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Review Gemtuzumab Safety Reports submitted to FDA

Total Gemtuzumab reports: 89.
Gemtuzumab FDA safety alerts: No.
Reported deaths: 64    Reported hospitalizations: 51.
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FDA Reported Gemtuzumab Side Effects: septic shock, multi-organ failure, thrombocytopenia, venoocclusive liver disease, shock haemorrhagic, pancytopenia, hyperbilirubinaemia, bronchopulmonary aspergillosis, fluid retention, sepsis, acute respiratory distress syndrome.
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Gemtuzumab Side Effects Report #5652886-0
Physician from BELGIUM reported GEMTUZUMAB problem on Feb 29, 2008. Male patient, 73 years of age, was diagnosed with leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, pyrexia. GEMTUZUMAB dosage: 9 MG/M^2 EVERY. During the same period patient was treated with ZANTAC, ZOVIRAX. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5655644-6
GEMTUZUMAB problem was reported by a Physician from NETHERLANDS on Mar 05, 2008. Male patient, weighting 169.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: respiratory failure. GEMTUZUMAB dosage: 5.7 MG-FREQUENCY NOT PROVIDED (CUMULATIVE DOSE GIVEN 29.3MG). During the same period patient was treated with MEROPENEM, ETOPOSIDE, CEFALORIDINE, CYTARABINE, IDARUBICIN. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5660736-1
Physician from ITALY reported GEMTUZUMAB problem on Mar 06, 2008. Female patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, pneumonia. GEMTUZUMAB dosage: 6 MG/M2 (CUMULATIVE DOSE 10 MG). Patient died on 06/08/2007.

Gemtuzumab Side Effects Report #5611055-0
GEMTUZUMAB problem was reported by a Physician from CANADA on Jan 30, 2008. Female patient, 58 years of age, weighting 198.4 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, septic shock, tumour lysis syndrome. GEMTUZUMAB dosage: 12 MG. During the same period patient was treated with CYTARABINE, DAUNORUBICIN. Patient was hospitalized. Patient died on 01/19/2008.

Gemtuzumab Side Effects Report #5623064-6
Physician from UNITED KINGDOM reported GEMTUZUMAB problem on Feb 08, 2008. Male patient was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: fungal infection, neutropenia, pneumonia. GEMTUZUMAB dosage: 3 MG/M^2 EVERY 1 TOT. During the same period patient was treated with DAUNORUBICIN. Patient was hospitalized. Patient died on 07/05/2007.

Gemtuzumab Side Effects Report #5624729-2
GEMTUZUMAB problem was reported by a Physician from FRANCE on Feb 05, 2008. Male patient, 72 years of age, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hepatitis acute, peritoneal effusion, pleural effusion. GEMTUZUMAB dosage: 6 MG/M2. During the same period patient was treated with ARACYTINE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5625866-9
Physician from UNITED KINGDOM reported GEMTUZUMAB problem on Feb 08, 2008. Male patient was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: fungal infection, neutropenia, pneumonia. GEMTUZUMAB dosage: 3 MG/M^2 EVERY 1 TOT. During the same period patient was treated with DAUNORUBICIN. Patient was hospitalized. Patient died on 07/05/2007.

Gemtuzumab Side Effects Report #5633348-3
GEMTUZUMAB problem was reported by a Physician from FRANCE on Feb 15, 2008. Male patient, weighting 134.5 lb, was diagnosed with acute myeloid leukaemia, bone pain, leukaemia recurrent and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: cholestasis, pancreatitis acute. GEMTUZUMAB dosage: 5.3 MG TOTAL DAILY. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, GEMTUZUMAB OZOGAMICIN, ARACYTINE, FORTUM, CIFLOX, RASBURICASE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5639284-0
Physician from FRANCE reported GEMTUZUMAB problem on Feb 21, 2008. Male patient, 72 years of age, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hepatitis acute, pleural effusion. GEMTUZUMAB dosage: 6 MG/M2. During the same period patient was treated with ARACYTINE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5643261-3
GEMTUZUMAB problem was reported by a Physician from GERMANY on Feb 25, 2008. Male patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: pneumonia, pulmonary haemorrhage, sepsis. GEMTUZUMAB dosage: 12 MG. During the same period patient was treated with DECORTIN. Patient died on 04/22/2007.

Gemtuzumab Side Effects Report #5643472-7
Physician from UNITED KINGDOM reported GEMTUZUMAB problem on Feb 25, 2008. Male patient was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: fungal infection, neutropenia, pneumonia. GEMTUZUMAB dosage: 3 MG/M^2 EVERY 1 TOT. During the same period patient was treated with DAUNORUBICIN. Patient was hospitalized. Patient died on 07/05/2007.

