Table 2.
TEAEs over induction and optimization/maintenance phases (all enrolled analysis set)
| TEAE | Korea (n = 26) | Malaysia (n = 19) | Taiwan (n = 33) | Asian (n = 78) | Non-Asian (n = 724) | Total (n = 802) |
|---|---|---|---|---|---|---|
| Any TEAE | 24 (92.3) | 16 (84.2) | 32 (97.0) | 72 (92.3) | 651 (89.9) | 723 (90.1) |
| TEAE possibly related to intranasal esketamine | 18 (69.2) | 13 (68.4) | 26 (78.8) | 57 (73.1) | 576 (79.6) | 633 (78.9) |
| TEAE possibly related to oral AD | 7 (26.9) | 9 (47.4) | 5 (15.2) | 21 (26.9) | 220 (30.4) | 241 (30.0) |
| TEAE leading to death | 0 | 0 | 0 | 0 | 2 (0.3) | 2 (0.2) |
| ≥ 1 serious TEAE | 4 (15.4) | 2 (10.5) | 3 (9.1) | 9 (11.5) | 46 (6.4) | 55 (6.9) |
| TEAE leading to intranasal esketamine discontinuation | 5 (19.2) | 3 (15.8) | 5 (15.2) | 13 (16.7) | 63 (8.7) | 76 (9.5) |
| TEAE leading to oral AD withdrawn | 4 (15.4) | 2 (10.5) | 1 (3.0) | 7 (9.0) | 26 (3.6) | 33 (4.1) |
Values are presented as number (%).
TEAE, treatment-emergent adverse event; AD, antidepressant.