Table 2.
Most Frequent Adverse Events That Emerged during Asciminib Monotherapy in Patients with Chronic-Phase or Accelerated-Phase CML.
| Event | All Grades (N = 150) | Grade 3 or 4 (N = 150) |
|---|---|---|
| number (percent) | ||
| Total* | 150 (100) | 90 (60.0) |
| Fatigue | 44 (29.3) | 2 (1.3) |
| Headache | 42 (28.0) | 1 (0.7) |
| Lipase increased | 40 (26.7) | 15 (10.0) |
| Arthralgia | 36 (24.0) | 2 (1.3) |
| Nausea | 36 (24.0) | 1 (0.7) |
| Diarrhea | 35 (23.3) | 0 |
| Rash | 35 (23.3) | 0 |
| Thrombocytopenia | 33 (22.0) | 14 (9.3) |
| Vomiting | 31 (20.7) | 4 (2.7) |
| Hypertension | 29 (19.3) | 14 (9.3) |
| Upper respiratory tract infection | 27 (18.0) | 0 |
| Abdominal pain | 25 (16.7) | 0 |
| Pain in arm or leg | 24 (16.0) | 0 |
| Pruritus | 24 (16.0) | 1 (0.7) |
| Back pain | 23 (15.3) | 2 (1.3) |
| Constipation | 21 (14.0) | 0 |
| Pyrexia | 21 (14.0) | 0 |
| Dizziness | 20 (13.3) | 1 (0.7) |
| Amylase increased | 19 (12.7) | 4 (2.7) |
| Cough | 19 (12.7) | 0 |
| Dyspnea | 19 (12.7) | 2 (1.3) |
| Myalgia | 19 (12.7) | 1 (0.7) |
| Anemia | 17 (11.3) | 11 (7.3) |
| Hypertriglyceridemia | 17 (11.3) | 4 (2.7) |
| Nasopharyngitis | 17 (11.3) | 0 |
| Alanine aminotransferase increased | 16 (10.7) | 4 (2.7) |
| Neutropenia | 16 (10.7) | 11 (7.3) |
| Abdominal pain, upper | 15 (10.0) | 0 |
| Aspartate aminotransferase increased | 15 (10.0) | 3 (2.0) |
| Bone pain | 15 (10.0) | 1 (0.7) |
| Insomnia | 15 (10.0) | 1 (0.7) |
| Edema, peripheral | 15 (10.0) | 0 |
| Hyperhidrosis | 14 (9.3) | 0 |
| Hypophosphatemia | 14 (9.3) | 2 (1.3) |
| Hyperglycemia | 13 (8.7) | 3 (2.0) |
| Noncardiac chest pain | 13 (8.7) | 1 (0.7) |
| Decreased appetite | 12 (8.0) | 1 (0.7) |
| Depression | 12 (8.0) | 0 |
| Dry eye | 12 (8.0) | 0 |
| γ-Glutamyltransferase increased | 12 (8.0) | 3 (2.0) |
| Hyperuricemia | 12 (8.0) | 2 (1.3) |
| Musculoskeletal pain | 12 (8.0) | 0 |
| Vision blurred | 12 (8.0) | 0 |
| Anxiety | 11 (7.3) | 2 (1.3) |
| Dry skin | 11 (7.3) | 0 |
| Flank pain | 11 (7.3) | 0 |
| Muscle spasms | 11 (7.3) | 0 |
| Oropharyngeal pain | 11 (7.3) | 0 |
| Weight increased | 11 (7.3) | 0 |
| Fall | 10 (6.7) | 1 (0.7) |
| Dyspepsia | 9 (6.0) | 0 |
| Hypokalemia | 9 (6.0) | 1 (0.7) |
| Influenza | 9 (6.0) | 1 (0.7) |
| Memory impairment | 9 (6.0) | 0 |
| Pleural effusion | 9 (6.0) | 4 (2.7) |
| Abdominal discomfort | 8 (5.3) | 0 |
| Blood creatinine increased | 8 (5.3) | 0 |
| Urinary tract infection | 8 (5.3) | 1 (0.7) |
*
Data are for all patients who received at least one dose of asciminib.