AEs regardless of relationship to study drug (reported in at least 5% of patients in any treatment arm)
| Event, n (%)∗ . | Asciminib 40 mg twice daily (N = 156) . | Bosutinib 500 mg once daily (N = 76) . | ||
|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Patients with ≥1 AE | 142 (91.0) | 93 (59.6) | 74 (97.4) | 52 (68.4) |
| Thrombocytopenia† | 46 (29.5) | 35 (22.4) | 16 (21.1) | 7 (9.2) |
| Neutropenia‡ | 36 (23.1) | 29 (18.6) | 16 (21.1) | 11 (14.5) |
| Anemia§ | 16 (10.3) | 2 (1.3) | 7 (9.2) | 3 (3.9) |
| Diarrhea | 20 (12.8) | 0 | 55 (72.4) | 8 (10.5) |
| Nausea | 18 (11.5) | 1 (0.6) | 35 (46.1) | 0 |
| Vomiting | 12 (7.7) | 2 (1.3) | 20 (26.3) | 0 |
| Upper abdominal pain | 7 (4.5) | 0 | 5 (6.6) | 1 (1.3) |
| Fatigue | 24 (15.4) | 2 (1.3) | 8 (10.5) | 1 (1.3) |
| Arthralgia | 23 (14.7) | 1 (0.6) | 2 (2.6) | 0 |
| Arterial hypertension | 23 (14.7) | 12 (7.7) | 4 (5.3) | 3 (3.9) |
| Headache | 30 (19.2) | 3 (1.9) | 12 (15.8) | 0 |
| COVID-19 | 17 (10.9) | 1 (0.6) | 5 (6.6) | 0 |
| Nasopharyngitis | 18 (11.5) | 0 | 3 (3.9) | 0 |
| Pain in extremity | 15 (9.6) | 1 (0.6) | 5 (6.6) | 0 |
| Rash | 15 (9.6) | 0 | 18 (23.7) | 3 (3.9) |
| Abdominal pain | 14 (9.0) | 1 (0.6) | 12 (15.8) | 1 (1.3) |
| Asthenia | 14 (9.0) | 1 (0.6) | 1 (1.3) | 0 |
| Cough | 14 (9.0) | 0 | 5 (6.6) | 0 |
| Dizziness | 14 (9.0) | 0 | 2 (2.6) | 0 |
| Upper respiratory tract infection | 14 (9.0) | 1 (0.6) | 4 (5.3) | 0 |
| Back pain | 12 (7.7) | 1 (0.6) | 3 (3.9) | 1 (1.3) |
| Peripheral edema | 12 (7.7) | 0 | 2 (2.6) | 0 |
| Dyspepsia | 11 (7.1) | 0 | 3 (3.9) | 0 |
| Insomnia | 11 (7.1) | 0 | 1 (1.3) | 0 |
| Myalgia | 10 (6.4) | 0 | 3 (3.9) | 0 |
| Amylase increased | 9 (5.8) | 1 (0.6) | 4 (5.3) | 0 |
| AST increased | 9 (5.8) | 3 (1.9) | 16 (21.1) | 5 (6.6) |
| Muscle spasms | 9 (5.8) | 1 (0.6) | 0 | 0 |
| Noncardiac chest pain | 9 (5.8) | 2 (1.3) | 1 (1.3) | 0 |
| ALT increased | 8 (5.1) | 1 (0.6) | 23 (30.3) | 11 (14.5) |
| Constipation | 8 (5.1) | 0 | 4 (5.3) | 0 |
| Decreased appetite | 8 (5.1) | 0 | 6 (7.9) | 0 |
| Dry skin | 8 (5.1) | 0 | 6 (7.9) | 0 |
| Dyspnea | 8 (5.1) | 0 | 4 (5.3) | 0 |
| Lipase increased | 8 (5.1) | 6 (3.8) | 5 (6.6) | 4 (5.3) |
| Oropharyngeal pain | 8 (5.1) | 0 | 2 (2.6) | 0 |
| Pruritus | 8 (5.1) | 0 | 5 (6.6) | 1 (1.3) |
| Maculopapular rash | 8 (5.1) | 0 | 2 (2.6) | 1 (1.3) |
| Blood creatinine increased | 6 (3.8) | 0 | 5 (6.6) | 0 |
| Pyrexia | 6 (3.8) | 2 (1.3) | 6 (7.9) | 1 (1.3) |
| Influenza-like illness | 3 (1.9) | 0 | 4 (5.3) | 0 |
| Hypophosphatemia | 2 (1.3) | 1 (0.6) | 4 (5.3) | 3 (3.9) |
| Pleural effusion | 2 (1.3) | 0 | 4 (5.3) | 3 (3.9) |
| Event, n (%)∗ . | Asciminib 40 mg twice daily (N = 156) . | Bosutinib 500 mg once daily (N = 76) . | ||
|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Patients with ≥1 AE | 142 (91.0) | 93 (59.6) | 74 (97.4) | 52 (68.4) |
