ECI
| ECI* . | All treated patients (N = 99), n (%) . | |
|---|---|---|
| All grades . | Grade ≥3 . | |
| Cardiac events | 20 (20)† | 4 (4) |
| Atrial fibrillation | 5 (5)‡ | 2 (2) |
| Ventricular tachyarrhythmias | 0 | 0 |
| Anemia | 8 (8) | 2 (2) |
| Leukopenia | 9 (9) | 9 (9) |
| Neutropenia | 9 (9) | 9 (9) |
| Other leukopenia | 1 (1) | 1 (1) |
| Thrombocytopenia | 3 (3) | 1 (1) |
| Hemorrhage§ | 65 (66) | 3 (3) |
| Major hemorrhage‖ | 4 (4) | 3 (3) |
| Hepatotoxicity | 4 (4) | 2 (2) |
| Hypertension | 22 (22) | 11 (11) |
| Infections¶,# | 83 (84) | 15 (15) |
| Interstitial lung disease/pneumonitis | 1 (1) | 0 |
| Second primary malignancies | 26 (26) | 5 (5) |
| Second primary malignancies, excluding nonmelanoma skin | 11 (11) | 5 (5) |
| Tumor lysis syndrome | 0 | 0 |
| ECI* . | All treated patients (N = 99), n (%) . | |
|---|---|---|
| All grades . | Grade ≥3 . | |
| Cardiac events | 20 (20)† | 4 (4) |
| Atrial fibrillation | 5 (5)‡ | 2 (2) |
| Ventricular tachyarrhythmias | 0 | 0 |
| Anemia | 8 (8) | 2 (2) |
| Leukopenia | 9 (9) | 9 (9) |
| Neutropenia | 9 (9) | 9 (9) |
| Other leukopenia | 1 (1) | 1 (1) |
| Thrombocytopenia | 3 (3) | 1 (1) |
| Hemorrhage§ | 65 (66) | 3 (3) |
| Major hemorrhage‖ | 4 (4) | 3 (3) |
| Hepatotoxicity | 4 (4) | 2 (2) |
| Hypertension | 22 (22) | 11 (11) |
| Infections¶,# | 83 (84) | 15 (15) |
| Interstitial lung disease/pneumonitis | 1 (1) | 0 |
| Second primary malignancies | 26 (26) | 5 (5) |
| Second primary malignancies, excluding nonmelanoma skin | 11 (11) | 5 (5) |
| Tumor lysis syndrome | 0 | 0 |
ECIs, events of clinical interest; UTI, urinary tract infection.
ECIs were based on combined AE terms for infections, bleeding events, hypertension, and second primary malignancies, excluding nonmelanoma skin and on a single AE term for atrial fibrillation.
Other cardiac events occurring in >1 patient included tachycardia (n = 8; all grade 1), sinus tachycardia (n = 3; all grade 1), palpitations (n = 3 [grade 1, n = 2; grade 2, n = 1]), and angina pectoris (n = 2; both grade 2).
Age range: 68 to 79 y.
Most common bleeding events (all grade, ≥15%) were contusion (42%), petechiae (18%), and ecchymosis (16%).
Includes 1 grade 1 AE (retinal hemorrhage) and 3 grade 3 AEs (hematuria, traumatic intracranial hemorrhage, and upper gastrointestinal hemorrhage).
Most common infections (all grade, ≥15%) were upper respiratory tract infections (44%) and sinusitis (21%); among patients with opportunistic infections, grade 2 fungal infection, grade 2 coccidioidomycosis, and grade 2 herpes zoster were reported in 1 patient each, and 1 patient experienced both grade 3 perineal infection fungal and grade 3 herpes zoster.
Acalabrutinib dosing was delayed in 10 patients because of infection AEs; 2 patients discontinued acalabrutinib because of grade 3 UTI and grade 4 sepsis.