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Review Gleevec Safety Reports submitted to FDA

Total Gleevec reports: 636.
Gleevec FDA safety alerts: 2006 .
Reported deaths: 184    Reported hospitalizations: 253.
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FDA Reported Gleevec Side Effects: oedema peripheral, nausea, cardiac failure congestive, haemoglobin decreased, fatigue, malignant neoplasm progression, blood creatinine increased, pyrexia, dyspnoea exertional, dyspnoea, asthenia.
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Gleevec Side Effects Report #5522988-8
Consumer or non-health professional from UNITED KINGDOM reported GLEEVEC problem on Nov 12, 2007. Male patient, 42 years of age, was diagnosed with chronic myeloid leukaemia, hypertension and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: headache, hypoaesthesia, tunnel vision. GLEEVEC dosage: 400MG. During the same period patient was treated with DICLOFENAC, PROPRANOLOL. Patient recovered.

Gleevec Side Effects Report #5524448-7
GLEEVEC problem was reported by a Physician from SPAIN on Nov 14, 2007. Female patient, 45 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: arrhythmia, cerebrovascular accident. GLEEVEC dosage: 600 MG/D. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5524529-8
Physician from PERU reported GLEEVEC problem on Nov 19, 2007. Male patient, 24 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, anaemia, anal ulcer, blast cell count increased, body temperature increased, bone pain, diarrhoea. GLEEVEC dosage: unknown. Patient was hospitalized. Patient died on 10/12/2007.

Gleevec Side Effects Report #5524729-7
GLEEVEC problem was reported by a Consumer or non-health professional from BRAZIL on Nov 15, 2007. Male patient, 40 years of age, weighting 180.8 lb, was diagnosed with myeloid leukaemia, hypertension and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: amnesia, chromosome analysis abnormal, delirium, fatigue, gait disturbance, gastroenteritis rotavirus, hallucination, nausea, pyrexia. GLEEVEC dosage: unknown. During the same period patient was treated with ENALAPRIL MALEATE, CHLORTHALIDONE, AMLODIPINE. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5524740-6
Consumer or non-health professional from BRAZIL reported GLEEVEC problem on Nov 14, 2007. Male patient, 59 years of age, weighting 198.4 lb, was diagnosed with leukaemia, pain, gastritis, muscle spasms, diabetes mellitus and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: dyspnoea, fatigue, pain in extremity, pulse abnormal, urinary tract infection, white blood cell count increased. GLEEVEC dosage: 400 MG, BID. During the same period patient was treated with ZYLORIC, LOSARTAN, LANZOPRAZOL, MOTILIUM, CLORETO DE POTASSIO, GILBENCLAMIDA, GILFAGE. Patient recovered.

Gleevec Side Effects Report #5524858-8
GLEEVEC problem was reported by a Consumer or non-health professional from GERMANY on Nov 19, 2007. Female patient, 74 years of age, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: catheter related infection, pneumonia pneumococcal, recurrent cancer, sepsis, streptococcal infection, surgery. GLEEVEC dosage: unknown. Patient was hospitalized. Patient died.

Gleevec Side Effects Report #5524926-0
Consumer or non-health professional from JAPAN reported GLEEVEC problem on Nov 22, 2007. Male patient, 52 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: pneumonia bacterial. GLEEVEC dosage: unknown. During the same period patient was treated with HEMATOPOETIC PROGENITOR CELLS. Patient died.

Gleevec Side Effects Report #5524946-6
GLEEVEC problem was reported by a Consumer or non-health professional from BRAZIL on Nov 15, 2007. Male patient, 40 years of age, weighting 180.8 lb, was diagnosed with myeloid leukaemia, hypertension and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: amnesia, chromosome analysis abnormal, delirium, fatigue, gait disturbance, gastroenteritis rotavirus, hallucination, nausea, pyrexia. GLEEVEC dosage: unknown. During the same period patient was treated with ENALAPRIL MALEATE, CHLORTHALIDONE, AMLODIPINE. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5525831-6
Physician from AUSTRIA reported GLEEVEC problem on Nov 15, 2007. Female patient, child 6 years of age, weighting 41.89 lb, was diagnosed with astrocytoma and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: malignant neoplasm progression, myotonia, tonic clonic movements. GLEEVEC dosage: 200 MG/D. Patient recovered.

