Trisenox and disseminated intravascular coagulation Patient Reports February 13, 2012

Trisenox Side Effects Report #5235169-2
Trisenox side effect was reported by a Physician from JAPAN on Jan 24, 2007. 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: concomitant disease aggravated, disseminated intravascular coagulation, respiratory distress, sepsis . Trisenox dosage: 5 MG QD INTRAVENOUS DRIP. During the same period patient was treated with GABEXATE MESILATE, DANAPAROID, FUROSEMIDE, SPIRONOLACTONE, NICORANDIL, AMLODIPINE BESYLATE, FAMOTIDINE, ALLOPURINOL. Patient died on 11/10/2006.

Trisenox Side Effects Report #5245997-5
Trisenox side effect was reported by a Physician from JAPAN on Feb 02, 2007. Female 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, condition aggravated, disseminated intravascular coagulation, respiratory distress, sepsis . Trisenox dosage: 5 MG QD INTRAVENOUS DRIP. During the same period patient was treated with GABEXATE MESILATE, DANAPAROID, FUROSEMIDE, SPIRONOLACTONE, NICORANDIL, AMLODIPNE BESILATE, FAMOTIDINE, ALLOPURINOL. Patient recovered.

Trisenox Side Effects Report #5047197-0
Trisenox side effect was reported by a Physician from JAPAN on June 21, 2006. Female patient, 84 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: c-reactive protein increased, disseminated intravascular coagulation, haemoglobin decreased, hypokalaemia, malignant neoplasm progression, platelet count decreased, renal failure, respiratory failure. Trisenox dosage: 4.1 MG QD, INTRAVENOUS DRIP. During the same period patient was treated with FUROSEMIDE, MEXILETINE HYDROCHLORIDE, NIFEDIPINE, NIZATIDINE, INSULIN. Patient was hospitalized. 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 #5320876-3
Trisenox side effect was reported by a Physician from JAPAN on Apr 24, 2007. Male 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: acute promyelocytic leukaemia, cerebral haemorrhage, cheilitis, chills, condition aggravated, disseminated intravascular coagulation, hyperhidrosis, pyrexia, rash . Trisenox dosage: 9.075 MG QD INTRAVENOUS DRIP. During the same period patient was treated with FAMOTIDINE, CANDESARTAN CILEXETIL, MEROPENEM TRIHYDRATE, LENOGRASTIM. Patient was hospitalized. Patient died on 03/22/2007.

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 #4609440-9
Trisenox side effect was reported by a Health Professional from on Feb 21, 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: disseminated intravascular coagulation, electrocardiogram qt prolonged, retinoic acid syndrome, 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 #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 #5116822-8
Trisenox side effect was reported by a Physician from JAPAN on Sept 08, 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: activated partial thromboplastin time prolonged, blood fibrinogen decreased, blood lactate dehydrogenase increased, cerebral haemorrhage, depressed level of consciousness, disease progression, disseminated intravascular coagulation, fibrin degradation products increased, leukocytosis. 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 #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 #4732834-8
Trisenox side effect was reported by a Physician from JAPAN on July 12, 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: central nervous system lesion, condition aggravated, depressed level of consciousness, disseminated intravascular coagulation, electrocardiogram qt corrected interval prolonged, electrocardiogram qt prolonged, hypocalcaemia, hyponatraemia, leukocytosis. Trisenox dosage: unknown. During the same period patient was treated with DAUNORUBICIN HYDROCHLORIDE, ITRACONAZOLE, SULFAMETHOXAZOLE, DALTEPARIN, METHOTREXATE, CYTARABINE. Patient recovered.

Trisenox Side Effects Report #5084861-1
Trisenox side effect was reported by a Physician from JAPAN on Aug 01, 2006. Male patient, 58 years of age, weighting 132.3 lb, 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, hyperglycaemia, oliguria, weight increased. Trisenox dosage: 9 MG QD INTRAVENOUS DRIP. During the same period patient was treated with GABEXATE MESILATE, DANAPAROID, FUROSEMIDE. Patient was hospitalized. Patient died on 05/16/2006.

Trisenox Side Effects Report #5125019-7
Trisenox side effect was reported by a Physician from JAPAN on Sept 22, 2006. Male patient, 58 years of age, weighting 132.3 lb, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, blood bilirubin increased, cerebral haemorrhage, condition aggravated, disseminated intravascular coagulation, hepatic function abnormal, hypercalcaemia, hyperglycaemia, hyponatraemia. Trisenox dosage: 9 MG QD INTRAVENOUS DRIP. During the same period patient was treated with GABEXATE MESILATE, DANAPAROID, FUROSEMIDE, VORICONAZOLE, SULFAMETHOXAZOLE. Patient was hospitalized. Patient died on 05/16/2006.

Trisenox Side Effects Report #5179504-2
Trisenox side effect was reported by a Physician from JAPAN on Nov 30, 2006. Male patient, 58 years of age, weighting 132.3 lb, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, blood bilirubin increased, cerebral haemorrhage, condition aggravated, disseminated intravascular coagulation, febrile neutropenia, fungal infection , hepatic function abnormal, hypercalcaemia. Trisenox dosage: 9 MG QD INTRAVENOUS DRIP. During the same period patient was treated with GABEXATE MESILATE, DANAPAROID, FUROSEMIDE, VORICONAZOLE, SULFAMETHOXAZOLE W. Patient was hospitalized. Patient died on 05/16/2006.

