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Temodal Side Effects submitted to FDA

Total Temodal reports: 683.
Temodal FDA safety alerts: No.
Reported deaths: 280    Reported hospitalizations: 377.
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FDA Reported Temodal Side Effects: platelet count decreased, alanine aminotransferase increased, thrombocytopenia, disease progression, aspartate aminotransferase increased, sepsis, pancytopenia, pneumocystis jiroveci pneumonia, pyrexia, febrile neutropenia, asthenia,
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Temodal Side Effects Report #5578528-0
Physician from CANADA reported TEMODAL problem on Dec 19, 2007. Female patient, 63 years of age, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, ill-defined disorder, infection. TEMODAL dosage: 75 MG/M2; PO. During the same period patient was treated with LISINOPRIL, AMLODIPINE, RAFFONIN. Patient was hospitalized and became disabled. Patient recovered.



Temodal Side Effects Report #5578567-X
TEMODAL problem was reported by a Physician from JAPAN on Dec 21, 2007. Male patient, 69 years of age, weighting 108.0 lb, was diagnosed with oligodendroglioma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, disease progression, disseminated intravascular coagulation, malignant oligodendroglioma, melaena, multi-organ failure, shock, thrombocytopenia. TEMODAL dosage: 150 MG/M2; QD; PO. During the same period patient was treated with ONCOVIN, NATULAN, DEPAKENE, ZONISAMIDE. Patient died on 11/07/2006.



Temodal Side Effects Report #5578574-7
Pharmacist from FRANCE reported TEMODAL problem on Dec 17, 2007. Male patient, 50 years of age, was diagnosed with oligodendroglioma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: bacterial infection, myalgia, myositis. TEMODAL dosage: unknown. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5578582-6
TEMODAL problem was reported by a Physician from FRANCE on Dec 19, 2007. Female patient, 51 years of age, was diagnosed with glioblastoma, epilepsy, nausea, bronchitis and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: hepatitis cholestatic. TEMODAL dosage: 120 MG; QD; PO. During the same period patient was treated with DEPAKENE, KEPPRA, MEDROL, ONDANSETRON, AUGMENTIN. Patient was hospitalized. Patient recovered.




Temodal Side Effects Report #5581203-X
Physician from ISRAEL reported TEMODAL problem on Dec 18, 2007. Male patient, 53 years of age, weighting 187.4 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. TEMODAL dosage: 150 MG; QD; PO. During the same period patient was treated with DEXAMETHASONE, DEPALEPT, ZANTAC, RESPRIM. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5582798-2
TEMODAL problem was reported by a Physician from FINLAND on Dec 20, 2007. Male patient, 60 years of age, was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: jc virus infection. TEMODAL dosage: unknown. Patient recovered.



Temodal Side Effects Report #5582800-8
Physician from JAPAN reported TEMODAL problem on Dec 21, 2007. Female patient, 65 years of age, weighting 119.0 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: anaemia, blood albumin decreased, blood alkaline phosphatase increased, blood beta-d-glucan increased, cardiac failure, condition aggravated, disease progression, gastrointestinal haemorrhage, hyperkalaemia. TEMODAL dosage: 75 MG/M2;QD;PO. During the same period patient was treated with BETAMETHASONE, DEPAKENE R, TAGAMET, NASEA, DOGMATYL, MAALOX, MAGLAX, GLYSENNID. Patient died on 05/09/2007.



Temodal Side Effects Report #5582865-3
TEMODAL problem was reported by a Physician from JAPAN on Dec 25, 2007. Male patient, 64 years of age, weighting 90.39 lb, was diagnosed with ependymoma malignant and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, lung neoplasm malignant, malignant pleural effusion, nausea, pneumonia aspiration, pneumonia staphylococcal. TEMODAL dosage: 150 MG/M2;QD;PO, 200 MG/M2;QD;PO, 200 MG/M2;QD;PO, 200 MG/M2;QD;PO. During the same period patient was treated with PHENYTOIN CAP, CYANOCOBALAMIN, RINDERON. Patient died on 03/05/2007.



Temodal Side Effects Report #5582885-9
Physician from JAPAN reported TEMODAL problem on Dec 27, 2007. Female patient, 63 years of age, weighting 130.1 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, anorexia, blood albumin decreased, blood creatinine increased, blood potassium decreased, blood pressure immeasurable, c-reactive protein increased, contusion, fall. TEMODAL dosage: 75 MG/M2;QD;PO. Patient died on 12/17/2006.




