Most commonly reported (≥5%) drug-related nonhematologic AEs
| Nonhematologic . | Nilotinib 400 mg twice daily (n = 101) . | Imatinib 400-600 mg once daily (n = 103) . | ||
|---|---|---|---|---|
| All grades, n (%) . | Grade 3/4, n (%) . | All grades, n (%) . | Grade 3/4, n (%) . | |
| Headache | 34 (33.7) | 2 (2.0) | 2 (1.9) | 0 |
| Rash | 28 (27.7) | 1 (1.0) | 2 (1.9) | 0 |
| Pruritus | 24 (23.8) | 1 (1.0) | 0 | 0 |
| Abdominal pain* | 15 (14.9) | 0 | 6 (5.8) | 0 |
| Nausea | 15 (14.9) | 0 | 12 (11.7) | 0 |
| Fatigue | 14 (13.9) | 1 (1.0) | 3 (2.9) | 0 |
| Myalgia | 13 (12.9) | 1 (1.0) | 1 (1.0) | 0 |
| Muscle spasms | 11 (10.9) | 0 | 13 (12.6) | 0 |
| Constipation | 10 (9.9) | 1 (1.0) | 0 | 0 |
| Dry skin | 10 (9.9) | 0 | 0 | 0 |
| Pain in extremity | 9 (8.9) | 0 | 0 | 0 |
| Alopecia | 8 (7.9) | 0 | 0 | 0 |
| Arthralgia | 7 (6.9) | 0 | 2 (1.9) | 0 |
| Asthenia | 6 (5.9) | 0 | 2 (1.9) | 0 |
| Diarrhea | 6 (5.9) | 0 | 11 (10.7) | 0 |
| Folliculitis | 6 (5.9) | 0 | 0 | 0 |
| Insomnia | 6 (5.9) | 0 | 2 (1.9) | 0 |
| Decreased appetite | 5 (5.0) | 0 | 3 (2.9) | 0 |
| Hyperglycemia | 5 (5.0) | 0 | 4 (3.9) | 0 |
| Vomiting | 5 (5.0) | 1 (1.0) | 4 (3.9) | 0 |
| Nonhematologic . | Nilotinib 400 mg twice daily (n = 101) . | Imatinib 400-600 mg once daily (n = 103) . | ||
|---|---|---|---|---|
| All grades, n (%) . | Grade 3/4, n (%) . | All grades, n (%) . | Grade 3/4, n (%) . | |
| Headache | 34 (33.7) | 2 (2.0) | 2 (1.9) | 0 |
| Rash | 28 (27.7) | 1 (1.0) | 2 (1.9) | 0 |
| Pruritus | 24 (23.8) | 1 (1.0) | 0 | 0 |
| Abdominal pain* | 15 (14.9) | 0 | 6 (5.8) | 0 |
| Nausea | 15 (14.9) | 0 | 12 (11.7) | 0 |
| Fatigue | 14 (13.9) | 1 (1.0) | 3 (2.9) | 0 |
| Myalgia | 13 (12.9) | 1 (1.0) | 1 (1.0) | 0 |
| Muscle spasms | 11 (10.9) | 0 | 13 (12.6) | 0 |
| Constipation | 10 (9.9) | 1 (1.0) | 0 | 0 |
| Dry skin | 10 (9.9) | 0 | 0 | 0 |
| Pain in extremity | 9 (8.9) | 0 | 0 | 0 |
| Alopecia | 8 (7.9) | 0 | 0 | 0 |
| Arthralgia | 7 (6.9) | 0 | 2 (1.9) | 0 |
| Asthenia | 6 (5.9) | 0 | 2 (1.9) | 0 |
| Diarrhea | 6 (5.9) | 0 | 11 (10.7) | 0 |
| Folliculitis | 6 (5.9) | 0 | 0 | 0 |
| Insomnia | 6 (5.9) | 0 | 2 (1.9) | 0 |
| Decreased appetite | 5 (5.0) | 0 | 3 (2.9) | 0 |
| Hyperglycemia | 5 (5.0) | 0 | 4 (3.9) | 0 |
| Vomiting | 5 (5.0) | 1 (1.0) | 4 (3.9) | 0 |
Includes the preferred terms abdominal pain and abdominal pain, upper.