Trisenox Side Effects Report #5197209-9
Trisenox side effect was reported by a Physician from JAPAN on Dec 12, 2006. Male patient, 58 years of age, weighting 132.3 lb, was diagnosed with acute promyelocytic leukaemia and was treated with Trisenox. After drug was administered, patient experienced the following side effects: cerebral haemorrhage, condition aggravated, disseminated intravascular coagulation, febrile neutropenia, fungal infection , hypercalcaemia, hyperglycaemia, hyponatraemia, oliguria. Trisenox dosage: 9 MG QD INTRAVENOUS DRIP. During the same period patient was treated with GABEXATE MESILATE, DANAPAROID, FUROSEMIDE, VORICONAZOLE, SULFAMETHOXAZOLE. Patient was hospitalized. Patient died on 05/16/2006.


Trisenox Side Effects Report #5401990-0
Trisenox side effect was reported by a Physician from JAPAN on July 10, 2007. Female patient, 58 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, aspartate aminotransferase increased, back pain , bone pain, disseminated intravascular coagulation, electrocardiogram qt prolonged, hypercalcaemia, hyperglycaemia, hyperkalaemia. Trisenox dosage: 7.5 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, NAFAMOSTAT MESILATE, GLUCOSE W, ELECTROLYTE, PARENTERAL FLUID OF HIGH, INSULIN. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5408384-2
Trisenox side effect was reported by a Physician from JAPAN on July 25, 2007. Female patient, 58 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, aspartate aminotransferase increased, back disorder, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, bone pain, disseminated intravascular coagulation, electrocardiogram qt prolonged, gamma-glutamyltransferase increased. Trisenox dosage: 7.245 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, NAFAMOSTAT MESILATE, GLUCOSE W, ELECTROLYTE, PARENTERAL FLUID OF HIGH, INSULIN. Patient recovered.

Trisenox Side Effects Report #4603180-8
Trisenox side effect was reported by a Physician from on Feb 16, 2005. Female patient, 54 years of age, was diagnosed with acute promyelocytic leukaemia, infection prophylaxis and was treated with Trisenox. After drug was administered, patient experienced the following side effects: chest pain , disseminated intravascular coagulation, interstitial lung disease, pleural effusion, retinoic acid syndrome, white blood cell count increased. Trisenox dosage: unknown. During the same period patient was treated with NEUPOGEN, AMPHOTERICIN B, POLYMYXIN B SULPHATE. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5844627-9
Trisenox side effect was reported by a Physician from JAPAN on July 28, 2008. Male patient, 49 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 albumin decreased, blood alkaline phosphatase increased, blood calcium decreased, blood cholesterol decreased, blood creatine phosphokinase decreased, blood sodium decreased, disseminated intravascular coagulation, electrocardiogram qt prolonged, hyperglycaemia. Trisenox dosage: 9.15 MG DAILY INTRAVENOUS DRIP. During the same period patient was treated with MAGNESIUM SULPHATE, CALCIUM, GABEXATE MESILATE, HYDROCORTISONE SUCCINATE, TOBRAMYCIN, CIPROFLOXACIN, MEROPENEM TRIHYDRATE, HALOPERIDOL. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5886835-7
Trisenox side effect was reported by a Physician from JAPAN on Sept 03, 2008. Male patient, 49 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 albumin decreased, blood alkaline phosphatase increased, blood calcium decreased, blood cholesterol decreased, blood creatine phosphokinase decreased, blood sodium decreased, disseminated intravascular coagulation, electrocardiogram qt prolonged, hyperglycaemia. Trisenox dosage: 9.15 MG DAILY INTRAVENOUS DRIP. During the same period patient was treated with MAGNESIUM SULPHATE, CALCIUM GLUCONATE, GABEXATE MESILATE, HYDROCORTISONE SUCCINATE, TOBRAMYCIN, CIPROFLOXACIN, MEROPENEM TRIHYDRATE, HALOPERIDOL. Patient was hospitalized. Patient recovered.


Trisenox Side Effects Report #6115919-3
Trisenox side effect was reported by a Physician from JAPAN on Feb 26, 2009. Male patient, 48 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 albumin decreased, blood alkaline phosphatase increased, blood calcium decreased, blood cholesterol decreased, blood creatine phosphokinase decreased, blood sodium decreased, colon cancer, disseminated intravascular coagulation, electrocardiogram qt prolonged. Trisenox dosage: 9.15 MG DAILY INTRAVENOUS DRIP. During the same period patient was treated with MAGNESIUM SULPHATE, CALCIUM, GABEXATE MESILATE, HYDROCORTISONE SUCCINATE, TOBRAMYCIN, CIPROFLOXACIN, MEROPENEM TRIHYDRATE, HALOPERIDOL. Patient was hospitalized. Patient died on 08/27/2007.

Trisenox Side Effects Report #6121941-3
Trisenox side effect was reported by a Physician from JAPAN on Feb 26, 2009. Male patient, 48 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 albumin decreased, blood alkaline phosphatase increased, blood calcium decreased, blood cholesterol decreased, blood creatine phosphokinase decreased, blood sodium decreased, disseminated intravascular coagulation, electrocardiogram qt prolonged, hyperglycaemia. Trisenox dosage: unknown. During the same period patient was treated with MAGNESIUM SULPHATE, CALCIUM, GABEXATE MESILATE, HYDROCORTISONE SUCCINATE, TOBRAMYCIN, CIPROFLOXACIN, MEROPENEM, HALOPERIDOL. Patient was hospitalized. Patient died on 08/27/2007.

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 #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.