Table 2.
Adverse Events
| Adverse Event | Grade | Experimental Arm (N = 83) | Standard Arm (N = 40) | ||
|---|---|---|---|---|---|
| Alopecia | All grades | 37 | (45%) | 19 | (48%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Anemia | All grades | 6 | (7%) | 0 | (0%) |
| Grade 3-4 | 1 | (1%) | 0 | (0%) | |
| Anorexia | All grades | 25 | (30%) | 10 | (25%) |
| Grade 3-4 | 1 | (1%) | 0 | (0%) | |
| Blurred vision | All grades | 16 | (19%) | 3 | (8%) |
| Grade 3-4 | 1 | (1%) | 0 | (0%) | |
| Chills | All grades | 3 | (4%) | 1 | (3%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Constipation | All grades | 30 | (36%) | 15 | (38%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Dehydration | All grades | 9 | (11%) | 2 | (5%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Dermatitis radiation | All grades | 17 | (20%) | 8 | (20%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Diarrhea | All grades | 16 | (19%) | 5 | (13%) |
| Grade 3-4 | 0 | (0%) | 2 | (5%) | |
| Dizziness | All grades | 15 | (18%) | 6 | (15%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Dry mouth | All grades | 12 | (14%) | 7 | (18%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Dysgeusia | All grades | 15 | (18%) | 7 | (18%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Dyspepsia | All grades | 10 | (12%) | 2 | (5%) |
| Grade 3-4 | 1 | (1%) | 0 | (0%) | |
| Ear pain | All grades | 6 | (7%) | 1 | (3%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Edema limbs | All grades | 14 | (17%) | 4 | (10%) |
| Grade 3-4 | 0 | (0%) | 1 | (3%) | |
| Fatigue | All grades | 67 | (81%) | 29 | (73%) |
| Grade 3-4 | 6 | (7%) | 1 | (3%) | |
| Headache | All grades | 57 | (69%) | 20 | (50%) |
| Grade 3-4 | 3 | (4%) | 1 | (3%) | |
| Insomnia | All grades | 31 | (37%) | 7 | (18%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Mucosal infection | All grades | 8 | (10%) | 3 | (8%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Nausea | All grades | 45 | (54%) | 17 | (43%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Vomiting | All grades | 12 | (14%) | 5 | (13%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) | |
| Weight loss | All grades | 10 | (12%) | 3 | (8%) |
| Grade 3-4 | 0 | (0%) | 0 | (0%) |