AEs leading to discontinuation
| . | R/I patients* (n = 23) . | ND patients (n = 25) . | All patients (n = 58) . |
|---|---|---|---|
| Patients with ≥1 AE | 5 (15.2) | 8 (32) | 13 (22.4) |
| Increased blood bilirubin | 3 (9.1) | 3 (12) | 6 (10.3) |
| Rash | 1 (3) | 1 (4) | 2 (3.4) |
| ALT increased | 0 | 1 (4) | 1 (1.7) |
| Anemia | 1 (3) | 0 | 1 (1.7) |
| AST increased | 0 | 1 (4) | 1 (1.7) |
| Autoimmune thyroiditis | 0 | 1 (4) | 1 (1.7) |
| Decreased appetite | 1 (3) | 0 | 1 (1.7) |
| Headache | 1 (3) | 0 | 1 (1.7) |
| Hyperamylasemia | 0 | 1 (4) | 1 (1.7) |
| Keratosis pilaris | 1 (3) | 0 | 1 (1.7) |
| Malaise | 1 (3) | 0 | 1 (1.7) |
| Nausea | 1 (3) | 0 | 1 (1.7) |
| Pain in extremity | 1 (3) | 0 | 1 (1.7) |
| Pancreatic enlargement | 0 | 1 (4) | 1 (1.7) |
| Platelet count decreased | 0 | 1 (4) | 1 (1.7) |
| Rash maculopapular | 0 | 1 (4) | 1 (1.7) |
| . | R/I patients* (n = 23) . | ND patients (n = 25) . | All patients (n = 58) . |
|---|---|---|---|
| Patients with ≥1 AE | 5 (15.2) | 8 (32) | 13 (22.4) |
| Increased blood bilirubin | 3 (9.1) | 3 (12) | 6 (10.3) |
| Rash | 1 (3) | 1 (4) | 2 (3.4) |
| ALT increased | 0 | 1 (4) | 1 (1.7) |
| Anemia | 1 (3) | 0 | 1 (1.7) |
| AST increased | 0 | 1 (4) | 1 (1.7) |
| Autoimmune thyroiditis | 0 | 1 (4) | 1 (1.7) |
| Decreased appetite | 1 (3) | 0 | 1 (1.7) |
| Headache | 1 (3) | 0 | 1 (1.7) |
| Hyperamylasemia | 0 | 1 (4) | 1 (1.7) |
| Keratosis pilaris | 1 (3) | 0 | 1 (1.7) |
| Malaise | 1 (3) | 0 | 1 (1.7) |
| Nausea | 1 (3) | 0 | 1 (1.7) |
| Pain in extremity | 1 (3) | 0 | 1 (1.7) |
| Pancreatic enlargement | 0 | 1 (4) | 1 (1.7) |
| Platelet count decreased | 0 | 1 (4) | 1 (1.7) |
| Rash maculopapular | 0 | 1 (4) | 1 (1.7) |
The MedDRA PT is expressed as the number of patients (percentage of group).
MedDRA, Medical Dictionary for Regulatory Activities.
Patients were R/I to 1 prior TKI, either imatinib or dasatinib.