Gemtuzumab Side Effects Report #5644254-2
GEMTUZUMAB problem was reported by a Physician from GERMANY on Feb 25, 2008. Female patient, weighting 146.6 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, subdural haematoma. GEMTUZUMAB dosage: 10.98 MG FOR A TOTAL DOSE OF 21.960. Patient was hospitalized. Patient died on 09/04/2006.

Gemtuzumab Side Effects Report #5591881-7
Physician from ITALY reported GEMTUZUMAB problem on Jan 04, 2008. Male patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, multi-organ failure, septic shock, staphylococcal infection. GEMTUZUMAB dosage: unknown. Patient died on 06/24/2007.

Gemtuzumab Side Effects Report #5592208-7
GEMTUZUMAB problem was reported by a Physician from ITALY on Jan 07, 2008. Male patient, weighting 147.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiac arrest. GEMTUZUMAB dosage: ACTUAL DOSE GIVEN .051 MG (CUMULATIVE DOSE GIVEN 15.500 MG). During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, MITOXANTRONE, TAZOCIN, ETOPOSIDE, CYTARABINE, IDARUBICIN. Patient was hospitalized. Patient died on 05/30/2007.

Gemtuzumab Side Effects Report #5595061-0
Physician from FRANCE reported GEMTUZUMAB problem on Jan 10, 2008. Male patient, weighting 180.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, lung infection pseudomonal, pyrexia, tuberculosis. GEMTUZUMAB dosage: SINGLE DOSE: 12.0 MG; CUMULATIVE DOSE: 24 MG. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5597064-9
GEMTUZUMAB problem was reported by a Physician from CANADA on Jan 11, 2008. Male patient, 47 years of age, weighting 196.7 lb, was diagnosed with acute myeloid leukaemia, pyrexia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: guillain-barre syndrome, rash maculo-papular, rash pruritic. GEMTUZUMAB dosage: 12 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with DAUNORUBICIN, TAZOCIN, CEFTAZIDIME, FLUCONAZOLE, VANCOMYCIN, CYTARABINE, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5598874-4
Physician from CANADA reported GEMTUZUMAB problem on Jan 15, 2008. Female patient, 58 years of age, weighting 198.4 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome. GEMTUZUMAB dosage: 12 MG. During the same period patient was treated with CYTARABINE, DAUNORUBICIN. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5608972-4
GEMTUZUMAB problem was reported by a Physician from FRANCE on Jan 25, 2008. Male patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity, multi-organ failure, oliguria, renal failure acute, venoocclusive liver disease. GEMTUZUMAB dosage: 4.8 MG EVERY 1 CYC. During the same period patient was treated with ETOPOSIDE, VANCOMYCIN, AMIKLIN, FORTUM, ARACYTINE, IDARUBICIN. Patient died on 01/25/2005.

Gemtuzumab Side Effects Report #5608973-6
Physician from FRANCE reported GEMTUZUMAB problem on Jan 25, 2008. Male patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity, multi-organ failure, oliguria, renal failure acute, venoocclusive liver disease. GEMTUZUMAB dosage: 4.8 MG EVERY 1 CYC. During the same period patient was treated with ETOPOSIDE, VANCOMYCIN, AMIKLIN, FORTUM, ARACYTINE, IDARUBICIN. Patient died on 01/25/2005.

Gemtuzumab Side Effects Report #5533310-5
GEMTUZUMAB problem was reported by a Physician from ITALY on Nov 22, 2007. Female patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: aplasia, sepsis. GEMTUZUMAB dosage: unknown. During the same period patient was treated with LEVOFLOXACIN, NEUPOGEN, IDARUBICIN, ETOPOSIDE, CYTARABINE, TRANEXAMIC ACID, HYDROCORTISON. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5535219-X
Physician from ITALY reported GEMTUZUMAB problem on Nov 26, 2007. Female patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, septic shock. GEMTUZUMAB dosage: unknown. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, METHYLPREDNISOLONE, MEROPENEM. Patient died on 08/21/2007.

Gemtuzumab Side Effects Report #5537604-9
GEMTUZUMAB problem was reported by a Physician from CANADA on Nov 28, 2007. Male patient, 47 years of age, weighting 196.7 lb, was diagnosed with acute myeloid leukaemia, pyrexia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: rash maculo-papular, rash pruritic. GEMTUZUMAB dosage: 12 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with DAUNORUBICIN, TAZOCIN, CEFTAZIDIME, FLUCONAZOLE, VANCOMYCIN, CYTARABINE, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5557936-8
Physician from ITALY reported GEMTUZUMAB problem on Dec 11, 2007. Female patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: aplasia, sepsis. GEMTUZUMAB dosage: unknown. During the same period patient was treated with LEVOFLOXACIN, FILGRASTIM, IDARUBICIN, ETOPOSIDE, CYTARABINE, TRANEXAMIC ACID. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5573367-9
GEMTUZUMAB problem was reported by a Physician from ITALY on Dec 21, 2007. Male patient, weighting 167.6 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hepatic failure, multi-organ failure. GEMTUZUMAB dosage: 10 MG (CUMULATIVE DOSE 10 MG). During the same period patient was treated with ACYCLOVIR, CYTARABINE, ITRACONAZOLE, MITOXANTRONE, ETOPOSIDE. Patient died on 11/15/2006.