Gleevec Side Effects Report #5526205-4
GLEEVEC problem was reported by a Consumer or non-health professional from CANADA on Nov 20, 2007. Male patient, 56 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, arrhythmia, cold sweat, diarrhoea, feeling cold, syncope, tremor, weight decreased. GLEEVEC dosage: unknown. During the same period patient was treated with PANTOPRAZOLE, NAPROXEN. Patient recovered.

Gleevec Side Effects Report #5526210-8
Consumer or non-health professional from GERMANY reported GLEEVEC problem on Nov 19, 2007. Female patient, 74 years of age, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: pneumonia pneumococcal, recurrent cancer, sepsis, surgery. GLEEVEC dosage: unknown. Patient was hospitalized. Patient died.

Gleevec Side Effects Report #5526231-5
GLEEVEC problem was reported by a Consumer or non-health professional from BRAZIL on Nov 19, 2007. Female patient, 74 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: immune system disorder, leukopenia. GLEEVEC dosage: 800 MG/DAY. Patient recovered.

Gleevec Side Effects Report #5526236-4
Consumer or non-health professional from JAPAN reported GLEEVEC problem on Nov 22, 2007. Male patient, 52 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: pneumonia bacterial. GLEEVEC dosage: unknown. During the same period patient was treated with HEMATOPOETIC PROGENITOR CELLS. Patient died.

Gleevec Side Effects Report #5526654-4
GLEEVEC problem was reported by a Physician from PERU on Nov 23, 2007. Male patient, 24 years of age, weighting 112.4 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, anaemia, anal ulcer, blast cell count increased, body temperature increased, bone pain, diarrhoea. GLEEVEC dosage: unknown. Patient was hospitalized. Patient died on 10/12/2007.

Gleevec Side Effects Report #5526663-5
Physician from COLOMBIA reported GLEEVEC problem on Nov 16, 2007. Female patient, 16 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: congestive cardiomyopathy, treatment noncompliance. GLEEVEC dosage: unknown. During the same period patient was treated with CARVEDILOL. Patient was hospitalized and became disabled. Patient recovered.

Gleevec Side Effects Report #5527466-8
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 23, 2007. Male patient, 66 years of age, weighting 208.8 lb, was diagnosed with adenoid cystic carcinoma, benign prostatic hyperplasia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: arrhythmia, atrial fibrillation, biopsy intestine abnormal, blood bicarbonate increased, blood bilirubin increased, blood creatinine increased, blood phosphorus decreased, blood thyroid stimulating hormone decreased, brunner's gland hyperplasia. GLEEVEC dosage: 400 MG, QD. During the same period patient was treated with FLOMAX, VERAPAMIL, BENICAR. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5527469-3
Physician from GERMANY reported GLEEVEC problem on Nov 22, 2007. Female patient, 38 years of age, weighting 158.7 lb, was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: dysarthria, facial paresis, hemiplegia, ischaemic cerebral infarction, raynaud's phenomenon. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5528645-6
GLEEVEC problem was reported by a Physician from BRAZIL on Nov 22, 2007. Male patient, 70 years of age, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy, cardiovascular disorder, coronary revascularisation, device breakage, osteomyelitis, osteoporosis, postoperative thoracic procedure complication, surgery, wound infection. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5528648-1
Health Professional from GERMANY reported GLEEVEC problem on Nov 19, 2007. Female patient, 62 years of age, weighting 112.4 lb, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: blood cholesterol increased, chills, diarrhoea, dizziness, hypoglycaemia, nausea. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5528680-8
GLEEVEC problem was reported by a Consumer or non-health professional from BRAZIL on Nov 16, 2007. Male patient, 65 years of age, weighting 209.4 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: bipolar disorder, blood test abnormal, c-reactive protein increased, chromosome analysis abnormal, gait disturbance, haemoglobin decreased, insomnia, intervertebral disc operation, intervertebral disc protrusion. GLEEVEC dosage: 400 MG/DAY. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5474006-8
Consumer or non-health professional from NETHERLANDS reported GLEEVEC problem on Sept 24, 2007. Female patient, 45 years of age, was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: amenorrhoea, menorrhagia, weight decreased. GLEEVEC dosage: 400 MG. During the same period patient was treated with OMEPRAZOLE, PLAVIX, TRICHINON. Patient recovered.

