The most frequent (≥20 %) undesirable reactions, noted against the background of therapy with axitinib, were diarrhea, increased blood pressure, fatigue, decreased appetite, nausea, weight loss, dysphonia, palmar-plantar syndrome erythrodysesthesia, bleeding, hypothyroidism, vomiting, proteinuria, cough and constipation.
The frequency of unwanted reactions is represented by the following classification:
Often | ≥ 10% |
Often | ≥ 1% and <10% |
Infrequently | ≥0.1% and <1% |
Rarely | ≥0.01% and <0.1% |
Rarely | < 0,01 % |
Frequency unknown | can not be determined on the basis of available of data |
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Violations from the heart and blood vessels: very often - Increased blood pressure, bleeding (including nasal bleeding, hematuria, rectal bleeding, cerebral hemorrhage, gastric bleeding and hemorrhage in the lower section gastrointestinal tract); often - venous embolic and thrombotic events (including pulmonary embolism, retinal vein occlusion / thrombosis and deep vein thrombosis), arterial embolic and thrombotic events (including transient ischemic attack and acute impairment of cerebral circulation), heart failure (including cardiac failure insufficiency, congestive heart failure,cardiopulmonary insufficiency, left ventricular dysfunction, reduced ejection fraction and right ventricular failure), in some cases fatal; infrequently - hypertensive crisis.
Disorders from the endocrine system: very often - hypothyroidism; often hyperthyroidism.
Disorders from the side of the organ of vision: infrequently - occlusion or thrombosis of the central vein of the retina.
Hearing disorders and labyrinthine disturbances: often - noise in ears.
Disorders from the gastrointestinal tract: very often - diarrhea, vomiting, nausea, abdominal pain, stomatitis, constipation, dyspepsia; often - hemorrhoids, pain in the upper abdomen, perforation of the gastrointestinal tract, fistula, flatulence, glossodynia.
Disorders from the liver and bile ducts: infrequently - Hyperbilirubinemia.
Disorders from the metabolism and nutrition: very often - decreased appetite; often - Dehydration, hyperkalemia, hypercalcemia, hypocalcemia.
Disorders from the nervous system: very often - headache, dysgeusia; often - dizziness; infrequently - a syndrome of reversible posterior leukoencephalopathy, stroke.
Disorders from the musculoskeletal and connective tissue: very often - Arthralgia, pain in the limbs; often - myalgia.
Disturbances from the blood and lymphatic system: often - anemia, polycythemia. thrombocytopenia; infrequently - Neutropenia, leukopenia.
Disturbances from the respiratory system, chest and mediastinal organs: very often - dyspnoea (in some cases with a fatal outcome), cough, dysphonia; often hemoptysis, pain in the oropharynx.
Disturbances from the skin and subcutaneous tissues: very often - syndrome of palmar-plantar erythrodysesthesia (palmar-plantar syndrome), skin rash, dry skin; often - erythema, itchy skin, alopecia.
Disorders from the kidneys and urinary tract: very often - proteinuria; often - Renal failure.
General disorders and disorders at the injection site: very often - increased fatigue, asthenia (in some cases with a fatal outcome), inflammation of the mucous membranes.
Laboratory and instrumental data: very often - weight loss; often - increase in the concentration of creatinine, increased activity of alanine aminotransferase (ALG), aspartate aminotransferase (ACT), alkaline phosphatase, lipase, amylase; hypoglycaemia, hyperglycemia, decreased bicarbonate concentration, hypernatremia, hyponatremia, hypoalbuminemia, hypophosphatemia, decreased platelet count, white blood cells, lymphocytes, decreased hemoglobin, increased thyroid-stimulating hormone concentration.