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

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

	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 TEAEs^e (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 disease^f	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)

^aDyskinesia*, femur fracture, intervertebral disc protrusion, Parkinson’s disease*, psoriasis* (all n = 1)
^bhallucination* (n = 2), dyskinesia*, epilepsy, hypotension*, transient ischemic attack (all n = 1)
^cedema peripheral, erysipelas* + psoriasis*, femur fracture, intervertebral disc protrusion, multiple fractures + road traffic accident (all n = 1
^dappendicitis, delusional perception*, Parkinson’s disease*, peripheral nerve injury, sick sinus syndrome, transient ischemic attack, venous stenosis (all n = 1)
^ean event that started after the first dose of study treatment and prior to the last protocol-specified contact with that patient
^fpatients reported symptom aggravation/disease progression
^*Considered by the investigator to be possibly or probably related to treatment

ISSN: 2047-9158