Gleevec Side Effects Report #5474013-5
GLEEVEC problem was reported by a Health Professional from UNITED STATES on Sept 21, 2007. Female patient, 74 years of age, weighting 152.0 lb, was diagnosed with chronic myeloid leukaemia, anaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: anaemia, dyspnoea, fatigue. GLEEVEC dosage: 400 MG, UNK. During the same period patient was treated with VYTORIN, GLIPIZIDE, METFORMIN, COREG, PROCRIT, PLAVIX, FUROSEMIDE, ECOTRIN. Patient recovered.

Gleevec Side Effects Report #5474047-0
Physician from UNITED STATES reported GLEEVEC problem on Sept 20, 2007. Female patient, 25 years of age, weighting 153.2 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, placental disorder, pregnancy induced hypertension, premature labour, premature rupture of membranes, vaginal haemorrhage. GLEEVEC dosage: 400 MG, QD. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5474355-3
GLEEVEC problem was reported by a Physician from JAPAN on Sept 28, 2007. Female patient, 69 years of age, weighting 81.57 lb, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: completed suicide, concomitant disease progression, depression, insomnia, stress. GLEEVEC dosage: 300 MG, QD. During the same period patient was treated with VITAMEDIN S, GASMOTIN, DAIOU, KAMAG, FERROMIA, CATLEP, TOLEDOMIN. Patient died on 03/29/2006.

Gleevec Side Effects Report #5474357-7
Physician from UNITED STATES reported GLEEVEC problem on Sept 27, 2007. Female patient, 66 years of age, was diagnosed with chronic myeloid leukaemia, anxiety disorder, hypertension, hypothyroidism and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abasia, abnormal behaviour, anaemia, asphyxia, blood potassium abnormal, cardiac failure congestive, cardiac valve disease, costochondritis, diarrhoea. GLEEVEC dosage: 400 MG, QD. During the same period patient was treated with NEXIUM, XANAX, METOPROLOL, SYNTHROID, HYDROXYUREA, DIOVAN HCT, COREG. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5474359-0
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 18, 2007. Female patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: renal disorder. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5474366-8
Pharmacist from GERMANY reported GLEEVEC problem on Sept 27, 2007. Male patient, weighting 178.6 lb, was diagnosed with chronic myeloid leukaemia, hyperlipidaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: muscle spasms, thyroid operation. GLEEVEC dosage: 400 MG, QD. During the same period patient was treated with SIMVASTATIN, ZYLORIC, CANDESARTAN CILEXETIL, BISOPROLOL, ASPIRIN, TRIAMTERENE AND HYDROCHLOROTHIAZIDE, EUTHYROX. Patient recovered.

Gleevec Side Effects Report #5474457-1
GLEEVEC problem was reported by a Physician from CANADA on Sept 25, 2007. Male patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: blast cell count increased, pulmonary mass. GLEEVEC dosage: 600 MG, QD. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5474459-5
Physician from JAPAN reported GLEEVEC problem on Sept 28, 2007. Female patient, 69 years of age, weighting 81.57 lb, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: completed suicide, concomitant disease progression, depression, insomnia, stress. GLEEVEC dosage: 300 MG, QD. During the same period patient was treated with VITAMEDIN S, GASMOTIN, DAIOU, KAMAG, FERROMIA, CATLEP, TOLEDOMIN. Patient died on 03/29/2006.

Gleevec Side Effects Report #5475380-9
GLEEVEC problem was reported by a Physician from UNITED STATES on Sept 25, 2007. Female patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: breast cancer. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5475383-4
Physician from UNITED STATES reported GLEEVEC problem on Sept 24, 2007. Female patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: iron overload. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5475386-X
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 28, 2007. Male patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis. GLEEVEC dosage: 300 MG, TID. Patient died on 06/28/2006.

