Table 2 Summary of treatment-related events
System organ class /Preferredterm | Quetiapine XR N = 23 | Placebo N = 13 |
|---|---|---|
Subjects with at least 1 related adverse event | 17 (47%) | 10 (28%) |
Eye disorders | 0 (0%) | 1 (3%) |
Vision blurred | 0 (0%) | 1 (3%) |
Gastrointestinal disorders | 9 (25%) | 4 (11%) |
Constipation | 3 (8%) | 2 (6%) |
Dry mouth | 7 (19%) | 2 (6%) |
Nausea | 1 (3%) | 0 (0%) |
Vomiting | 1 (3%) | 0 (0%) |
Investigations | 3 (8%) | 4 (11%) |
Blood pressure increased | 0 (0%) | 1 (3%) |
Glycosylated haemoglobin increased | 0 (0%) | 1 (3%) |
Weight increased | 3 (8%) | 3 (8%) |
Metabolism and nutrition disorders | 2 (6%) | 2 (6%) |
Increased appetite | 2 (6%) | 2 (6%) |
Nervous system disorders | 11 (31%) | 5 (14%) |
Dizziness | 4 (11%) | 1 (3%) |
Headache | 1 (3%) | 1 (3%) |
Memory impairment | 0 (0%) | 1 (3%) |
Restless legs syndrome | 0 (0%) | 1 (3%) |
Sedation | 3 (8%) | 1 (3%) |
Somnolence | 4 (11%) | 1 (3%) |
Tremor | 1 (3%) | 1 (3%) |
Renal and urinary disorders | 1 (3%) | 1 (3%) |
Dysuria | 1 (3%) | 1 (3%) |
Reproductive system and breast disorders | 0 (0%) | 1 (3%) |
Oligomenorrhoea | 0 (0%) | 1 (3%) |
Skin and subcutaneous tissue disorders | 0 (0%) | 1 (3%) |
Rash papular | 0 (0%) | 1 (3%) |