Table 5.

Incidence of Adverse Events in the Study

Adverse Event	Tamoxifen (n = 55)	Placebo during Randomized (receiving Placebo; n = 52)	Placebo during Open Label (receiving Tamoxifen; n = 42)
Acne	0 (0)	3 (6)	0 (0)
Cramping/changes in menstrual fluid	3 (5)	0 (0)	0 (0)
Fluid retention	10 (18)	1 (2)	2 (5)
Headache/migraine	16 (29)	1 (2)	3 (7)
Hot flashes	6 (11)	3 (6)	0 (0)
Mood changes	11 (20)	2 (4)	2 (5)
Nausea/vomiting	5 (9)	2 (4)	1 (2)
Rash	0 (0)	2 (4)	0 (0)
Vision flashes	1 (2)	0 (0)	0 (0)
Weakness/fatigue/dizziness	6 (11)	1 (2)	1 (2)
Weight loss	1 (2)	0 (0)	0 (0)
Yeast infection/BV	5 (9)	0 (0)	0 (0)

Data are n(%).