Temodal Side Effects Report #5506239-6
TEMODAL problem was reported by a Physician from JAPAN on Oct 25, 2007. Male patient, 53 years of age, weighting 125.7 lb, was diagnosed with anaplastic astrocytoma, recurrent cancer and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: blood fibrinogen increased, deep vein thrombosis, dehydration, fibrin degradation products increased, intracranial tumour haemorrhage, neoplasm progression, pneumonia. TEMODAL dosage: 150 MG/M2; QD; PO. During the same period patient was treated with SELBEX, LEXIN, SELENICA, PROTECADIN, MAGNESIUM OXIDE, RINDERON. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5506307-9
Physician from UNITED KINGDOM reported TEMODAL problem on Oct 23, 2007. Male patient, 58 years of age, weighting 215.2 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: fall, ill-defined disorder, lower respiratory tract infection, lung consolidation, musculoskeletal pain, neoplasm progression, pleural effusion, pulmonary embolism. TEMODAL dosage: 170 MG; QD; PO. During the same period patient was treated with AUGMENTIN, DEXAMETHASONE, PHENYTOIN, CODEINE SUL, PARACETAMOL, METOCLOPRAMIDE, MORPHINE, OROMORPH. Patient was hospitalized and became disabled. Patient recovered.



Temodal Side Effects Report #5507324-5
TEMODAL problem was reported by a Physician from SWITZERLAND on Oct 25, 2007. Female patient, 69 years of age, was diagnosed with metastases to central nervous system, non-small cell lung cancer metastatic and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, transaminases increased. TEMODAL dosage: 120 MG;QD;PO. During the same period patient was treated with DALMADORM, FORTECORTIN, DEANXIT. Patient recovered.



Temodal Side Effects Report #5507376-2
Physician from UNITED KINGDOM reported TEMODAL problem on Oct 25, 2007. Male patient, 58 years of age, weighting 215.2 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: fall, lung consolidation, musculoskeletal pain, neoplasm progression, platelet count decreased, pleural effusion, pulmonary embolism. TEMODAL dosage: 170 MG;QD;PO. During the same period patient was treated with AUGMENTIN, DEXAMETHASONE, PHENYTOIN, CODEINE SUL, PARACETAMOL, METOCLOPRAMIDE, MORPHINE, OROMORPH. Patient was hospitalized and became disabled. Patient recovered.



Temodal Side Effects Report #5508601-4
TEMODAL problem was reported by a Physician from JAPAN on Oct 29, 2007. Male patient, 43 years of age, weighting 180.8 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: cerebral infarction. TEMODAL dosage: 150 MG/M2; QD; PO. During the same period patient was treated with KYTRIL, PHENYTOIN CAP, RINDERON, TEGRETOL. Patient recovered.




Temodal Side Effects Report #5508658-0
Physician from JAPAN reported TEMODAL problem on Oct 30, 2007. Female patient, 67 years of age, weighting 101.4 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, c-reactive protein increased, convulsion, hydrocephalus, hypoproteinaemia, lymphocyte count decreased, neoplasm progression, pneumocystis jiroveci pneumonia, respiratory failure. TEMODAL dosage: 75 MG/M2; QD; PO. During the same period patient was treated with ZOFRAN, NIVADIL, SIMVASTATIN, DOXAZOSIN MESYLATE, FAMOTIDINE, EXCEGRAN, WAKOBITAL, PREDNISOLONE. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5509030-X
TEMODAL problem was reported by a Physician from JAPAN on Oct 31, 2007. Female patient, child 7 years of age, weighting 81.57 lb, was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute, tumour haemorrhage. TEMODAL dosage: 150 MG/M2; QD; PO. During the same period patient was treated with BACTRIM, GLEEVEC, RINDERON. Patient died on 05/12/2007.



Temodal Side Effects Report #5513518-5
Physician from JAPAN reported TEMODAL problem on Oct 31, 2007. Male patient, 70 years of age, weighting 132.3 lb, was diagnosed with gliomatosis cerebri and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood albumin decreased, blood chloride decreased, blood creatinine decreased, blood glucose increased, blood lactate dehydrogenase increased, blood potassium decreased, blood sodium increased, blood urea increased. TEMODAL dosage: 150 MG/M2; QD; PO. During the same period patient was treated with ISOBIDE, DEPAKENE, NAUZELIN, MAGNESIUM OXIDE. Patient died on 11/04/2006.