Gemtuzumab Side Effects Report #5573516-2
Physician from FRANCE reported GEMTUZUMAB problem on Dec 20, 2007. Male patient, weighting 134.5 lb, was diagnosed with acute myeloid leukaemia, bone pain, leukaemia recurrent and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: cholestasis, pancreatitis acute. GEMTUZUMAB dosage: 5.3 MG TOTAL DAILY. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, GEMTUZUMAB OZOGAMICIN, ARACYTINE, FORTUM, CIFLOX, RASBURICASE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5573686-6
GEMTUZUMAB problem was reported by a Physician from ITALY on Dec 21, 2007. Male patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, septic shock. GEMTUZUMAB dosage: unknown. Patient died on 06/25/2007.

Gemtuzumab Side Effects Report #5573768-9
Physician from BELGIUM reported GEMTUZUMAB problem on Dec 20, 2007. Male patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: escherichia sepsis, haematemesis, stenotrophomonas sepsis, thrombocytopenia. GEMTUZUMAB dosage: 5.75 MG (CUMULATIVE DOSE 7.25 MG) FREQUENCY NOT SPECIFIED. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, GEMTUZUMAB OZOGAMICIN, PROLOPA. Patient died on 10/26/2007.

Gemtuzumab Side Effects Report #5506674-6
GEMTUZUMAB problem was reported by a Health Professional from CANADA on Oct 25, 2007. Male patient, weighting 27.56 lb, was diagnosed with blast crisis in myelogenous leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: chills, infusion related reaction, pyrexia, tachycardia. GEMTUZUMAB dosage: unknown. During the same period patient was treated with PETHIDINE HYDROCHLORIDE, HYDROCORTISONE, ACETAMINOPHEN, DIPHENHYDRAMINE. Patient recovered.

Gemtuzumab Side Effects Report #5509777-5
Physician from BELGIUM reported GEMTUZUMAB problem on Nov 06, 2007. Male patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, sepsis. GEMTUZUMAB dosage: 5.75 MG (CUMULATIVE DOSE 7.25 MG) FREQUENCY NOT SPECIFIED. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, PROLOPA. Patient died.

Gemtuzumab Side Effects Report #5519868-0
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Nov 14, 2007. Female patient, weighting 125.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, capillary leak syndrome, cardiac failure, neutropenia. GEMTUZUMAB dosage: unknown. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, TARGOCID, TOBRACIN, DIFLUCAN. Patient died on 03/22/2006.

Gemtuzumab Side Effects Report #5520558-9
Physician from BELGIUM reported GEMTUZUMAB problem on Nov 14, 2007. Female patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: aspergillosis, neutropenia, pneumonia, sepsis, thrombocytopenia. GEMTUZUMAB dosage: DAILY DOSE 5 MG;CUMULATIVE DOSE 15 MG. Patient was hospitalized. Patient died on 11/08/2006.

Gemtuzumab Side Effects Report #5520559-0
GEMTUZUMAB problem was reported by a Physician from ITALY on Nov 14, 2007. Male patient, weighting 136.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: colitis ischaemic, disease progression, intestinal haemorrhage, pneumonia, respiratory distress. GEMTUZUMAB dosage: ACTUAL DOSE 5 MG; CUMMULATIVE DOSE 15 MG. During the same period patient was treated with MEROPENEM, LEVOFLOXACIN, VORICONAZOLE, GLAZIDIM, TRIDECANAMINE. Patient died on 12/05/2006.

Gemtuzumab Side Effects Report #5523082-2
Physician from BELGIUM reported GEMTUZUMAB problem on Nov 20, 2007. Male patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, sepsis. GEMTUZUMAB dosage: 5.75 MG (CUMULATIVE DOSE 7.25 MG) FREQUENCY NOT SPECIFIED. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, GEMTUZUMAB OZOGAMICIN, PROLOPA. Patient died.

Gemtuzumab Side Effects Report #5523658-2
GEMTUZUMAB problem was reported by a Health Professional from CANADA on Nov 14, 2007. Male patient, weighting 27.56 lb, was diagnosed with blast crisis in myelogenous leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: chills, infusion related reaction, pyrexia, tachycardia. GEMTUZUMAB dosage: unknown. During the same period patient was treated with PETHIDINE HYDROCHLORIDE, HYDROCORTISONE, PARACETAMOL, DIPHENHYDRAMINE. Patient recovered.

