Trisenox and leukocytosis Patient Reports February 13, 2012

Trisenox Side Effects Report #5768221-3
Trisenox side effect was reported by a Physician from JAPAN on May 26, 2008. Male patient, 85 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, diarrhoea, electrocardiogram qt prolonged, hepatic function abnormal, hyperglycaemia, leukocytosis, pleural effusion, pneumonia . Trisenox dosage: 8.4 MG DAILY INTRAVENOUS. During the same period patient was treated with GABAXATE MESILATE. Patient recovered.

Trisenox Side Effects Report #6073095-X
Trisenox side effect was reported by a Physician from JAPAN on Jan 28, 2009. Male patient, 85 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, blood lactate dehydrogenase increased, diarrhoea, electrocardiogram qt prolonged, gamma-glutamyltransferase increased, hyperglycaemia, leukocytosis, leukopenia. Trisenox dosage: 8.4 MG DAILY INTRAVENOUS. During the same period patient was treated with GABEXATE MESILATE. Patient recovered.

Trisenox Side Effects Report #6115920-X
Trisenox side effect was reported by a Physician from JAPAN on Feb 27, 2009. Female patient, 81 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: cholecystitis, disseminated intravascular coagulation, hyperkalaemia, hypokalaemia, leukocytosis. Trisenox dosage: 6.225 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN HYDROCHLORIDE, PAZUFLOXACIN MESILATE, IMIPENEM AND CILASTATIN, MICAFUNGIN, CIPROFLOXACIN, TEICOPLANIN. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5325380-4
Trisenox side effect was reported by a Physician from JAPAN on Apr 26, 2007. Female patient, 73 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: altered state of consciousness, blood bilirubin increased, cerebral haemorrhage, condition aggravated, dialysis , disseminated intravascular coagulation, hyperglycaemia, leukocytosis, pulmonary haemorrhage. Trisenox dosage: 7.62 MG QD INTRAVENOUS DRIP. During the same period patient was treated with ETOPOSIDE, TEICOPLANIN, NAFAMOSTAT MESILATE, MICONAZOLE, HYDROCORTISONE SUCCINATE, FAMOTIDINE. Patient died on 11/09/2005.


Trisenox Side Effects Report #4569722-6
Trisenox side effect was reported by a Health Professional from on Dec 21, 2004. Male patient, 66 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: body temperature increased, disseminated intravascular coagulation, dyspnoea, electrocardiogram qt prolonged, leukocytosis, ventricular tachycardia. Trisenox dosage: 0.15MG/KG (QD), INTRAVENOUS. Patient recovered.

Trisenox Side Effects Report #4661118-1
Trisenox side effect was reported by a Physician from on Apr 26, 2005. Male patient, 66 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: body temperature increased, disseminated intravascular coagulation, dyspnoea, electrocardiogram qt corrected interval prolonged, leukocytosis, platelet count decreased, ventricular tachycardia, white blood cell count decreased. Trisenox dosage: unknown. During the same period patient was treated with NAFAMOSTAT, MAGNESIUM SULPHATE. Patient recovered.

Trisenox Side Effects Report #5390028-X
Trisenox side effect was reported by a Physician from JAPAN on July 05, 2007. Female patient, 65 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, leukocytosis. Trisenox dosage: 8.76 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, DANAPAROID. Patient died on 04/28/2007.

Trisenox Side Effects Report #5397293-3
Trisenox side effect was reported by a Physician from JAPAN on July 09, 2007. Female patient, 65 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: blood lactate dehydrogenase increased, cerebral haemorrhage, disseminated intravascular coagulation, hypokalaemia, leukocytosis. Trisenox dosage: 8.75 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, DANAPAROID. Patient died on 04/28/2007.

