Trisenox and acute promyelocytic leukaemia differentiation syndrome Patient Reports February 13, 2012

Trisenox Side Effects Report #5853357-9
Trisenox side effect was reported by a Health Professional from ITALY on Apr 26, 2007. Male patient, 76 years of age, weighting 169.8 lb, was diagnosed with myelodysplastic syndrome and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, atrial fibrillation , atrial flutter, cardiac failure congestive, dyspnoea, left ventricular hypertrophy, lung consolidation, mitral valve incompetence, pericardial effusion. Trisenox dosage: unknown. During the same period patient was treated with MAG, CALCIUM SANDOZ, ASPIRIN, GLIBOMET, OMEPRAZOLE, HUMALOG. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5853402-0
Trisenox side effect was reported by a Physician from ITALY on Feb 12, 2008. Female patient, 72 years of age, weighting 143.3 lb, was diagnosed with myelodysplastic syndrome and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, gastrointestinal toxicity, pleural effusion, pneumonia . Trisenox dosage: unknown. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5853387-7
Trisenox side effect was reported by a Physician from ITALY on Sept 04, 2007. Female patient, 67 years of age, weighting 145.5 lb, was diagnosed with myelodysplastic syndrome and was treated with Trisenox. After drug was administered, patient experienced the following side effects: acute promyelocytic leukaemia differentiation syndrome, atrial fibrillation , electrocardiogram qt prolonged, pleural effusion, pneumonia , weight increased. Trisenox dosage: unknown. During the same period patient was treated with AXAGON, SYLORIC, RAMIPRIL, GLIBOMET, INSULINE NPH. Patient was hospitalized. 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 #6016196-4
Trisenox side effect was reported by a Health Professional from JAPAN on Nov 13, 2008. Female 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: acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic function abnormal, pericardial effusion, pseudomembranous colitis. Trisenox dosage: 4.75 MG QD INTRAVENOUS DRIP. During the same period patient was treated with ANTITHROMBIN, INSULIN. Patient recovered.

Trisenox Side Effects Report #5518647-8
Trisenox side effect was reported by a Physician from JAPAN on Oct 29, 2007. Male patient, 61 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, multi-organ failure, ventricular tachycardia. Trisenox dosage: 8.85 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, TRETINOIN, GABEXATE MESILATE, CEFEPIME DIHYDROCHLORIDE, ITRACONAZOLE, DEXAMETHASONE PHOSPHATE. Patient was hospitalized. Patient died on 08/03/2007.

Trisenox Side Effects Report #5483251-7
Trisenox side effect was reported by a Physician from JAPAN on Sept 27, 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: acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, blood creatine phosphokinase increased, haemolysis, hepatic function abnormal, hyperglycaemia, renal impairment, retinoic acid syndrome. Trisenox dosage: 8.85 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, POTASSIUM SUPPLEMENT, GABEXATE MESILATE, CARPERITIDE, MICAFUNGIN. Patient recovered.

Trisenox Side Effects Report #5632251-2
Trisenox side effect was reported by a Physician from JAPAN on Jan 28, 2008. 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: acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine increased, blood lactate dehydrogenase increased, blood potassium decreased, dyspnoea, electrocardiogram qt prolonged. Trisenox dosage: 8.85 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, POTASSIUM SUPPLEMENT, GABEXATE MESILATE, CARPERITIDE, MICAFUNGIN. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5718737-0
Trisenox side effect was reported by a Physician from JAPAN on Apr 10, 2008. 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: acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, blood potassium decreased, blood urea increased, electrocardiogram qt prolonged, gamma-glutamyltransferase increased. Trisenox dosage: 8.85 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, POTASSIUM SUPPLEMENT, GABEXATE MESILATE, CARPERITIDE, MICAFUNGIN. Patient was hospitalized. Patient recovered.


Trisenox Side Effects Report #6108578-7
Trisenox side effect was reported by a Physician from UNITED KINGDOM on Feb 20, 2009. Female patient, 58 years of age, weighting 282.2 lb, 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. Trisenox dosage: 20 MG/KG QD INTRAVENOUS. During the same period patient was treated with TAZOCIN, VANCOMYCIN, SALBUTAMOL NEBULIZERS, ATROVENT, FUROSEMIDE, BUPRENORPHINE, TIOTROPIUM. Patient was hospitalized and became disabled. Patient recovered.

