Overall summary of TEAE (safety population)*
| TEAE, n (%) | Saline placebo (n=101) | Bupivacaine HCl 50 mg (n=154) | HTX-011 60 mg/1.8 mg (n=157) |
| Any TEAE | 79 (78.2) | 131 (85.1) | 131 (83.4) |
| Severe TEAEs | 3 (3.0) | 7 (4.5) | 5 (3.2) |
| SAEs | 1 (1.0) | 3 (1.9) | 3 (1.9) |
| Deaths | 0 | 1 (0.6) | 0 |
| Drug-related SAEs | 0 | 0 | 0 |
| TEAEs leading to study withdrawal | 0 | 0 | 1 (0.6) |
| ORAEs† | 54 (53.5) | 78 (50.6) | 69 (43.9) |
| Most common TEAEs (occurring in ≥15% of subjects in any group) | |||
| Nausea | 44 (43.6) | 70 (45.5) | 59 (37.6) |
| Dizziness | 18 (17.8) | 36 (23.4) | 34 (21.7) |
| Incision site edema | 13 (12.9) | 22 (14.3) | 27 (17.2) |
| Vomiting | 19 (18.8) | 33 (21.4) | 23 (14.6) |
Adverse events were coded to preferred term using the Medical Dictionary for Regulatory Activities, version 19.1.
*Safety population includes all subjects who receive study drug, using actual treatment received.
†Subjects reporting more than 1 ORAE are counted only once.
ORAEs, opioid-related adverse events;SAE, serious adverse event;TEAE, treatment-emergent adverse event.