About this FactMed analysis covering adverse side effect reports of SORAFENIB (RAF KINASE INHIBITOR) patients who developed INTERNATIONAL NORMALISED RATIO INCREASED.

FactMed provides MD-approved analysis to help both patients, researchers, and physicians accurately assess the risk profile for more than 20,000 different pharmaceutical products. The below report offers compiled information from Food & Drug Administration and FactMed user submissions. Between January 2004 and October 2012, 16 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported INTERNATIONAL NORMALISED RATIO INCREASED to the FDA. A total of 3329 SORAFENIB (RAF KINASE INHIBITOR) drug adverse event reaction reports were made with the FDA during this time period. Often the FDA only receives reports of the most critical and severe cases; these numbers may therefore underrepresent the complication rate of the medication.

FDA Research Report

Introduction This page is designed to help you determine the relationship, if any, between SORAFENIB (RAF KINASE INHIBITOR) and INTERNATIONAL NORMALISED RATIO INCREASED. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause INTERNATIONAL NORMALISED RATIO INCREASED, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes INTERNATIONAL NORMALISED RATIO INCREASED. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if INTERNATIONAL NORMALISED RATIO INCREASED ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing INTERNATIONAL NORMALISED RATIO INCREASED: 16
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where INTERNATIONAL NORMALISED RATIO INCREASED is a reported side effect: 0.4806%

FDA reports of any drug causing INTERNATIONAL NORMALISED RATIO INCREASED : 16489
Average percentage for all medicated patients where INTERNATIONAL NORMALISED RATIO INCREASED is reported as a complication: 0.1033%

Physician opinion on SORAFENIB (RAF KINASE INHIBITOR) as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing SORAFENIB (RAF KINASE INHIBITOR):
HEPATIC NEOPLASM MALIGNANT ( 770 patients )
RENAL CELL CARCINOMA ( 114 patients )
THYROID CANCER ( 65 patients )
METASTATIC RENAL CELL CARCINOMA ( 44 patients )
THYROID CANCER METASTATIC ( 35 patients )
BREAST CANCER ( 31 patients )
BREAST CANCER METASTATIC ( 27 patients )
GASTRIC CANCER ( 25 patients )
NON-SMALL CELL LUNG CANCER ( 25 patients )
COLORECTAL CANCER METASTATIC ( 22 patients )
RENAL CANCER ( 17 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 14 patients )
BILE DUCT CANCER ( 14 patients )
SALIVARY GLAND CANCER ( 7 patients )
HEPATIC CANCER METASTATIC ( 7 patients )
COLORECTAL CANCER ( 7 patients )
SMALL CELL LUNG CANCER STAGE UNSPECIFIED ( 6 patients )
RECTAL CANCER ( 5 patients )
PANCREATIC CARCINOMA ( 4 patients )
PROSTATE CANCER ( 4 patients )
INTRAOCULAR MELANOMA ( 4 patients )
HEPATIC NEOPLASM MALIGNANT RECURRENT ( 3 patients )
NEOPLASM ( 3 patients )
