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. 2021 Jun 17;137(24):3327–3338. doi: 10.1182/blood.2020009617

Table 3.

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

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.