Table 1 Common adverse events (AEs) and selected AEs of interest.

From: Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia

 

A + O (n = 178)

A (n = 179)

O + Clb (n = 169)

Treatment exposure, median (range), months

46.6 (2.3–58.6)

45.7 (0.3–59.3)

5.6 (0.9–7.4)

Common AEs (in ≥ 25% of patients [any grade] in any group), n (%)

 

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

 Diarrhea

73 (41.0)

9 (5.1)

72 (40.2)

1 (0.6)

36 (21.3)

3 (1.8)

 Headache

71 (39.9)

2 (1.1)

68 (38.0)

2 (1.1)

20 (11.8)

0

 Neutropenia

60 (33.7)

55 (30.9)

22 (12.3)

20 (11.2)

76 (45.0)

70 (41.4)

 Fatigue

50 (28.1)

4 (2.2)

39 (21.8)

2 (1.1)

30 (17.8)

2 (1.2)

 Arthralgia

47 (26.4)

2 (1.1)

35 (19.6)

2 (1.1)

8 (4.7)

2 (1.2)

 Cough

46 (25.8)

1 (0.6)

40 (22.3)

1 (0.6)

15 (8.9)

0

 URTI

44 (24.7)

4 (2.2)

46 (25.7)

0

16 (9.5)

1 (0.6)

 Nausea

41 (23.0)

0

41 (22.9)

0

53 (31.4)

0

 IRR

25 (14.0)

5 (2.8)

0

0

68 (40.2)

10 (5.9)

Selected events of clinical interest, n (%)

 Cardiac eventsa

37 (20.8)

14 (7.9)b

34 (19.0)

15 (8.4)c

13 (7.7)

3 (1.8)

  Atrial fibrillation/flutter

7 (3.9)

1 (0.6)

11 (6.1)

2 (1.1)

1 (0.6)

0

 Bleeding

84 (47.2)

5 (2.8)

75 (41.9)

5 (2.8)

20 (11.8)

0

  Major bleedingd

7 (3.9)

5 (2.8)

7 (3.9)

5 (2.8)

2 (1.2)

0

 Hypertension

14 (7.9)

6 (3.4)

13 (7.3)

5 (2.8)

7 (4.1)

6 (3.6)

 Infections

134 (75.3)

42 (23.6)

132 (73.7)

29 (16.2)

75 (44.4)

14 (8.3)

 SPMs

28 (15.7)

13 (7.3)

24 (13.4)

5 (2.8)

7 (4.1)

3 (1.8)

  Excluding NMS

15 (8.4)

10 (5.6)

11 (6.1)

4 (2.2)

3 (1.8)

2 (1.2)

  1. A acalabrutinib, AE adverse event, Clb chlorambucil, IRR infusion-related reaction, NMS non-melanoma skin, O obinutuzumab, SPMs secondary primary malignancies, URTI upper respiratory tract infection.
  2. aCardiac events that occurred in >1 patient (any grade; other than atrial fibrillation) in any group include angina pectoris, palpitations, atrioventricular block complete, myocardial ischemia, tachycardia, bradycardia, cardiac failure, left ventricular failure, myocardial infarction, pericardial effusion, acute myocardial infarction, and supraventricular tachycardia.
  3. bCardiac events (grade ≥3) that occurred in >1 patient (other than atrial fibrillation) include atrioventricular block complete (n = 3), angina pectoris (n = 2), myocardial ischemia (n = 2), and myocardial infarction (n = 2).
  4. cCardiac events (grade ≥3) that occurred in >1 patient (other than atrial fibrillation) include acute myocardial infarction (n = 3), cardiac failure (n = 2), and myocardial infarction (n = 2).
  5. dDefined as any serious or grade ≥3 hemorrhagic event, or any-grade hemorrhagic event in the central nervous system.
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