LIVER DISORDER ( 3 patients )
ANGIOSARCOMA ( 3 patients )
NON-SMALL CELL LUNG CANCER STAGE IV ( 3 patients )
METASTASES TO LUNG ( 3 patients )
HEPATIC NEOPLASM MALIGNANT NON-RESECTABLE ( 3 patients )
COLORECTAL CANCER STAGE IV ( 3 patients )
NEOPLASM MALIGNANT ( 3 patients )
GALLBLADDER CANCER METASTATIC ( 3 patients )
BILIARY CANCER METASTATIC ( 3 patients )
METASTASIS ( 3 patients )
COLON CANCER METASTATIC ( 2 patients )
HYPOPHARYNGEAL CANCER ( 2 patients )
DESMOID TUMOUR ( 2 patients )
NEUROENDOCRINE CARCINOMA ( 2 patients )
ACUTE MYELOID LEUKAEMIA (IN REMISSION) ( 2 patients )
LUNG NEOPLASM MALIGNANT ( 2 patients )
OESOPHAGEAL CARCINOMA ( 2 patients )
METASTATIC MALIGNANT MELANOMA ( 2 patients )
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED ( 2 patients )
METASTATIC SQUAMOUS CELL CARCINOMA ( 2 patients )
ANGINA PECTORIS ( 2 patients )
RENAL CELL CARCINOMA STAGE IV ( 2 patients )
OSTEOSARCOMA METASTATIC ( 2 patients )
BONE SARCOMA ( 2 patients )
METASTATIC OCULAR MELANOMA ( 2 patients )
METASTATIC SALIVARY GLAND CANCER ( 2 patients )
TONSIL CANCER ( 2 patients )
MYELODYSPLASTIC SYNDROME ( 1 patients )
PROSTATE CANCER METASTATIC ( 1 patients )
GALLBLADDER CANCER ( 1 patients )
NEUROENDOCRINE TUMOUR ( 1 patients )
MALIGNANT NEOPLASM OF RENAL PELVIS ( 1 patients )
GLIOMA ( 1 patients )
BLADDER CANCER ( 1 patients )
OVARIAN CANCER METASTATIC ( 1 patients )
CAROTID ARTERY DISEASE ( 1 patients )
HEPATOBLASTOMA ( 1 patients )
NASOPHARYNGEAL CANCER ( 1 patients )
ACUTE MYELOID LEUKAEMIA ( 1 patients )
LUNG ADENOCARCINOMA ( 1 patients )
RENAL CANCER METASTATIC ( 1 patients )
DIFFUSE LARGE B-CELL LYMPHOMA ( 1 patients )
NEUROENDOCRINE CARCINOMA OF THE SKIN ( 1 patients )
MALIGNANT HISTIOCYTOSIS ( 1 patients )
ANTICOAGULANT THERAPY ( 1 patients )
MALIGNANT SOFT TISSUE NEOPLASM ( 1 patients )
SARCOMA ( 1 patients )
GERM CELL CANCER ( 1 patients )
OESOPHAGEAL ADENOCARCINOMA ( 1 patients )
SQUAMOUS CELL CARCINOMA ( 1 patients )
HEAD AND NECK CANCER ( 1 patients )
OVARIAN EPITHELIAL CANCER ( 1 patients )
( 0 patients )
Drugs with high FDA adverse event association with INTERNATIONAL NORMALISED RATIO INCREASED:

WARFARIN SODIUM (5217 patients)
COUMADIN (4366 patients)
ASPIRIN (1878 patients)
LASIX (1461 patients)
DIGOXIN (1456 patients)
FUROSEMIDE (1316 patients)
ACETAMINOPHEN (966 patients)
WARFARIN (918 patients)
PREVISCAN (852 patients)
SIMVASTATIN (826 patients)
OMEPRAZOLE (741 patients)
LISINOPRIL (722 patients)
PRADAXA (631 patients)
POTASSIUM CHLORIDE (622 patients)
ALLOPURINOL (575 patients)
LIPITOR (560 patients)
LEVOTHYROXINE SODIUM (557 patients)
ATENOLOL (547 patients)
SPIRONOLACTONE (510 patients)
PLAVIX (502 patients)
PREDNISONE (488 patients)
CORDARONE (474 patients)
VIOXX (450 patients)
NEXIUM (437 patients)
ZOCOR (430 patients)
FOLIC ACID (419 patients)
METOPROLOL TARTRATE (412 patients)
RAMIPRIL (381 patients)
ALDACTONE (370 patients)
