Table 3.

Frequency of TEAEs occurring in ≥5%of patients receiving istradefylline 20 or 40 mg/day in the safety population

Adverse event, n (%)	Placebo	Istradefylline
		20 mg/day	40 mg/day
8-study pool, n	1010	869	896
Any TEAE	661 (65.4)	614 (70.7)	628 (70.1)
Dyskinesia	97 (9.6)	140 (16.1)	159 (17.7)
Nausea	46 (4.6)	52 (6.0)	54 (6.0)
Fall	50 (5.0)	35 (4.0)	45 (5.0)
Dizziness	42 (4.2)	44 (5.1)	44 (4.9)
Constipation	33 (3.3)	50 (5.8)	48 (5.4)
Insomnia	42 (4.2)	31 (3.6)	48 (5.4)
4-study pool, n	426	356	378
Any TEAE	278 (65.3)	241 (67.7)	263 (69.6)
Dyskinesia	32 (7.5)	52 (14.6)	63 (16.7)
Nausea	20 (4.7)	15 (4.2)	24 (6.3)
Dizziness	16 (3.8)	11 (3.1)	21 (5.6)
Constipation	12 (2.8)	19 (5.3)	21 (5.6)
Insomnia	15 (3.5)	2 (0.6)	21 (5.6)
Viral upper respiratory tract infection	20 (4.7)	22 (6.2)	20 (5.3)

TEAE, treatment-emergent adverse event.