Gleevec Side Effects Report #5475407-4
Physician from FRANCE reported GLEEVEC problem on Oct 01, 2007. Male patient, 55 years of age, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: haemorrhagic tumour necrosis. GLEEVEC dosage: unknown. Patient died.

Gleevec Side Effects Report #5476598-1
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 28, 2007. Male patient, 62 years of age, was diagnosed with leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: asthenia, eye haemorrhage, feeling abnormal, nausea, nocturia, oedema peripheral, polydipsia, swelling face. GLEEVEC dosage: 200 MG, BID. Patient recovered.

Gleevec Side Effects Report #5477891-9
Consumer or non-health professional from JAPAN reported GLEEVEC problem on Sept 27, 2007. Female patient, child 2 years of age, weighting 23.59 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, growth retardation, muscle injury, pain in extremity. GLEEVEC dosage: 170 MG/D. Patient recovered.

Gleevec Side Effects Report #5477894-4
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 01, 2007. Male patient, 76 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: catheter placement, cough, fluid retention, haemoptysis, hepatic cirrhosis, hiccups. GLEEVEC dosage: 300 MG, TID. Patient was hospitalized. Patient died on 06/28/2006.

Gleevec Side Effects Report #5477926-3
Physician from SPAIN reported GLEEVEC problem on Sept 27, 2007. Male patient, 68 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: papillary thyroid cancer, thyroid neoplasm, thyroidectomy. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5479233-1
GLEEVEC problem was reported by a Consumer or non-health professional from GERMANY on Oct 01, 2007. Male patient, 62 years of age, weighting 176.4 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, antithrombin iii decreased, arteriogram coronary abnormal, biopsy, blood bilirubin increased, blood creatinine increased, blood fibrinogen increased, blood lactic acid increased, chest pain. GLEEVEC dosage: 400 MG/DAY. During the same period patient was treated with RAMIPRIL, PANTOPRAZOLE, TORSEMIDE, NEBILET, INSULIN, PROTAPHAN. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5479257-4
Physician from SPAIN reported GLEEVEC problem on Sept 29, 2007. Male patient, 52 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: parotid gland enlargement. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5479302-6
GLEEVEC problem was reported by a Physician from SPAIN on Sept 29, 2007. Male patient, 52 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: parotid gland enlargement. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5479307-5
Physician from UNITED KINGDOM reported GLEEVEC problem on Oct 02, 2007. Female patient, 71 years of age, weighting 125.7 lb, was diagnosed with gastrointestinal stromal tumour, angina pectoris, gastrointestinal disorder, cardiac fibrillation and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: amnesia, faecal incontinence, fatigue. GLEEVEC dosage: 400 MG, QD. During the same period patient was treated with ACETYLSALICYLIC ACID, OMEPRAZOLE, DIGOXIN. Patient recovered.

Gleevec Side Effects Report #5479314-2
GLEEVEC problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on Oct 01, 2007. Male patient, 41 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, intervertebral disc protrusion. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5480400-1
Consumer or non-health professional from UNITED STATES reported GLEEVEC problem on Oct 04, 2007. Male patient, weighting 169.8 lb, was diagnosed with glioblastoma and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, pulmonary embolism. GLEEVEC dosage: 400 MG BID PO. During the same period patient was treated with HYDROXYUREA, PRILOSEC, NORVASC, LOVENOX, DILANTIN, KEPPRA, DEXAMETHASONE. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5481181-8
GLEEVEC problem was reported by a Physician from UNITED STATES on Oct 04, 2007. Female patient was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: csf pressure increased, headache, meningeal disorder. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5481232-0
Physician from UNITED STATES reported GLEEVEC problem on Oct 04, 2007. Female patient was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: csf pressure increased, headache, meningeal disorder. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5481481-1
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 05, 2007. Male patient, 65 years of age, weighting 169.8 lb, was diagnosed with glioblastoma and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: embolism, thrombosis. GLEEVEC dosage: 400 MG BID PO. During the same period patient was treated with HYDROXYUREA, PRILOSEC, NORVASC, LOVENOX, DILANTIN, KEPPRA, DEXAMETHASONE. Patient was hospitalized. Patient died on 10/03/2007.

