Table 4.
Summary of TEAEs (all grade TEAEs reported in ≥10% of patients).
| n (%) | Total (N = 163) | |
|---|---|---|
| All grades | Grades 3/4 | |
| Any TEAE | 162 (99.4) | 120 (73.6) |
| Diarrhea | 143 (87.7) | 26 (16.0) |
| Nausea | 65 (39.9) | 4 (2.5) |
| Vomiting | 53 (32.5) | 6 (3.7) |
| Abdominal pain | 46 (28.2) | 7 (4.3) |
| Headache | 45 (27.6) | 1 (0.6) |
| ALT increased | 42 (25.8) | 23 (14.1) |
| Fatigue | 39 (23.9) | 2 (1.2) |
| Abdominal pain upper | 36 (22.1) | 2 (1.2) |
| Dyspnea | 35 (21.5) | 5 (3.1) |
| Asthenia | 33 (20.2) | 4 (2.5) |
| AST increased | 32 (19.6) | 7 (4.3) |
| Cough | 30 (18.4) | 1 (0.6) |
| Pyrexia | 29 (17.8) | 5 (3.1) |
| Constipation | 28 (17.2) | 2 (1.2) |
| Arthralgia | 28 (17.2) | 1 (0.6) |
| Pleural effusion | 27 (16.6) | 10 (6.1) |
| Back pain | 27 (16.6) | 4 (2.5) |
| Anemia | 25 (15.3) | 7 (4.3) |
| Rash | 25 (15.3) | 7 (4.3) |
| Dizziness | 25 (15.3) | 0 |
| Blood creatinine increased | 24 (14.7) | 0 |
| Nasopharyngitis | 24 (14.7) | 0 |
| Lipase increased | 23 (14.1) | 11 (6.7) |
| Myalgia | 22 (13.5) | 2 (1.2) |
| Decreased appetite | 22 (13.5) | 1 (0.6) |
| Edema peripheral | 22 (13.5) | 1 (0.6) |
| Thrombocytopenia | 18 (11.0) | 13 (8.0) |
| Pain in extremity | 17 (10.4) | 2 (1.2) |
| Pruritus | 17 (10.4) | 2 (1.2) |
Full analysis set. Classification of adverse events is based on the Medical Dictionary for Regulatory Activities (v21.1).
ALT alanine aminotransferase, AST aspartate aminotransferase, CML chronic myeloid leukemia, TEAE treatment-emergent adverse event.