Trisenox Side Effects Report #5087026-2
Trisenox side effect was reported by a Physician from JAPAN on Aug 09, 2006. Male patient, 63 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: blood lactate dehydrogenase increased, disease progression, disseminated intravascular coagulation, fibrin degradation products increased, leukocytosis, putamen haemorrhage. Trisenox dosage: 8.025 MG QD INTRAVENOUS DRIP. During the same period patient was treated with DALTEPARIN SODIM, FAMOTIDINE, BROTIZOLAM, CARBAZOCHROME SULFONATE, TRANEXAMIC ACID, BICARBONATE. Patient died on 12/26/2005.


Trisenox Side Effects Report #5142705-3
Trisenox side effect was reported by a Physician from JAPAN on Oct 17, 2006. Male patient, 63 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: blood fibrinogen decreased, blood lactate dehydrogenase increased, disease progression, disseminated intravascular coagulation, fibrin degradation products increased, leukocytosis, prothrombin time prolonged. Trisenox dosage: 8.025 MG Q72HR INTRAVENOUS DRIP. During the same period patient was treated with DALTEPARIN, FAMOTIDINE, BROTIZOLAM, CARBAZOCHROME SULFONATE, TRANEXAMIC ACID, BICARBONATE. Patient died on 12/26/2005.

Trisenox Side Effects Report #4716462-6
Trisenox side effect was reported by a Physician from JAPAN on July 05, 2005. Male patient, 63 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: depressed level of consciousness, disseminated intravascular coagulation, electrocardiogram qt corrected interval prolonged, hypocalcaemia, hyponatraemia, leukocytosis, nervous system disorder, restlessness. Trisenox dosage: unknown. During the same period patient was treated with DAUNORUBICIN HYDROCHLORIDE, ITRACONAZOLE, SULFAMETHOXAZOLE, DALTEPARIN, METHOTREXATE, CYTARABINE, DEXAMETHASONE PHOSPHATE. Patient recovered.

Trisenox Side Effects Report #5220983-X
Trisenox side effect was reported by a Physician from JAPAN on Jan 09, 2007. Female patient, 62 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, condition aggravated, gamma-glutamyltransferase increased, hepatic function abnormal, leukocytosis. Trisenox dosage: 8.19 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN HDYROCHLORIDE, CYTARABINE, DANAPAROID. Patient recovered.

Trisenox Side Effects Report #4638293-8
Trisenox side effect was reported by a Physician from on Mar 14, 2005. Female patient, 52 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: basophilia, electrocardiogram qt corrected interval prolonged, leukocytosis, pyrexia. Trisenox dosage: unknown. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #4848006-2
Trisenox side effect was reported by a Physician from JAPAN on Aug 24, 2005. Female patient, 52 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: basophilia, electrocardiogram qt corrected interval prolonged, leukocytosis, pyrexia. Trisenox dosage: 9.52 MG QD INTRAVENOUS DRIP. During the same period patient was treated with INSULIN, SPIRONOLACTONE, LANSOPRAZOLE, LEVOFLOXACIN, TAZOBACTAM, VANCOMYCIN HYDROCHLORIDE. Patient was hospitalized. Patient recovered.


Trisenox Side Effects Report #5084863-5
Trisenox side effect was reported by a Physician from JAPAN on July 31, 2006. Male patient, 50 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia, condition aggravated, headache , leukaemic infiltration brain, leukocytosis, myalgia, promyelocyte count increased, pyrexia, subarachnoid haemorrhage. Trisenox dosage: 11.692 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN. Patient recovered.

Trisenox Side Effects Report #6084441-5
Trisenox side effect was reported by a Physician from JAPAN on Feb 05, 2009. Male patient, 46 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, electrocardiogram qt prolonged, febrile neutropenia, leukocytosis, pleural effusion, renal impairment, respiratory disorder, sepsis , septic shock. Trisenox dosage: 11 MG QD INTRAVENOUS DRIP. Patient died on 01/30/2009.

