Table 2.

Incidence of adverse events

	No. Toremifene (%)	No. Placebo (%)
General:
Any AE	482 (74.6)	481 (75.4)
Serious AE	136 (21.1)	128 (20.1)
Death from AE	14 (2.2)	10 (1.6)
Discontinuation due to AE	127 (19.7)	110 (17.2)
Most common AEs (more than 5% in either group):
Arthralgia	47 (7.3)	75 (11.8)
Dizziness	41 (6.3)	33 (5.2)
Back pain	39 (6.0)	33 (5.2)
Hot flush	25 (3.9)	34 (5.3)
Hematuria	24 (3.7)	34 (5.3)
Fatigue	24 (3.7)	32 (5.0)
Diarrhea	20 (3.1)	33 (5.2)
VTEs:
Any	17 (2.6)	7 (1.1)
Fatal	0 (0)	0 (0)
Yr 1	13 (2.0)	4 (0.6)
Yr 2	4 (0.6)	3 (0.5)
Cardiovascular events:
Myocardial infarction	6 (0.9)	8 (1.3)
Stroke	4 (0.7)	4 (0.7)