Table 3 Most frequent adverse events over time in patients treated with first-line ibrutinib

From: Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study

Adverse events, n (%)

Ibrutinib

n = 135a

 

0–1 year

n = 135

1–2 years

n = 123

2–3 years

n = 111

3–4 years

n = 100

4–5 years

n = 89

Totald,e

n = 135

Any gradeb

133 (99)

118 (96)

104 (94)

97 (97)

87 (98)

135 (100)

 Diarrhea

57 (42)

11 (9)

13 (12)

8 (8)

8 (9)

67 (50)

 Fatigue

38 (28)

27 (22)

21 (19)

19 (19)

18 (20)

48 (36)

 Cough

26 (19)

13 (11)

12 (11)

10 (10)

11 (12)

49 (36)

 Peripheral edema

23 (17)

17 (14)

13 (12)

12 (12)

11 (12)

37 (27)

 Anemia

22 (16)

12 (10)

9 (8)

9 (9)

6 (7)

35 (26)

 Nausea

27 (20)

9 (7)

5 (5)

3 (3)

3 (3)

35 (26)

 Pyrexia

20 (15)

8 (7)

7 (6)

6 (6)

6 (7)

36 (27)

 Arthralgia

19 (14)

13 (11)

10 (9)

6 (6)

13 (15)

35 (26)

 Upper respiratory tract infection

17 (13)

8 (7)

10 (9)

10 (10)

7 (8)

35 (26)

 Hypertension

16 (12)

12 (10)

15 (14)

16 (16)

17 (19)

31 (23)

 Constipation

16 (12)

14 (11)

11 (10)

6 (6)

7 (8)

28 (21)

 Vomiting

16 (12)

5 (4)

7 (6)

3 (3)

1 (1)

27 (20)

Grade ≥3c

78 (58)

48 (39)

30 (27)

39 (39)

32 (36)

112 (83)

 Neutropenia

11 (8)

4 (3)

1 (1)

1 (1)

0 (0)

17 (13)

 Pneumonia

7 (5)

3 (2)

3 (3)

4 (4)

2 (2)

16 (12)

 Hypertension

6 (4)

2 (2)

0

3 (3)

4 (4)

11 (8)

 Anemia

8 (6)

1 (1)

1 (1)

0

0 (0)

10 (7)

 Hyponatremia

3 (2)

4 (3)

0

0

1 (1)

8 (6)

 Atrial fibrillation

2 (1)

0

4 (4)

1 (1)

0 (0)

7 (5)

 Cataract

1 (1)

1 (1)

1 (1)

1 (1)

3 (3)

7 (5)

 Diarrhea

5 (4)

0

1 (1)

0

0 (0)

6 (4)

  1. aOne patient did not receive any doses of ibrutinib
  2. bOccurring in ≥20% of patients
  3. cOccurring in ≥4% of patients
  4. dMedian 5 years follow-up
  5. eIncludes 5–6 year data