Table 3. Adverse events and changes in Extrapyramidal Symptom Rating Scale (ESRS) scores and metabolic parameters.
|
Treatment group |
||||||
|---|---|---|---|---|---|---|
|
0 weeks |
24 weeks |
52 weeks |
||||
| N | % | N | % | N | % | |
| Serious adverse events | ||||||
| Death | 0 | 0 | 0 | 0 | 1 | 2 |
| Non-serious adverse events | ||||||
| Cold/cold Symptoms | 5 | 10 | 6 | 11 | 7 | 13 |
| Headache | 9 | 17 | 3 | 6 | 6 | 11 |
| Weight gain | 4 | 8 | 6 | 11 | 7 | 13 |
| Fatigue/sedation/sleep change | 4 | 8 | 5 | 9 | 4 | 8 |
| Muscle related injuries | 4 | 8 | 3 | 6 | 5 | 9 |
| Constipation | 3 | 6 | 5 | 9 | 1 | 2 |
| Menstrual irregularity/cramps | 2 | 4 | 2 | 4 | 6 | 11 |
| Nausea | 3 | 6 | 4 | 7 | 1 | 2 |
| Diarrhea | 1 | 2 | 4 | 7 | 2 | 4 |
| Breast changes/galactorrhea | 1 | 2 | 3 | 6 | 1 | 2 |
| Dry mouth | 2 | 4 | 1 | 2 | 1 | 2 |
| Dry skin/itch/rash | 1 | 2 | 2 | 4 | 1 | 2 |
| Extrapyramidal symptoms | 1 | 2 | 2 | 4 | 1 | 2 |
| Bloating/flatulence | 1 | 2 | 1 | 2 | 1 | 2 |
| Dizziness | 0 | 0 | 2 | 4 | 1 | 2 |
| Hair loss | 1 | 2 | 0 | 0 | 2 | 4 |
| Impaired sexual function | 0 | 0 | 3 | 6 | 0 | 0 |
| Elevated glucose | 0 | 0 | 1 | 2 | 1 | 2 |
| Elevated prolactin level | 0 | 0 | 1 | 2 | 1 | 2 |
| Impaired vision | 0 | 0 | 2 | 4 | 0 | 0 |
| Increased appetite | 0 | 0 | 1 | 2 | 1 | 2 |
| Elevated lipids | 0 | 0 | 1 | 2 | 0 | 0 |
| Elevated liver function test | 0 | 0 | 1 | 2 | 0 | 0 |
| Increased dreaming | 0 | 0 | 1 | 2 | 0 | 0 |
| Tardive dyskinesia | 1 | 2 | 0 | 0 | 0 | 0 |
| Other | 6 | 12 | 3 | 6 | 3 | 6 |
| Change from baseline to last visit | Mean | s.d. | Mean | s.d. | Mean | s.d. |
| ESRS score | ||||||
| Total | 1.3 | 8.9 | 2.3 | 8.3 | 2.3 | 9.8 |
| Parkinsonism+Dystonia subscale | −0.7 | 3.2 | −0.2 | 1.8 | 0.0 | 4.2 |
| Dyskinesia subscale | 0.02 | 0.32 | 0.00 | 0.00 | 0.02 | 0.14 |
| Metabolic parameters | ||||||
| Weight (kg)a | −0.2 | 4.8 | −0.1 | 6.8 | 3.2 | 6.8 |
| Glucose level (mmol I−1) | 0.7 | 3.7 | −0.01 | 0.7 | 0.1 | 0.9 |
| Cholesterol level (mmol I−1) | −0.2 | 1 | −0.3 | 0.7 | 0.02 | 1.0 |
| Triglycerides (mmol I−1) | 0.3 | 1.6 | −0.02 | 0.7 | 0.1 | 1.8 |
Abbreviation: s.d., standard deviation.
P-value=0.01 for the difference between the 52-weeks and 0-weeks groups and between the 52-weeks and 24-weeks groups.