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Table 3 : Adverse Reactions Occurring with an Incidence of at Least 5% in Trials 0030 and 0027 Body system Adverse Reaction* Number (%) of subjects ARIMIDEX (N=506) Tamoxifen (N=511) Whole body Asthenia 83 (16) 81(16) Pain 70(14) 73 (14) Back pain 60(12) 68 (13) Headache 47 (9) 40 (8) Abdominal pain 40 (8) 38 (7) Chest pain 37 (7) 37 (7) Flu syndrome 35 (7) 30 (6) Pelvic pain 23 (5) 30 (6) Cardiovascular Vasodilation 128 (25) 106 (21) Hypertension 25 (5) 36 (7) Digestive Nausea 94 (19) 106 (21) Constipation 47 (9) 66 (13) Diarrhea 40 (8) 33 (6) Vomiting 38 (8) 36 (7) Anorexia 26 (5) 46 (9) Metabolic and Nutritional Peripheral edema 51 (10) 41 (8) Musculoskeletal Bone pain 54 (11) 52 (10) Nervous Dizziness 30 (6) 22 (4) Insomnia 30 (6) 38 (7) Depression 23 (5) 32 (6) Hypertonia 16 (3) 26 (5) Respiratory Cough increased 55 (11) 52 (10) Dyspnea 51 (10) 47 (9) Pharyngitis 49 (10) 68 (13) Skin and appendages Rash 38 (8) 34 (8) Urogenital Leukorrhea 9 (2) 31 (6) * A patient may have had more than 1 adverse event. Less frequent adverse experiences reported in patients receiving ARIMIDEX l mg in either Trial 0030 or Trial 0027 were similar to those reported for second-line therapy. Based on results from second-line therapy and the established safety profile of tamoxifen, the incidences of 9 pre-specified adverse event categories potentially causally related to one or both of the therapies because of their pharmacology were statistically analyzed. No significant differences were seen between treatment groups. Table 4 : Number of Patients with Pre-specified Adverse Reactions in Trials 0030 and 0027 Adverse Reaction* Number (n) and Percentage of Patients ARIMIDEX 1 mg (N=506) n (%) NOLVADEX 20 mg (N=511) n (%) Depression 23 (5) 32 (6) Tumor Flare 15 (3) 18 (4) Thromboembolic Disease’ 18 (4) 33 (6) Venous’ 5 15 Coronary and Cerebral’ 13 19 Gastrointestinal Disturbance 170 (34) 196 (38) Hot Flushes 134 (26) 118 (23) Vaginal Dryness 9 (2) 3 (1) Lethargy 6 (1) 15 (3) Vaginal Bleeding 5 (1) 11 (2) Weight Gain 11 (2) 8 (2) * A patient may have had more than 1 adverse reaction. ARIMIDEX was tolerated in two controlled clinical trials (i. The principal adverse reaction more common with ARIMIDEX than megestrol acetate was diarrhea. Adverse reactions reported in greater than 5% of the patients in any of the treatment groups in these two controlled clinical trials, regardless of causality, are presented below: Table 5 :Number (N) and Percentage of Patients with Adverse Reactions in Trials 0004 and 0005 Adverse Reaction* ARIMIDEX 1 mg (N=262) ARIMIDEX 10 mg (N=246) Megestrol Acetate 160 mg (N=253) n % n % n % Asthenia 42 (16) 33 (13) 47 (19) Nausea 41 (16) 48 (20) 28 (11) Headache 34 (13) 44 (18) 24 (9) Hot Flashes 32 (12) 29 (11) 21 (8) Pain 28 (11) 38 (15) 29 (11) Back Pain 28 (11) 26 (11) 19 (8) Dyspnea 24 (9) 27 (11) 53 (21) Vomiting 24 (9) 26 (11) 16 (6) Cough Increased 22 (8) 18 (7) 19 (8) Diarrhea 22 (8) 18 (7) 7 (3) Constipation 18 (7) 18 (7) 21 (8) Abdominal Pain 18 (7) 14 (6) 18 (7) Anorexia 18 (7) 19 (8) 11 (4) Bone Pain 17 (6) 26 (12) 19 (8) Pharyngitis 16 (6) 23 (9) 15 (6) Dizziness 16 (6) 12 (5) 15 (6) Rash 15 (6) 15 (6) 19 (8) Dry Mouth 15 (6) 11 (4) 13 (5) Peripheral Edema 14 (5) 21 (9) 28 (11) Pelvic Pain 14 (5) 17 (7) 13 (5) Depression 14 (5) 6 (2) 5 (2) Chest Pain 13 (5) 18 (7) 13 (5) Paresthesia 12 (5) 15 (6) 9 (4) Vaginal Hemorrhage 6 (2) 4 (2) 13 (5) Weight Gain 4 (2) 9 (4) 30 (12) Sweating 4 (2) 3 (1) 16 (6) Increased Appetite 0 (0) 1 (0) 13 (5) * A patient may have had more than one adverse reaction. Other less frequent (2% to 5%) adverse reactions reported in patients receiving ARIMIDEX l mg in either Trial 0004 or Trial 0005 are listed below. These adverse experiences are listed by body system and are in order of decreasing frequency within each body system regardless of assessed causality. Body as a Whole: Flu syndrome; fever; neck pain; malaise; accidental injury; infection. Hepatic: Gamma GT increased; SGOT increased; SGPT increased Hematologic: Anemia; leukopenia. Metabolic and Nutritional: Alkaline phosphatase increased; weight loss. Mean serum total cholesterol levels increased by 0. Increases in LDL cholesterol have been shown to contribute to these changes. Musculoskeletal: Myalgia; arthralgia; pathological fracture. Nervous: Somnolence; confusion; insomnia; anxiety; nervousness. Skin and Appendages: Hair thinning (alopecia); pruritus. The incidences of the following adverse reaction groups potentially causally related to one or both of the therapies because of their pharmacology, were statistically analyzed: weight gain, edema, thromboembolic disease, gastrointestinal disturbance, hot flushes, and vaginal dryness. These six groups, and the adverse reactions captured in the groups, were prospectively defined. The results are shown in the table below. Table 6 : Number (n) and Percentage of Patients with Pre-specified Adverse Reactions in Trials 0004 and 0005 Adverse Reaction Group ARIMIDEX1 mg (N=262) ARIMIDEX10 mg (N=246) Megestrol Acetate160 mg (N=253) n (%) n (%) n (%) Gastrointestinal Disturbance 77 (29) 81 (33) 54 (21) Hot Flushes 33 (13) 29 (12) 35 (14) Edema 19 (7) 28 (11) 35 (14) Thromboembolic Disease 9 (3) 4 (2) 12 (5) Vaginal Dryness 5 (2) 3 (1) 2 (1) Weight Gain 4 (2) 10 (4) 30 (12) Post-Marketing Experience. 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