TOPROL-XL (370 patients)
LOVENOX (366 patients)
AMIODARONE HCL (363 patients)
ALBUTEROL (352 patients)
SYNTHROID (350 patients)
SINTROM (344 patients)
FOSAMAX (342 patients)
HYDROCHLOROTHIAZIDE (335 patients)
PROTONIX (317 patients)
METOPROLOL (315 patients)
LORAZEPAM (307 patients)
BISOPROLOL FUMARATE (300 patients)
METFORMIN HCL (290 patients)
AMLODIPINE (285 patients)
LANSOPRAZOLE (282 patients)
CRESTOR (278 patients)
NORVASC (277 patients)
COREG (276 patients)
METRONIDAZOLE (275 patients)
CIPROFLOXACIN (274 patients)
PRILOSEC (269 patients)
CARVEDILOL (266 patients)
NEURONTIN (253 patients)
HEPARIN (251 patients)
INSULIN (250 patients)
DEXAMETHASONE (246 patients)
FERROUS SULFATE TAB (237 patients)
XANAX (236 patients)
LANTUS (235 patients)
NITROGLYCERIN (233 patients)
MULTAQ (232 patients)
LEVAQUIN (229 patients)
LANOXIN (229 patients)
TRAMADOL HCL (228 patients)
ZOLOFT (224 patients)
IBUPROFEN (224 patients)
CITALOPRAM HYDROBROMIDE (223 patients)
AUGMENTIN '125' (223 patients)
PERCOCET (219 patients)
CYMBALTA (218 patients)
VITAMIN D (217 patients)
MICONAZOLE (216 patients)
TRACLEER (216 patients)
PREVACID (212 patients)
MORPHINE (211 patients)
DILTIAZEM (211 patients)
NUVARING (209 patients)
FLUCONAZOLE (206 patients)
MULTI-VITAMIN (203 patients)
SPIRIVA (201 patients)
GABAPENTIN (201 patients)
AMBIEN (200 patients)
PREDNISONE TAB (200 patients)
METOPROLOL SUCCINATE (197 patients)
VICODIN (196 patients)
ATORVASTATIN CALCIUM (195 patients)
LOPRESSOR (193 patients)
ENALAPRIL MALEATE (193 patients)
PREDNISOLONE (193 patients)
ATIVAN (191 patients)
REVLIMID (188 patients)
DIOVAN (188 patients)
VANCOMYCIN (187 patients)
ADVAIR DISKUS 100/50 (184 patients)
KETEK (184 patients)
HEPARIN SODIUM INJECTION (184 patients)
PARACETAMOL (180 patients)
PREVISCAN (FLUINDIONE) (179 patients)
ALTACE (178 patients)
LEVOFLOXACIN (177 patients)
PRAVASTATIN (177 patients)
ZETIA (176 patients)
RANITIDINE (175 patients)
OXYCODONE HCL (174 patients)
COZAAR (174 patients)
PANTOPRAZOLE (173 patients)
AMIODARONE (172 patients)
ZOFRAN (171 patients)
XIGRIS (166 patients)
CLARITHROMYCIN (165 patients)
ENOXAPARIN SODIUM (165 patients)
COLACE (165 patients)
GLIPIZIDE (165 patients)
CALCIUM (163 patients)
ZOMETA (160 patients)
ALPRAZOLAM (159 patients)
LEXAPRO (159 patients)
ATORVASTATIN (158 patients)
LYRICA (158 patients)
AMOXICILLIN (157 patients)
GLUCOPHAGE (155 patients)
ASCORBIC ACID (155 patients)
FLUINDIONE (154 patients)
MARCUMAR (154 patients)
CLOPIDOGREL (152 patients)
AVELOX (152 patients)
CALCIUM CARBONATE (150 patients)
BACTRIM (149 patients)
ROCEPHIN (148 patients)
VELCADE (147 patients)
METFORMIN (145 patients)
VITAMIN B-12 (145 patients)
DECADRON (141 patients)
TORSEMIDE (141 patients)
NAMENDA (140 patients)
POTASSIUM (140 patients)
METHOTREXATE (138 patients)
SEROQUEL (138 patients)
AZITHROMYCIN (137 patients)
TEMAZEPAM (136 patients)
