Safety findings
| . | Nilotinib, n = 133 . | Imatinib, n = 132 . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Adverse events | ||||
| Rash | 47 (35.3) | 2 (1.5) | 17 (12.9) | 1 (0.8) |
| Myalgia | 16 (12.0) | 1 (0.8) | 8 (6.1) | 0 |
| Nasopharyngitis | 14 (10.5) | 0 | 22 (16.7) | 0 |
| Eyelid edema | 4 (3.0) | 0 | 23 (17.4) | 0 |
| Diarrhea | 4 (3.0) | 0 | 15 (11.4) | 1 (0.8) |
| Hematologic abnormalities | ||||
| Platelet count (direct) | 78 (58.6) | 34 (25.6) | 81 (61.4) | 40 (30.3) |
| Absolute neutrophils (segmented and bands) | 70 (52.6) | 28 (21.1) | 107 (81.1) | 29 (22.0) |
| Total white blood cells | 77 (57.9) | 13 (9.8) | 106 (80.3) | 23 (17.4) |
| Absolute lymphocytes | 91 (68.4) | 6 (4.5) | 108 (81.8) | 18 (13.6) |
| Hemoglobin | 51 (38.3) | 5 (3.8) | 70 (53.0) | 8 (6.1) |
| Biochemical abnormalities | ||||
| Bilirubin (total) | 116 (87.2) | 6 (4.5) | 25 (18.9) | 0 |
| Alanine aminotransferase | 77 (57.9) | 4 (3.0) | 47 (35.6) | 1 (0.8) |
| Phosphate (inorganic phosphorus) | 66 (49.6) | 6 (4.5) | 95 (72.0) | 7 (5.3) |
| Cholesterol (total) | 58 (43.6) | 0 | 11 (8.3) | 0 |
| Lipase (blood) | 55 (41.4) | 19 (14.3) | 59 (44.7) | 9 (6.8) |
| Glucose: hyper | 47 (35.3) | 2 (1.5) | 36 (27.3) | 0 |
| Calcium: hypo | 46 (34.6) | 1 (0.8) | 67 (50.8) | 1 (0.8) |
| Aspartate aminotransferase | 43 (32.3) | 0 | 27 (20.5) | 1 (0.8) |
| Sodium: hyper | 37 (27.8) | 0 | 32 (24.2) | 0 |
| Triglycerides | 34 (25.6) | 1 (0.8) | 35 (26.5) | 3 (2.3) |
| Magnesium: hyper | 31 (23.3) | 8 (6.0) | 27 (20.5) | 7 (5.3) |
| Potassium: hypo | 28 (21.1) | 2 (1.5) | 66 (50.0) | 3 (2.3) |
| Alkaline phosphatase, serum | 18 (13.5) | 0 | 35 (26.5) | 0 |
| . | Nilotinib, n = 133 . | Imatinib, n = 132 . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Adverse events | ||||
| Rash | 47 (35.3) | 2 (1.5) | 17 (12.9) | 1 (0.8) |
| Myalgia | 16 (12.0) | 1 (0.8) | 8 (6.1) | 0 |
| Nasopharyngitis | 14 (10.5) | 0 | 22 (16.7) | 0 |
| Eyelid edema | 4 (3.0) | 0 | 23 (17.4) | 0 |
| Diarrhea | 4 (3.0) | 0 | 15 (11.4) | 1 (0.8) |
| Hematologic abnormalities | ||||
| Platelet count (direct) | 78 (58.6) | 34 (25.6) | 81 (61.4) | 40 (30.3) |
| Absolute neutrophils (segmented and bands) | 70 (52.6) | 28 (21.1) | 107 (81.1) | 29 (22.0) |
| Total white blood cells | 77 (57.9) | 13 (9.8) | 106 (80.3) | 23 (17.4) |
| Absolute lymphocytes | 91 (68.4) | 6 (4.5) | 108 (81.8) | 18 (13.6) |
| Hemoglobin | 51 (38.3) | 5 (3.8) | 70 (53.0) | 8 (6.1) |
| Biochemical abnormalities | ||||
| Bilirubin (total) | 116 (87.2) | 6 (4.5) | 25 (18.9) | 0 |
| Alanine aminotransferase | 77 (57.9) | 4 (3.0) | 47 (35.6) | 1 (0.8) |
| Phosphate (inorganic phosphorus) | 66 (49.6) | 6 (4.5) | 95 (72.0) | 7 (5.3) |
| Cholesterol (total) | 58 (43.6) | 0 | 11 (8.3) | 0 |
| Lipase (blood) | 55 (41.4) | 19 (14.3) | 59 (44.7) | 9 (6.8) |
| Glucose: hyper | 47 (35.3) | 2 (1.5) | 36 (27.3) | 0 |
| Calcium: hypo | 46 (34.6) | 1 (0.8) | 67 (50.8) | 1 (0.8) |
| Aspartate aminotransferase | 43 (32.3) | 0 | 27 (20.5) | 1 (0.8) |
| Sodium: hyper | 37 (27.8) | 0 | 32 (24.2) | 0 |
| Triglycerides | 34 (25.6) | 1 (0.8) | 35 (26.5) | 3 (2.3) |
| Magnesium: hyper | 31 (23.3) | 8 (6.0) | 27 (20.5) | 7 (5.3) |
| Potassium: hypo | 28 (21.1) | 2 (1.5) | 66 (50.0) | 3 (2.3) |
| Alkaline phosphatase, serum | 18 (13.5) | 0 | 35 (26.5) | 0 |
Values are n (%).
Nonlaboratory adverse events occurring in ≥10% of patients in either arm at any grade (regardless of relationship to study drug) and newly occurring or worsening laboratory abnormalities occurring in ≥25% of patients in either arm at any grade or ≥5% of patients in either arm at grade 3/4.