Gleevec Side Effects Report #5482109-7
Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA reported GLEEVEC problem on Oct 04, 2007. Male patient, 44 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: nephrolithiasis, renal colic. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5482110-3
GLEEVEC problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on Oct 04, 2007. Male patient, 34 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: diarrhoea haemorrhagic. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5482118-8
Consumer or non-health professional from JAPAN reported GLEEVEC problem on Oct 04, 2007. Female patient, 64 years of age, weighting 147.7 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: colon cancer, intestinal polyp, nasopharyngitis, occult blood positive, polypectomy. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5482296-0
GLEEVEC problem was reported by a Physician from JAPAN on Oct 04, 2007. Female patient, 58 years of age, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal, hepatitis viral, rash. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5482297-2
Consumer or non-health professional from FRANCE reported GLEEVEC problem on Oct 08, 2007. Female patient, 73 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: amyotrophic lateral sclerosis. GLEEVEC dosage: 400 MG DAILY. Patient recovered.

Gleevec Side Effects Report #5482299-6
GLEEVEC problem was reported by a Physician from UNITED STATES on Oct 04, 2007. Female patient was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: csf pressure increased, headache, meningeal disorder. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5483321-3
Consumer or non-health professional from GUATEMALA reported GLEEVEC problem on Oct 09, 2007. Male patient, 65 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, acute respiratory distress syndrome, diabetes mellitus, gastrointestinal haemorrhage, intubation. GLEEVEC dosage: 400 MG/D. Patient was hospitalized. Patient died on 10/06/2007.

Gleevec Side Effects Report #5483323-7
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 08, 2007. Male patient was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: malignant neoplasm progression. GLEEVEC dosage: 400 MG, BID. Patient died on 10/02/2007.

Gleevec Side Effects Report #5485074-1
Physician from JAPAN reported GLEEVEC problem on Oct 09, 2007. Female patient was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: anuria, bacteraemia, bone marrow failure, diarrhoea, disseminated intravascular coagulation, face oedema, febrile neutropenia, heart rate increased. GLEEVEC dosage: 400 MG/D. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5485095-9
GLEEVEC problem was reported by a Physician from THAILAND on Oct 10, 2007. Female patient, 23 years of age, weighting 72.75 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, pneumonia, pseudomonas infection, sputum culture positive. GLEEVEC dosage: 600 MG, QD. Patient died on 08/12/2007.

Gleevec Side Effects Report #5486305-4
Physician from POLAND reported GLEEVEC problem on Oct 05, 2007. Female patient, 37 years of age, weighting 123.5 lb, was diagnosed with chronic myeloid leukaemia, hypertension and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: anaemia, asthenia, face oedema, hypophosphataemia, leukopenia, metrorrhagia, thrombocytopenia, uterine haemorrhage, vaginal haemorrhage. GLEEVEC dosage: 800 MG, QD. During the same period patient was treated with PLENDIL, AMLOZEK, BETALOC. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5487125-7
GLEEVEC problem was reported by a Physician from JAPAN on Oct 12, 2007. Male patient, 56 years of age, weighting 205.0 lb, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: anaemia, malignant neoplasm progression, melaena, tumour haemorrhage. GLEEVEC dosage: 400 MG, QD. Patient died on 08/17/2006.

Gleevec Side Effects Report #5489044-9
Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA reported GLEEVEC problem on Oct 08, 2007. Male patient, 44 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: nephrolithiasis, renal colic. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5490383-6
GLEEVEC problem was reported by a Consumer or non-health professional from on Oct 10, 2007. Male patient, 59 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: parotitis, tooth infection. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5490390-3
Consumer or non-health professional from JAPAN reported GLEEVEC problem on Oct 10, 2007. Male patient, 41 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: encephalitis herpes. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5490396-4
GLEEVEC problem was reported by a Physician from CYPRUS on Oct 09, 2007. Female patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: multiple myeloma. GLEEVEC dosage: 400MG DAILY. Patient recovered.