TYLENOL (CAPLET) (133 patients)
OXYCONTIN (132 patients)
TRAZODONE HCL (132 patients)
TYLENOL (131 patients)
CARDIZEM (130 patients)
AMLODIPINE BESYLATE (129 patients)
ATROVENT (129 patients)
FLAGYL (129 patients)
CLONAZEPAM (129 patients)
ACYCLOVIR (128 patients)
BISOPROLOL (128 patients)
SINGULAIR (128 patients)
DILTIAZEM HCL (127 patients)
M.V.I. (127 patients)
HUMALOG (126 patients)
FLUOROURACIL (126 patients)
LACTULOSE (126 patients)
TRIMETHOPRIM (126 patients)
FAMOTIDINE (125 patients)
CELEBREX (125 patients)
CARBOPLATIN (125 patients)
CISPLATIN (125 patients)
PAXIL (123 patients)
CELEXA (123 patients)
ZESTRIL (121 patients)
FISH OIL (120 patients)
PANTOPRAZOLE SODIUM (119 patients)
MORPHINE SULFATE (119 patients)
ISOSORBIDE MONONITRATE (118 patients)
KLOR-CON (116 patients)
GLYBURIDE (116 patients)
ACENOCOUMAROL (116 patients)
LASILIX (114 patients)
FENOFIBRATE (114 patients)
ARICEPT (113 patients)
ARGATROBAN (112 patients)
HYDROCORTISONE (112 patients)
DIFLUCAN (112 patients)
TAMIFLU (112 patients)
CEPHALEXIN (112 patients)
EFFEXOR (110 patients)
VITAMIN E (110 patients)
BUMETANIDE (109 patients)
SOLIRIS (109 patients)
COLCHICINE (109 patients)
FENTANYL (108 patients)
NIFEDIPINE (108 patients)
REGLAN (108 patients)
PERINDOPRIL ERBUMINE (107 patients)
PROZAC (107 patients)
PROMETHAZINE (107 patients)
TAHOR (106 patients)
ZOLPIDEM (105 patients)
PREMARIN (105 patients)
MIRTAZAPINE (105 patients)
CUBICIN (105 patients)
WARFARIN POTASSIUM (104 patients)
KARDEGIC (104 patients)
VERAPAMIL (104 patients)
FLOMAX (104 patients)
NAPROXEN (104 patients)
BYETTA (104 patients)
ACETYLSALICYLIC ACID SRT (103 patients)
SOTALOL HCL (102 patients)
AVANDIA (100 patients)
ZITHROMAX (99 patients)
ACTOS (99 patients)
DOCUSATE (98 patients)
DAKTARIN (98 patients)
ALLEGRA (96 patients)
TRICOR (96 patients)
Most common side effects for patients taking SORAFENIB (RAF KINASE INHIBITOR):
DIARRHOEA (613 patients)
HEPATIC FAILURE (378 patients)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (342 patients)
HEPATIC ENCEPHALOPATHY (320 patients)
FATIGUE (300 patients)
RASH (276 patients)
ASCITES (253 patients)
ABDOMINAL PAIN (237 patients)
DECREASED APPETITE (226 patients)
UPPER GASTROINTESTINAL HAEMORRHAGE (198 patients)
PYREXIA (191 patients)
ASPARTATE AMINOTRANSFERASE INCREASED (179 patients)
NAUSEA (165 patients)
HYPERTENSION (160 patients)
ASTHENIA (154 patients)
DEHYDRATION (140 patients)
HEPATIC FUNCTION ABNORMAL (133 patients)
DYSPNOEA (131 patients)
CONFUSIONAL STATE (131 patients)
HYPOKALAEMIA (125 patients)
ALOPECIA (124 patients)
VOMITING (118 patients)
CONSTIPATION (115 patients)
INTERSTITIAL LUNG DISEASE (114 patients)
LEFT VENTRICULAR DYSFUNCTION (113 patients)
DEATH (113 patients)
ENDOCARDITIS (112 patients)
ARTHRALGIA (111 patients)
STOMATITIS (111 patients)
ABDOMINAL PAIN UPPER (110 patients)
JAUNDICE (108 patients)