Gemtuzumab Side Effects Report #5523824-6
Physician from FRANCE reported GEMTUZUMAB problem on Nov 20, 2007. Male patient, weighting 180.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, lung infection pseudomonal, pyrexia, tuberculosis. GEMTUZUMAB dosage: SINGLE DOSE: 12.0 MG; CUMULATIVE DOSE: 24 MG. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5526700-8
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Nov 20, 2007. Male patient, weighting 147.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: escherichia sepsis, folliculitis, vasculitis. GEMTUZUMAB dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYTOSAR, MITOXANTRONE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5485827-X
Physician from NETHERLANDS reported GEMTUZUMAB problem on Oct 12, 2007. Male patient, weighting 174.2 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: respiratory failure. GEMTUZUMAB dosage: unknown. Patient was hospitalized. Patient died on 01/01/2007.

Gemtuzumab Side Effects Report #5488607-4
GEMTUZUMAB problem was reported by a Physician from UNITED KINGDOM on Oct 16, 2007. Male patient, weighting 191.6 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood bilirubin increased, c-reactive protein increased, gamma-glutamyltransferase increased, venoocclusive liver disease. GEMTUZUMAB dosage: 5 MG EVERY 1 TOT. During the same period patient was treated with ETOPOSIDE, CYTARABINE, ATORVASTATIN CALCIUM, CIPROFLOXACIN, METRONIDAZOLE, GENTAMICIN. Patient recovered.

Gemtuzumab Side Effects Report #5495090-1
Physician from ITALY reported GEMTUZUMAB problem on Oct 22, 2007. Male patient, weighting 167.6 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hepatic failure. GEMTUZUMAB dosage: 10 MG (CUMULATIVE DOSE 10 MG). During the same period patient was treated with ACYCLOVIR, CYTARABINE, ITRACONAZOLE, MITOXANTRONE, ETOPOSIDE. Patient died on 11/15/2006.

Gemtuzumab Side Effects Report #5445027-6
GEMTUZUMAB problem was reported by a Physician from ITALY on Sept 03, 2007. Female patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, septic shock. GEMTUZUMAB dosage: unknown. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient died on 08/21/2007.

Gemtuzumab Side Effects Report #5462478-4
Physician from ITALY reported GEMTUZUMAB problem on Sept 17, 2007. Female patient was diagnosed with acute myeloid leukaemia, hypertension, prophylaxis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: fungal infection. GEMTUZUMAB dosage: 5.6 MG CUMULATIVE DOSE GIVEN. During the same period patient was treated with CYTARABINE, CIPROFLOXACIN, LENOGRASTIM, IRBESARTAN, ALLOPURINOL, ETOPOSIDE, DAUNORUBICIN. Patient was hospitalized. Patient died on 07/24/2007.

Gemtuzumab Side Effects Report #5464339-3
GEMTUZUMAB problem was reported by a Physician from ITALY on Sept 20, 2007. Male patient, weighting 158.7 lb, was diagnosed with acute myeloid leukaemia, hypertension, prophylaxis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: fungal infection. GEMTUZUMAB dosage: 5.6 MG CUMULATIVE DOSE GIVEN. During the same period patient was treated with CYTARABINE, CIPROFLOXACIN, LENOGRASTIM, IRBESARTAN, ALLOPURINOL, ETOPOSIDE, DAUNORUBICIN. Patient was hospitalized. Patient died on 07/24/2007.

Gemtuzumab Side Effects Report #5465305-4
Physician from CANADA reported GEMTUZUMAB problem on Sept 19, 2007. Male patient, 46 years of age, weighting 203.9 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: pericardial effusion. GEMTUZUMAB dosage: 12.9 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with DAUNORUBICIN, CYTARABINE. Patient recovered.

Gemtuzumab Side Effects Report #5409292-3
GEMTUZUMAB problem was reported by a Physician from ITALY on Aug 03, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia, infection and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: septic shock. GEMTUZUMAB dosage: ACTUAL DOSE GIVEN 10 MG; CUMULATIVE DOSE GIVEN 20 MG. During the same period patient was treated with ETOPOSIDE, CYTARABINE, CANCIDAS, TAZOCIN, ZYVOX, LEVOFLOXACIN, AMBISOME, MITOXANTRONE. Patient died on 07/01/2007.

Gemtuzumab Side Effects Report #5429701-3
Physician from BELGIUM reported GEMTUZUMAB problem on Aug 22, 2007. Male patient, 72 years of age, weighting 163.1 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, fluid retention, hyperbilirubinaemia, pancytopenia, shock haemorrhagic, venoocclusive disease. GEMTUZUMAB dosage: 11.6 MG. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient was hospitalized. Patient died on 03/21/2005.

