TABLE 2.
Summary of Most Frequently Reported* Treatment-Emergent Adverse Events During Double-Blind Phase
| No. (%) of Patients | ||
|---|---|---|
| Adverse Event | Placebo + Standard of Care (n = 225) | Esketamine 84 mg† + Standard of Care (n = 227) |
| Dizziness | 31 (13.8) | 87 (38.3) |
| Dissociation | 13 (5.8) | 77 (33.9) |
| Nausea | 31 (13.8) | 61 (26.9) |
| Somnolence | 23 (10.2) | 47 (20.7) |
| Headache | 46 (20.4) | 46 (20.3) |
| Dysgeusia | 29 (12.9) | 45 (19.8) |
| Blurred vision | 11 (4.9) | 27 (11.9) |
| Blood pressure increased | 9 (4.0) | 26 (11.5) |
| Paresthesia | 7 (3.1) | 26 (11.5) |
| Vomiting | 12 (5.3) | 26 (11.5) |
| Anxiety | 17 (7.6) | 23 (10.1) |
| Sedation | 5 (2.2) | 23 (10.1) |
*Most frequently reported is defined as ≥10% of patients in either treatment group during the double-blind phase. Events are presented in descending order in the esketamine group and in alphabetical order for events with the same incidence.
†Includes patients who had their dose reduced because of tolerability issues.