Table 3 Drug related AEs, Occurring in more than 10% of patients.
AE | AP (n = 73) | AG (n = 84) | p value | ||||
|---|---|---|---|---|---|---|---|
Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | ||
Hematologic | |||||||
Neutropenia | 72 (98.6%) | 16 (21.9%) | 46 (63%) | 63 (75.0%) | 21 (25.0%) | 17 (20.2%) | 0.000 |
Febrile neutropenia | 9 (12.3%) | 9 (12.3%) | 0 | 2 (2.4%) | 1 (1.2%) | 1 (1.2%) | 0.0338 |
Anemia | 68 (93.2%) | 10 (13.7%) | 3 (4.1%) | 21 (25.0%) | 4 (4.8%) | 0 | 0.018 |
Thrombocytopenia | 16 (21.9%) | 1 (1.4%) | 0 | 17 (20.2%) | 6 (7.1%) | 1 (1.2%) | 0.069 |
Non-Hematologic | |||||||
Neuropathy | 53 (72.6%) | 19 (26%) | 0 | 42 (50.0%) | 6 (7.1%) | 0 | 0.001 |
Anorexia | 24 (33.0%) | 0 | 0 | 3 (3.6%) | 0 | 0 | 0.000 |
Fatigue | 25 (34.2%) | 0 | 0 | 14 (16.7%) | 0 | 0 | 0.011 |
Rash | 27 (37%) | 1 (1.4%) | 0 | 28 (33.3%) | 2 (2.4%) | 0 | 0.238 |
Alopecia | 73 (100.0%) | 0 | 0 | 34 (40.5%) | 0 | 0 | 0.000 |
Nausea | 47 (64.4%) | 2 (2.7%) | 0 | 16 (19.1%) | 0 | 0 | 0.000 |
Vomiting | 45 (61.6%) | 2 (2.7%) | 0 | 14 (16.7%) | 0 | 0.000 | |
Diarrhea | 9 (12.3%) | 2 (2.7%) | 0 | 2 (2.4%) | 0 | 0 | 0.0339 |
Constipation | 12 (16.4%) | 0 | 0 | 0 | 0 | 0 | 0.000 |
Abdominal pain | 10 (13.7%) | 0 | 0 | 0 | 0 | 0 | 0.000 |
Skin hyperpigmentation | 14 (19.2%) | 0 | 0 | 8 (9.5%) | 0 | 0 | 0.082 |
Blurred vision | 4 (5.5%) | 0 | 0 | 8 (9.5%) | 0 | 0 | 0.516 |
Nail change | 8 (11.0%) | 0 | 0 | 19 (22.6%) | 0 | 0 | 0.053 |
Edema | 2 (2.7%) | 0 | 0 | 20 (23.8%) | 0 | 0 | 0.000 |
Myalgia | 6 (8.2%) | 0 | 0 | 20 (23.8%) | 1 (1.2%) | 0 | 0.009 |