HEPATIC NEOPLASM MALIGNANT (106 patients)
GASTROINTESTINAL HAEMORRHAGE (106 patients)
RETINAL VASCULAR THROMBOSIS (103 patients)
LOWER GASTROINTESTINAL HAEMORRHAGE (103 patients)
LIVER CARCINOMA RUPTURED (101 patients)
OEDEMA PERIPHERAL (97 patients)
PLEURAL EFFUSION (97 patients)
STAPHYLOCOCCAL INFECTION (96 patients)
PNEUMONIA BACTERIAL (96 patients)
ENTEROBACTER INFECTION (96 patients)
MYOPATHY (95 patients)
DRY MOUTH (94 patients)
PAIN IN EXTREMITY (93 patients)
ANXIETY (90 patients)
MALAISE (89 patients)
PULMONARY EMBOLISM (85 patients)
ANAEMIA (84 patients)
PLATELET COUNT DECREASED (81 patients)
BACK PAIN (79 patients)
SEPSIS (78 patients)
PRURITUS (78 patients)
DUODENAL ULCER (77 patients)
MIGRAINE (76 patients)
MITRAL VALVE INCOMPETENCE (76 patients)
HYPOGLYCAEMIA (76 patients)
C-REACTIVE PROTEIN INCREASED (74 patients)
BLOOD PRESSURE INCREASED (73 patients)
VARICES OESOPHAGEAL (73 patients)
HEADACHE (72 patients)
RETINAL VEIN OCCLUSION (72 patients)
ABASIA (69 patients)
RENAL FAILURE ACUTE (69 patients)
WEIGHT DECREASED (67 patients)
DEEP VEIN THROMBOSIS (67 patients)
DIZZINESS (65 patients)
ERYTHEMA (65 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (64 patients)
CONVULSION (63 patients)
ALANINE AMINOTRANSFERASE INCREASED (62 patients)
DYSPHONIA (62 patients)
CEREBRAL HAEMORRHAGE (60 patients)
APHAGIA (58 patients)
COLITIS (58 patients)
PNEUMONIA (57 patients)
GASTRIC ULCER (56 patients)
HYPONATRAEMIA (55 patients)
HAEMOGLOBIN DECREASED (53 patients)
RESPIRATORY FAILURE (52 patients)
LUNG DISORDER (52 patients)
CEREBRAL ISCHAEMIA (49 patients)
PARAESTHESIA (49 patients)
BLOOD BILIRUBIN INCREASED (48 patients)
GAIT DISTURBANCE (48 patients)
THYROID CANCER METASTATIC (44 patients)
DEPRESSED LEVEL OF CONSCIOUSNESS (43 patients)
PERICARDIAL EFFUSION (41 patients)
THROMBOCYTOPENIA (41 patients)
BLISTER (41 patients)
FEBRILE NEUTROPENIA (40 patients)
BLOOD LACTATE DEHYDROGENASE INCREASED (40 patients)
HALLUCINATION (40 patients)
CHILLS (40 patients)
AMMONIA INCREASED (39 patients)
SKIN ULCER (39 patients)
BLOOD ALKALINE PHOSPHATASE INCREASED (38 patients)
PAIN (38 patients)
HYPOALBUMINAEMIA (38 patients)
HYPOCALCAEMIA (37 patients)
FALL (37 patients)
POLLAKIURIA (37 patients)
BLOOD PRESSURE DECREASED (37 patients)
SKIN EXFOLIATION (37 patients)
INSOMNIA (36 patients)
CARDIAC ARREST (36 patients)
HYPOAESTHESIA (35 patients)
INFECTIOUS PERITONITIS (35 patients)
MYOCARDIAL INFARCTION (35 patients)
RETINAL VASCULAR DISORDER (34 patients)
RENAL FAILURE (34 patients)
LIPASE INCREASED (34 patients)
HYPERKALAEMIA (33 patients)
HYPERGLYCAEMIA (33 patients)
HAEMOPTYSIS (31 patients)
ATRIAL FIBRILLATION (30 patients)
GENERALISED OEDEMA (30 patients)
FAECAL INCONTINENCE (30 patients)
WHITE BLOOD CELL COUNT DECREASED (30 patients)
CELLULITIS (29 patients)
CHEST PAIN (29 patients)
SOMNOLENCE (29 patients)
HYPERBILIRUBINAEMIA (28 patients)
