Gemtuzumab and multi-organ failure Patient Reports February 13, 2012

Gemtuzumab Side Effects Report #4911216-X
Gemtuzumab side effect was reported by a Consumer or non-health professional from GERMANY on June 27, 2003. Female 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: acute myeloid leukaemia, bone pain, candidiasis, condition aggravated, fungal infection , hypertension, multi-organ failure, oedema peripheral, pleural effusion. Gemtuzumab dosage: 6 MG/M^2 1X PER 1 DAY, INTRAVENOUS. During the same period patient was treated with CYTARABINE, VANCOMYCIN, SPORANOX. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #5000025-1
Gemtuzumab side effect was reported by a Consumer or non-health professional from NETHERLANDS on Apr 28, 2006. Female patient, 58 years of age, was diagnosed with myelodysplastic syndrome and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: infection , multi-organ failure, respiratory failure. Gemtuzumab dosage: 5 MG/M2 FOR ONE DAY ON DAY 7. During the same period patient was treated with CYTARABINE, IDARUBICIN. Patient died.

Gemtuzumab Side Effects Report #5270233-3
Gemtuzumab side effect 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 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 #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 #5196120-7
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Dec 20, 2006. 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, renal failure acute, venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1X PER 1 CYC INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKIN, CEFTAZIDIME PENTAHYDRATE, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #4579955-0
Gemtuzumab side effect was reported by a Consumer or non-health professional from on Feb 02, 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: multi-organ failure, renal failure acute, venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKLIN, FORTUM, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #4603388-1
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: ascites, cholestasis, cytolytic hepatitis, hepatomegaly, hepatotoxicity, multi-organ failure, oliguria, renal failure acute, sepsis . Gemtuzumab dosage: 4.8 MG 1X PER 1 CYC. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKLIN, FORTUM, VANCOMYCIN. Patient died.


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 #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 #5293573-0
Gemtuzumab side effect was reported by a Physician from FRANCE 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 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 #4911213-4
Gemtuzumab side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Dec 01, 2003. Male patient, 34 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, cardiovascular disorder, hepatic vein thrombosis, hepatorenal failure, liver disorder, multi-organ failure, pneumonia fungal, respiratory disorder, venoocclusive liver disease. Gemtuzumab dosage: 18 MG ONE TIME PER ONE DOSE, INTRAVENOUS. During the same period patient was treated with AMPHOTERICIN B, CYCLIZINE, AMILORIDE, AMBISOME, PENTAMIDINE, DAUNORUBUCIN, SALBUTAMOL, CHLORPHENAMINE. Patient was hospitalized. Patient died.


Gemtuzumab Side Effects Report #5277131-X
Gemtuzumab side effect was reported by a Physician from BELGIUM 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 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.

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 #5380944-7
Gemtuzumab side effect was reported by a Physician from ITALY 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 side effects: acute respiratory distress syndrome, multi-organ failure, septic shock. Gemtuzumab dosage: unknown. Patient died on 06/25/2007.

Gemtuzumab Side Effects Report #5573367-9
Gemtuzumab side effect 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 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 #5591881-7
Gemtuzumab side effect was reported by a Physician from ITALY 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 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 #5608972-4
Gemtuzumab side effect 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 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
Gemtuzumab side effect 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 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 #5660736-1
Gemtuzumab side effect was reported by a Physician from ITALY 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 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 #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.