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Review Mylotarg Safety Reports submitted to FDA

Total Mylotarg reports: 290.
Mylotarg FDA safety alerts: No.
Reported deaths: 111    Reported hospitalizations: 184.
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FDA Reported Mylotarg Side Effects: febrile neutropenia, platelet count decreased, anaemia, neutrophil count decreased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, condition aggravated, sepsis, blood alkaline phosphatase increased, disseminated intravascular coagulation.
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Mylotarg Side Effects Report #5373416-7
Physician from JAPAN reported MYLOTARG problem on June 25, 2007. Female patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, haematemesis, hepatic function abnormal, melaena. MYLOTARG dosage: unknown. Patient recovered.

Mylotarg Side Effects Report #5373486-6
MYLOTARG problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2007. Female patient, weighting 85.76 lb, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: aspergillosis, blood culture positive, brain stem infarction, cerebral haemorrhage, facial palsy, fungal infection, meningitis, nerve compression, neutropenia. MYLOTARG dosage: unknown. During the same period patient was treated with MITOXANTRONE, CYTARABINE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5374514-4
Physician from JAPAN reported MYLOTARG problem on June 21, 2007. Female patient, weighting 88.18 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blast cells present, chills, condition aggravated, febrile neutropenia, hepatitis, neutrophil count decreased, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with DIFLUCAN, BAKTAR, LEVOFLOXACIN. Patient recovered.

Mylotarg Side Effects Report #5376408-7
MYLOTARG problem was reported by a Consumer or non-health professional from UNITED STATES on June 27, 2007. Male patient, weighting 150.1 lb, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: neutropenia, pyrexia. MYLOTARG dosage: 5 MG. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5313880-2
Physician from JAPAN reported MYLOTARG problem on Apr 24, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: haematocrit decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, pneumonia, pyrexia, red blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with BAKTAR, SIGMART, FRANDOL, HERBESSER, PURSENNID, GASTER, DIFLUCAN. Patient died on 03/10/2007.

Mylotarg Side Effects Report #5315462-5
MYLOTARG problem was reported by a Health Professional from UNITED STATES on Apr 25, 2007. Female patient, weighting 200.2 lb, was diagnosed with acute myeloid leukaemia, deep vein thrombosis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: dyspnoea, pleural effusion, pulmonary oedema. MYLOTARG dosage: unknown. During the same period patient was treated with COUMADIN. Patient recovered.

Mylotarg Side Effects Report #5315496-0
Physician from JAPAN reported MYLOTARG problem on Apr 24, 2007. Male patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anaemia, ascites, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, blood urea increased, chills. MYLOTARG dosage: unknown. During the same period patient was treated with HYDROCORTISONE SUCCINATE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5315902-1
MYLOTARG problem was reported by a Physician from JAPAN on Apr 24, 2007. Female patient, weighting 108.0 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, blood potassium decreased, fibrin degradation products increased, neutrophil count decreased, sepsis, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with LIPOVAS, ENOCITABINE, FLUCONAZOLE, DAUNORUBICIN HYDROCHLORIDE, FAMOTIDINE, MICARDIS. Patient died on 10/03/2006.

Mylotarg Side Effects Report #5316413-X
Physician from JAPAN reported MYLOTARG problem on Apr 26, 2007. Male patient, weighting 108.0 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blood urea increased, c-reactive protein increased, condition aggravated, performance status decreased, pneumonia, white blood cell count increased. MYLOTARG dosage: unknown. During the same period patient was treated with CYTARABINE, MEROPEN, AMIKACIN, GASTER, PREDONINE, DIFLUCAN, BAKTAR. Patient recovered.

Mylotarg Side Effects Report #5316591-2
MYLOTARG problem was reported by a Physician from JAPAN on Apr 27, 2007. Male patient, weighting 90.39 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, fibrin degradation products increased, lung infection, obliterative bronchiolitis, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with MAXIPIME, FIRSTCIN, CIPROFLOXACIN, NORMAL IMMUNOGLOBULIN, TARGOCID, FUNGUARD, PREDONINE. Patient was hospitalized. Patient died on 01/31/2007.

Mylotarg Side Effects Report #5316705-4
Health Professional from UNITED STATES reported MYLOTARG problem on Apr 24, 2007. Male patient, 79 years of age, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: venoocclusive liver disease. MYLOTARG dosage: 9 MG/M2 (FEQUENCY NOT SPECIFIED). Patient recovered.

Mylotarg Side Effects Report #5318951-2
MYLOTARG problem was reported by a Physician from JAPAN on Apr 27, 2007. Male patient, weighting 143.3 lb, was diagnosed with acute myeloid leukaemia recurrent, sepsis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, body temperature increased, c-reactive protein increased, hypoalbuminaemia, hypoproteinaemia, performance status decreased. MYLOTARG dosage: unknown. During the same period patient was treated with MAXIPIME, FUNGUARD, MEROPEN, ISEPACIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5320434-0
Physician from UNITED STATES reported MYLOTARG problem on May 01, 2007. Male patient, 75 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: granuloma. MYLOTARG dosage: 9 MG/M^2. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5321011-8
MYLOTARG problem was reported by a Physician from UNITED STATES on Apr 30, 2007. Male patient, 59 years of age, weighting 145.1 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: chest pain, haemothorax, platelet disorder, pleural effusion, urinary bladder haemorrhage, white blood cell disorder. MYLOTARG dosage: 10.44 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with CYTARABINE, DAUNORUBICIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5324992-1
Physician from JAPAN reported MYLOTARG problem on May 07, 2007. Male patient, weighting 143.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blast cell count increased, blood lactate dehydrogenase increased, c-reactive protein increased, condition aggravated, haematuria, hypokalaemia, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with ITRACONAZOLE, MAXIPIME, IDAMYCIN, NOVANTRONE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5325407-X
MYLOTARG problem was reported by a Physician from UNITED STATES on May 10, 2007. Male patient, 47 years of age, weighting 213.0 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. MYLOTARG dosage: 12.6 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with DAUNORUBICIN, COZAAR, GLUCOSAMINE, SENOKOT, PREVACID, VALTREX, COLACE, IMIPENEM. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5326593-8
Physician from JAPAN reported MYLOTARG problem on May 09, 2007. Male patient, weighting 147.7 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, febrile neutropenia, gastrointestinal haemorrhage, hepatic function abnormal, platelet count decreased, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with BAKTAR, GASTER, LENOGRASTIM, MEPTIN, LEVOFLOXACIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5333847-8
MYLOTARG problem was reported by a Physician from JAPAN on May 16, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, abdominal pain upper and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anorexia, gingival bleeding, hepatic function abnormal, neutrophil count decreased, platelet count decreased, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with ITRACONAZOLE, FAMOTIDINE, MAGNESIUM HYDROXIDE, ZOVIRAX, BAKTAR, BENET, DALTEPARIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5333891-0
Physician from JAPAN reported MYLOTARG problem on May 22, 2007. Female patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, infection, insomnia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, c-reactive protein increased, febrile neutropenia, neutrophil count decreased, platelet count decreased, systemic mycosis, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with BIFIDOBACTERIUM BIFIDUM, TOBRACIN, NITRAZEPAM, TIENAM, TAKEPRON, OLOPATADINE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5334244-1
MYLOTARG problem was reported by a Physician from JAPAN on May 17, 2007. Female patient, weighting 88.18 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, hepatitis, neutrophil count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with DIFLUCAN, BAKTAR, LEVOFLOXACIN. Patient recovered.

Mylotarg Side Effects Report #5334293-3
Health Professional from UNITED STATES reported MYLOTARG problem on May 15, 2007. Female patient, weighting 200.2 lb, was diagnosed with acute myeloid leukaemia, deep vein thrombosis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, dyspnoea exertional, pleural effusion, pulmonary oedema. MYLOTARG dosage: unknown. During the same period patient was treated with COUMADIN. Patient was hospitalized and became disabled. Patient died on 04/01/2007.

Mylotarg Side Effects Report #5340447-2
MYLOTARG problem was reported by a Physician from JAPAN on May 21, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blood albumin decreased, c-reactive protein increased, febrile neutropenia, fibrin degradation products increased, nausea, neutrophil count decreased, platelet count decreased, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with PREDNISOLONE, PARIET, ZEFFIX, DIFLUCAN, CIPROFLOXACIN, PURSENNID, FRAGMIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5283671-X
Physician from JAPAN reported MYLOTARG problem on Mar 25, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, sedation and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, cellulitis, disseminated intravascular coagulation, dysphagia, hepatic function abnormal, herpes simplex, hypoalbuminaemia, mouth haemorrhage. MYLOTARG dosage: unknown. During the same period patient was treated with NOVANTRONE, POLYMYXIN B SULPHATE, FAMOTIDINE, BAKTAR, MIDAZOLAM, VFEND. Patient was hospitalized. Patient died on 10/15/2006.

Mylotarg Side Effects Report #5283730-1
MYLOTARG problem was reported by a Physician from JAPAN on Mar 23, 2007. Male patient, weighting 169.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, insomnia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, blood fibrinogen increased, blood lactate dehydrogenase increased, blood pressure diastolic increased, c-reactive protein increased, condition aggravated, fibrin degradation products increased, nausea. MYLOTARG dosage: unknown. During the same period patient was treated with GASTER, PRORENAL, ACLARUBICIN HYDROCHLORIDE, MUCOSTA, ZOLPIDEM TARTRATE, CYTARABINE, ETODOLAC, BAKTAR. Patient recovered.

Mylotarg Side Effects Report #5283739-8
Physician from JAPAN reported MYLOTARG problem on Mar 23, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, emphysema and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, anaemia, c-reactive protein increased, condition aggravated, disseminated intravascular coagulation, febrile neutropenia, peptic ulcer, thrombocytopenia. MYLOTARG dosage: unknown. During the same period patient was treated with MUCOSTA, BAKTAR, POLYMYXIN B SULPHATE, CLARITHROMYCIN, ZANTAC, DIFLUCAN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5283746-5
MYLOTARG problem was reported by a Physician from JAPAN on Mar 23, 2007. Female patient, 37 years of age, weighting 97.00 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: thrombotic microangiopathy, venoocclusive liver disease. MYLOTARG dosage: unknown. During the same period patient was treated with HEPARIN, FUNGUARD, BUSULFAN, OMEPRAL. Patient died on 06/21/2006.

Mylotarg Side Effects Report #5284200-7
Physician from JAPAN reported MYLOTARG problem on Mar 22, 2007. Female patient, weighting 105.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, disseminated intravascular coagulation, gamma-glutamyltransferase increased, herpes simplex, pyrexia, tumour lysis syndrome, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with BAKTAR, VFEND, TARGOCID, ISEPACIN, DALACIN, GASTER. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5284681-9
MYLOTARG problem was reported by a Physician from JAPAN on Mar 23, 2007. Female patient, weighting 145.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with DIFLUCAN. Patient recovered.

Mylotarg Side Effects Report #5284850-8
Health Professional from UNITED STATES reported MYLOTARG problem on Mar 26, 2007. Male patient, 75 years of age, weighting 197.2 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, respiratory distress. MYLOTARG dosage: unknown. During the same period patient was treated with PLATELETS. Patient died on 04/06/2006.

Mylotarg Side Effects Report #5286578-7
MYLOTARG problem was reported by a Physician from JAPAN on Mar 27, 2007. Male patient, weighting 108.0 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blood urea increased, c-reactive protein increased, condition aggravated, performance status decreased, pneumonia, white blood cell count increased. MYLOTARG dosage: unknown. During the same period patient was treated with CYTARABINE, MEROPEN, AMIKACIN, GASTER, PREDONINE, DIFLUCAN, BAKTAR. Patient died on 02/16/2007.

Mylotarg Side Effects Report #5286743-9
Physician from JAPAN reported MYLOTARG problem on Mar 27, 2007. Male patient, 44 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: pneumonia. MYLOTARG dosage: unknown. Patient died on 03/27/2007.

Mylotarg Side Effects Report #5287665-X
MYLOTARG problem was reported by a Physician from JAPAN on Mar 27, 2007. Male patient, weighting 121.3 lb, was diagnosed with acute leukaemia, prophylaxis, sepsis, cytomegalovirus viraemia, cholestasis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, chronic graft versus host disease, condition aggravated, disseminated intravascular coagulation, hyperbilirubinaemia, oxygen saturation decreased, platelet count decreased, renal failure acute, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with ACYCLOVIR, MEROPEN, VFEND, TARGOCID, CIPROFLOXACIN, GANCICLOVIR. Patient recovered.

Mylotarg Side Effects Report #5288513-4
Physician from JAPAN reported MYLOTARG problem on Mar 27, 2007. Female patient, 51 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: bone marrow failure. MYLOTARG dosage: unknown. Patient died on 03/27/2007.

Mylotarg Side Effects Report #5288523-7
MYLOTARG problem was reported by a Physician from JAPAN on Mar 29, 2007. Male patient, weighting 39.68 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, cardiac failure, disseminated intravascular coagulation, dyspnoea, hepatic function abnormal, hypoxia, pericardial effusion, pleural effusion, tumour lysis syndrome. MYLOTARG dosage: unknown. During the same period patient was treated with NOVANTRONE, LENOGRASTIM, IDARUBICIN, FRAGMIN. Patient was hospitalized. Patient died on 03/29/2006.

Mylotarg Side Effects Report #5289593-2
Physician from JAPAN reported MYLOTARG problem on Mar 27, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anorexia, blood pressure decreased, haemorrhagic diathesis, hepatic function abnormal, neutrophil count decreased, platelet count decreased, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with ITRACONAZOLE, FAMOTIDINE, DALTEPARIN, ZOVIRAX, BAKTAR, BENET, ALLORINE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5289610-X
MYLOTARG problem was reported by a Physician from JAPAN on Mar 29, 2007. Male patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood urea increased, cerebral haemorrhage, disseminated intravascular coagulation, febrile neutropenia, hypernatraemia, pneumonia, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with MAGNESIUM OXIDE, ALTAT, SELBEX, GLUCOSEECTION, VITAMEDIN, SOLDEM, STRONG NEO MINOPHAGEN C. Patient was hospitalized. Patient died on 02/27/2007.

Mylotarg Side Effects Report #5291882-2
Physician from JAPAN reported MYLOTARG problem on Mar 29, 2007. Male patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, ascites, blood alkaline phosphatase increased, blood bilirubin increased, gamma-glutamyltransferase increased, hepatomegaly, leucine aminopeptidase increased, neutrophil count decreased, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with HYDROCORTISONE SUCCINATE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5291884-6
MYLOTARG problem was reported by a Physician from JAPAN on Mar 29, 2007. Male patient, weighting 152.1 lb, was diagnosed with acute myeloid leukaemia recurrent, hyperlipidaemia, diabetes mellitus, constipation, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, atelectasis, neutropenic infection, oral herpes, pseudomonal sepsis, serratia sepsis, stomatitis, thrombocytopenia. MYLOTARG dosage: unknown. During the same period patient was treated with LIPITOR, ACTOS, MAGNESIUM OXIDE, PURSENNID, BACTRIM, POLYMYXIN B SULPHATE, FUNGIZONE. Patient was hospitalized. Patient died on 01/18/2007.

Mylotarg Side Effects Report #5292925-2
Physician from JAPAN reported MYLOTARG problem on Mar 30, 2007. Male patient, weighting 141.1 lb, was diagnosed with acute myeloid leukaemia recurrent, pyrexia, prophylaxis, hypertension, pain and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: neutrophil count decreased, platelet count decreased, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with VOLTAREN, POLYMYXIN B SULPHATE, CONIEL, DIFLUCAN, MORPHINE, GASTER. Patient was hospitalized. Patient died on 10/22/2006.

Mylotarg Side Effects Report #5294652-4
MYLOTARG problem was reported by a Physician from JAPAN on Apr 03, 2007. Male patient, weighting 119.0 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, pneumonia. MYLOTARG dosage: unknown. During the same period patient was treated with GASTER, DIFLUCAN, LEVOFLOXACIN, LASIX, SELBEX. Patient died on 03/27/2007.

Mylotarg Side Effects Report #5294994-2
Physician from UNITED STATES reported MYLOTARG problem on Apr 05, 2007. Female patient, 38 years of age, weighting 158.6 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: arthralgia, back pain, blood creatinine increased, blood glucose increased, condition aggravated, disease progression, hyperuricaemia, neutrophil count decreased, platelet count decreased. MYLOTARG dosage: 10.8 MG OVER 2 HOURS. During the same period patient was treated with DAUNORUBICIN, CYTARABINE. Patient died on 12/12/2006.

