Table 5.
Most Frequently Reported Adverse Eventsa in the Double-Blind Phase
| Number (%) of patients | ||||
|---|---|---|---|---|
| Adverse event | Esketamine 56 mg/ oral antidepressant N = 115 | Esketamine 84 mg/ oral antidepressant N = 116 | Total esketamine/ oral antidepressant N = 231 | Oral antidepressant/placebo N = 113 |
| Nausea | 31 (27.0%) | 37 (31.9%) | 68 (29.4%) | 12 (10.6%) |
| Dissociation | 30 (26.1%) | 32 (27.6%) | 62 (26.8%) | 4 (3.5%) |
| Dizziness | 32 (27.8%) | 26 (22.4%) | 58 (25.1%) | 10 (8.8%) |
| Vertigo | 24 (20.9%) | 24 (20.7%) | 48 (20.8%) | 2 (1.8%) |
| Headache | 23 (20.0%) | 24 (20.7%) | 47 (20.3%) | 19 (16.8%) |
| Somnolence | 24 (20.9%) | 21 (18.1%) | 45 (19.5%) | 13 (11.5%) |
| Dysgeusia | 17 (14.8%) | 20 (17.2%) | 37 (16.0%) | 17 (15.0%) |
| Hypoesthesia | 14 (12.2%) | 16 (13.8%) | 30 (13.3%) | 2 (1.8%) |
| Paresthesia | 19 (16.5%) | 11 (9.5%) | 30 (13.0%) | 3 (2.7%) |
| Hypoesthesia oral | 16 (13.9%) | 12 (10.3%) | 28 (12.1%) | 2 (1.8%) |
| Vomiting | 7 (6.1%) | 14 (12.1%) | 21 (9.1%) | 2 (1.8%) |
| Fatigue | 12 (10.4%) | 8 (6.9%) | 20 (8.7%) | 5 (4.4%) |
| Anxiety | 10 (8.7%) | 9 (7.8%) | 19 (8.2%) | 7 (6.2%) |
| Blood pressure increased | 8 (7.0%) | 11 (9.5%) | 19 (8.2%) | 5 (4.4%) |
| Insomnia | 10 (8.7%) | 8 (6.9%) | 18 (7.8%) | 11 (9.7%) |
| Vision blurred | 8 (7.0%) | 9 (7.8%) | 17 (7.4%) | 0 |
| Dizziness postural | 7 (6.1%) | 7 (6.0%) | 14 (6.1%) | 0 |
| Sedation | 6 (5.2%) | 8 (6.9%) | 14 (6.1%) | 1 (0.9%) |
| Throat irritation | 5 (4.3%) | 9 (7.8%) | 14 (6.1%) | 4 (3.5%) |
| Diarrhea | 8 (7.0%) | 5 (4.3%) | 13 (5.6%) | 3 (2.7%) |
| Lethargy | 7 (6.1%) | 5 (4.3%) | 12 (5.2%) | 1 (0.9%) |
| Euphoric mood | 8 (7.0%) | 2 (1.7%) | 10 (4.3%) | 2 (1.8%) |
| Feeling drunk | 7 (6.1%) | 3 (2.6%) | 10 (4.3%) | 0 |
| Paresthesia oral | 9 (7.8%) | 1 (0.9%) | 10 (4.3%) | 2 (1.8%) |
| Tremor | 4 (3.5%) | 6 (5.2%) | 10 (4.3%) | 2 (1.8%) |
| Mental impairment | 6 (5.2%) | 3 (2.6%) | 9 (3.9%) | 1 (0.9%) |
| Nasal discomfort | 4 (3.5%) | 5 (4.3%) | 9 (3.9%) | 7 (6.2%) |
| Pollakiuria | 6 (5.2%) | 2 (1.7%) | 8 (3.5%) | 1 (0.9%) |
Notes: Adverse events listed in decreasing order based on incidence within the total esketamine/antidepressant group, and in alphabetical order for events with the same incidence.
aIncidence ≥5% any treatment group.