Table 2.
Summary of Most Frequently Reporteda Treatment-Emergent Adverse Events During Double-Blind Phases
| Number (%) of patients | ||||
|---|---|---|---|---|
| Placebo + standard of care n = 113 | Esketamine 84 mg + standard of care n = 114 | |||
| Dizziness | 21 | (18.6) | 47 | (41.2) |
| Dissociation | 9 | (8.0) | 44 | (38.6) |
| Nausea | 16 | (14.2) | 38 | (33.3) |
| Dysgeusia | 18 | (15.9) | 29 | (25.4) |
| Somnolence | 12 | (10.6) | 26 | (22.8) |
| Headache | 26 | (23.0) | 25 | (21.9) |
| Paresthesia | 7 | (6.2) | 23 | (20.2) |
| Vomiting | 5 | (4.4) | 18 | (15.8) |
| Anxiety | 7 | (6.2) | 17 | (14.9) |
| Vision blurred | 6 | (5.3) | 17 | (14.9) |
| Sedation | 3 | (2.7) | 16 | (14.0) |
| Paresthesia oral | 3 | (2.7) | 14 | (12.3) |
| Euphoric mood | 1 | (0.9) | 13 | (11.4) |
| Hypoesthesia | 1 | (0.9) | 12 | (10.5) |
| Nasal discomfort | 9 | (8.0) | 10 | (8.8) |
| Constipation | 1 | (0.9) | 9 | (7.9) |
| Depersonalization/derealization disorder | 0 | 9 | (7.9) | |
| Insomnia | 11 | (9.7) | 9 | (7.9) |
| Dry mouth | 5 | (4.4) | 8 | (7.0) |
| Blood pressure increased | 3 | (2.7) | 7 | (6.1) |
| Constipation | 9 | (8.0) | 7 | (6.1) |
| Hypoesthesia oral | 2 | (1.8) | 7 | (6.1) |
| Vertigo | 0 | 7 | (6.1) | |
| Diplopia | 0 | 6 | (5.3) | |
| Hyperhidrosis | 3 | (2.7) | 6 | (5.3) |
| Oropharyngeal pain | 3 | (2.7) | 6 | (5.3) |
| Feeling drunk | 1 | (0.9) | 6 | (5.3) |
| Throat irritation | 4 | (3.5) | 6 | (5.3) |
| Suicide ideation | 6 | (5.3) | 5 | (4.4) |
aMost frequently reported is defined as ≥5% of patients in either treatment group during the double-blind phase. Events are presented in descending order in the esketamine group for the double-blind phase.