All adverse events and SAEs
| Placebo (n=3) | Clozapine (n=3) | Risperidone (n=3) | |
| CNS | |||
| Sedation/drowsiness | 0 | 3 | 0 |
| Headache | 0 | 0 | 1 |
| Parkinsonism | 0 | 0 | 1 |
| Balance problems | 1 | 0 | 0 |
| Vertigo/dizziness | 1 | 0 | 0 |
| Gastrointestinal | |||
| Dry mouth | 0 | 2 | 3 |
| Hypersalivation | 0 | 0 | 1 |
| Constipation | 1 | 0 | 0 |
| Nausea | 1 | 0 | 0 |
| Neuromuscular | |||
| Rapid progression of weakness | 0 | 0 | 1* |
| Muscle weakness | 0 | 3 | 2 |
| Leg dragging | 1 | 0 | 0 |
| Other | |||
| Dry eyes | 0 | 0 | 3 |
| Rash | 0 | 0 | 1 |
| Fall | 0 | 1 | 13 |
| Increased prolactin | 0 | 0 | 2 |
| Pain or aches | 2 | 0 | 1 |
| Itchiness | 1 | 0 | 0 |
| Can't stand smell of meat | 1 | 0 | 0 |
| Sore throat | 1 | 0 | 0 |
| Fatigue | 0 | 0 | 1 |
| Vivid dreams | 0 | 0 | 1 |
| Urinary tract infection | 1 | 0 | 0 |
| Broken wrist, broken clavicle (motor vehicle accident) | 2* | 0 | 0 |
| Total | 13 | 9 | 31 |
| Number of person-days | 535 | 24 | 281 |
| Normalised (per 100 person-days) | 2.43 | 37.5 | 11 |
| P value† | 0.00001 | 0.00001 |
*SAE.
†Calculated by Fisher’s exact test compared with placebo.
SAE, serious adverse event.