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Table 3 Frequency of adverse events (all-patients-treated set)

From: Adjunct rasagiline to treat Parkinson’s disease with motor fluctuations: a randomized, double-blind study in China

  Number of patients (%)
Placebo (n = 158) Rasagiline 1 mg/day (n = 163)
Patients with AEs 59 (37.3) 66 (40.5)
Patients with AEs leading to withdrawal 5 (3.2)a 6 (3.7)b
Patients with SAEs 5 (3.2)c 7 (4.3)d
Most frequent TEAEse (preferred terms; ≥1% in either group):
 Dyskinesia 12 (7.6) 11 (6.7)
 Dizziness 0 (0.0) 8 (4.9)
 Hypotension 0 (0.0) 6 (3.7)
 Parkinson’s diseasef 7 (4.4) 5 (3.1)
 Alanine aminotransferase increased 1 (0.6) 3 (1.8)
 Aspartate aminotransferase increased 1 (0.6) 3 (1.8)
 Nausea 2 (1.3) 3 (1.8)
 Vomiting 0 (0.0) 3 (1.8)
 Fall 2 (1.3) 2 (1.2)
 Hallucination 0 (0.0) 2 (1.2)
 Headache 0 (0.0) 2 (1.2)
 Herpes zoster 0 (0.0) 2 (1.2)
 Insomnia 0 (0.0) 2 (1.2)
 Pain in extremity 1 (0.6) 2 (1.2)
 Rib fracture 0 (0.0) 2 (1.2)
 Diarrhea 4 (2.5) 1 (0.6)
 Abdominal distension 3 (1.9) 1 (0.6)
 Nasopharyngitis 3 (1.9) 1 (0.6)
 Accidental overdose 3 (1.9) 0 (0.0)
 Constipation 3 (1.9) 0 (0.0)
 Fatigue 2 (1.3) 1 (0.6)
 Somnolence 2 (1.3) 1 (0.6)
 Muscle spasms 2 (1.3) 0 (0.0)
 Thrombocytopenia 2 (1.3) 0 (0.0)
 URTI 2 (1.3) 0 (0.0)
 Viral URTI 2 (1.3) 0 (0.0)
  1. aDyskinesia*, femur fracture, intervertebral disc protrusion, Parkinson’s disease*, psoriasis* (all n = 1)
  2. bhallucination* (n = 2), dyskinesia*, epilepsy, hypotension*, transient ischemic attack (all n = 1)
  3. cedema peripheral, erysipelas* + psoriasis*, femur fracture, intervertebral disc protrusion, multiple fractures + road traffic accident (all n = 1
  4. dappendicitis, delusional perception*, Parkinson’s disease*, peripheral nerve injury, sick sinus syndrome, transient ischemic attack, venous stenosis (all n = 1)
  5. ean event that started after the first dose of study treatment and prior to the last protocol-specified contact with that patient
  6. fpatients reported symptom aggravation/disease progression
  7. *Considered by the investigator to be possibly or probably related to treatment