Gemtuzumab Side Effects Report #5434258-7
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Aug 28, 2007. Male patient, 72 years of age, weighting 163.1 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, fluid retention, hyperbilirubinaemia, pancytopenia, shock haemorrhagic, venoocclusive liver disease. GEMTUZUMAB dosage: 11.6 MG. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient was hospitalized. Patient died on 03/21/2005.

Gemtuzumab Side Effects Report #5376734-1
Physician from GERMANY reported GEMTUZUMAB problem on June 22, 2007. Male patient, weighting 165.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. GEMTUZUMAB dosage: TOTAL DOSE RECEIVED DURING FIRST CYCLE 11.0 MG. During the same period patient was treated with ETOPOSIDE, CYTARABINE, MITOXANTRONE. Patient died on 06/27/2005.

Gemtuzumab Side Effects Report #5379193-8
GEMTUZUMAB problem was reported by a Physician from GERMANY on June 25, 2007. Male patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: lung infiltration, pulmonary haemorrhage, sepsis. GEMTUZUMAB dosage: 12 MG. During the same period patient was treated with DECORTIN. Patient died on 04/22/2007.

Gemtuzumab Side Effects Report #5380944-7
Physician from ITALY reported GEMTUZUMAB problem on July 04, 2007. Male patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, multi-organ failure, septic shock. GEMTUZUMAB dosage: unknown. Patient died on 06/25/2007.

Gemtuzumab Side Effects Report #5383162-1
GEMTUZUMAB problem was reported by a Physician from ITALY on July 09, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: septic shock. GEMTUZUMAB dosage: ACTUAL DOSE GIVEN 10 MG; CUMULATIVE DOSE GIVEN 20 MG. During the same period patient was treated with ETOPOSIDE, PREDNISOLONE, DOPAMINE, MORPHINE, MITOXANTRONE, CYTARABINE. Patient died on 07/01/2007.

Gemtuzumab Side Effects Report #5376734-1
Physician from GERMANY reported GEMTUZUMAB problem on June 22, 2007. Male patient, weighting 165.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. GEMTUZUMAB dosage: TOTAL DOSE RECEIVED DURING FIRST CYCLE 11.0 MG. During the same period patient was treated with ETOPOSIDE, CYTARABINE, MITOXANTRONE. Patient died on 06/27/2005.

Gemtuzumab Side Effects Report #5379193-8
GEMTUZUMAB problem was reported by a Physician from GERMANY on June 25, 2007. Male patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: lung infiltration, pulmonary haemorrhage, sepsis. GEMTUZUMAB dosage: 12 MG. During the same period patient was treated with DECORTIN. Patient died on 04/22/2007.

Gemtuzumab Side Effects Report #5380944-7
Physician from ITALY reported GEMTUZUMAB problem on July 04, 2007. Male patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, multi-organ failure, septic shock. GEMTUZUMAB dosage: unknown. Patient died on 06/25/2007.

Gemtuzumab Side Effects Report #5383162-1
GEMTUZUMAB problem was reported by a Physician from ITALY on July 09, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: septic shock. GEMTUZUMAB dosage: ACTUAL DOSE GIVEN 10 MG; CUMULATIVE DOSE GIVEN 20 MG. During the same period patient was treated with ETOPOSIDE, PREDNISOLONE, DOPAMINE, MORPHINE, MITOXANTRONE, CYTARABINE. Patient died on 07/01/2007.

