Table 3.
Pooled analysis of most frequently reported TEAEs (>10%) in the nine RCTs evaluating the safety of IN esketamine [30,31,32,33,34,35,37,38,39] during the 4 weeks of the induction phase (except for Daly et al., 2018, who evaluated TEAEs during the first 2 weeks [39]).
| TEAEs | Placebo n = 782 [30,31,32,33,34,35,37,38,39] |
IN Esketamine 28 mg n = 60 [32,39] |
IN Esketamine 56 mg n = 176 [32,37,39] |
IN Esketamine 84 mg n = 435 [31,32,33,35,37,39] |
IN Esketamine Flexible Dose n = 312 [30,34,38] |
IN Esktamine Any Doses n = 983 [30,31,32,33,34,35,37,38,39] |
|---|---|---|---|---|---|---|
| Dizziness | 86 (11.0) | 15 (25.0) | 58 (33.0) | 148 (34.0) | 136 (43.6) | 357 (36.3) |
| Dissociation | 42 (5.4) | 14 (23.3) | 47 (26.7) | 146 (33.6) | 114 (36.5) | 321 (32.7) |
| Nausea | 81 (10.4) | 9 (15.0) | 42 (23.9) | 123 (28.3) | 96 (30.8) | 270 (27.5) |
| Headache | 114 (14.6) | 12 (20.0) | 31 (17.6) | 88 (20.2) | 48 (15.4) | 179 (18.2) |
| Somnolence | 70 (9.0) | 10 (16.7) | 37 (21.0) | 83 (19.1) | 35 (11.2) | 165 (16.8) |
| Increased blood pressure | 40 (5.1) | 12 (20.0) | 29 (16.5) | 57 (13.1) | 58 (18.6) | 156 (15.9) |
| Dysgeusia | 80 (10.2) | 2 (3.3) | 20 (11.4) | 81 (18.6) | 46 (14.7) | 149 (15.2) |
| Vertigo | 9 (1.2) | 6 (10.0) | 32 (18.2) | 51 (11.7) | 38 (12.2) | 127 (12.9) |
| Hypoesthesia | 12 (1.5) | 7 (11.7) | 22 (12.5) | 41 (9.4) | 37 (11.9) | 107 (10.9) |
| Vomiting | 22 (2.8) | 1 (1.7) | 10 (5.7) | 51 (11.7) | 39 (12.5) | 101 (10.3) |
| Blurred vision | 15 (1.9) | 0 (0.0) | 8 (4.5) | 38 (8.7) | 37 (11.9) | 83 (8.4) |
| Paresthesia | 14 (1.8) | 0 (0.0) | 19 (10.8) | 40 (9.2) | 17 (5.4) | 76 (7.7) |
All data are n (%).