Trisenox Side Effects Report #5266132-3
Trisenox side effect was reported by a Physician from JAPAN on Feb 27, 2007. Female patient, 57 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, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, c-reactive protein increased, condition aggravated, disseminated intravascular coagulation. Trisenox dosage: unknown. During the same period patient was treated with CYTARABINE, IDARUBICIN, DANAPAROID, CARBAZOCHROME SULFONATE, TRANEXAMIC ACID, MONOAMMONIUM GLYCYRRHIZINATE. Patient died on 12/31/2006.

Trisenox Side Effects Report #5320868-4
Trisenox side effect was reported by a Physician from JAPAN on Apr 24, 2007. Male patient, 53 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, ascites, electrocardiogram qt corrected interval prolonged, electrocardiogram qt prolonged, neuropathy peripheral, pancytopenia, pleural effusion, respiratory failure, weight increased. Trisenox dosage: 8.25 MG QD INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN, FUROSEMIDE, DANAPAROID. Patient recovered.

Trisenox Side Effects Report #5679663-9
Trisenox side effect was reported by a Physician from JAPAN on Mar 07, 2008. Male patient, 53 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, ascites, blood calcium decreased, blood fibrinogen increased, blood potassium decreased, electrocardiogram qt prolonged, fibrin degradation products increased, lung disorder, neuropathy peripheral. Trisenox dosage: 8.25 MG QD INTRAVENOUS DRIP. During the same period patient was treated with FUROSEMIDE, IDARUBICIN, DANAPAROID, MEROPENEM TRIHYDRATE, CEFEPIME DIHYDROCHLORIDE, ISEPAMICIN SULPHATE, MICAFUNGIN. Patient recovered.

Trisenox Side Effects Report #5413103-X
Trisenox side effect was reported by a Consumer or non-health professional from JAPAN on July 09, 2007. Female patient, 51 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, pancytopenia. Trisenox dosage: unknown. Patient was hospitalized. Patient recovered.


Trisenox Side Effects Report #5642186-7
Trisenox side effect was reported by a Health Professional from UNITED STATES on Feb 12, 2008. Female patient, child 5 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, anorexia, hyperglycaemia, neuralgia, pneumonitis. Trisenox dosage: 0.15 MG/KG INTRAVENOUS DRIP. 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 #5817327-9
Trisenox side effect was reported by a Physician from JAPAN on July 01, 2008. Male patient, 42 years of age, weighting 133.8 lb, 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 potassium decreased, blood sodium decreased, hepatic function abnormal, hyperglycaemia, hyperuricaemia, hypoalbuminaemia, hypoproteinaemia. Trisenox dosage: 8.7 MG DAILY; INTRAVENOUS DRIP. During the same period patient was treated with IDARUBICIN HYDROCHLORIDE, LANSOPRAZOLE, ITRACONAZOLE. Patient recovered.

Trisenox Side Effects Report #5933636-7
Trisenox side effect was reported by a Physician from JAPAN on Oct 16, 2008. Male patient, 42 years of age, weighting 133.8 lb, 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, blood lactate dehydrogenase increased, cardiomegaly, gamma-glutamyltransferase increased, hyperglycaemia, hyperuricaemia, hypoalbuminaemia. Trisenox dosage: 8.7 MG QD INTRAVENOUS DRIP. During the same period patient was treated with DEXAMETHASONE PHOSPHATE, DEXAMETHASONE PHOSPHATE, DEXAMETHASONE PHOSPHATE, IDARUBICIN HYDROCHLORIDE, LANSOPRAZOLE, ITRACONAZOLE. Patient recovered.


Trisenox Side Effects Report #5175210-9
Trisenox side effect was reported by a Physician from JAPAN on Nov 22, 2006. 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, acute promyelocytic leukaemia differentiation syndrome, alanine aminotransferase increased, alopecia, aspartate aminotransferase increased, blood lactate dehydrogenase increased, c-reactive protein increased, electrocardiogram qt corrected interval prolonged, gamma-glutamyltransferase increased. Trisenox dosage: 8.978 MG QD INTRAVENOUS DRIP. During the same period patient was treated with MEXILETINE HYDROCHLORIDE, GRANISETRON. Patient recovered.

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.