Temodal Side Effects Report #5515809-0
TEMODAL problem was reported by a Physician from JAPAN on Nov 06, 2007. Male patient, 61 years of age, weighting 121.3 lb, was diagnosed with anaplastic astrocytoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, disseminated intravascular coagulation, septic shock, staphylococcal infection. TEMODAL dosage: 150 MG/M2; QD; PO, 150 MG/M2; QD; PO, 150 MG/M2; QD; PO. During the same period patient was treated with DEPAKENE, GLYBURIDE, GLIMICRON, ABILIT. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5515813-2
Physician from FRANCE reported TEMODAL problem on Nov 07, 2007. Male patient, 71 years of age, weighting 105.8 lb, was diagnosed with gastrointestinal disorder, glioblastoma, prophylaxis and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: coma, dysgeusia, epilepsy, leukopenia, lymphopenia. TEMODAL dosage: 110 MG; QD, 300 MG; QD; PO. During the same period patient was treated with ONDANSETRON, BACTRIM DS, DEPAKINE CHRONO, MOTILIUM. Patient died on 09/21/2007.




Temodal Side Effects Report #5518330-9
TEMODAL problem was reported by a Pharmacist from JAPAN on Nov 08, 2007. Female patient, 76 years of age, weighting 104.7 lb, was diagnosed with glioblastoma multiforme, convulsion, bone marrow failure and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, electrolyte imbalance, female genital tract fistula, hypoalbuminaemia, hypoproteinaemia, liver disorder, renal impairment, stevens-johnson syndrome. TEMODAL dosage: 100 MG;QD;NGT. During the same period patient was treated with POLARAMINE, PHENYTOIN, BACTRIM, MINOCYCLINE, HALFDIGOXIN, MAINTATE, ZOFRAN, ASPIRIN. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5518843-X
Physician from JAPAN reported TEMODAL problem on Nov 07, 2007. Male patient, weighting 134.5 lb, was diagnosed with oligodendroglioma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: tumour haemorrhage. TEMODAL dosage: unknown. During the same period patient was treated with ALEVIATION. Patient recovered.



Temodal Side Effects Report #5518844-1
TEMODAL problem was reported by a Health Professional from GERMANY on Nov 05, 2007. Male patient, 75 years of age, weighting 198.4 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: bronchitis bacterial, pneumonia. TEMODAL dosage: 210 MG; QD; PO. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5521654-2
Physician from JAPAN reported TEMODAL problem on Nov 07, 2007. Male patient, 64 years of age, weighting 114.6 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: aspiration, pneumonia. TEMODAL dosage: 150 MG/M2; QD; PO; 200 MG/M2; QD; PO. During the same period patient was treated with EXCEGRAN, RINDERON, FAMOTIDINE, ZOFRAN ZYDIS. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5521656-6
TEMODAL problem was reported by a Physician from JAPAN on Nov 08, 2007. Female patient, 71 years of age, weighting 114.6 lb, was diagnosed with ependymoma malignant and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal, hydronephrosis, liver function test abnormal, platelet count decreased, pyelonephritis, urinary tract infection, white blood cell count decreased. TEMODAL dosage: 120 MG; QD; PO. During the same period patient was treated with PREDONINE, ONEALFA, GLAKAY, FOSAMAC, TAKEPRON OD, FASTIC. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5521693-1
Physician from JAPAN reported TEMODAL problem on Nov 07, 2007. Female patient, 58 years of age, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, haemolytic anaemia. TEMODAL dosage: 120 MG; QD; PO. Patient recovered.



Temodal Side Effects Report #5522139-X
TEMODAL problem was reported by a Pharmacist from CANADA on Nov 12, 2007. Female patient, 70 years of age, was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: metastatic malignant melanoma. TEMODAL dosage: unknown. Patient died.



Temodal Side Effects Report #5523188-8
Physician from JAPAN reported TEMODAL problem on Nov 12, 2007. Female patient, child 7 years of age, weighting 81.57 lb, was diagnosed with brain stem glioma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: hyperlipidaemia, pancreatitis acute, tumour haemorrhage. TEMODAL dosage: unknown. During the same period patient was treated with BACTRIM, GLEEVEC, RINDERON, FAMOTIDINE, ERYTHROCIN, NAUZELIN. Patient was hospitalized. Patient died on 05/12/2007.



Temodal Side Effects Report #5525169-7
TEMODAL problem was reported by a Physician from FRANCE on Nov 13, 2007. Male patient was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: cholestasis, cytolytic hepatitis. TEMODAL dosage: 75 MG/M2; PO; 150 MG/M2; PO. Patient recovered.



Temodal Side Effects Report #5525170-3
Health Professional from GERMANY reported TEMODAL problem on Nov 09, 2007. Male patient, 75 years of age, weighting 198.4 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: bronchitis bacterial, candida serology positive, pneumonia primary atypical. TEMODAL dosage: 210 MG; QD; PO. During the same period patient was treated with STAPHYLEX, UNACID, DIOVAN, DEXAMETHASONE, NORVASC, PANTOPRAZOLE, LAMICTAL. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5525185-5
TEMODAL problem was reported by a Physician from CANADA on Nov 09, 2007. Female patient was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: blood count abnormal. TEMODAL dosage: unknown. Patient died.



Temodal Side Effects Report #5525189-2
Physician from JAPAN reported TEMODAL problem on Nov 13, 2007. Female patient, 69 years of age, weighting 130.1 lb, was diagnosed with disease recurrence, glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, depressed level of consciousness, gastric ulcer, gastrointestinal haemorrhage, hepatic function abnormal, pneumonia aspiration, pulmonary fibrosis, scleroderma. TEMODAL dosage: 150 MG/M2; QD; PO. During the same period patient was treated with BACTRIM, DEPAKENE, RINDERON, TAGAMET. Patient died on 01/19/2007.



Temodal Side Effects Report #5525336-2
TEMODAL problem was reported by a Physician from JAPAN on Nov 14, 2007. Male patient, 76 years of age, weighting 66.14 lb, was diagnosed with glioma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: anorexia, malignant neoplasm progression, malnutrition, pneumonia. TEMODAL dosage: 75 MG/M2; QD; PO. During the same period patient was treated with BACTRIM, DEPAKENE. Patient was hospitalized. Patient died on 10/06/2007.



Temodal Side Effects Report #5525435-5
Physician from GERMANY reported TEMODAL problem on Nov 08, 2007. Male patient, 53 years of age, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: leukopenia, pneumonia, thrombocytopenia. TEMODAL dosage: unknown. Patient was hospitalized. Patient died on 05/31/2007.



Temodal Side Effects Report #5527708-9
TEMODAL problem was reported by a Physician from JAPAN on Nov 15, 2007. Female patient, 76 years of age, weighting 99.21 lb, was diagnosed with glioblastoma multiforme, decreased appetite, nausea and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: decreased appetite, interstitial lung disease, lymphocyte count decreased, nausea. TEMODAL dosage: 75 MG/M2;QD;PO. During the same period patient was treated with ZONISAMIDE, PRIMEPERAN, DOGMATYL, PREDONINE, BLOPRESS, BERIZYM. Patient recovered.



Temodal Side Effects Report #5527909-X
Physician from JAPAN reported TEMODAL problem on Nov 20, 2007. Male patient, 24 years of age, weighting 94.80 lb, was diagnosed with medulloblastoma recurrent and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: disease progression, neoplasm progression, pneumonia, respiratory disorder, staphylococcal infection. TEMODAL dosage: PO; 200 MG/M2;QD; PO. During the same period patient was treated with RANIMUSTINE, METHOTREXATE, IFOSFAMIDE, LOXONIN, PREDNISOLONE. Patient was hospitalized. Patient died on 02/21/2007.



