Table 3.
Incidence of adverse events in the two treatment groups in the study*
| Adverse event | PGATx (n=52) | TAU (n=48) |
|---|---|---|
| Sleep disturbance | 16 (30.8) | 15 (31.3 ) |
| Headache | 6 (11.5) | 13 (27.1) |
| Anxiety | 12 (23.1) | 11 (22.9) |
| Somnolence | 8 (15.4) | 10 (20.8) |
| Gastrointestinal discomfort | 10 (19.2) | 7 (14.6) |
| Dizziness | 2 (3.8) | 6 (12.5) |
| Dry mouth | 6 (11.5) | 6 (12.5) |
| Fatigue | 3 (5.8) | 3 (6.3) |
| Constipation | 1 (1.9) | 3 (6.3) |
| Increased appetite | 1 (1.9) | 2 (4.2) |
| Sexual dysfunction | 1 (1.9) | 1 (2.1) |
| Sweating | 3 (5.8) | 1 (2.1) |
| Skin rash | 1 (1.9) | 0 (0.0) |
| Dry eye | 0 (0.0) | 1 (2.1) |
| Extrapyramidal symptoms | 0 (0.0) | 1 (2.1) |
| Tinnitus | 0 (0.0) | 2 (4.2) |
| Concentration difficulty | 1 (1.9) | 0 (0.0) |
| Tremor | 1 (1.9) | 0 (0.0 ) |
Values are presented as number (%).
*
Safety population including all the subjects took at least one dose of medication during the study.