Table 4.
Summary of adverse events (AEs) (safety set)
| HSK3486 (n = 135) | Propofol (n = 132) | P-value | |
|---|---|---|---|
| Any AEs | 71 (52.6) | 101 (76.5) | < 0.001 |
| Grade 1 (mild) | 61 (45.2) | 86 (65.2) | 0.001 |
| Grade 2 (moderate) | 20 (14.8) | 30 (22.7) | 0.098 |
| Grade 3 (severe) | 0 (0.0) | 4 (3.0) | 0.125 |
| Drug-related AEs | 50 (37.0) | 93 (70.5) | < 0.001 |
| Grade 1 (mild) | 37 (27.4) | 74 (56.1) | < 0.001 |
| Grade 2 (moderate) | 19 (14.1) | 26 (19.7) | 0.220 |
| Grade 3 (severe) | 0 (0.0) | 4 (3.0) | 0.125 |
| Any SAEs | 0 (0.0) | 0 (0.0) | – |
| Sedation-related AEs | 40 (29.6) | 42 (31.8) | 0.698 |
| Hypoxia | 8 (5.9) | 3 (2.3) | 0.133 |
| Duration (s) | 0.609 | ||
| Mean ± SD | 180.80 ± 172.93 | 180.70 ± 103.35 | |
| Median (range) | 142.00 (32,555) | 122.00 (120, 300) | |
| Hypotension | 28 (20.7) | 36 (27.3) | 0.211 |
| Duration (s) | 0.520 | ||
| Mean ± SD | 462.80 ± 379.78 | 646.30 ± 830.31 | |
| Median (range) | 390.00 (120, 1620) | 360.00 (120, 4800) | |
| Bradycardia | 8 (5.9) | 9 (6.8) | 0.765 |
| Duration (s) | 0.656 | ||
| Mean ± SD | 687.00 ± 540.84 | 591.80 ± 304.93 | |
| Median (range) | 566.00 (143, 1560) | 567.00 (124, 1080) | |
| AEs related to operant reactions to fiberoptic bronchoscopy | 3 (2.2) | 4 (3.0) | 0.976 |
Data are given as numbers with percentages in parentheses
SAEs serious AEs, SD standard deviation