Trisenox Side Effects Report #6106670-4
Trisenox side effect was reported by a Physician from JAPAN on Feb 17, 2009. Male patient, 46 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, electrocardiogram qt prolonged, febrile neutropenia, leukocytosis, neutrophil count decreased, pleural effusion, renal impairment, respiratory disorder, septic shock. Trisenox dosage: 11 MG QD, INTRAVENOUS DRIP. During the same period patient was treated with AMPHOTERICIN B, AMPHOTERICIN B, IDARUBICIN HYDROCHLORIDE, ITRACONAZOLE, POTASSIUM CHLORIDE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, SENNOSIDE. Patient died on 01/30/2009.

Trisenox Side Effects Report #4892030-0
Trisenox side effect was reported by a Physician from JAPAN on Jan 10, 2006. Female patient, 41 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: condition aggravated, disseminated intravascular coagulation, leukocytosis, leukopenia. Trisenox dosage: 7.32 MG QD INTRAVENOUS DRIP. Patient recovered.

Trisenox Side Effects Report #4903384-0
Trisenox side effect was reported by a Physician from JAPAN on Jan 25, 2006. Female patient, 41 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: condition aggravated, disseminated intravascular coagulation, leukocytosis, leukopenia. Trisenox dosage: 7.32 MG QD INTRAVENOUS DRIP. During the same period patient was treated with FAMOTIDINE, HEPARIN, IDARUBICIN, FUROSEMIDE. Patient was hospitalized. Patient recovered.


Trisenox Side Effects Report #5301086-2
Trisenox side effect was reported by a Physician from JAPAN on Mar 26, 2007. Female patient, 37 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: accelerated idioventricular rhythm, alanine aminotransferase increased, alopecia, aspartate aminotransferase increased, c-reactive protein increased, electrocardiogram qt corrected interval prolonged, gamma-glutamyltransferase increased, leukocytosis, nausea . Trisenox dosage: 8.978 MG QD INTRAVENOUS DRIP. During the same period patient was treated with MEXILETINE HYDROCHLORIDE, GRANISETRN HYDROCHLORIDE. Patient recovered.

Trisenox Side Effects Report #4747967-X
Trisenox side effect was reported by a Physician from JAPAN on July 26, 2005. Female patient, 33 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, disseminated intravascular coagulation, leukocytosis, nystagmus. Trisenox dosage: 9 MG (9 MG), IVI. During the same period patient was treated with MEROPENEM, AMIKACIN, LEVOFLOXACIN. Patient died.

Trisenox Side Effects Report #5497267-8
Trisenox side effect was reported by a Physician from JAPAN on Oct 10, 2007. Female patient, 27 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, aspartate aminotransferase increased, electrocardiogram qt prolonged, haemoglobin decreased, hepatic function abnormal, hypokalaemia, leukocytosis, platelet count decreased. Trisenox dosage: 7.8 MG QD INTRAVENOUS DRIP. During the same period patient was treated with ELECTROLYTE, IDARUBICIN, PANIPENEM, AMIKACIN SULPHATE, MICAFUNGIN, ABREKACIN SULPHATE, MEROPENEM HYDRATE. Patient recovered.

Trisenox Side Effects Report #5525457-4
Trisenox side effect was reported by a Physician from JAPAN on Nov 05, 2007. Female patient, 27 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, aspartate aminotransferase increased, electrocardiogram qt prolonged, haemoglobin decreased, hepatic function abnormal, hypokalaemia, leukocytosis, platelet count decreased. Trisenox dosage: 7.8 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, PANIPENEM, AMIKACIN SULPHATE, MICAFUNGIN, ARBEKACIN SULPHATE, MEROPENEM HYDRATE. Patient recovered.

Trisenox Side Effects Report #5688096-0
Trisenox side effect was reported by a Health Professional from UNITED STATES on Mar 14, 2008. Female patient was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: haemorrhage intracranial, leukocytosis. Trisenox dosage: 0.15 MG/KG 5 DAYS/WEEK QD INTRAVENOUS. During the same period patient was treated with METHOTREXATE, HYDROCORTISONE, CYTARABINE. Patient was hospitalized. Patient recovered.