Table 3. Most Frequently Reported Adverse Events in the Maintenance Phase in Patients Who Achieved Stable Remission and Those Who Achieved Stable Responsea.
| Adverse Event | No. (%) of Patients | |
|---|---|---|
| Esketamine Nasal Spray and Oral Antidepressant (n = 152) | Oral Antidepressant and Placebo Nasal Spray (n = 145) | |
| Dysgeusia | 41 (27.0) | 10 (6.9) |
| Vertigo | 38 (25.0) | 8 (5.5) |
| Dissociation | 35 (23.0) | 0 |
| Somnolence | 32 (21.1) | 3 (2.1) |
| Dizziness | 31 (20.4) | 7 (4.8) |
| Headache | 27 (17.8) | 14 (9.7) |
| Nausea | 25 (16.4) | 1 (0.7) |
| Vision blurred | 24 (15.8) | 1 (0.7) |
| Hypoesthesia oral | 20 (13.2) | 0 |
| Anxiety | 12 (7.9) | 5 (3.4) |
| Nasal discomfort | 11 (7.2) | 4 (2.8) |
| Paresthesia | 11 (7.2) | 0 |
| Viral upper respiratory tract infection | 11 (7.2) | 12 (8.3) |
| Blood pressure increased | 10 (6.6) | 5 (3.4) |
| Dizziness postural | 10 (6.6) | 3 (2.1) |
| Sedation | 10 (6.6) | 1 (0.7) |
| Vomiting | 10 (6.6) | 1 (0.7) |
| Confusional state | 9 (5.9) | 0 |
| Diplopia | 9 (5.9) | 0 |
| Hypoesthesia | 9 (5.9) | 0 |
| Paresthesia oral | 8 (5.3) | 1 (0.7) |
| Throat irritation | 8 (5.3) | 1 (0.7) |
a
Adverse events are listed in decreasing order based on incidence within the esketamine plus antidepressant group and in alphabetical order for events with the same incidence. The incidence was 5% or greater in either treatment group.