Gemtuzumab and cerebral haemorrhage Patient Reports February 13, 2012

Gemtuzumab Side Effects Report #5225705-4
Gemtuzumab side effect was reported by a Consumer or non-health professional from BELGIUM on Jan 22, 2007. Female patient, 86 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, cerebrovascular accident, sepsis . Gemtuzumab dosage: 2.6 MG GIVEN AT LAST ADMINISTRATION; CUMULATIVE DOSE 14.3 MG. Patient died.

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 #4716985-X
Gemtuzumab side effect was reported by a Consumer or non-health professional from NETHERLANDS on July 06, 2005. 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, pneumonitis. Gemtuzumab dosage: unknown. During the same period patient was treated with MITOXANTRONE, CYTARABINE, ETOPOSIDE, VORICONAZOLE, ACYCLOVIR, VANCOMYCIN. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #4720227-9
Gemtuzumab side effect was reported by a Consumer or non-health professional from NETHERLANDS on July 06, 2005. 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, pneumonitis, streptococcal bacteraemia. Gemtuzumab dosage: unknown. During the same period patient was treated with MITOXANTRONE, CYTARABINE, VORICONAZOLE, ACYCLOVIR, VANCOMYCIN. Patient was hospitalized. Patient died.


Gemtuzumab Side Effects Report #5014443-9
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on May 18, 2006. Male 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: cerebral haemorrhage, meningorrhagia. Gemtuzumab dosage: unknown. Patient died.

Gemtuzumab Side Effects Report #5013873-9
Gemtuzumab side effect was reported by a Health Professional from FRANCE on May 19, 2006. Male patient, 68 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, meningorrhagia. Gemtuzumab dosage: unknown. Patient died.

Gemtuzumab Side Effects Report #5016924-0
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on May 18, 2006. Male patient, 68 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, meningorrhagia. Gemtuzumab dosage: unknown. Patient died.

Gemtuzumab Side Effects Report #4799898-7
Gemtuzumab side effect was reported by a Consumer or non-health professional from JAPAN on Sept 30, 2005. Female patient, 64 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blast cells present, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, cerebral haemorrhage, disseminated intravascular coagulation, gamma-glutamyltransferase increased, haematocrit decreased. Gemtuzumab dosage: 13.5 MG 1X PER 1 DAY INTRAVENOUS DRIP. During the same period patient was treated with MEROPEN, FUNGIZONE, VANCOMYCIN, MINOPHAGEN C, SOLCOSERYL, PRIMPERAN, FAMOTIDINE, VISCORIN. Patient died.

Gemtuzumab Side Effects Report #4866417-6
Gemtuzumab side effect was reported by a Consumer or non-health professional from JAPAN on Dec 13, 2005. Female patient, 64 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: activated partial thromboplastin time prolonged, alanine aminotransferase increased, aspartate aminotransferase increased, blast cell count increased, blood lactate dehydrogenase increased, c-reactive protein increased, cerebral haemorrhage, chills, gamma-glutamyltransferase increased. Gemtuzumab dosage: 13.5 MG 1X PER 1 DAY. During the same period patient was treated with MEROPEN, FUNGIZONE, VANCOMYCIN, MINOPHAGEN C, SOLCOSERYL, PRIMPERAN, FAMOTIDINE, VISCORIN. Patient died.


Gemtuzumab Side Effects Report #4721938-1
Gemtuzumab side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on July 08, 2005. Female patient, 48 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, convulsion, hydrocephalus . Gemtuzumab dosage: unknown. During the same period patient was treated with AMSACRINE, CYTARABINE, ETOPOSIDE. Patient recovered.

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 #4867032-0
Gemtuzumab side effect was reported by a Health Professional from GERMANY on Mar 10, 2002. Female patient, 44 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 respiratory failure, bone marrow failure, cerebral haemorrhage, epistaxis, haemorrhage intracranial, herpes simplex , mouth haemorrhage, petechiae. Gemtuzumab dosage: 9 MG/M^ 1X PER 1 DOS INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient was hospitalized. Patient died.

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 #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.

Gemtuzumab Side Effects Report #5258283-4
Gemtuzumab side effect 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 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 #5078153-4
Gemtuzumab side effect was reported by a Consumer or non-health professional from BELGIUM on Aug 02, 2006. Female patient, 44 years of age, was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, coma. Gemtuzumab dosage: 7 MG 1X PER 1 DAY. During the same period patient was treated with CYTARABINE, IDARUBICIN, DIFLUCAN, CHLORPROMAZINE, AMINOMIX. Patient died.