Gemtuzumab Side Effects Report #5763706-8
Physician from FRANCE reported GEMTUZUMAB problem on June 05, 2008. Female patient, weighting 160.9 lb, was diagnosed with acute myeloid leukaemia, staphylococcal sepsis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, liver disorder. GEMTUZUMAB dosage: 5 MG (3 MG/M^2) TOTAL DAILY. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, GEMTUZUMAB OZOGAMICIN, QUINAPRIL AND HYDROCHLOROTHIAZIDE, EQUANIL, NEXIUM, TAZOCILLINE, TIORFAN, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5766780-8
GEMTUZUMAB problem was reported by a Physician from FRANCE on June 05, 2008. Female patient, weighting 160.9 lb, was diagnosed with acute myeloid leukaemia, staphylococcal sepsis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, liver disorder. GEMTUZUMAB dosage: 5 MG (3 MG/M^2) TOTAL DAILY. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, GEMTUZUMAB OZOGAMICIN, QUINAPRIL AND HYDROCHLOROTHIAZIDE, EQUANIL, NEXIUM, TAZOCILLINE, TIORFAN, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5767930-X
Physician from NETHERLANDS reported GEMTUZUMAB problem on June 04, 2008. Male patient, weighting 169.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: caecitis, gastrointestinal haemorrhage, renal failure, respiratory failure. GEMTUZUMAB dosage: 5.7 MG-FREQUENCY NOT PROVIDED (CUMULATIVE DOSE GIVEN 29.3MG). During the same period patient was treated with CEFTAZIDIME, ETOPOSIDE, CYTARABINE, IDARUBICIN. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5717315-7
GEMTUZUMAB problem was reported by a Health Professional from UNITED STATES on Apr 24, 2008. Male patient, 32 years of age, weighting 145.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: back pain, heart rate increased, pain in extremity, pyrexia, respiratory rate increased. GEMTUZUMAB dosage: 5.25 MG ONCE ON DAY 1,4,7 IV DRIP. During the same period patient was treated with CLOFARABINE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5353990-7
Physician from ITALY reported GEMTUZUMAB problem on June 07, 2007. Male patient, weighting 147.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiac arrest, enteritis, febrile neutropenia. GEMTUZUMAB dosage: ACTUAL DOSE GIVEN .051 MG (CUMULATIVE DOSE GIVEN 15.500 MG). During the same period patient was treated with TAZOCIN, AMIODARONE, VFEND, IDARUBICIN. Patient was hospitalized. Patient died on 05/30/2007.

Gemtuzumab Side Effects Report #5354356-6
GEMTUZUMAB problem was reported by a Physician from ITALY on June 01, 2007. Female patient, weighting 202.8 lb, was diagnosed with acute myeloid leukaemia, vomiting and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: blood culture positive, circulatory collapse, diarrhoea, pyrexia, septic shock, vomiting. GEMTUZUMAB dosage: unknown. During the same period patient was treated with CYTARABINE, ONDANSETRON, ACYCLOVIR, SERTRALINE, IDARUBICIN, ETOPOSIDE. Patient was hospitalized. Patient died on 03/29/2007.

Gemtuzumab Side Effects Report #5363276-2
Physician from ITALY reported GEMTUZUMAB problem on June 11, 2007. Male patient, weighting 136.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: colitis ischaemic, disease progression, intestinal haemorrhage, pneumonia. GEMTUZUMAB dosage: ACTUAL DOSE 5 MG; CUMMULATIVE DOSE 15 MG. During the same period patient was treated with MEROPENEM, LEVOFLOXACIN, VORICONAZOLE, GLAZIDIM, TRIDECANAMINE. Patient died on 12/05/2006.

Gemtuzumab Side Effects Report #5366964-7
GEMTUZUMAB problem was reported by a Physician from ITALY on June 19, 2007. Male patient, weighting 147.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiac arrest, enteritis, febrile neutropenia. GEMTUZUMAB dosage: ACTUAL DOSE GIVEN .051 MG (CUMULATIVE DOSE GIVEN 15.500 MG). During the same period patient was treated with IDARUBICIN, TAZOCIN, CYTARABINE. Patient was hospitalized. Patient died on 05/30/2007.

Gemtuzumab Side Effects Report #5372242-2
Physician from ITALY reported GEMTUZUMAB problem on June 21, 2007. Female patient, weighting 105.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, cyanosis, multi-organ failure, sepsis, shock. GEMTUZUMAB dosage: CUMULATIVE DOSE GIVEN 19.50 MG (3.00 MG GIVEN AT LAST DOSE). During the same period patient was treated with IDARUBICIN. Patient was hospitalized. Patient died on 05/16/2007.

Gemtuzumab Side Effects Report #5374754-4
GEMTUZUMAB problem was reported by a Physician from NETHERLANDS on June 28, 2007. Male patient was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: lung infection, respiratory failure. GEMTUZUMAB dosage: unknown. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5338594-4
Physician from ITALY reported GEMTUZUMAB problem on May 25, 2007. Female patient, weighting 105.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: aplasia, sepsis. GEMTUZUMAB dosage: CUMULATIVE DOSE GIVEN 19.50 MG (3.00 MG GIVEN AT LAST DOSE). During the same period patient was treated with IDARUBICIN. Patient was hospitalized. Patient died on 05/16/2007.

Gemtuzumab Side Effects Report #5288624-3
GEMTUZUMAB problem was reported by a Physician from ITALY on Mar 30, 2007. Male patient, weighting 136.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: colitis ischaemic, disease progression, infection, respiratory distress. GEMTUZUMAB dosage: unknown. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, MEROPENEM, LEVOFLOXACIN, VORICONAZOLE, GLAZIDIM, TRIDECANAMINE. Patient died on 12/05/2006.

