Table 3.

Adverse Events (Safety Population)

	Placebo (n=56)	5 mg Ulipristal (n=53)	10 mg Ulipristal (n=48)	Ulipristal Total (n=101)
Treatment phase
AE leading to discontinuation	1 (1.8)*	0	0	0
Serious AE†	0	1 (1.9)	2 (4.2)	3 (3.0)
Death	0	0	0	0
TEAE	16 (28.6)	23 (43.4)	26 (54.2)	49 (48.5)
Most frequently reported TEAEs‡
Hot flush	0	3 (5.7)	2 (4.2)	5 (5.0)
Blood CPK elevated	0	1 (1.9)	3 (6.3)	4 (4.0)
Hypertension	0	0	3 (6.3)	3 (3.0)
Follow-up phase
AE leading to discontinuation	0	0	0	0
Serious AE§	1 (1.8)	0	0	0
Death	0	0	0	0
TEAE	10 (17.9)	10 (18.9)	12 (25.0)	22 (21.8)

AE, adverse event; TEAE, treatment-emergent AE; CPK, creatine phosphokinase.

Data are n (%).

^*Type 2 diabetes mellitus.

^†Includes cellulitis, hemorrhoids, hypertension, and influenza.

^‡Five percent or greater in any group.

^§Includes angina pectoris and anxiety.