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 |