Gemtuzumab Side Effects Report #5291103-0
Physician from BELGIUM reported GEMTUZUMAB problem on Apr 04, 2007. Male patient, weighting 163.1 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, fluid retention, hyperbilirubinaemia, pancytopenia, shock haemorrhagic. GEMTUZUMAB dosage: 11.6 MG. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient was hospitalized. Patient died on 03/21/2005.

Gemtuzumab Side Effects Report #5292219-5
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Apr 04, 2007. Male patient, weighting 163.1 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, fluid retention, hyperbilirubinaemia, pancytopenia, shock haemorrhagic. GEMTUZUMAB dosage: 11.6 MG. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient was hospitalized. Patient died on 03/21/2005.

Gemtuzumab Side Effects Report #5293573-0
Physician from FRANCE reported GEMTUZUMAB problem on Apr 06, 2007. Male patient, 49 years of age, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: disease progression, multi-organ failure, venoocclusive liver disease. GEMTUZUMAB dosage: unknown. During the same period patient was treated with ACYCLOVIR, VANCOMYCIN, FLUDARABINE PHOSPHATE, IDARUBICIN, INIPOMP, CONTRAMAL, CIPROFLOXACIN, ZOPHREN. Patient died on 03/03/2007.

Gemtuzumab Side Effects Report #5294845-6
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Apr 10, 2007. Female patient, weighting 125.7 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, capillary leak syndrome, cardiac failure, neutropenia. GEMTUZUMAB dosage: unknown. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, TARGOCID, TOBRACIN, DIFLUCAN. Patient died on 03/22/2006.

Gemtuzumab Side Effects Report #5297246-X
Physician from BELGIUM reported GEMTUZUMAB problem on Apr 10, 2007. Female patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: aspergillosis, neutropenia, pneumonia, sepsis, thrombocytopenia. GEMTUZUMAB dosage: DAILY DOSE 5 MG;CUMULATIVE DOSE 15 MG. Patient was hospitalized. Patient died on 11/08/2006.

Gemtuzumab Side Effects Report #5297997-7
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Apr 11, 2007. Male patient, 62 years of age, weighting 154.3 lb, was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, encephalopathy, hepatotoxicity, pyrexia, rectal haemorrhage. GEMTUZUMAB dosage: unknown. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5298828-1
Physician from ITALY reported GEMTUZUMAB problem on Apr 05, 2007. Female patient, weighting 202.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: blood culture positive, circulatory collapse, diarrhoea, pyrexia, shock, vomiting. GEMTUZUMAB dosage: unknown. During the same period patient was treated with CYTARABINE, ONDANSETRON, ACYCLOVIR, SERTRALINE, IDARUBICIN, ETOPOSIDE. Patient was hospitalized. Patient died on 03/29/2007.

Gemtuzumab Side Effects Report #5300516-X
GEMTUZUMAB problem was reported by a Health Professional from UNITED STATES on Apr 13, 2007. Male patient, weighting 181.9 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity. GEMTUZUMAB dosage: 9 MG/M2/DAY -18.27 X1 IV DRIP. Patient recovered.

Gemtuzumab Side Effects Report #5300878-3
Physician from FRANCE reported GEMTUZUMAB problem on Apr 17, 2007. Male patient, weighting 152.1 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: infusion site haemorrhage, thrombocytopenia. GEMTUZUMAB dosage: SINGLE DOSE: 5.5 MG; CUMULATIVE DOSE: 28.5 MG. During the same period patient was treated with ZOPHREN, IDARUBICIN, ARACYTIN, ETOPOSIDE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5303395-X
GEMTUZUMAB problem was reported by a Physician from GERMANY on Apr 16, 2007. Male patient, weighting 146.6 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, subdural haematoma. GEMTUZUMAB dosage: 10.98 MG FOR A TOTAL DOSE OF 21.960. Patient was hospitalized. Patient died on 09/04/2006.

Gemtuzumab Side Effects Report #5305824-4
Physician from GERMANY reported GEMTUZUMAB problem on Apr 17, 2007. Male patient, weighting 165.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. GEMTUZUMAB dosage: TOTAL DOSE RECEIVED DURING FIRST CYCLE 11.0 MG. During the same period patient was treated with ETOPOSIDE, CYTARABINE, MITOXANTRONE. Patient died on 06/27/2005.

Gemtuzumab Side Effects Report #5258283-4
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Mar 02, 2007. Female patient, 44 years of age, weighting 102.5 lb, was diagnosed with antifungal prophylaxis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, coma, lymphocyte percentage increased, neutrophil percentage decreased, platelet count decreased, white blood cell count decreased. GEMTUZUMAB dosage: unknown. During the same period patient was treated with TPN ELECTROLYTES IN PLASTIC CONTAINER, DIFLUCAN, LARGACTIL, IDARUBICIN, CYTARABINE. Patient died on 04/16/2006.

