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Table 3 Safety profile of ixazomib plus lenalidomide–dexamethasone, overall and by East Asian ethnicity

From: Pharmacokinetics and safety of ixazomib plus lenalidomide–dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study

AE, n (%)

Chinese

Korean

Other

Overall

 

(n = 20)

(n = 16)

(n = 7)

(N = 43)

Any AE

20 (100)

16 (100)

7 (100)

43 (100)

 Any drug-related AE

19 (95)

11 (69)

7 (100)

37 (86)

Any grade ≥3 AE

12 (60)

12 (75)

7 (100)

31 (72)

 Any drug-related grade ≥3 AE

7 (35)

8 (50)

6 (86)

21 (49)

Any SAEa

8 (40)

5 (31)

5 (71)

18 (42)

 Any drug-related SAE

3 (15)

4 (25)

3 (43)

10 (23)

AE resulting in any study drug dose reduction, n (%)

12 (60)

7 (44)

5 (71)

24 (56)

AE leading to discontinuation, n (%)

4 (20)

2 (13)

1 (14)

7 (16)

On-study deaths, n (%)

0

0

0

0

  1. AE adverse event, SAE serious adverse event
  2. aDefined as any AE or adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect