Gemtuzumab and thrombocytopenia Patient Reports February 13, 2012

Gemtuzumab Side Effects Report #6119964-3
Gemtuzumab side effect was reported by a Physician from JAPAN on Mar 10, 2009. Male patient, 75 years of age, was diagnosed with myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: neutropenia, pneumonia , thrombocytopenia. Gemtuzumab dosage: 9 MG/M^2 ON DAY 1 AND 15. Patient died.

Gemtuzumab Side Effects Report #6119965-5
Gemtuzumab side effect was reported by a Physician from JAPAN on Mar 10, 2009. Female patient, 61 years of age, was diagnosed with myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: condition aggravated, neutropenia, pneumonia , thrombocytopenia. Gemtuzumab dosage: 9 MG/M^2 ON DAY 1 AND 15. Patient died.

Gemtuzumab Side Effects Report #5086084-9
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Aug 08, 2006. Male patient, 66 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cholestasis, coagulopathy, cytolytic hepatitis, loss of consciousness, multi-organ failure, thrombocytopenia, venoocclusive liver disease. Gemtuzumab dosage: 9 MG/M^2 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, AZACTAM, AMIKIN, OMEPRAZOLE, FLUCONAZOLE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #5087233-9
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Aug 08, 2006. Male patient, 66 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: ascites, cholestasis, coagulation factor v level increased, cytolytic hepatitis, loss of consciousness, multi-organ failure, prothrombin time prolonged, thrombocytopenia, venoocclusive liver disease. Gemtuzumab dosage: 9 MG/M^2 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, AZACTAM, AMIKIN, OMEPRAZOLE, FLUCONAZOLE. Patient was hospitalized. Patient died.


Gemtuzumab Side Effects Report #5087261-3
Gemtuzumab side effect was reported by a Health Professional from FRANCE on Aug 08, 2006. Male patient, 65 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: abdominal pain upper, ascites, cholestasis, cytolytic hepatitis, loss of consciousness, multi-organ failure, thrombocytopenia, venoocclusive liver disease, weight increased. Gemtuzumab dosage: 9 MG/M^2 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, AZACTAM, AMIKIN, OMEPRAZOLE, FLUCONAZOLE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #4927935-5
Gemtuzumab side effect was reported by a Consumer or non-health professional from DENMARK on Feb 10, 2006. Male patient was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: blood creatine phosphokinase increased, blood lactate dehydrogenase increased, haemoglobin decreased, haemolysis, infection , neutrophil count increased, thrombocytopenia. Gemtuzumab dosage: 3.8 MG 1X PER 1 DASY, INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient recovered.

Gemtuzumab Side Effects Report #4867013-7
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Mar 10, 2002. Male patient, 79 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: anaemia, leukopenia, pyrexia, thrombocytopenia. Gemtuzumab dosage: 9 MG/M (2) OR 15.48 MG SINGLE DOSE INTRAVENOUS. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5134221-X
Gemtuzumab side effect was reported by a Consumer or non-health professional from ITALY on Oct 10, 2006. Female patient, 72 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: aplasia, neutropenia, oliguria, pneumonitis, septic shock, syncope, thrombocytopenia. Gemtuzumab dosage: 9.5 MG. During the same period patient was treated with FUROSEMIDE, MEROPENEM, AMIKACIN, TEICOPLANIN. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5192195-X
Gemtuzumab side effect was reported by a Consumer or non-health professional from ITALY on Dec 18, 2006. Female patient, 72 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: condition aggravated, neutropenia, pneumonitis, septic shock, thrombocytopenia. Gemtuzumab dosage: 9.5 MG,. During the same period patient was treated with FUROSEMIDE, MEROPENEM, AMIKACIN, TEICOPLANIN. Patient was hospitalized. Patient recovered.


