Adverse events during the study treatment in the safety population
| . | Nilotinib (n = 226) . | Dasatinib (n = 226) . | ||||||
|---|---|---|---|---|---|---|---|---|
| Grade . | 3 . | 4 . | 5 . | ≥3 . | 3 . | 4 . | 5 . | ≥3 . |
| Hematologic toxicities, n (%) | ||||||||
| Leukopenia | 5 (2.2) | 0 (0) | 0 (0) | 5 (2.2) | 6 (2.7) | 1 (0.4) | 0 (0) | 7 (3.1) |
| Neutropenia | 6 (2.7) | 3 (1.3) | 0 (0) | 9 (4.0) | 22 (9.7) | 7 (3.1) | 0 (0) | 29 (12.8) |
| Lymphopenia | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 2 (0.9) | 2 (0.9) | 0 (0) | 4 (1.8) |
| Decreased Hb | 3 (1.3) | 0 (0) | 0 (0) | 3 (1.3) | 14 (6.2) | 2 (0.9) | 0 (0) | 16 (7.1) |
| Thrombocytopenia | 6 (2.7) | 3 (1.3) | 0 (0) | 9 (4.0) | 32 (14.2) | 6 (2.7) | 0 (0) | 38 (16.8) |
| Nonhematologic toxicities, n (%) | ||||||||
| Rash | 5 (2.2) | 0 (0) | 0 (0) | 5 (2.2) | 4 (1.8) | 0 (0) | 0 (0) | 4 (1.8) |
| Edema | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 6 (2.7) | 0 (0) | 0 (0) | 6 (2.7) |
| Diarrhea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Nausea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Myalgia | 4 (1.8) | 0 (0) | 0 (0) | 4 (1.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Pleural effusion | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 10 (4.4) | 1 (0.4) | 0 (0) | 11 (4.9) |
| QTc prolongation | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Interstitial pneumonia | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) |
| Gastrointestinal bleeding | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) |
| Other bleeding | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.4) | 1 (0.4) | 1 (0.4) | 3 (1.3) |
| Increased glucose | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Increased amylase | 3 (1.3) | 2 (0.9) | 0 (0) | 5 (2.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Increased lipase | 23 (10.2) | 3 (1.3) | 0 (0) | 26 (11.5) | 4 (1.8) | 0 (0) | 0 (0) | 4 (1.8) |
| Increased bilirubin | 14 (6.2) | 0 (0) | 0 (0) | 14 (6.2) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Increased AST | 10 (4.4) | 0 (0) | 0 (0) | 10 (4.4) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Increased ALT | 19 (8.4) | 1 (0.4) | 0 (0) | 20 (8.8) | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) |
| Increased creatinine | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| . | Nilotinib (n = 226) . | Dasatinib (n = 226) . | ||||||
|---|---|---|---|---|---|---|---|---|
| Grade . | 3 . | 4 . | 5 . | ≥3 . | 3 . | 4 . | 5 . | ≥3 . |
| Hematologic toxicities, n (%) | ||||||||
| Leukopenia | 5 (2.2) | 0 (0) | 0 (0) | 5 (2.2) | 6 (2.7) | 1 (0.4) | 0 (0) | 7 (3.1) |
| Neutropenia | 6 (2.7) | 3 (1.3) | 0 (0) | 9 (4.0) | 22 (9.7) | 7 (3.1) | 0 (0) | 29 (12.8) |
| Lymphopenia | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 2 (0.9) | 2 (0.9) | 0 (0) | 4 (1.8) |
| Decreased Hb | 3 (1.3) | 0 (0) | 0 (0) | 3 (1.3) | 14 (6.2) | 2 (0.9) | 0 (0) | 16 (7.1) |
| Thrombocytopenia | 6 (2.7) | 3 (1.3) | 0 (0) | 9 (4.0) | 32 (14.2) | 6 (2.7) | 0 (0) | 38 (16.8) |
| Nonhematologic toxicities, n (%) | ||||||||
| Rash | 5 (2.2) | 0 (0) | 0 (0) | 5 (2.2) | 4 (1.8) | 0 (0) | 0 (0) | 4 (1.8) |
| Edema | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 6 (2.7) | 0 (0) | 0 (0) | 6 (2.7) |
| Diarrhea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Nausea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Myalgia | 4 (1.8) | 0 (0) | 0 (0) | 4 (1.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Pleural effusion | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 10 (4.4) | 1 (0.4) | 0 (0) | 11 (4.9) |
| QTc prolongation | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Interstitial pneumonia | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) |
| Gastrointestinal bleeding | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) |
| Other bleeding | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.4) | 1 (0.4) | 1 (0.4) | 3 (1.3) |
| Increased glucose | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Increased amylase | 3 (1.3) | 2 (0.9) | 0 (0) | 5 (2.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Increased lipase | 23 (10.2) | 3 (1.3) | 0 (0) | 26 (11.5) | 4 (1.8) | 0 (0) | 0 (0) | 4 (1.8) |
| Increased bilirubin | 14 (6.2) | 0 (0) | 0 (0) | 14 (6.2) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Increased AST | 10 (4.4) | 0 (0) | 0 (0) | 10 (4.4) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
| Increased ALT | 19 (8.4) | 1 (0.4) | 0 (0) | 20 (8.8) | 2 (0.9) | 0 (0) | 0 (0) | 2 (0.9) |
| Increased creatinine | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) | 1 (0.4) | 0 (0) | 0 (0) | 1 (0.4) |
ALT, Alanine transaminase; AST, Aspartate aminotransferase; QTc, Corrected QT interval.