| Thrombocytopenia† | 46 (29.5) | 35 (22.4) | 16 (21.1) | 7 (9.2) |
| Neutropenia‡ | 36 (23.1) | 29 (18.6) | 16 (21.1) | 11 (14.5) |
| Anemia§ | 16 (10.3) | 2 (1.3) | 7 (9.2) | 3 (3.9) |
| Diarrhea | 20 (12.8) | 0 | 55 (72.4) | 8 (10.5) |
| Nausea | 18 (11.5) | 1 (0.6) | 35 (46.1) | 0 |
| Vomiting | 12 (7.7) | 2 (1.3) | 20 (26.3) | 0 |
| Upper abdominal pain | 7 (4.5) | 0 | 5 (6.6) | 1 (1.3) |
| Fatigue | 24 (15.4) | 2 (1.3) | 8 (10.5) | 1 (1.3) |
| Arthralgia | 23 (14.7) | 1 (0.6) | 2 (2.6) | 0 |
| Arterial hypertension | 23 (14.7) | 12 (7.7) | 4 (5.3) | 3 (3.9) |
| Headache | 30 (19.2) | 3 (1.9) | 12 (15.8) | 0 |
| COVID-19 | 17 (10.9) | 1 (0.6) | 5 (6.6) | 0 |
| Nasopharyngitis | 18 (11.5) | 0 | 3 (3.9) | 0 |
| Pain in extremity | 15 (9.6) | 1 (0.6) | 5 (6.6) | 0 |
| Rash | 15 (9.6) | 0 | 18 (23.7) | 3 (3.9) |
| Abdominal pain | 14 (9.0) | 1 (0.6) | 12 (15.8) | 1 (1.3) |
| Asthenia | 14 (9.0) | 1 (0.6) | 1 (1.3) | 0 |
| Cough | 14 (9.0) | 0 | 5 (6.6) | 0 |
| Dizziness | 14 (9.0) | 0 | 2 (2.6) | 0 |
| Upper respiratory tract infection | 14 (9.0) | 1 (0.6) | 4 (5.3) | 0 |
| Back pain | 12 (7.7) | 1 (0.6) | 3 (3.9) | 1 (1.3) |
| Peripheral edema | 12 (7.7) | 0 | 2 (2.6) | 0 |
| Dyspepsia | 11 (7.1) | 0 | 3 (3.9) | 0 |
| Insomnia | 11 (7.1) | 0 | 1 (1.3) | 0 |
| Myalgia | 10 (6.4) | 0 | 3 (3.9) | 0 |
| Amylase increased | 9 (5.8) | 1 (0.6) | 4 (5.3) | 0 |
| AST increased | 9 (5.8) | 3 (1.9) | 16 (21.1) | 5 (6.6) |
| Muscle spasms | 9 (5.8) | 1 (0.6) | 0 | 0 |
| Noncardiac chest pain | 9 (5.8) | 2 (1.3) | 1 (1.3) | 0 |
| ALT increased | 8 (5.1) | 1 (0.6) | 23 (30.3) | 11 (14.5) |
| Constipation | 8 (5.1) | 0 | 4 (5.3) | 0 |
| Decreased appetite | 8 (5.1) | 0 | 6 (7.9) | 0 |
| Dry skin | 8 (5.1) | 0 | 6 (7.9) | 0 |
| Dyspnea | 8 (5.1) | 0 | 4 (5.3) | 0 |
| Lipase increased | 8 (5.1) | 6 (3.8) | 5 (6.6) | 4 (5.3) |
| Oropharyngeal pain | 8 (5.1) | 0 | 2 (2.6) | 0 |
| Pruritus | 8 (5.1) | 0 | 5 (6.6) | 1 (1.3) |
| Maculopapular rash | 8 (5.1) | 0 | 2 (2.6) | 1 (1.3) |
| Blood creatinine increased | 6 (3.8) | 0 | 5 (6.6) | 0 |
| Pyrexia | 6 (3.8) | 2 (1.3) | 6 (7.9) | 1 (1.3) |
| Influenza-like illness | 3 (1.9) | 0 | 4 (5.3) | 0 |
| Hypophosphatemia | 2 (1.3) | 1 (0.6) | 4 (5.3) | 3 (3.9) |
| Pleural effusion | 2 (1.3) | 0 | 4 (5.3) | 3 (3.9) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Based on the safety analysis set reported by the investigator. Numbers represent the counts of patients. A patient with multiple severity grades for an AE is only counted under the maximum grade; Medical Dictionary for Regulatory Activities version 26.0, Common Terminology Criteria for Adverse Events version 4.03.
Includes thrombocytopenia and platelet count decreased.
Includes neutropenia and neutrophil count decreased.
Includes anemia and normocytic anemia.