TABLE 4.
Treatment‐emergent adverse events
| Acalabrutinib monotherapy N = 43 | ||
|---|---|---|
| Common TEAEs (any grade in >10% of patients or grade ≥3 in ≥2 patients), n (%) | Any grade | Grade ≥3 |
| Any TEAE | 41 (95.3) | 17 (39.5) |
| Headache | 14 (32.6) | 0 |
| Diarrhoea | 11 (25.6) | 0 |
| Fatigue | 12 (27.9) | 2 (4.7) |
| Nausea | 12 (27.9) | 0 |
| Blood creatinine increased | 8 (18.6) | 0 |
| Cough | 8 (18.6) | 0 |
| Constipation | 7 (16.3) | 0 |
| Neutropenia a | 6 (14.0) | 6 (14.0) |
| Anaemia | 6 (14.0) | 3 (7.0) |
| Arthralgia | 6 (14.0) | 0 |
| Contusion | 6 (14.0) | 0 |
| Myalgia | 6 (14.0) | 0 |
| Back pain | 5 (11.6) | 0 |
| Dyspnoea | 5 (11.6) | 3 (7.0) |
| Insomnia | 5 (11.6) | 0 |
| Muscle spasms | 5 (11.6) | 0 |
| Pain in extremity | 5 (11.6) | 1 (2.3) |
| Rash | 5 (11.6) | 1 (2.3) |
| Thrombocytopenia | 3 (7.0) | 2 (4.7) |
| Events of clinical interest, n (%) | ||
| Cardiac events | 6 (14.0) b | 1 (2.3) |
| Atrial fibrillation c | 0 | 0 |
| Ventricular tachyarrhythmias d | 0 | 0 |
| Anaemia | 6 (14.0) | 3 (7.0) |
| Neutropenia a | 6 (14.0) | 6 (14.0) |
| Thrombocytopenia | 5 (11.6) | 3 (7.0) |
| Bleeding | 10 (23.3) | 0 |
| Major bleeding e | 0 | 0 |
| Hepatotoxicity | 5 (11.6) | 1 (2.3) |
| Hypertension | 2 (4.7) | 0 |
| Infections | 15 (34.9) | 3 (7.0) |
| Interstitial lung disease/pneumonitis | 1 (2.3) | 1 (2.3) |
| Second primary malignancies | 2 (4.7) | 0 |
| Second primary malignancies, excluding non‐melanoma skin cancer | 1 (2.3) | 0 |
Note: Treatment‐emergent AEs were defined as those events with onset or worsening on or after the date of the first dose of acalabrutinib, through the treatment phase to 30 days after the last dose of acalabrutinib, or the first date of subsequent anticancer therapy, whichever is earlier.
Abbreviations: AE, adverse event; CNS, central nervous system; TEAEs, treatment‐emergent adverse events.
Includes preferred terms neutropenia and neutrophil count decreased.
Cardiac events included tachycardia (n = 2), palpitations (n = 2), sinus bradycardia (n = 1), and acute myocardial infarction (n = 1).
Includes preferred terms atrial fibrillation and atrial flutter.
Includes preferred terms torsade de pointes, ventricular arrhythmia, ventricular extrasystoles, ventricular fibrillation, ventricular flutter, ventricular tachyarrhythmia, and ventricular tachycardia.
Defined as any haemorrhagic event that is serious, or grade ≥3 in severity, or that is a CNS haemorrhage.