Mylotarg Side Effects Report #5295739-2
MYLOTARG problem was reported by a Physician from JAPAN on Apr 04, 2007. Female patient, weighting 110.2 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blood pressure decreased, condition aggravated, small intestinal haemorrhage. MYLOTARG dosage: unknown. During the same period patient was treated with OMEPRAZOLE, MAXIPIME, CARBENIN, MICAFUNGIN. Patient died on 03/20/2007.

Mylotarg Side Effects Report #5295850-6
Physician from JAPAN reported MYLOTARG problem on Apr 05, 2007. Female patient, weighting 105.8 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: colitis, neutropenia, pancytopenia, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with RYTHMODAN, FUNGUARD, ASPARA K, POTASSIUM CHLORIDE, VANCOMYCIN HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5299276-0
MYLOTARG problem was reported by a Physician from JAPAN on Apr 12, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, cellulitis, condition aggravated, diarrhoea, epistaxis, hepatic function abnormal, mucous membrane disorder, neutrophil count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with CYTARABINE, KYTRIL, SAXIZON, NOVANTRONE, ITRACONAZOLE, FAMOTIDINE. Patient was hospitalized. Patient died on 09/02/2006.

Mylotarg Side Effects Report #5299311-X
Physician from JAPAN reported MYLOTARG problem on Apr 10, 2007. Male patient, weighting 160.9 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, pancytopenia, pseudomembranous colitis. MYLOTARG dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE, NOVANTRONE, HEPARIN, MEYLON, HUMULIN, NEORAL. Patient recovered.

Mylotarg Side Effects Report #5299514-4
MYLOTARG problem was reported by a Physician from JAPAN on Apr 12, 2007. Female patient, weighting 125.7 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated, neutrophil count decreased, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with VFEND, LASIX, DIAMOX. Patient died on 11/17/2006.

Mylotarg Side Effects Report #5300795-9
Physician from JAPAN reported MYLOTARG problem on Apr 12, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, sedation and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, cellulitis, disseminated intravascular coagulation, dysphagia, hepatic function abnormal, hypoalbuminaemia, mouth haemorrhage, neutrophil count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with NOVANTRONE, POLYMYXIN B SULPHATE, FAMOTIDINE, BAKTAR, MIDAZOLAM, VFEND. Patient was hospitalized. Patient died on 10/15/2006.

Mylotarg Side Effects Report #5300796-0
MYLOTARG problem was reported by a Physician from JAPAN on Apr 12, 2007. Female patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, condition aggravated, herpes zoster, malaise, platelet count decreased, pleural effusion, pneumonia, pyrexia. MYLOTARG dosage: unknown. During the same period patient was treated with VFEND, MODACIN, MEROPENEM, TARGOCID, BAKTAR, POLYMYXIN B SULPHATE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5302162-0
Physician from JAPAN reported MYLOTARG problem on Apr 12, 2007. Male patient, weighting 121.3 lb, was diagnosed with acute myeloid leukaemia, constipation, arrhythmia, prophylaxis, benign prostatic hyperplasia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, gastrointestinal haemorrhage, haemorrhagic diathesis, hepatic function abnormal, renal failure, sepsis, septic shock, subdural haemorrhage. MYLOTARG dosage: unknown. During the same period patient was treated with MAGNESIUM OXIDE, SUNRYTHM, SELBEX, FUNGUARD, BAKTAR, HARNAL, FLUCONAZOLE. Patient was hospitalized. Patient died on 02/01/2007.

Mylotarg Side Effects Report #5303031-2
MYLOTARG problem was reported by a Physician from JAPAN on Apr 13, 2007. Male patient, weighting 152.1 lb, was diagnosed with acute myeloid leukaemia recurrent, hyperlipidaemia, diabetes mellitus, constipation, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: abdominal distension, agranulocytosis, ascites, atelectasis, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, chest x-ray abnormal, cholestasis. MYLOTARG dosage: unknown. During the same period patient was treated with LIPITOR, ACTOS, MAGNESIUM OXIDE, HUMULIN, BACTRIM, POLYMYXIN B SULPHATE, FUNGIZONE. Patient was hospitalized. Patient died on 01/18/2007.

