Table 4.
TEAEs in At least 5% of Patients in any Treatment Group; DB Induction Phase
| Esk28 (N = 41) | Esk56 (N = 41)a | Esk84 (N = 40) | Comb Esk (N = 122) | Placebo (N = 80) | |
|---|---|---|---|---|---|
| Patients with TEAEs, n (%) | 33 (80.5%) | 39 (95.1%) | 39 (97.5%) | 111 (91.0%) | 51 (63.8%) |
| Blood pressure increased | 12 (29.3%) | 19 (46.3%) | 19 (47.5%) | 50 (41.0%) | 8 (10.0%) |
| Dissociation | 14 (34.1%) | 10 (24.4%) | 22 (55.0%) | 46 (37.7%) | 7 (8.8%) |
| Dizziness | 11 (26.8%) | 18 (43.9%) | 15 (37.5%) | 44 (36.1%) | 5 (6.3%) |
| Somnolence | 10 (24.4%) | 13 (31.7%) | 11 (27.5%) | 34 (27.9%) | 14 (17.5%) |
| Nausea | 7 (17.1%) | 7 (17.1%) | 8 (20.0%) | 22 (18.0%) | 7 (8.8%) |
| Hypoaesthesia | 7 (17.1%) | 8 (19.5%) | 5 (12.5%) | 20 (16.4%) | 4 (5.0%) |
| Vertigo | 4 (9.8%) | 7 (17.1%) | 8 (20.0%) | 19 (15.6%) | 1 (1.3%) |
| Headache | 6 (14.6%) | 5 (12.2%) | 4 (10.0%) | 15 (12.3%) | 3 (3.8%) |
| Asthenia | 2 (4.9%) | 7 (17.1%) | 3 (7.5%) | 12 (9.8%) | 0 |
| Sedation | 1 (2.4%) | 4 (9.8%) | 5 (12.5%) | 10 (8.2%) | 0 |
| Vomiting | 1 (2.4%) | 3 (7.3%) | 4 (10.0%) | 8 (6.6%) | 3 (3.8%) |
| Feeling drunk | 1 (2.4%) | 5 (12.2%) | 2 (5.0%) | 8 (6.6%) | 1 (1.3%) |
| Euphoric mood | 0 | 4 (9.8%) | 3 (7.5%) | 7 (5.7%) | 0 |
| Hypoaesthesia oral | 3 (7.3%) | 2 (4.9%) | 2 (5.0%) | 7 (5.7%) | 0 |
| Diarrhoea | 0 | 4 (9.8%) | 2 (5.0%) | 6 (4.9%) | 3 (3.8%) |
| Malaise | 0 | 3 (7.3%) | 3 (7.5%) | 6 (4.9%) | 0 |
| Dizziness postural | 0 | 3 (7.3%) | 2 (5.0%) | 5 (4.1%) | 0 |
| Mental impairment | 3 (7.3%) | 2 (4.9%) | 0 | 5 (4.1%) | 0 |
| Palpitations | 1 (2.4%) | 2 (4.9%) | 2 (5.0%) | 5 (4.1%) | 1 (1.3%) |
| Diplopia | 1 (2.4%) | 3 (7.3%) | 0 | 4 (3.3%) | 0 |
| Muscular weakness | 0 | 2 (4.9%) | 2 (5.0%) | 4 (3.3%) | 0 |
| Dysarthria | 1 (2.4%) | 0 | 2 (5.0%) | 3 (2.5%) | 0 |
| Hypotonia | 0 | 0 | 3 (7.5%) | 3 (2.5%) | 0 |
| Hallucination | 0 | 1 (2.4%) | 2 (5.0%) | 3 (2.5%) | 0 |
| Suicidal ideation | 0 | 1 (2.4%) | 2 (5.0%) | 3 (2.5%) | 2 (2.5%) |
| Hyperacusis | 0 | 1 (2.4%) | 2 (5.0%) | 3 (2.5%) | 0 |
| Oropharyngeal pain | 0 | 1 (2.4%) | 2 (5.0%) | 3 (2.5%) | 2 (2.5%) |
| Tinnitus | 1 (2.4%) | 0 | 2 (5.0%) | 3 (2.5%) | 0 |
| Blood pressure diastolic increased | 0 | 0 | 2 (5.0%) | 2 (1.6%) | 2 (2.5%) |
| Dyslalia | 0 | 0 | 2 (5.0%) | 2 (1.6%) | 0 |
| Respiratory rate decreased | 0 | 0 | 2 (5.0%) | 2 (1.6%) | 0 |
| Thirst | 0 | 0 | 2 (5.0%) | 2 (1.6%) | 0 |
| Weight increased | 0 | 0 | 2 (5.0%) | 2 (1.6%) | 0 |
Incidence is based on the number of patients experiencing at least 1 adverse event, not the number of events
Adverse events are coded using MedDRA version 22.0
a1 patient was randomized to the Esk84 mg group but was dosed with Esk56 mg on Days 1 and 4 and 28 mg on Day 8, then was withdrawn due to an adverse event on Day 11. This patient is summarized under the Esk84 mg group for the efficacy analyses, and under the Esk56 group for the safety analyses
Abbreviations: Comb combined, DB double-blind, Esk esketamine, MedDRA Medical Dictionary for Regulatory Activities, TEAE treatment-emergent adverse event