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The following table summarizes the incidence of adverse reactions reported at a frequency of 2% or greater from clinical trials (Ingle, Pritchard, Buchanan) which compared NOLVADEX (tamoxifen citrate) therapy to ovarian ablation in premenopausal patients with metastatic breast cancer. Adverse Reactions* NOLVADEX (tamoxifen citrate) All Effects % of Women n=104 OVARIAN ABLATION All Effects % of Women n =100 Flush 33 46 Amenorrhea 16 69 Altered Menses 13 5 Oligomenorrhea 9 1 Bone Pain 6 6 Menstrual Disorder 6 4 Nausea 5 4 Cough/Coughing 4 1 Edema 4 1 Fatigue 4 1 Muscoloskeletal Pain 3 0 Pain 3 4 Ovarian Cyst(s) 3 2 Depression 2 2 Abdominal Cramps 1 2 Anorexia 1 2 *Some women had more than one adverse reaction. NOLVADEX (tamoxifen citrate) is well tolerated in males with breast cancer. Reports from the literature and case reports suggest that the safety profile of NOLVADEX (tamoxifen citrate) in males is similar to that seen in women. Loss of libido and impotence have resulted in discontinuation of tamoxifen therapy in male patients. Also, in oligospermic males treated with tamoxifen, LH, FSH, testosterone and estrogen levels were elevated. No significant clinical changes were reported. In the NSABP B-14 study, women with axillary node-negative breast cancer were randomized to 5 years of NOLVADEX (tamoxifen citrate) 20 mg/day or placebo following primary surgery. The reported adverse effects are tabulated below (mean follow-up of approximately 6. The incidence of hot flashes (64% vs. All other adverse effects occurred with similar frequency in the 2 treatment groups, with the exception of thrombotic events; a higher incidence was seen in NOLVADEX (tamoxifen citrate) -treated patients (through 5 years, 1. Two of the patients treated with NOLVADEX (tamoxifen citrate) who had thrombotic events died. NSABP B-14 Study Adverse Effect % of Women NOLVADEX (n=1422) Placebo (n=1437) Hot Flashes 64 48 Fluid Retention 32 30 Vaginal Discharge 30 15 Nausea 26 24 Irregular Menses 25 19 Weight Loss ( > 5%) 23 18 Skin Changes 19 15 Increased SGOT 5 3 Increased Bilirubin 2 1 Increased Creatinine 2 1 Thrombocytopenia* 2 1 Thrombotic Events Deep Vein Thrombosis 0. In the Eastern Cooperative Oncology Group (ECOG) adjuvant breast cancer trial, NOLVADEX (tamoxifen citrate) or placebo was administered for 2 years to women following mastectomy. 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