Mylotarg Side Effects Report #5303424-3
Physician from JAPAN reported MYLOTARG problem on Apr 13, 2007. Female patient, weighting 108.0 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, gastric disorder, white blood cell count decreased and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, febrile neutropenia, platelet count decreased, pneumonia, pyrexia. MYLOTARG dosage: unknown. During the same period patient was treated with ADALAT, GASTER, PARIET, LEVOFLOXACIN, DIFLUCAN, VICCILLIN, NEUTROGIN, FUNGIZONE. Patient was hospitalized. Patient died on 09/01/2006.

Mylotarg Side Effects Report #5305238-7
MYLOTARG problem was reported by a Physician from JAPAN on Apr 13, 2007. Male patient, weighting 141.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, insomnia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: neutrophil count decreased, platelet count decreased, pneumonia. MYLOTARG dosage: unknown. During the same period patient was treated with FUNGIZONE, LEVOFLOXACIN, DIFLUCAN, CYTARABINE, LENDORMIN. Patient died on 09/16/2006.

Mylotarg Side Effects Report #5305825-6
Physician from UNITED STATES reported MYLOTARG problem on Apr 13, 2007. Male patient, 47 years of age, weighting 213.0 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. MYLOTARG dosage: 12.6 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with DAUNORUBICIN, CYTARABINE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5306874-4
MYLOTARG problem was reported by a Physician from JAPAN on Apr 13, 2007. Male patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, febrile neutropenia, neutrophil count decreased, platelet count decreased, pneumonia, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with GLEEVEC, FLUCONAZOLE, ALTAT, BAKTAR, CIPROFLOXACIN. Patient died on 02/02/2006.

Mylotarg Side Effects Report #5307227-5
Physician from JAPAN reported MYLOTARG problem on Apr 19, 2007. Male patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, pruritus and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, depression, hepatic function abnormal, insomnia, memory impairment, neutrophil count decreased, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with ITRACONAZOLE, GASTER, MUCOSTA, PREDONINE, BAKTAR, ISODINE, MYSER. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5309417-4
MYLOTARG problem was reported by a Physician from UNITED STATES on Apr 18, 2007. Male patient, 59 years of age, weighting 145.1 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: haemoglobin abnormal, pleural effusion, white blood cell disorder. MYLOTARG dosage: 10.44 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with CYTARABINE, DAUNORUBICIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5310152-7
Physician from JAPAN reported MYLOTARG problem on Apr 18, 2007. Male patient, weighting 143.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, febrile neutropenia, hypertension, pulmonary mycosis. MYLOTARG dosage: unknown. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5253016-X
MYLOTARG problem was reported by a Physician from JAPAN on Feb 19, 2007. Male patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, ascites, blood alkaline phosphatase increased, blood bilirubin increased, gamma-glutamyltransferase increased, hepatomegaly, leucine aminopeptidase increased, neutrophil count decreased, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with MAXIPIME, AMIKACIN SULPHATE, TIENAM, CIPROFLOXACIN, OMEPRAL, MEROPENEM. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5254321-3
Physician from JAPAN reported MYLOTARG problem on Feb 21, 2007. Male patient, weighting 141.1 lb, was diagnosed with acute myeloid leukaemia recurrent, pyrexia, prophylaxis, hypertension, pain and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: neutrophil count decreased, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with VOLTAREN, POLYMYXIN B SULPHATE, CONIEL, DIFLUCAN, MORPHINE, GASTER. Patient died on 10/22/2006.

Mylotarg Side Effects Report #5255383-X
MYLOTARG problem was reported by a Physician from JAPAN on Feb 21, 2007. Male patient, weighting 119.0 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, disseminated intravascular coagulation, hypoxia, infection, interstitial lung disease, tumour lysis syndrome. MYLOTARG dosage: unknown. During the same period patient was treated with FIRSTCIN, DIOVAN, AMARYL, MELBIN, ORGARAN, FUNGUARD. Patient died on 06/23/2006.