HYPOTENSION (28 patients)
MUSCLE SPASMS (28 patients)
ABDOMINAL DISTENSION (27 patients)
WHITE BLOOD CELL COUNT INCREASED (27 patients)
VISION BLURRED (27 patients)
HEPATIC PAIN (26 patients)
BLOOD ALBUMIN DECREASED (26 patients)
DYSURIA (25 patients)
RASH GENERALISED (25 patients)
BLOOD SODIUM DECREASED (25 patients)
BLOOD URIC ACID INCREASED (25 patients)
COMA (25 patients)
COUGH (25 patients)
PANCYTOPENIA (25 patients)
ACUTE ABDOMEN (24 patients)
EOSINOPHIL COUNT INCREASED (24 patients)
CEREBROVASCULAR ACCIDENT (24 patients)
METASTASES TO CENTRAL NERVOUS SYSTEM (23 patients)
CEREBRAL INFARCTION (23 patients)
HYPOMAGNESAEMIA (23 patients)
RETINAL VEIN THROMBOSIS (23 patients)
GAMMA-GLUTAMYLTRANSFERASE INCREASED (23 patients)
TUMOUR LYSIS SYNDROME (22 patients)
HYPOPHOSPHATAEMIA (22 patients)
INFECTION (22 patients)
ORAL PAIN (22 patients)
BLOOD CREATININE INCREASED (22 patients)
NEUTROPENIA (22 patients)
RENAL IMPAIRMENT (22 patients)
LETHARGY (22 patients)
SKIN TOXICITY (21 patients)
TONGUE BLISTERING (21 patients)
LIVER ABSCESS (21 patients)
HAEMATEMESIS (21 patients)
OESOPHAGEAL VARICES HAEMORRHAGE (20 patients)
MENTAL IMPAIRMENT (20 patients)
NERVOUSNESS (20 patients)
NEPHROTIC SYNDROME (20 patients)
HYPOPHAGIA (20 patients)
ADRENAL INSUFFICIENCY (19 patients)
DRY SKIN (19 patients)
BLOOD AMYLASE INCREASED (19 patients)
OEDEMA (19 patients)
INFECTIOUS PLEURAL EFFUSION (19 patients)
DYSPEPSIA (19 patients)
COMA HEPATIC (19 patients)
HEART RATE INCREASED (18 patients)
HYPERTENSIVE CRISIS (18 patients)
MYALGIA (18 patients)
ECZEMA (18 patients)
URINARY TRACT INFECTION (18 patients)
NEUROMYOPATHY (18 patients)
MEDICAL DEVICE COMPLICATION (18 patients)
DIVERTICULITIS (18 patients)
OSTEOMYELITIS (18 patients)
CEREBRAL ATROPHY (18 patients)
CEREBRAL VENTRICLE DILATATION (18 patients)
DIABETIC FOOT INFECTION (18 patients)
NECK PAIN (18 patients)
OLIGURIA (17 patients)
GASTROINTESTINAL DISORDER (17 patients)
HAEMATOCHEZIA (17 patients)
DISSEMINATED INTRAVASCULAR COAGULATION (17 patients)
HYPOTHYROIDISM (17 patients)
TRANSAMINASES INCREASED (17 patients)
OROPHARYNGEAL PAIN (17 patients)
CHRONIC MYELOID LEUKAEMIA (17 patients)
NEOPLASM PROGRESSION (17 patients)
METASTASES TO ADRENALS (16 patients)
LYMPHOCYTE COUNT DECREASED (16 patients)
INTERNATIONAL NORMALISED RATIO INCREASED (16 patients)
MULTI-ORGAN FAILURE (16 patients)
FEAR (16 patients)
PANCREATIC CARCINOMA (16 patients)
HYPERSOMNIA (16 patients)
EPILEPSY (16 patients)
SUBARACHNOID HAEMORRHAGE (16 patients)
METASTASES TO LUNG (16 patients)
TACHYCARDIA (16 patients)
MUSCULAR WEAKNESS (16 patients)
KLEBSIELLA SEPSIS (16 patients)
MYOCARDIAL ISCHAEMIA (16 patients)
DYSGEUSIA (16 patients)
LUNG INFECTION (16 patients)
FAECES DISCOLOURED (16 patients)
PAIN OF SKIN (16 patients)
SPINAL FRACTURE (16 patients)
PANIC REACTION (16 patients)

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