AEs occurring in ≥10% in either arm (HU or PEG), regardless of attribution
| . | HU (n = 80) . | PEG (n = 82) . | ||||||
|---|---|---|---|---|---|---|---|---|
| AE . | Grade 1-2, n (%) . | Grade 3-4, n (%) . | Grade 1-2, n (%) . | Grade 3-4, n (%) . | ||||
| Hematologic | ||||||||
| Leukopenia* | 11 | 14 | 22 | 27 | ||||
| Anemia | 14 | 18 | 11 | 13 | 1 | 1 | ||
| Thrombocytopenia | 11 | 14 | 1 | 1 | 10 | 12 | ||
| Neutropenia | 6 | 8 | 3 | 4 | 7 | 9 | 2 | 2 |
| Lymphopenia | 4 | 5 | 1 | 1 | 6 | 7 | 3 | 4 |
| Nonhematologic | ||||||||
| Fatigue | 34 | 43 | 2 | 3 | 40 | 49 | 6 | 7 |
| Pain in extremity | 14 | 18 | 2 | 3 | 16 | 20 | 1 | 1 |
| Headache | 12 | 15 | 18 | 22 | 3 | 4 | ||
| Diarrhea | 11 | 14 | 1 | 1 | 14 | 17 | ||
| Peripheral sensory neuropathy | 7 | 9 | 3 | 4 | 16 | 20 | ||
| Nausea | 12 | 15 | 13 | 16 | ||||
| Flu-like symptoms* | 4 | 5 | 18 | 22 | 2 | 2 | ||
| Cough | 10 | 13 | 12 | 15 | ||||
| Pruritus* | 5 | 6 | 14 | 17 | 2 | 2 | ||
| Abdominal pain | 5 | 6 | 1 | 1 | 13 | 16 | ||
| Injection site reaction* | 18 | 22 | ||||||
| Constipation | 12 | 15 | 5 | 6 | ||||
| Dizziness | 9 | 11 | 8 | 10 | ||||
| Hyperglycemia | 5 | 6 | 1 | 1 | 9 | 11 | 2 | 2 |
| Dyspnea | 5 | 6 | 10 | 12 | 2 | 2 | ||
| Back pain | 4 | 5 | 2 | 3 | 9 | 11 | 1 | 1 |
| Upper respiratory infection | 5 | 6 | 11 | 13 | ||||
| Alanine aminotransferase increased* | 3 | 4 | 1 | 1 | 10 | 12 | 2 | 2 |
| Mucositis, oral* | 12 | 15 | 1 | 1 | 2 | 2 | ||
| Urinary tract infection | 5 | 6 | 3 | 4 | 6 | 7 | ||
| Rash, maculopapular | 8 | 10 | 5 | 6 | 1 | 1 | ||
| Blurred vision | 5 | 6 | 9 | 11 | ||||
| Depression* | 2 | 3 | 12 | 15 | ||||
| Hypertension | 2 | 3 | 2 | 3 | 3 | 4 | 6 | 7 |
| Edema, limbs | 8 | 10 | 3 | 4 | ||||
| Anorexia* | 8 | 10 | 1 | 1 | ||||
| . | HU (n = 80) . | PEG (n = 82) . | ||||||
|---|---|---|---|---|---|---|---|---|
| AE . | Grade 1-2, n (%) . | Grade 3-4, n (%) . | Grade 1-2, n (%) . | Grade 3-4, n (%) . | ||||
| Hematologic | ||||||||
| Leukopenia* | 11 | 14 | 22 | 27 | ||||
| Anemia | 14 | 18 | 11 | 13 | 1 | 1 | ||
| Thrombocytopenia | 11 | 14 | 1 | 1 | 10 | 12 | ||
| Neutropenia | 6 | 8 | 3 | 4 | 7 | 9 | 2 | 2 |
| Lymphopenia | 4 | 5 | 1 | 1 | 6 | 7 | 3 | 4 |
| Nonhematologic | ||||||||
| Fatigue | 34 | 43 | 2 | 3 | 40 | 49 | 6 | 7 |
| Pain in extremity | 14 | 18 | 2 | 3 | 16 | 20 | 1 | 1 |
| Headache | 12 | 15 | 18 | 22 | 3 | 4 | ||
| Diarrhea | 11 | 14 | 1 | 1 | 14 | 17 | ||
| Peripheral sensory neuropathy | 7 | 9 | 3 | 4 | 16 | 20 | ||
| Nausea | 12 | 15 | 13 | 16 | ||||
| Flu-like symptoms* | 4 | 5 | 18 | 22 | 2 | 2 | ||
| Cough | 10 | 13 | 12 | 15 | ||||
| Pruritus* | 5 | 6 | 14 | 17 | 2 | 2 | ||
| Abdominal pain | 5 | 6 | 1 | 1 | 13 | 16 | ||
| Injection site reaction* | 18 | 22 | ||||||
| Constipation | 12 | 15 | 5 | 6 | ||||
| Dizziness | 9 | 11 | 8 | 10 | ||||
| Hyperglycemia | 5 | 6 | 1 | 1 | 9 | 11 | 2 | 2 |
| Dyspnea | 5 | 6 | 10 | 12 | 2 | 2 | ||
| Back pain | 4 | 5 | 2 | 3 | 9 | 11 | 1 | 1 |
| Upper respiratory infection | 5 | 6 | 11 | 13 | ||||
| Alanine aminotransferase increased* | 3 | 4 | 1 | 1 | 10 | 12 | 2 | 2 |
| Mucositis, oral* | 12 | 15 | 1 | 1 | 2 | 2 | ||
| Urinary tract infection | 5 | 6 | 3 | 4 | 6 | 7 | ||
| Rash, maculopapular | 8 | 10 | 5 | 6 | 1 | 1 | ||
| Blurred vision | 5 | 6 | 9 | 11 | ||||
| Depression* | 2 | 3 | 12 | 15 | ||||
| Hypertension | 2 | 3 | 2 | 3 | 3 | 4 | 6 | 7 |
| Edema, limbs | 8 | 10 | 3 | 4 | ||||
| Anorexia* | 8 | 10 | 1 | 1 | ||||
P < .05 for comparison of AEs (all grades combined) between arms.