Gemtuzumab Side Effects Report #5170553-7
Gemtuzumab side effect was reported by a Consumer or non-health professional from NETHERLANDS on Nov 29, 2006. Female patient, 69 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: aspergillosis, cellulitis streptococcal, cerebral haemorrhage, herpes virus infection, pneumonia herpes viral, pneumonitis, streptococcal bacteraemia, thrombocytopenia. Gemtuzumab dosage: unknown. During the same period patient was treated with MITOXANTRONE, CYTARABINE, ETOPOSIDE, VORICONAZOLE, ACYCLOVIR, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #4867030-7
Gemtuzumab side effect was reported by a Health Professional from GERMANY on Mar 10, 2002. Male patient, 58 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, aplasia, arrhythmia , epistaxis, malignant neoplasm progression, melaena, thrombocytopenia. Gemtuzumab dosage: 9 MG/M^2 1X PER 1 DOS INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient died.

Gemtuzumab Side Effects Report #4867059-9
Gemtuzumab side effect was reported by a Consumer or non-health professional from ITALY on Sept 14, 2000. Female patient, 57 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: anaemia, thrombocytopenia. Gemtuzumab dosage: 9 MG/M^2. Patient died.

Gemtuzumab Side Effects Report #4867058-7
Gemtuzumab side effect was reported by a Consumer or non-health professional from GERMANY on Mar 05, 1999. Male patient, 56 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: leukopenia, thrombocytopenia. Gemtuzumab dosage: 9 MG/M^2. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #4867007-1
Gemtuzumab side effect was reported by a Consumer or non-health professional from NETHERLANDS on July 06, 1999. Male patient, 53 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: thrombocytopenia. Gemtuzumab dosage: 9 MG/M^2. Patient was hospitalized. Patient died.


Gemtuzumab Side Effects Report #4867129-5
Gemtuzumab side effect was reported by a Health Professional from FRANCE on Mar 10, 2002. Female patient, 46 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, disease progression, haemorrhage, menometrorrhagia, neutropenia, thrombocytopenia. Gemtuzumab dosage: 9 MG/M (2) INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #4867711-5
Gemtuzumab side effect was reported by a Consumer or non-health professional from UNITED STATES on Sept 28, 1999. Female patient, 45 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: anorexia, cerebral haemorrhage, dehydration, thrombocytopenia. Gemtuzumab dosage: 9 MG PROTEIN/M2. Patient was hospitalized. Patient died on 12/16/1999.

Gemtuzumab Side Effects Report #4867128-3
Gemtuzumab side effect was reported by a Physician from FRANCE on Mar 10, 2002. Male patient, 40 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: aplasia, cerebral haemorrhage, coma, febrile neutropenia, haemorrhagic stroke, hyperthermia, malaise, thrombocytopenia, white blood cell count decreased. Gemtuzumab dosage: 9 MG/M (2) [18 MG] INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, ALIZAPRIDE, PIPERACILLIN W, CLORAZEPATE, COLISTIN, CISAPRIDE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #5259180-0
Gemtuzumab side effect was reported by a Physician from FRANCE 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 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 #5297246-X
Gemtuzumab side effect was reported by a Physician from BELGIUM 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 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 #5300878-3
Gemtuzumab side effect was reported by a Physician from FRANCE 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 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 #5520558-9
Gemtuzumab side effect was reported by a Physician from BELGIUM 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 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 #5573768-9
Gemtuzumab side effect was reported by a Physician from BELGIUM 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 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 #6084935-2
Gemtuzumab side effect was reported by a Physician from FRANCE on Feb 13, 2009. 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 side effects: cerebral haematoma, cerebral haemorrhage, disease progression, thrombocytopenia, treatment failure. Gemtuzumab dosage: 5 MG TOTAL DAILY. Patient was hospitalized. Patient died on 02/10/2009.

Gemtuzumab Side Effects Report #6086130-X
Gemtuzumab side effect was reported by a Physician from FRANCE on Feb 13, 2009. 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 side effects: cerebral haematoma, cerebral haemorrhage, disease progression, thrombocytopenia. Gemtuzumab dosage: 5 MG TOTAL DAILY. Patient was hospitalized. Patient died on 02/10/2009.


Gemtuzumab Side Effects Report #6099042-2
Gemtuzumab side effect was reported by a Physician from FRANCE on Feb 23, 2009. 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 side effects: cerebral haematoma, cerebral haemorrhage, disease progression, thrombocytopenia. Gemtuzumab dosage: 5 MG TOTAL DAILY. During the same period patient was treated with CYTARABINE, DAUNORUBICIN. Patient was hospitalized. Patient died on 02/10/2009.