Table 3 Incidence of TEAEs and common TEAEs, and AE management of TDB treatment
| Â | Safety population | |||
|---|---|---|---|---|
Hong Kong (n = 26) n (%) | Korea (n = 62) n (%) | Philippines (n = 26) n (%) | All (n = 114) n (%) | |
Incidence of TEAEs | 25 (96.2) | 43 (69.4) | 21 (80.8) | 89 (78.1) |
 TEAEs leading to discontinuation | 10 (38.5) | 9 (14.5) | 7 (26.9) | 26 (22.8) |
aCommon TEAEs | ||||
 Nausea | 11 (42.3) | 27 (43.6) | 7 (26.9) | 45 (39.5) |
 Constipation | 10 (38.5) | 20 (32.3) | 6 (23.1) | 36 (31.6) |
 Dizziness | 13 (50.0) | 9 (14.5) | 9 (34.6) | 31 (27.2) |
 Somnolence | 9 (34.6) | 8 (12.9) | 5 (19.2) | 22 (19.3) |
 Vomiting | 9 (34.6) | 4 (6.5) | 6 (23.1) | 19 (16.7) |
 Headache | 4 (15.4) | 2 (3.2) | 4 (15.4) | 10 (8.8) |
 Pruritus | 4 (15.4) | 4 (6.5) | 1 (3.9) | 9 (7.9) |
 Application site reactions | 3 (11.5) | 0 (0.0) | 4 (15.4) | 7 (6.1) |
bAE management of TDB treatment | ||||
 Received medications for prevention and/or treatment of common AEs | 10 (38.5) | 26 (41.9) | 5 (19.2) | 41 (36.0) |
  cPrevention | 2 (7.7) | 15 (24.2) | 0 (0.0) | 17 (14.9) |
  Antiemetics | 1 (3.9) | 15 (24.2) | 0 (0.0) | 16 (14.0) |
  Laxatives | 1 (3.9) | 0 (0.0) | 0 (0.0) | 1 (0.88) |
  dTreatment | 8 (30.8) | 14 (22.6) | 5 (19.2) | 27 (23.7) |
  Antiemetics | 2 (7.7) | 11 (17.7) | 2 (7.7) | 15 (13.2) |
  Laxatives | 5 (19.2) | 3 (4.8) | 5 (19.2) | 13 (11.4) |
  Antivertigo agents | 3 (11.5) | 0 (0.0) | 0 (0.0) | 3 (2.6) |