Gleevec Side Effects Report #5490407-6
Consumer or non-health professional from JAPAN reported GLEEVEC problem on Oct 10, 2007. Male patient, 75 years of age, was diagnosed with chronic myeloid leukaemia, atypical mycobacterial infection and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: anaemia, blood creatinine increased, blood urea increased, c-reactive protein increased, malignant neoplasm progression, platelet count decreased, pyelonephritis, pyrexia, renal failure acute. GLEEVEC dosage: 200 MG/D. During the same period patient was treated with KLARICID, FAMOTIDINE, ZYLORIC, BLADDERON. Patient was hospitalized and became disabled. Patient recovered.

Gleevec Side Effects Report #5490409-X
GLEEVEC problem was reported by a Physician from JAPAN on Oct 11, 2007. Female patient, child 10 years of age, weighting 74.96 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: blood creatinine abnormal, bone pain, creatinine renal clearance, haematocrit decreased, haemoglobin decreased, hypercalcaemia, hyponatraemia, marasmus, normochromic normocytic anaemia. GLEEVEC dosage: 100 MG/D. During the same period patient was treated with HYDREA. Patient died on 09/15/2007.

Gleevec Side Effects Report #5491507-7
Physician from ISRAEL reported GLEEVEC problem on Oct 14, 2007. Female patient, 80 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune, haemoglobin decreased. GLEEVEC dosage: 400 MG/DAY. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5491525-9
GLEEVEC problem was reported by a Consumer or non-health professional from JAPAN on Oct 10, 2007. Male patient, 59 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: enterocolitis bacterial, multi-organ failure. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5491540-5
Consumer or non-health professional from UNITED STATES reported GLEEVEC problem on Oct 11, 2007. Female patient, 52 years of age, was diagnosed with chronic myeloid leukaemia, insomnia, depression and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, arthropod bite, aspartate aminotransferase increased, autoimmune hepatitis, bilirubin conjugated increased, blood albumin decreased, blood bilirubin increased, blood bilirubin unconjugated increased, haematoma. GLEEVEC dosage: 300 MG, QD. During the same period patient was treated with AMBIEN, PROZAC. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5491548-X
GLEEVEC problem was reported by a Consumer or non-health professional from JAPAN on Oct 16, 2007. Male patient, 39 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, encephalitis herpes, human herpes virus 6 serology positive, mechanical ventilation, memory impairment, pyrexia, status epilepticus. GLEEVEC dosage: unknown. During the same period patient was treated with DIFLUCAN, ALKERAN, FLUDARA, URSO, ZOVIRAX, DENOSINE. Patient recovered.

Gleevec Side Effects Report #5491654-X
Health Professional from UNITED STATES reported GLEEVEC problem on Oct 18, 2007. Male patient, 79 years of age, weighting 171.7 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: ascites, renal failure. GLEEVEC dosage: 400MG DAILY PO. During the same period patient was treated with ALBUTEROL, ALBUTEROL SULPHATE AND IPRATROPIUM BROMIDE, AMIODARONE, HEPARIN, IPRATROPIUM BROMIDE, METOPROLOL, RANITIDINE. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5491862-8
GLEEVEC problem was reported by a Physician from UNITED STATES on Oct 11, 2007. Female patient, 60 years of age, weighting 150.0 lb, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: cough, lung disorder, nodule. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5491863-X
Physician from UNITED STATES reported GLEEVEC problem on Oct 11, 2007. Female patient, 60 years of age, weighting 150.0 lb, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: cough, lung disorder, nodule. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5492780-1
GLEEVEC problem was reported by a Physician from JAPAN on Oct 15, 2007. Female patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: hernia repair, ileus paralytic. GLEEVEC dosage: 300 MG/D. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5494155-8
Consumer or non-health professional from CANADA reported GLEEVEC problem on Oct 15, 2007. Male patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: hyperaesthesia, skin atrophy, skin fragility, skin haemorrhage. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5495576-X
GLEEVEC problem was reported by a Consumer or non-health professional from JAPAN on Oct 17, 2007. Female patient, 85 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: pleural effusion, pneumonia aspiration. GLEEVEC dosage: unknown. During the same period patient was treated with VINCRISTINE SULPHATE, PREDNISOLONE. Patient recovered.

