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Incidence (%) of Adverse Reactions of all Grades* and Illnesses Occurring in (?5%) of Patients in Any Treatment Group in Study IES in Postmenopausal Women with Early Breast Cancer % of patients Body system and Adverse Reaction by MedDRA dictionary Aromasin 25 mg daily (N=2252) Tamoxifen 20 mg daily’ (N=2280) * Graded according to Common Toxicity Criteria; ‘ 75 patients received tamoxifen 30 mg daily; ‘ Event actively sought. Eye Visual disturbances’ 5. Treatment of Advanced Breast Cancer. A total of 1058 patients were treated with exemestane 25 mg once daily in the clinical trials program. Only one death was considered possibly related to treatment with exemestane; an 80-year-old woman with known coronary artery disease had a myocardial infarction with multiple organ failure after 9 weeks on study treatment. In the clinical trials program, only 3% of the patients discontinued treatment with exemestane because of adverse reactions, mainly within the first 10 weeks of treatment; late discontinuations because of adverse reactions were uncommon (0. In the comparative study, adverse reactions were assessed for 358 patients treated with Aromasin and 400 patients treated with megestrol acetate. Fewer patients receiving Aromasin discontinued treatment because of adverse reactions than those treated with megestrol acetate (2% vs. Adverse reactions that were considered drug related or of indeterminate cause included hot flashes (13% vs. The proportion of patients experiencing an excessive weight gain (>10% of their baseline weight) was significantly higher with megestrol acetate than with Aromasin (17% vs. Table 4 shows the adverse reactions of all CTC grades, regardless of causality, reported in 5% or greater of patients in the study treated either with Aromasin or megestrol acetate. Incidence (%) of Adverse Reactions of all Grades* and Causes Occurring in ?5% of Advanced Breast Cancer Patients In Each Treatment Arm in the Comparative Study Body system and Adverse Reaction by WHO ART dictionary Aromasin 25 mg once daily (N=358) Megestrol Acetate 40 mg QID (N=400) * Graded according to Common Toxicity Criteria Autonomic Nervous Increased sweating 6 9 Body as a Whole Fatigue 22 29 Hot flashes 13 6 Pain 13 13 Influenza-like symptoms 6 5 Edema (includes edema, peripheral edema, leg edema) 7 6 Cardiovascular Hypertension 5 6 Nervous Depression 13 9 Insomnia 11 9 Anxiety 10 11 Dizziness 8 6 Headache 8 7 Gastrointestinal Nausea 18 12 Vomiting 7 4 Abdominal pain 6 11 Anorexia 6 5 Constipation 5 8 Diarrhea 4 5 Increased appetite 3 6 Respiratory Dyspnea 10 15 Coughing 6 7. Less frequent adverse reactions of any cause (from 2% to 5%) reported in the comparative study for patients receiving Aromasin 25 mg once daily were fever, generalized weakness, paresthesia, pathological fracture, bronchitis, sinusitis, rash, itching, urinary tract infection, and lymphedema. Additional adverse reactions of any cause observed in the overall clinical trials program (N = 1058) in 5% or greater of patients treated with exemestane 25 mg once daily but not in the comparative study included pain at tumor sites (8%), asthenia (6%), and fever (5%). Adverse reactions of any cause reported in 2% to 5% of all patients treated with exemestane 25 mg in the overall clinical trials program but not in the comparative study included chest pain, hypoesthesia, confusion, dyspepsia, arthralgia, back pain, skeletal pain, infection, upper respiratory tract infection, pharyngitis, rhinitis, and alopecia, buy anavar 10 mg oral steroids anavar, var. 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