Table 3.
Common TEAEs (≥ 5% in any group) over induction and optimization/maintenance phases (all enrolled analysis set)
| Common TEAE | Korea (n = 26) | Malaysia (n = 19) | Taiwan (n = 33) | Asian (n = 78) | Non-Asian (n = 724) | Total (n = 802) |
|---|---|---|---|---|---|---|
| Nervous system disorders | 14 (53.8) | 13 (68.4) | 26 (78.8) | 53 (67.9) | 475 (65.6) | 528 (65.8) |
| Dizziness | 6 (23.1) | 7 (36.8) | 16 (48.5) | 29 (37.2) | 235 (32.5) | 264 (32.9) |
| Headache | 3 (11.5) | 4 (21.1) | 10 (30.3) | 17 (21.8) | 183 (25.3) | 200 (24.9) |
| Somnolence | 1 (3.8) | 6 (31.6) | 5 (15.2) | 12 (15.4) | 122 (16.9) | 134 (16.7) |
| Dysgeusia | 0 | 6 (31.6) | 1 (3.0) | 7 (9.0) | 88 (12.2) | 95 (11.8) |
| Hypoesthesia | 0 | 2 (10.5) | 7 (21.2) | 9 (11.5) | 86 (11.9) | 95 (11.8) |
| Sedation | 1 (3.8) | 6 (31.6) | 2 (6.1) | 9 (11.5) | 62 (8.6) | 71 (8.9) |
| Dizziness postural | 7 (26.9) | 0 | 2 (6.1) | 9 (11.5) | 58 (8.0) | 67 (8.4) |
| Paraesthesia | 0 | 0 | 0 | 0 | 58 (8.0) | 58 (7.2) |
| Psychiatric disorders | 14 (53.8) | 10 (52.6) | 21 (63.6) | 45 (57.7) | 339 (46.8) | 384 (47.9) |
| Dissociation | 8 (30.8) | 3 (15.8) | 11 (33.3) | 22 (28.2) | 199 (27.5) | 221 (27.6) |
| Anxiety | 0 | 1 (5.3) | 2 (6.1) | 3 (3.8) | 69 (9.5) | 72 (9.0) |
| Insomnia | 2 (7.7) | 1 (5.3) | 9 (27.3) | 12 (15.4) | 51 (7.0) | 63 (7.9) |
| Gastrointestinal disorders | 15 (57.7) | 7 (36.8) | 17 (51.5) | 39 (50.0) | 334 (46.1) | 373 (46.5) |
| Nausea | 10 (38.5) | 5 (26.3) | 8 (24.2) | 23 (29.5) | 178 (24.6) | 201 (25.1) |
| Vomiting | 2 (7.7) | 2 (10.5) | 5 (15.2) | 9 (11.5) | 78 (10.8) | 87 (10.8) |
| Hypoesthesia oral | 0 | 0 | 1 (3.0) | 1 (1.3) | 72 (9.9) | 73 (9.1) |
| Diarrhoea | 3 (11.5) | 0 | 9 (27.3) | 12 (15.4) | 48 (6.6) | 60 (7.5) |
| Infections and infestations | 8 (30.8) | 5 (26.3) | 16 (48.5) | 29 (37.2) | 250 (34.5) | 279 (34.8) |
| Viral upper respiratory tract infection | 6 (23.1) | 0 | 10 (30.3) | 16 (20.5) | 66 (9.1) | 82 (10.2) |
| Urinary tract infection | 0 | 1 (5.3) | 6 (18.2) | 7 (9.0) | 58 (8.0) | 65 (8.1) |
| Influenza | 0 | 0 | 0 | 0 | 43 (5.9) | 43 (5.4) |
| General disorders and administration site conditions | 9 (34.6) | 2 (10.5) | 8 (24.2) | 19 (24.4) | 168 (23.2) | 187 (23.3) |
| Fatigue | 1 (3.8) | 0 | 3 (9.1) | 4 (5.1) | 59 (8.1) | 63 (7.9) |
| Musculoskeletal and connective tissue disorders | 8 (30.8) | 3 (15.8) | 11 (33.3) | 22 (28.2) | 132 (18.2) | 154 (19.2) |
| Back pain | 2 (7.7) | 0 | 2 (6.1) | 4 (5.1) | 37 (5.1) | 41 (5.1) |
| Investigations | 3 (11.5) | 1 (5.3) | 9 (27.3) | 13 (16.7) | 130 (18.0) | 143 (17.8) |
| Blood pressure increased | 0 | 1 (5.3) | 2 (6.1) | 3 (3.8) | 72 (9.9) | 75 (9.4) |
| Ear and labyrinth disorders | 1 (3.8) | 3 (15.8) | 6 (18.2) | 10 (12.8) | 116 (16.0) | 126 (15.7) |
| Vertigo | 0 | 1 (5.3) | 6 (18.2) | 7 (9.0) | 81 (11.2) | 88 (11.0) |
| Eye disorders | 4 (15.4) | 3 (15.8) | 5 (15.2) | 12 (15.4) | 93 (12.8) | 105 (13.1) |
| Vision blurred | 1 (3.8) | 0 | 2 (6.1) | 3 (3.8) | 57 (7.9) | 60 (7.5) |
Values are presented as number (%).
TEAE, treatment-emergent adverse event.