Gleevec Side Effects Report #5497361-1
Physician from GERMANY reported GLEEVEC problem on Oct 17, 2007. Female patient, weighting 297.6 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: dermatitis, excessive granulation tissue, skin atrophy, skin erosion, skin ulcer. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5497599-3
GLEEVEC problem was reported by a Consumer or non-health professional from FRANCE on Oct 23, 2007. Female patient, 60 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: computerised tomogram abnormal, cough, dengue fever, dyspnoea, lung adenocarcinoma stage i, lung lobectomy, nodule, tendon sheath lesion excision. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5498548-4
Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA reported GLEEVEC problem on Oct 15, 2007. Male patient, 44 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: nephrolithiasis, renal colic. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5498619-2
GLEEVEC problem was reported by a Consumer or non-health professional from JAPAN on Oct 22, 2007. Male patient, 39 years of age, was diagnosed with acute lymphocytic leukaemia, prophylaxis against graft versus host disease and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, convulsion, disorientation, encephalitis herpes, human herpes virus 6 serology positive, mechanical ventilation, memory impairment, pyrexia. GLEEVEC dosage: 800 MG/D. During the same period patient was treated with DIFLUCAN, ALKERAN, FLUDARA, URSO, ZOVIRAX, DENOSINE, METHOTREXATE. Patient recovered.

Gleevec Side Effects Report #5499157-3
Physician from UNITED KINGDOM reported GLEEVEC problem on Oct 19, 2007. Female patient, 46 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: acute lymphocytic leukaemia, acute myeloid leukaemia, neutropenic sepsis, transplant. GLEEVEC dosage: 400 MG/DAY. Patient recovered.

Gleevec Side Effects Report #5499434-6
GLEEVEC problem was reported by a Physician from UNITED STATES on Oct 22, 2007. Male patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, oedema, thrombocytopenia. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5500930-3
Consumer or non-health professional from UNITED STATES reported GLEEVEC problem on Oct 22, 2007. Female patient, 69 years of age, was treated with GLEEVEC. GLEEVEC dosage: unknown. Patient died on 10/18/2007.

Gleevec Side Effects Report #5500940-6
GLEEVEC problem was reported by a Physician from CHINA on Oct 23, 2007. Female patient, 56 years of age, weighting 92.59 lb, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: anaemia, gastrointestinal stromal tumour. GLEEVEC dosage: 400MG DAILY. Patient died on 09/12/2006.

Gleevec Side Effects Report #5500976-5
Physician from SPAIN reported GLEEVEC problem on Oct 19, 2007. Male patient, 75 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: colon cancer. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5500982-0
GLEEVEC problem was reported by a Physician from UNITED STATES on Oct 22, 2007. Female patient, 50 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: basedow's disease, condition aggravated, exophthalmos, periorbital oedema, skin lesion, surgery. GLEEVEC dosage: 400 MG, QD. Patient recovered.

Gleevec Side Effects Report #5501018-8
Health Professional from reported GLEEVEC problem on Oct 17, 2007. Female patient, 74 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: alopecia, hip arthroplasty, nausea, spondylolisthesis. GLEEVEC dosage: 400MG/UNK. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5501446-0
GLEEVEC problem was reported by a Health Professional from SWEDEN on Oct 22, 2007. Female patient was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: chronic lymphocytic leukaemia, white blood cell count increased. GLEEVEC dosage: 400 MG/D. Patient recovered.

Gleevec Side Effects Report #5501453-8
Consumer or non-health professional from JAPAN reported GLEEVEC problem on Oct 22, 2007. Male patient, 59 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: enterocolitis bacterial, multi-organ failure. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5501455-1
GLEEVEC problem was reported by a Consumer or non-health professional from on Oct 22, 2007. Male patient, 59 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: parotitis, tooth infection. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5501780-4
Physician from JAPAN reported GLEEVEC problem on Oct 26, 2007. Male patient, 74 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: basophil count increased, blast cell count increased, blood creatinine increased, bone pain, brain oedema, dyslalia, eosinophil count increased, haematocrit decreased, haemoglobin decreased. GLEEVEC dosage: 100 MG, QD. Patient was hospitalized and became disabled. Patient died on 09/21/2005.

