Table 3:

Adverse events and Patient-reported Symptoms by Study Arm

	Low-dose tamoxifen (n=34)	Placebo (n=38)	P-value*
	N (%)*	N (%)*
Patient-reported symptoms
Arthralgia/arthritis	6 (18%)	5 (13%)	0.7458
Back pain	7 (21%)	4 (11%)	0.3288
Myalgias	7 (21%)	1 (3%)	0.0227
Malaise	6 (18%)	5 (13%)	0.7458
Hot flashes	9 (27%)	11 (29%)	1.0000
Night sweats	7 (21%)	6 (16%)	0.7606
Irregular menstruation	9 (27%)	6 (16%)	0.3843
Vaginal discharge	8 (24%)	5 (13%)	0.3593
Vaginal spotting/bleeding	5 (15%)	8 (21%)	0.5512
Breast pain	5 (15%)	3 (8%)	0.4630
Urinary incontinence/frequency/urgency	7 (21%)	10 (26%)	0.5926
Weight gain/ loss	17 (50%)	19 (50%)	1.0000
Insomnia	4 (12%)	7 (18%)	0.5225
Somnolence	9 (27%)	4 (11%)	0.1241
Fatigue	10 (29%)	3 (8%)	0.0296
Irritability	6 (18%)	6 (16%)	1.0000
Memory impairment	6 (18%)	2 (5%)	0.1375
Inability to concentrate	7 (21%)	3 (8%)	0.1748
Restlessness	7 (21%)	4 (11%)	0.3288
Paresthesia	7 (21%)	2 (5%)	0.0746
Mood swings	5 (15%)	4 (11%)	0.7265
Feelings of depression	7 (21%)	8 (21%)	1.0000
Diarrhea	6 (18%)	5 (13%)	0.7458
Constipation	7 (21%)	6 (16%)	0.7606
Heartburn	9 (27%)	7 (18%)	0.5713
Headaches	8 (24%)	6 (16%)	0.5527
Adverse Events**
Grades 3-4 Adverse Events
Any grade 3-4 adverse events	4 (12%)	7 (18%)	0.5225
Breast cancer	1 (3%)	3 (8%)	0.6167
Myocardial infarction	2 (6%)	2 (5%)	1.0000
Carotid artery occlusion	1 (3%)	0 (0%)	0.4722
Relapse of primary disease	0	2 (5%)	0.4945
Grades 1-2 Adverse Events
Any grade 1-2 adverse events	6 (18%)	7 (18%)	1.0000
Pregnancy	0	1 (3%)	1.0000
Cataract	2 (6%)	2 (5%)	1.0000
Basal cell carcinoma	0	3 (8%)	0.2418
Endometriosis	0	1 (3%)	1.0000
Thyroid nodules	4 (12%)	0 (0%)	0.0451

^*P-value calculated using Fisher’s exact test.

^**Of note, no episodes of venous thromboembolism, or uterine cancer were observed