Mylotarg Side Effects Report #5255460-3
Physician from JAPAN reported MYLOTARG problem on Feb 21, 2007. Female patient, weighting 94.80 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, pyrexia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anorexia, electrocardiogram qt prolonged, fungal sepsis, hypokalaemia, platelet count decreased, staphylococcal sepsis, torsade de pointes, ventricular flutter. MYLOTARG dosage: unknown. During the same period patient was treated with BAKTAR, OMEPRAL, NAUZELIN, SAXIZON, HEPARIN, GATIFLOXACIN, CYTARABINE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5255549-9
MYLOTARG problem was reported by a Physician from JAPAN on Feb 22, 2007. Male patient, weighting 169.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, insomnia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blast cell count increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, neutrophil count decreased, performance status decreased, pneumonia, pyrexia, white blood cell count increased. MYLOTARG dosage: unknown. During the same period patient was treated with GASTER, ZOLPIDEM TARTRATE, BAKTAR, MUCOSTA, ETODOLAC, PRORENAL. Patient recovered.

Mylotarg Side Effects Report #5256286-7
Physician from JAPAN reported MYLOTARG problem on Feb 23, 2007. Female patient, weighting 125.7 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated, neutrophil count decreased, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with VFEND, LASIX, DIAMOX, TIENAM. Patient died on 11/17/2006.

Mylotarg Side Effects Report #5257029-3
MYLOTARG problem was reported by a Physician from JAPAN on Feb 26, 2007. Female patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, diarrhoea, infection, insomnia, gastritis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, c-reactive protein increased, febrile neutropenia, neutrophil count decreased, platelet count decreased, systemic mycosis, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with BIFIDOBACTERIUM BIFIDUM, TOBRACIN, NITRAZEPAM, TIENAM, TAKEPRON, OLOPATADINE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5257030-X
Physician from JAPAN reported MYLOTARG problem on Feb 23, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, cellulitis, condition aggravated, diarrhoea, epistaxis, hepatic function abnormal, mucous membrane disorder, neutrophil count decreased, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with CYTARABINE, KYTRIL, SAXIZON, NOVANTRONE, ITRACONAZOLE, FAMOTIDINE. Patient was hospitalized. Patient died on 09/02/2006.

Mylotarg Side Effects Report #5257031-1
MYLOTARG problem was reported by a Physician from JAPAN on Feb 24, 2007. Male patient, weighting 90.39 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, fibrin degradation products increased, lung infection, obliterative bronchiolitis, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with MAXIPIME, FIRSTCIN, CIPROFLOXACIN, NORMAL IMMUNOGLOBULIN, TARGOCID, FUNGUARD, PREDONINE. Patient was hospitalized. Patient died on 01/31/2007.

Mylotarg Side Effects Report #5258288-3
Physician from JAPAN reported MYLOTARG problem on Feb 27, 2007. Female patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia recurrent, reflux oesophagitis, liver abscess, constipation and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: enteritis, febrile neutropenia, gastrointestinal haemorrhage. MYLOTARG dosage: unknown. During the same period patient was treated with ISALON, VFEND, PANTOSIN, MAGNESIUM OXIDE, MAGNESIUM OXIDE, NEOPHAGEN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5258291-3
MYLOTARG problem was reported by a Physician from UNITED STATES on Feb 23, 2007. Female patient, weighting 124.1 lb, was diagnosed with myelodysplastic syndrome, diabetes mellitus non-insulin-dependent, hypothyroidism, folate deficiency, hyperlipidaemia, candidiasis, pyrexia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: mental status changes. MYLOTARG dosage: unknown. During the same period patient was treated with GLYBURIDE, LEVOTHYROXINE, FOLIC ACID, VYTORIN, FLUCONAZOLE, VITAMIN B, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5259036-3
Physician from JAPAN reported MYLOTARG problem on Mar 02, 2007. Female patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, condition aggravated, herpes zoster, malaise, platelet count decreased, pleural effusion, pneumonia, pyrexia. MYLOTARG dosage: unknown. During the same period patient was treated with VFEND, MODACIN, MEROPENEM, TARGOCID, BAKTAR, POLYMYXIN B SULPHATE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5259103-4
MYLOTARG problem was reported by a Physician from JAPAN on Mar 06, 2007. Male patient, weighting 169.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, insomnia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blast cell count increased, blood lactate dehydrogenase increased, c-reactive protein increased, neutrophil count decreased, performance status decreased, pneumonia, pyrexia, white blood cell count increased. MYLOTARG dosage: unknown. During the sam