Table 2 Safety results (most commonly reported treatment-emergent adverse events)a.
From: Methods to address functional unblinding of raters in CNS trials
TEAE reported | X/T (n = 340) | Placebo (n = 343) |
|---|---|---|
At least one TEAE, n (%) | 231 (67.9%) | 176 (51.3%) |
Gastrointestinal | ||
Nausea | 63 (18.5%) | 13 (3.8%) |
Constipation | 58 (17.1%) | 21 (6.1%) |
Dyspepsia | 52 (15.3%) | 16 (4.7%) |
Vomiting | 46 (13.5%) | 6 (1.7%) |
Dry mouth | 17 (5.0%) | 5 (1.5%) |
Diarrhoea | 16 (4.7%) | 9 (2.6%) |
Gastroesophageal reflux | 10 (2.9%) | 1 (0.3%) |
Salivary hypersecretion | 7 (2.1%) | 1 (0.3%) |
Other | ||
Headache | 37 (10.9%) | 35 (10.2%) |
Hypertension | 21 (6.2%) | 4 (1.2%) |
Dizziness | 16 (4.7%) | 8 (2.3%) |
Somnolence | 13 (3.8%) | 9 (2.6%) |
Tachycardia | 8 (2.4%) | 5 (1.5%) |
Blurred vision | 8 (2.4%) | 1 (0.3%) |
