Table 3.
Safety profile of ixazomib plus lenalidomide–dexamethasone, overall and by East Asian ethnicity
| 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 |
AE adverse event, SAE serious adverse event
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