Table 2.

Summary of treatment-emergent adverse events (TEAEs) occurring in ≥ 5% of subjects in the ospemifene 60 mg/day group. Data are given as n (%). Note: Counts include adverse events that were ongoing from the 12-week pivotal safety study

	Ospemifene 60 mg/day (n = 364)*	Placebo (n = 62)*
TEAE	308 (84.6)	47 (75.8)
Withdrawals due to adverse events	49 (13.5)	6 (9.7)
Serious TEAEs	18 (4.9)	4 (6.5)
Most frequent TEAEs
Urinary tract infection	61 (16.8)	15 (24.2)
Hot flush	46 (12.6)	4 (6.5)
Nasopharyngitis	36 (9.9)	4 (6.5)
Other TEAEs
Vaginal candidiasis and/or vulvovaginal mycotic infection	35 (9.6)	2 (3.2)
Headache	33 (9.1)	6 (9.7)
Muscle spasms	31 (8.5)	4 (6.5)
Back pain	24 (6.6)	2 (3.2)
Hyperhidrosis	22 (6.0)	5 (8.1)
Vaginal discharge	20 (5.5)	0 (0)
Insomnia	19 (5.2)	0 (0)
Cystitis	19 (5.2)	0 (0)

*, One subject randomized to placebo was correctly treated until week 39 when by mistake she received ospemifene 60 mg for weeks 39−52. Since placebo was the correct randomized treatment for this subject, but she also received active drug, her data are included in the placebo group for the ITT population and in the ospemifene group for the safety population. Thus, the safety population includes 62 subjects in the placebo group and 364 subjects in the ospemifene 60 mg group, while the ITT population includes 63 subjects in the placebo group and 363 subjects in the ospemifene 60 mg group