KISQALI fulvestrant N 483 Placebo fulvestrant N 241 All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 Adverse Drug Rea Infections and Infestations Infections 1 42 5 0 30 2 0 Blood and Lymphatic System Disorders Neutropenia 69 46 7 2 0 0 Leukopenia 27 12 0 0 Anemia 17 3 0 5 2 0 Metabolism and Nutrition Disorders Decreased appetite 16 0 13 0 0 Nervous System Disorders Dizziness 13 1 8 0 0 Respiratory, Thoracic and Mediastinal Disorders Cough 22 0 0 15 0 0 Dyspnea 15 1 12 2 0 Gastrointestinal Disorders Nausea 45 1 0 28 0 Diarrhea 29 0 20 0 Vomiting 27 1 0 13 0 0 Constipation 25 0 12 0 0 Abdominal pain 17 1 0 13 0 Skin and Subcutaneous Tissue Disorders Alopecia 19 0 0 5 0 0 Pruritus 20 0 7 0 0 Rash 23 0 7 0 0 General Disorders and Administration site Conditions Edema peripheral 15 0 0 7 0 0 Pyrexia 11 0 7 0 0 Investigations Alanine aminotransferase increased 15 7 2 5 0 Aspartate aminotransferase increased 13 5 1 5 0 Grading according to Common Terminology Criteria for Adverse Event CTCAE version 4
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