Gemtuzumab Side Effects Report #5259180-0
Physician from FRANCE reported GEMTUZUMAB problem on Mar 05, 2007. Male patient, weighting 152.1 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: infusion site haemorrhage, thrombocytopenia. GEMTUZUMAB dosage: SINGLE DOSE: 5.5 MG; CUMULATIVE DOSE: 28.5 MG. During the same period patient was treated with ZOFRAN, IDARUBICIN, ARACYTIN, ETOPOSIDE. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5259681-5
GEMTUZUMAB problem was reported by a Physician from FRANCE on Mar 05, 2007. Male patient, weighting 180.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, lung infection pseudomonal, tuberculosis. GEMTUZUMAB dosage: SINGLE DOSE: 12.0 MG; CUMULATIVE DOSE: 24 MG. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5270170-4
Physician from ITALY reported GEMTUZUMAB problem on Mar 15, 2007. Female patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: hypotension, septic shock. GEMTUZUMAB dosage: unknown. During the same period patient was treated with AMIKACIN, TEICOPLANIN, MEROPENEM. Patient died on 01/25/2006.

Gemtuzumab Side Effects Report #5270231-X
GEMTUZUMAB problem was reported by a Physician from GERMANY on Mar 15, 2007. Male patient, weighting 183.0 lb, was diagnosed with hypertension and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, sepsis. GEMTUZUMAB dosage: 12.18 MG. During the same period patient was treated with ETOPOSIDE, RAMIPRIL, NOVANTRONE. Patient was hospitalized. Patient died on 12/12/2005.

Gemtuzumab Side Effects Report #5270232-1
Physician from PORTUGAL reported GEMTUZUMAB problem on Mar 15, 2007. Female patient, weighting 178.6 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypersensitivity, hypotension, hypoxia, somnolence. GEMTUZUMAB dosage: unknown. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, FLUCONAZOLE, ACYCLOVIR. Patient recovered.

Gemtuzumab Side Effects Report #5270233-3
GEMTUZUMAB problem was reported by a Physician from NETHERLANDS on Mar 15, 2007. Female patient, weighting 149.9 lb, was diagnosed with myelodysplastic syndrome and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: infection, multi-organ failure, respiratory failure. GEMTUZUMAB dosage: 5MG/M2 FOR ONE DAY ON DAY 7. During the same period patient was treated with COMOX, COLISTIN, IDARUBICIN, CYTARABINE. Patient died on 01/02/2006.

Gemtuzumab Side Effects Report #5270235-7
Physician from BELGIUM reported GEMTUZUMAB problem on Mar 15, 2007. Male patient, weighting 147.7 lb, was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease. GEMTUZUMAB dosage: unknown. During the same period patient was treated with IDARUBICIN. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5270239-4
GEMTUZUMAB problem was reported by a Physician from BELGIUM on Mar 15, 2007. Male patient, weighting 152.1 lb, was diagnosed with acute myeloid leukaemia, pyrexia, weight increased and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: emphysema. GEMTUZUMAB dosage: A SINGLE 11 MG DOSE. During the same period patient was treated with FLUCONAZOLE, ZOVIRAX, CONTRAMAL, EUSAPRIMTE, PERFALGAN, NYSTATIN, TARGOCID, LASIX. Patient died on 09/11/2005.

Gemtuzumab Side Effects Report #5276095-2
Physician from NETHERLANDS reported GEMTUZUMAB problem on Mar 15, 2007. Female patient, weighting 149.9 lb, was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, candidiasis, fluid retention, hepatic function abnormal, lung infiltration. GEMTUZUMAB dosage: 5.2 MG. During the same period patient was treated with COLISTIN, IDARUBICIN, CYTARABINE, ETOPOSIDE. Patient died on 01/16/2004.

Gemtuzumab Side Effects Report #5276104-0
GEMTUZUMAB problem was reported by a Physician from ITALY on Mar 15, 2007. Female patient, weighting 154.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: lung infection, respiratory failure. GEMTUZUMAB dosage: 10 MG. During the same period patient was treated with LEVOFLOXACIN, CYTARABINE, MITOXANTRONE, ETOPOSIDE. Patient died on 02/02/2005.

Gemtuzumab Side Effects Report #5277131-X
Physician from BELGIUM reported GEMTUZUMAB problem on Mar 15, 2007. Male patient, weighting 186.3 lb, was diagnosed with acute myeloid leukaemia and was treated with GEMTUZUMAB. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, condition aggravated, disseminated intravascular coagulation, hepatocellular damage, multi-organ failure. GEMTUZUMAB dosage: unknown. During the same period patient was treated with MERONEM, TARGOCID. Patient died on 03/23/2004.


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