Table 2.
Adverse events regardless of relationship to study drug (occurring in ≥5% of patients in any treatment arm) reported by the data cutoff
| Event, n (%)*,† | Asciminib 40 mg twice daily (n = 156) | Bosutinib 500 mg once daily (n = 76) | ||
|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | |
| No. of patients with ≥1 adverse event | 140 (89.7) | 79 (50.6) | 73 (96.1) | 46 (60.5) |
| Thrombocytopenia‡ | 45 (28.8) | 34 (21.8) | 14 (18.4) | 7 (9.2) |
| Neutropenia§ | 34 (21.8) | 28 (17.9) | 16 (21.1) | 11 (14.5) |
| Headache | 25 (16.0) | 3 (1.9) | 10 (13.2) | 0 |
| Diarrhea | 18 (11.5) | 0 | 54 (71.1) | 8 (10.5) |
| Hypertension | 18 (11.5) | 9 (5.8) | 3 (3.9) | 3 (3.9) |
| Nausea | 18 (11.5) | 1 (0.6) | 35 (46.1) | 0 |
| Fatigue | 16 (10.3) | 0 | 7 (9.2) | 1 (1.3) |
| Anemia | 15 (9.6) | 2 (1.3) | 6 (7.9) | 3 (3.9) |
| Nasopharyngitis | 15 (9.6) | 0 | 2 (2.6) | 0 |
| Arthralgia | 14 (9.0) | 0 | 1 (1.3) | 0 |
| Rash | 11 (7.1) | 0 | 18 (23.7) | 3 (3.9) |
| Upper respiratory tract infection | 11 (7.1) | 1 (0.6) | 4 (5.3) | 0 |
| Vomiting | 11 (7.1) | 2 (1.3) | 20 (26.3) | 0 |
| Back pain | 10 (6.4) | 1 (0.6) | 1 (1.3) | 1 (1.3) |
| Cough | 10 (6.4) | 0 | 4 (5.3) | 0 |
| Dizziness | 10 (6.4) | 0 | 2 (2.6) | 0 |
| Pain in extremity | 10 (6.4) | 1 (0.6) | 5 (6.6) | 0 |
| Increased amylase | 9 (5.8) | 1 (0.6) | 4 (5.3) | 0 |
| Asthenia | 9 (5.8) | 0 | 1 (1.3) | 0 |
| Peripheral edema | 9 (5.8) | 0 | 2 (2.6) | 0 |
| Constipation | 8 (5.1) | 0 | 4 (5.3) | 0 |
| Dyspepsia | 8 (5.1) | 0 | 3 (3.9) | 0 |
| Insomnia | 8 (5.1) | 0 | 1 (1.3) | 0 |
| Increased lipase | 8 (5.1) | 6 (3.8) | 5 (6.6) | 3 (3.9) |
| Pruritus | 8 (5.1) | 0 | 5 (6.6) | 1 (1.3) |
| Abdominal pain | 7 (4.5) | 0 | 11 (14.5) | 1 (1.3) |
| Upper abdominal pain | 7 (4.5) | 0 | 5 (6.6) | 1 (1.3) |
| Increased ALT | 6 (3.8) | 1 (0.6) | 21 (27.6) | 11 (14.5) |
| Increased AST | 6 (3.8) | 1 (0.6) | 16 (21.1) | 5 (6.6) |
| Decreased appetite | 6 (3.8) | 0 | 6 (7.9) | 0 |
| Pyrexia | 5 (3.2) | 2 (1.3) | 6 (7.9) | 0 |
| Dry skin | 3 (1.9) | 0 | 6 (7.9) | 0 |
| Hypophosphatemia | 2 (1.3) | 1 (0.6) | 4 (5.3) | 3 (3.9) |
*
Safety analysis set.
†
Numbers represent counts of patients. A patient with multiple severity grades for an adverse event is only counted under the maximum grade; Medical Dictionary for Regulatory Activities version 23.0, Common Terminology Criteria for Adverse Events version 4.03.
‡
Includes thrombocytopenia and decreased platelet count.
§
Includes neutropenia, decreased neutrophil count, and febrile neutropenia.