Table 3.
Most common (≥ 5% in any treatment group) TEAEs by system organ class and preferred term (safety population)
| System organ class preferred term |
INL-001 300 mg n = 34 |
0.25% Bupivacaine HCl infiltration 175 mg n = 16 |
|---|---|---|
| Patients with any TEAE, n (%) | 33 (97.1) | 15 (93.8) |
| Nervous system disorders | 26 (76.5) | 13 (81.3) |
| Somnolence | 19 (55.9) | 10 (62.5) |
| Dizziness | 12 (35.3) | 7 (43.8) |
| Tremor | 6 (17.6) | 3 (18.8) |
| Dysgeusia | 4 (11.8) | 4 (25.0) |
| Headache | 4 (11.8) | 1 (6.3) |
| Gastrointestinal disorders | 12 (35.3) | 4 (25.0) |
| Constipation | 8 (23.5) | 1 (6.3) |
| Oral hypoesthesia | 3 (8.8) | 2 (12.5) |
| Nausea | 3 (8.8) | 2 (12.5) |
| Oral paresthesia | 3 (8.8) | 2 (12.5) |
| Eye disorders | 10 (29.4) | 3 (18.8) |
| Vision blurred | 8 (23.5) | 3 (18.8) |
| Psychiatric disorders | 7 (20.6) | 4 (25.0) |
| Restlessness | 6 (17.6) | 2 (12.5) |
| Anxiety | 2 (5.9) | 1 (6.3) |
| Injury, poisoning, and procedural complications | 6 (17.6) | 1 (6.3) |
| Incision site complications | 3 (8.8) | 0 |
| Ear and labyrinth disorders | 3 (8.8) | 1 (6.3) |
| Tinnitus | 3 (8.8) | 1 (6.3) |
| Cardiac disorders | 2 (5.9) | 2 (12.5) |
| Bradycardia | 2 (5.9) | 1 (6.3) |
TEAEs were defined as any adverse event that occurred after implantation/infiltration. Adverse events were coded using the MedDRA (version 18.0)
HCl hydrochloride, MedDRA Medical Dictionary for Regulatory Activities, TEAE treatment-emergent adverse event