Gemtuzumab and sepsis 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 #4686095-9
Gemtuzumab side effect was reported by a Consumer or non-health professional from on May 27, 2005. Female patient, 29 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: neutropenia, pyrexia, sepsis , staphylococcal infection , stomatitis. Gemtuzumab dosage: 6 MG 1X PER 1 DAY INTRAVENOUS. Patient was hospitalized. Patient recovered.

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 #4866971-4
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Mar 10, 2002. 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: beta haemolytic streptococcal infection, blood culture positive, bone marrow failure, nausea , pyrexia, sepsis , staphylococcal infection . Gemtuzumab dosage: 9 MG/M(2) INTRAVENOUS. Patient was hospitalized. Patient recovered.


Gemtuzumab Side Effects Report #4607267-5
Gemtuzumab side effect was reported by a Consumer or non-health professional from on Feb 28, 2005. Male patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cholestasis, cytolytic hepatitis, hepatotoxicity, multi-organ failure, oliguria, renal failure acute, sepsis , venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1X PER 1 CYC, INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKLIN, FORTUM, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #4867130-1
Gemtuzumab side effect was reported by a Physician from SWEDEN on Apr 13, 2002. Female patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: pharyngolaryngeal pain, sepsis . Gemtuzumab dosage: CYCLE 1 (02-NOV-98): 9 MG/M(2), CYCLE 2 (26-NOV-98): 9 MG/M(2) INTRAVENOUS. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #4869580-6
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Dec 22, 2005. Male patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cholestasis, cytolytic hepatitis, hepatotoxicity, multi-organ failure, refractoriness to platelet transfusion, renal failure acute, sepsis , venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1 PER 1 CYC INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKIN, FORTUM, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #6084947-9
Gemtuzumab side effect was reported by a Physician from CANADA on Feb 18, 2009. Male patient, 55 years of age, weighting 181.9 lb, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: multi-organ failure, pancytopenia, sepsis . Gemtuzumab dosage: TOTAL DOSE ADMINISTERED THIS COURSE: 12.4 MG. During the same period patient was treated with CYTARABINE, DAUNORUBICIN. Patient was hospitalized. Patient died on 02/07/2009.

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 #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 #5372242-2
Gemtuzumab side effect was reported by a Physician from ITALY 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 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 #5379193-8
Gemtuzumab side effect 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 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 #5509777-5
Gemtuzumab side effect was reported by a Physician from BELGIUM 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 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 #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 #5523082-2
Gemtuzumab side effect was reported by a Physician from BELGIUM 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 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 #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 #5643261-3
Gemtuzumab side effect 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 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 #5913969-0
Gemtuzumab side effect was reported by a Health Professional from JAPAN on Oct 02, 2008. Female patient was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: ileus paralytic, sepsis . Gemtuzumab dosage: unknown. Patient recovered.


Gemtuzumab Side Effects Report #4631147-2
Gemtuzumab side effect was reported by a Pharmacist from on Apr 07, 2005. Male patient, child 10 years of age, weighting 143.3 lb, was diagnosed with acute lymphocytic leukaemia, leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: ascites, fluid overload, hyperbilirubinaemia, hypotension, sepsis , transaminases increased, venoocclusive liver disease. Gemtuzumab dosage: 7.8 MG X 1 DOSE INTRAVENOU. During the same period patient was treated with ALEMTUZUMAB, MEROPENEM, VANCOMYCIN, METHYLPREDNISOLONE, PENTAMIDINE, AMBISOME, PROZAC. Patient recovered.

Gemtuzumab Side Effects Report #4891991-3
Gemtuzumab side effect was reported by a Pharmacist from UNITED STATES on Jan 24, 2006. Male patient, child 10 years of age, weighting 14.33 lb, was diagnosed with acute leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: blood bilirubin increased, fluid overload, hepatic function abnormal, sepsis , transaminases increased, venoocclusive liver disease, weight increased. Gemtuzumab dosage: 6 MG /M2 IV (1 DOSE). During the same period patient was treated with ALEMTUZUMAB. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #4785638-4
Gemtuzumab side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 23, 2005. Male patient, 49 years of age, was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: multi-organ failure, sepsis . Gemtuzumab dosage: unknown. During the same period patient was treated with DAUNORUBICIN, CYTARABINE, ETOPOSIDE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #4786854-8
Gemtuzumab side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 26, 2005. Male patient, 49 years of age, was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: multi-organ failure, pneumonia , sepsis . Gemtuzumab dosage: unknown. During the same period patient was treated with DAUNORUBICIN, CYTARABINE, ETOPOSIDE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #5270231-X
Gemtuzumab side effect 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 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.