Table 4.
Overall summary of adverse events (safety population)
| Saline placebo (n = 82) | Bupivacaine HCl 75 mg (n = 173) | HTX-011 300 mg/9 mg (n = 163) | |
|---|---|---|---|
| Any AE | 61 (74.4%) | 127 (73.4%) | 119 (73.0%) |
| Severe AEs | 2 (2.4%) | 2 (1.2%) | 3 (1.8%) |
| SAEs | 1 (1.2%) | 1 (0.6%) | 2 (1.2%) |
| Deaths or fatal AEs | 0 | 0 | 0 |
| Drug-related SAEs | 0 | 0 | 0 |
| AEs leading to study withdrawal | 0 | 0 | 0 |
| Opioid-related AEsa | 36 (43.9%) | 73 (42.2%) | 53 (32.5%) |
| Potential LAST-related AEsb | 28 (34.1%) | 71 (41.0%) | 54 (33.1%) |
| Local inflammatory AEsc | 2 (2.4%) | 10 (5.8%) | 6 (3.7%) |
| Most common AEs | |||
| Nausea | 28 (34.1%) | 37 (21.4%) | 30 (18.4%) |
| Constipation | 15 (18.3%) | 41 (23.7%) | 28 (17.2%) |
| Dizziness | 13 (15.9%) | 42 (24.3%) | 24 (14.7%) |
| Headache | 10 (12.2%) | 24 (13.9%) | 21 (12.9%) |
AEs were coded to PT using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.1
Safety population includes all subjects who receive study drug. This population was used for all summaries of safety data. The actual treatment received was used for analysis in this population
AE adverse event, HCl hydrochloride, LAST local anaesthetic systemic toxicity, ORAE opioid-related adverse event, PT preferred term, SAE serious adverse event
aAt each level of summarization (any event and PT), subjects reporting more than 1 ORAE are counted only once. ORAEs include those with sponsor-prespecified preferred terms of nausea, vomiting, constipation, pruritus, pruritus generalized, somnolence, respiratory depression, and urinary retention
bAt each level of summarization (any event and PT), subjects reporting more than 1 potential LAST-related AE are counted only once. LAST include those with sponsor-prespecified preferred terms of any PT that includes “arrhythmia,” any PT that includes “bradycardia,” cardiac arrest, dizziness, dysgeusia, hypotension, muscle twitching, paraesthesia, paraesthesia oral, respiratory arrest, seizure, tinnitus, tremor, vision blurred, and visual impairment
cAt each level of summarization (any event and PT), subjects reporting more than 1 potential local inflammatory AE are counted only once. Local inflammatory AEs include those with sponsor-prespecified preferred terms of blister, blood blister, cellulitis, erythema, impaired healing, incision site cellulitis, incision site complication, incision site erythema, incision site hemorrhage, incision site infection, incision site edema, incision site, rash, incision site swelling, incision site vesicles, infection, postoperative wound complications, postoperative wound infection, postprocedural cellulitis, purulent discharge, wound complication, wound dehiscence, wound infection, and wound secretion