Temodal Side Effects Report #5527935-0
TEMODAL problem was reported by a Physician from GERMANY on Nov 14, 2007. Male patient, 65 years of age, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, pulmonary embolism. TEMODAL dosage: 75 MG/M2; QD; PO. During the same period patient was treated with LISINOPRIL COMP. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5529019-4
Physician from GERMANY reported TEMODAL problem on Nov 15, 2007. Female patient, 74 years of age, weighting 132.3 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: enterococcal infection, fall, herpes zoster, neuralgia, pancytopenia, pneumonia klebsiella, urinary tract infection. TEMODAL dosage: 260 MG; QD; PO. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5530378-7
TEMODAL problem was reported by a Physician from GERMANY on Nov 15, 2007. Female patient, 76 years of age, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: balance disorder, hydrocephalus. TEMODAL dosage: 75 MG/M2;QD;. During the same period patient was treated with FORTECORTIN. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5532208-6
Physician from JAPAN reported TEMODAL problem on Nov 19, 2007. Female patient, 69 years of age, weighting 103.6 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: disseminated tuberculosis, stevens-johnson syndrome. TEMODAL dosage: 75 MG/M2; QD; PO, 150 MG/M2; QD; PO, 200 MG/M2; QD; PO. During the same period patient was treated with BACTRIM, PHENYTOIN CAP, DEPAKENE, GASTER, ALLEGRA, TETRAMIDE. Patient died on 06/28/2007.



Temodal Side Effects Report #5533778-4
TEMODAL problem was reported by a Physician from GERMANY on Nov 19, 2007. Male patient, 66 years of age, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, back pain, blood lactate dehydrogenase increased, disturbance in attention, gamma-glutamyltransferase increased, hydrocephalus, nervous system disorder, oxygen saturation decreased. TEMODAL dosage: unknown. During the same period patient was treated with FLOMAX, NEXIUM, FORTECORTIN. Patient was hospitalized. Patient died on 09/09/2007.



Temodal Side Effects Report #5533795-4
Physician from JAPAN reported TEMODAL problem on Nov 26, 2007. Male patient, 33 years of age, weighting 132.3 lb, was diagnosed with glioblastoma multiforme, recurrent cancer and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: disease progression, gastric cancer, neoplasm progression, platelet count decreased. TEMODAL dosage: 220 MG/M2;QD;PO; 340 MG/M2;QD;PO. During the same period patient was treated with BAKTAR. Patient died on 08/17/2007.



Temodal Side Effects Report #5534800-1
TEMODAL problem was reported by a Consumer or non-health professional from GERMANY on Nov 25, 2007. Female patient, 73 years of age, weighting 130.1 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: inguinal hernia, non-hodgkin's lymphoma. TEMODAL dosage: unknown. During the same period patient was treated with RANITIDINE, ALLOPURINOL, PREDNISONE. Patient died on 11/03/2007.



Temodal Side Effects Report #5477384-9
Consumer or non-health professional from GERMANY reported TEMODAL problem on Sept 20, 2007. Female patient, 73 years of age, weighting 130.1 lb, was diagnosed with glioblastoma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: inguinal hernia, non-hodgkin's lymphoma. TEMODAL dosage: unknown. During the same period patient was treated with RANTIDINE, ALLOPURINOL, PREDNISONE. Patient recovered.



Temodal Side Effects Report #5477385-0
TEMODAL problem was reported by a Physician from JAPAN on Sept 25, 2007. Male patient, 52 years of age, weighting 143.3 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, c-reactive protein increased, platelet count decreased, pneumonia bacterial, post procedural infection. TEMODAL dosage: 150 MG/M2;QD;PO; 200 MG/M2;QD;PO; 150 MG/M2;QD;PO. During the same period patient was treated with AMOXAN, ISALON, MYSTAN, DEPAKENE, PHENYTOIN CAP, MAGNESIUM OXIDE. Patient was hospitalized. Patient recovered.



Temodal Side Effects Report #5477386-2
Physician from ITALY reported TEMODAL problem on Sept 24, 2007. Male patient, 51 years of age, was diagnosed with glioma and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anaemia, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic function abnormal, neutropenia, thrombocytopenia. TEMODAL dosage: 150 MG;QD;PO; 400 MG;QD;PO. Patient recovered.



Temodal Side Effects Report #5477389-8
TEMODAL problem was reported by a Physician from JAPAN on Sept 25, 2007. Female patient, 74 years of age, was diagnosed with glioblastoma multiforme and was treated with TEMODAL. After drug was administered, patient experienced the following problems/side effects: malnutrition, pulmonary oedema. TEMODAL dosage: unknown. During the same period patient was treated with INTERFERON BETA. Patient recovered.



Temodal Side Effects Report #5477391-6
Physician from JAPAN reported TEMODAL problem on Sept 26, 2007. Male patient, 83 years of age, weighting 90.39 lb, was d