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. 2015 Oct 13;21(8):1050–1056. doi: 10.1038/mp.2015.158

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.

a

P-value=0.01 for the difference between the 52-weeks and 0-weeks groups and between the 52-weeks and 24-weeks groups.