EAIRs of AEs of special interest
| Exposure-adjusted incidence, n (IR per 100 patient-years)∗ . | Asciminib 40 mg twice daily (N = 156) . | Bosutinib 500 mg once daily (N = 76) . |
|---|---|---|
| Pancreatic enzyme elevations | 13 (3.8) | 7 (9.0) |
| AOEs | 8 (2.2) | 1 (1.2) |
| Cardiac failure | 4 (1.1) | 1 (1.1) |
| Edema and fluid retention | 17 (5.1) | 8 (9.9) |
| Gastrointestinal toxicity | 52 (20.8) | 60 (275.5) |
| Hemorrhage | 20 (5.8) | 8 (9.5) |
| Hepatotoxicity | 19 (5.8) | 25 (34.9) |
| Hypersensitivity | 32 (10.5) | 26 (42.6) |
| Ischemic heart and CNS conditions | 10 (2.8) | 4 (5.3) |
| Myelosuppression | 60 (22.1) | 28 (42.7) |
| Anemia† | 16 (4.7) | 7 (8.6) |
| Leucopenia‡ | 36 (11.8) | 17 (22.6) |
| Neutropenia§ | 36 (11.8) | 16 (21.1) |
| Thrombocytopenia|| | 46 (15.5) | 16 (21.0) |
| Cytopenias affecting >1 lineage | 0 | 1 (1.1) |
| QTc prolongation | 8 (2.3) | 1 (1.1) |
| Reproductive toxicity | 6 (1.7) | 1 (1.1) |
| Exposure-adjusted incidence, n (IR per 100 patient-years)∗ . | Asciminib 40 mg twice daily (N = 156) . | Bosutinib 500 mg once daily (N = 76) . |
|---|---|---|
| Pancreatic enzyme elevations | 13 (3.8) | 7 (9.0) |
| AOEs | 8 (2.2) | 1 (1.2) |
| Cardiac failure | 4 (1.1) | 1 (1.1) |
| Edema and fluid retention | 17 (5.1) | 8 (9.9) |
| Gastrointestinal toxicity | 52 (20.8) | 60 (275.5) |
| Hemorrhage | 20 (5.8) | 8 (9.5) |
| Hepatotoxicity | 19 (5.8) | 25 (34.9) |
| Hypersensitivity | 32 (10.5) | 26 (42.6) |
| Ischemic heart and CNS conditions | 10 (2.8) | 4 (5.3) |
| Myelosuppression | 60 (22.1) | 28 (42.7) |
| Anemia† | 16 (4.7) | 7 (8.6) |
| Leucopenia‡ | 36 (11.8) | 17 (22.6) |
| Neutropenia§ | 36 (11.8) | 16 (21.1) |
| Thrombocytopenia|| | 46 (15.5) | 16 (21.0) |
| Cytopenias affecting >1 lineage | 0 | 1 (1.1) |
| QTc prolongation | 8 (2.3) | 1 (1.1) |
| Reproductive toxicity | 6 (1.7) | 1 (1.1) |
AOE, arterial occlusive event; CNS, central nervous system; QTc, corrected QT interval.
Based on the safety analysis set. Numbers represent counts of patients.
Includes anemia and normocytic anemia.
Includes white blood cell count decreased; leukopenia, febrile neutropenia, and lymphocyte count decreased.
Includes neutropenia and neutrophil count decreased.
Includes thrombocytopenia and platelet count decreased.