Table 4.
Treatment-emergent adverse events in at least 10% of participants in any treatment group (safety analysis set)
Esketamine 84 mg N = 24 |
Placebo N = 24 |
|
---|---|---|
Participants with 1 or more TEAEs | 24 (100) | 9 (38) |
Dizziness | 16 (67) | 1 (4) |
Headache | 5 (21) | 3 (13) |
Disturbance in attention | 7 (29) | 0 |
Somnolence | 6 (25) | 1 (4) |
Dysgeusia | 3 (13) | 1 (4) |
Hypoaesthesia | 4 (17) | 0 |
Paraesthesia | 3 (13) | 1 (4) |
Fatigue | 7 (29) | 0 |
Feeling abnormal | 6 (25) | 0 |
Feeling drunk | 4 (17) | 0 |
Feeling hot | 4 (17) | 0 |
Nausea | 9 (38) | 0 |
Vomiting | 5 (21) | 0 |
Vision blurred | 4 (17) | 0 |
Hallucination, visual | 3 (13) | 0 |
Values denoted as n (%). Percentages calculated with the number of participants in each group as denominator
TEAE treatment-emergent adverse events