Table 3.

AE profile

	Placebo (n = 222)	Safinamide 100 mg/day (n = 224)	Safinamide 50 mg/day (n = 223)
AE category
Patients with any TEAEs	152 (68.5)	147 (65.6)	147 (65.9)
Patients with study drug-related TEAEs	51 (23.0)	67 (29.9)	69 (30.9)
Patients with SAEs	18 (8.1)	22 (9.8)	8 (3.6)
Patients discontinued due to AE	12 (5.4)	14 (6.3)	11 (4.9)
Most common AEs (reported by ≥5% of patients in any group)
Dyskinesia	28 (12.6)	41 (18.3)	47 (21.1)
Worsening PD	18 (8.1)	9 (4.0)	12 (5.4)
Cataract	13 (5.9)	14 (6.3)	11 (4.9)
Back pain	13 (5.9)	12 (5.4)	10 (4.5)
Depression	12 (5.4)	4 (1.8)	2 (0.9)
Headache	10 (4.5)	11 (4.9)	13 (5.8)
Hypertension	8 (3.6)	10 (4.5)	13 (5.8)

Values are n (%).

AE, adverse event; TEAE, treatment-emergent adverse event; SAE, serious adverse event; PD, Parkinson's disease.