Adverse event, n (%) | Korean subgroup | Non-Korean subgroup | ||
---|---|---|---|---|
FCM (n = 45) | FS (n = 44) | FCM (n = 78) | FS (n = 80) | |
Any adverse event | 27 (60.0) | 28 (63.6) | 33 (42.3) | 22 (27.5) |
Severe | 0 (0) | 0 (0) | 0 (0) | 2 (2.5) |
Leading to discontinuation | 0 (0) | 2 (4.5) | 1 (1.3) | 5 (6.3) |
Outcome of death | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Any treatment-related adverse event | 4 (8.9) | 8 (18.2) | 10 (12.8) | 11 (13.8) |
Severe | 0 (0) | 0 (0) | 0 (0) | 1 (1.3) |
Leading to discontinuation | 0 (0) | 2 (4.5) | 1 (1.3) | 4 (5.0) |