Gleevec Side Effects Report #5502556-4
GLEEVEC problem was reported by a Physician from JAPAN on Oct 26, 2007. Male patient, 74 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: basophil count increased, blast cell count increased, blood creatinine increased, bone pain, brain oedema, dyslalia, eosinophil count increased, haematocrit decreased, haemoglobin decreased. GLEEVEC dosage: 100 MG, QD. Patient was hospitalized and became disabled. Patient died on 09/21/2005.

Gleevec Side Effects Report #5502565-5
Consumer or non-health professional from UNITED KINGDOM reported GLEEVEC problem on Oct 24, 2007. Male patient, 41 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal mass, gastrointestinal carcinoma, laparotomy. GLEEVEC dosage: 400MG / DAY. Patient recovered.

Gleevec Side Effects Report #5502578-3
GLEEVEC problem was reported by a Physician from UNITED STATES on Oct 25, 2007. Female patient, 50 years of age, weighting 143.0 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: basedow's disease, condition aggravated, exophthalmos, periorbital oedema, skin lesion, surgery. GLEEVEC dosage: 400 MG, QD. During the same period patient was treated with SYNTHROID. Patient recovered.

Gleevec Side Effects Report #5502580-1
Physician from CANADA reported GLEEVEC problem on Oct 22, 2007. Male patient, 60 years of age, was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. GLEEVEC dosage: unknown. Patient recovered.

Gleevec Side Effects Report #5502582-5
GLEEVEC problem was reported by a Physician from UNITED KINGDOM on Oct 24, 2007. Female patient, 70 years of age, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: coagulopathy, disseminated intravascular coagulation, platelet count decreased, pneumonia, tongue haemorrhage. GLEEVEC dosage: 400 MG/DAY. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5502593-X
Consumer or non-health professional from GERMANY reported GLEEVEC problem on Oct 22, 2007. Female patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: asthenia, fatigue, headache, pityriasis rosea, pruritus, psoriasis, septic shock. GLEEVEC dosage: 400 MG, QD. During the same period patient was treated with PRIMAXIN, TAVANIC. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5441306-7
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 22, 2007. Female patient, 78 years of age, weighting 109.0 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus. GLEEVEC dosage: 300 MG, QD. Patient recovered.

Gleevec Side Effects Report #5441309-2
Consumer or non-health professional from CANADA reported GLEEVEC problem on Aug 22, 2007. Male patient, 56 years of age, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, arrhythmia, cold sweat, diarrhoea, feeling cold, syncope, tremor, weight decreased. GLEEVEC dosage: unknown. During the same period patient was treated with PANTOPRAZOLE, NAPROXEN. Patient recovered.

Gleevec Side Effects Report #5441334-1
GLEEVEC problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 31, 2007. Male patient, 78 years of age, was diagnosed with gastrointestinal stromal tumour and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. GLEEVEC dosage: unknown. Patient died.

Gleevec Side Effects Report #5441368-7
Physician from UNITED STATES reported GLEEVEC problem on Aug 28, 2007. Male patient, 23 years of age, weighting 66.99 lb, was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: dry skin, idiopathic thrombocytopenic purpura, iron binding capacity total decreased, oedema peripheral, pain in extremity, paraesthesia, platelet count decreased, rash, thrombosis. GLEEVEC dosage: 400 MG, QD. During the same period patient was treated with ALLOPURINOL. Patient was hospitalized. Patient recovered.

Gleevec Side Effects Report #5441378-X
GLEEVEC problem was reported by a Consumer or non-health professional from GERMANY on Aug 28, 2007. Male patient was diagnosed with chronic myeloid leukaemia and was treated with GLEEVEC. After drug was administered, patient experienced the following problems/side effects: intervertebral disc protrusion. GLEEVEC dosage: 400 MG, QD. Patient was hospitalized. Patient recovered.

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