TABLE 2.
Summary of treatment-emergent adverse events of enrolled patients in stage 1 and stage 2 (safety set).
| Variables | Stage 1 | Stage 2 | |||||||
| Placebo group (n = 12) |
HSK21542 group | Placebo group (n = 20) |
HSK21542-0.5 μg/kg group (n = 20) |
HSK21542-1.0 μg/kg group (n = 20) |
|||||
| Group 1 (n = 12) |
Group 2 (n = 12) |
Group 3 (n = 12) |
Group 4 (n = 12) |
Total (n = 48) |
|||||
| Any AEs, n (%) | 10 (83.3) | 11 (91.7) | 9 (75.0) | 11 (91.7) | 8 (66.7) | 39 (81.3) | 18 (90.0) | 17 (85.0) | 16 (80.0) |
| Any TEAEs, n (%) | 9 (75.0) | 10 (83.3) | 9 (75.0) | 10 (83.3) | 8 (66.7) | 37 (77.1) | 16 (80.0) | 17 (85.0) | 15 (75.0) |
| Grade 1 | 8 (66.7) | 7 (58.3) | 8 (66.7) | 7 (58.3) | 5 (41.7) | 27 (56.3) | 15 (75.0) | 12 (60.0) | 14 (70.0) |
| Grade 2 | 7 (58.3) | 7 (58.3) | 4 (33.3) | 6 (50.0) | 5 (41.7) | 22 (45.8) | 9 (45.0) | 11 (55.0) | 5 (25.0) |
| Grade 3 | 2 (16.7) | 3 (25.0) | 1 (8.3) | 0 | 0 | 4 (8.3) | 2 (10.0) | 0 | 0 |
| Drug-related TEAEs, n (%) | 2 (16.7) | 2 (16.7) | 2 (16.7) | 1 (8.3) | 1 (8.3) | 6 (12.5) | 2 (10.0) | 0 | 3 (15.0) |
| Grade 1 | 2 (16.7) | 0 | 2 (16.7) | 1 (8.3) | 0 | 3 (6.3) | 1 (5.0) | 0 | 3 (15.0) |
| Grade 2 | 1 (8.3) | 2 (16.7) | 1 (8.3) | 0 | 1 (8.3) | 4 (8.3) | 1 (5.0) | 0 | 1 (5.0) |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any SAEs | 1 (8.3) | 0 | 0 | 0 | 0 | 1 (5.0) | 0 | 0 | |
| TEAEs leading to treatment interruptions, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs resulting in study discontinuation, n (%) | 0 | 1 (8.3) | 0 | 0 | 0 | 1 (2.1) | 0 | 0 | 0 |
| Antiemetic used, n (%) | |||||||||
| 0–12 h after first postoperative dosing of experimental drugs | 5 (41.7) | 5 (41.7) | 3 (25.0) | 2 (16.7) | 1 (8.3) | 11 (22.9) | 6 (30.0) | 5 (25.0) | 2 (10.0) |
| 0–24 h after first postoperative dosing of experimental drugs | 5 (41.7) | 5 (41.7) | 3 (25.0) | 2 (16.7) | 2 (16.7) | 12 (25.0) | 6 (30.0) | 5 (25.0) | 3 (15.0) |
| TEAEs occurring in > 10% of patients, termed by PT, n (%) | |||||||||
| Fever | 5 (41.7) | 1 (8.3) | 4 (33.3) | 3 (25.0) | 3 (25.0) | 11 (22.9) | 3 (15.0) | 1 (5.0) | 4 (20.0) |
| Nausea | 4 (33.3) | 3 (25.0) | 4 (33.3) | 2 (16.7) | 3 (25.0) | 12 (25.0) | 4 (20.0) | 2 (10.0) | 4 (20.0) |
| Vomiting | 3 (25.0) | 5 (41.7) | 3 (25.0) | 1 (8.3) | 2 (16.7) | 11 (22.9) | 8 (40.0) | 6 (30.0) | 4 (20.0) |
| Decreased free triiodothyronine | 2 (16.7) | 1 (8.3) | 0 | 2 (16.7) | 2 (16.7) | 5 (10.4) | 1 (5.0) | 1 (5.0) | 2 (10.0) |
| Decreased serum potassium | 1 (8.3) | 2 (16.7) | 0 | 1 (8.3) | 2 (16.7) | 5 (10.4) | 3 (15.0) | 0 | 1 (5.0) |
| Elevated WBC counts | 1 (8.3) | 2 (16.7) | 0 | 1 (8.3) | 0 | 3 (6.3) | 1 (5.0) | 1 (5.0) | 2 (10.0) |
| Decreased heart rate | 1 (8.3) | 2 (16.7) | 0 | 0 | 0 | 2 (4.2) | 0 | 1 (5.0) | 0 |
| Anemia | 0 | 0 | 0 | 1 (8.3) | 1 (8.3) | 2 (4.2) | 3 (15.0) | 4 (20.0) | 1 (5.0) |
For HSK21542 dose groups in stage 1: group 1: preoperative 0.4 μg/kg + 0.2 μg/kg at postoperative 0 h, 8 h and 16 h; group 2: preoperative 1.0 μg/kg + 0.5 μg/kg at postoperative 0 h, 8 h and 16 h; group 3: 0.5 μg/kg at postoperative 0 h, 8 h and 16 h; group 4: 1.0 μg/kg at postoperative 0 h, 8 h and 16 h. Stage 2: HSK21542-0.5 μg/kg or HSK21542-1.0 μg/kg were administered postoperatively at 0 h, 8 h and 16 h. AE, adverse event; SAE, serious adverse event; TEAE, treatment-emergent adverse event.