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%) |