Gemtuzumab and aplasia Patient Reports February 13, 2012

Gemtuzumab Side Effects Report #5819510-5
Gemtuzumab side effect was reported by a Physician from FRANCE on July 18, 2008. Female patient, 65 years of age, was diagnosed with leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: aplasia, colitis, hepatic fibrosis, hepatic steatosis, sepsis , venoocclusive liver disease. Gemtuzumab dosage: unknown. During the same period patient was treated with ARACYTINE, DAUNORUBICIN. 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 #5019632-5
Gemtuzumab side effect was reported by a Consumer or non-health professional from ITALY on May 20, 2006. Male patient, 71 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, aspergillosis, bone marrow disorder, disease progression, fungal infection , lung infiltration, mouth haemorrhage, oral fungal infection, skin necrosis. Gemtuzumab dosage: 10 MG 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, NOVANTRONE, AMPHOTERICIN B. 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 #4867026-5
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Mar 10, 2002. Male 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: aplasia, blast cell count increased, chills, haemoglobin decreased, leukopenia, neutrophil count decreased, neutrophil percentage decreased, pyrexia, thrombocytopenia. Gemtuzumab dosage: 9 MG/M2 INTRAVENOUS. Patient was hospitalized. Patient recovered.

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 #5338594-4
Gemtuzumab side effect was reported by a Physician from ITALY 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 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 #5533310-5
Gemtuzumab side effect 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 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 #5557936-8
Gemtuzumab side effect was reported by a Physician from ITALY 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 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 #4713087-3
Gemtuzumab side effect was reported by a Consumer or non-health professional from GERMANY on June 28, 2005. Female patient was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: aplasia. Gemtuzumab dosage: unknown. Patient recovered.

Gemtuzumab Side Effects Report #4724253-5
Gemtuzumab side effect was reported by a Health Professional from GERMANY on July 14, 2005. Female patient was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: aplasia, stem cell transplant. Gemtuzumab dosage: 6 MG/M^2 1X PER 1 DAY 21 DAYS BEFORE ALLOGENEIC TRANSPLANTATION. Patient recovered.