 (67) | 2 | 0 | 2 | 2 (67) | 11 (61) |
| Fever | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 (17) | 0 | 0 | 0 | 0 | 2 (11) |
| Flushing | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Headache | 0 | 1 | 0 | 1 (33) | 0 | 3 | 0 | 3 (25) | 0 | 1 | 0 | 1 (33) | 5 (28) |
| Hyperglycemia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Hypomagnesemia | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Insomnia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Lymphocyte count decreased | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Mucosal infection | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Myalgia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8) | 0 | 0 | 0 | 0 | 1 (6) |
| Nausea | 0 | 3 | 0 | 3 (100) | 0 | 9 | 0 | 9 (75) | 1 | 2 | 1 | 3 (100) | 15 (83) |
| Neutrophil count decreased | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 3 (25) | 0 | 0 | 2 | 2 (67) | 5 (28) |
| Platelet count decreased | 0 | 1 | 0 | 1 (33) | 0 | 3 | 0 | 3 (25) | 0 | 0 | 1 | 1 (33) | 5 (28) |
| Vomiting | 0 | 1 | 0 | 1 (33) | 0 | 2 | 0 | 2 (17) | 0 | 2 | 0 | 2 (67) | 5 (28) |
| Weight loss | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 (17) | 0 | 2 | 0 | 2 (67) | 4 (22) |
| White blood cell decreased | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 2 (17) | 0 | 0 | 0 | 0 | 2 (11) |