Most commonly reported (≥5%) newly occurring or worsening grade 3/4 hematologic and biochemical abnormalities
| . | Nilotinib 400 mg twice daily (n = 101) . | Imatinib 400-600 mg once daily (n = 103) . |
|---|---|---|
| Newly occurring or worsening grade 3/4 hematologic laboratory abnormalities, n (%) | ||
| Anemia* | 1 (1.0) | 1 (1.0) |
| Thrombocytopenia | 0 | 1 (1.0) |
| Neutropenia | 2 (2.0) | 4 (3.9) |
| Newly occurring or worsening grade 3/4 biochemical abnormalities, n (%) | ||
| Decreased phosphate | 12 (11.9) | 18 (17.5) |
| Elevated lipase | 10 (9.9) | 1 (1.0) |
| Elevated bilirubin (total)† | 5 (5.0) | 0 |
| Increase alanine aminotransferase | 4 (4.0) | 0 |
| Decreased potassium | 0 | 1 (1.0) |
| Decreased magnesium | 0 | 1 (1.0) |
| . | Nilotinib 400 mg twice daily (n = 101) . | Imatinib 400-600 mg once daily (n = 103) . |
|---|---|---|
| Newly occurring or worsening grade 3/4 hematologic laboratory abnormalities, n (%) | ||
| Anemia* | 1 (1.0) | 1 (1.0) |
| Thrombocytopenia | 0 | 1 (1.0) |
| Neutropenia | 2 (2.0) | 4 (3.9) |
| Newly occurring or worsening grade 3/4 biochemical abnormalities, n (%) | ||
| Decreased phosphate | 12 (11.9) | 18 (17.5) |
| Elevated lipase | 10 (9.9) | 1 (1.0) |
| Elevated bilirubin (total)† | 5 (5.0) | 0 |
| Increase alanine aminotransferase | 4 (4.0) | 0 |
| Decreased potassium | 0 | 1 (1.0) |
| Decreased magnesium | 0 | 1 (1.0) |
Five cases of anemia were reported in the nilotinib arm and 2 in the imatinib arm, but 4 in the nilotinib arm and 1 in the imatinib arm were determined to be a result of errors in unit conversion. None of these patients actually had hemoglobin values consistent with anemia.
Includes the preferred terms hyperbilirubinemia and increased blood bilirubin.