Table 2.
Adverse events
| Category, n (%) | Vehicle (n = 6) | OC-01 VNS (n = 12) |
|---|---|---|
| Patients with any TEAE | 1 (16.7) | 6 (50.0) |
| Patients with any ocular TEAE | 0 | 0 |
| Patients with any non-ocular TEAE | 1 (16.7) | 6 (50.0) |
| Sneezing | 1 (16.7) | 5 (41.7) |
| Nasal discomfort | 0 | 2 (16.7) |
| Patients with any treatment-emergent SAE | 0 | 0 |
| Patients with any TEAE by maximum severitya | ||
| Mild | 1 (16.7) | 6 (50.0) |
| Moderate | 0 | 0 |
| Severe | 0 | 0 |
| Patients with any TEAE related to study drug | 1 (16.7) | 6 (50.0) |
| Patients with any AE leading to study discontinuation | 0 | 0 |
| Patients with any TEAE leading to death | 0 | 0 |
OC-01 VNS OC-01 (varenicline solution) nasal spray, TEAE treatment-emergent adverse event, SAE serious adverse event, AE adverse event
All AEs were coded according to the Medical Dictionary for Regulatory Activities (Version 22.0)
aPatients reporting more than one event were counted only once at the maximum severity reported